Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-5241EnglishN2022September24Healthcare
Coronavirus Diseases (covid -19) and Mucormycosis: A Mini-Review
English0104Chakraborty ArindamEnglishhttps://doi.org/10.31782/IJCRR.2022.141801
Introduction: Mucormycosis is an opportunistic infection emerging as a major public health problem during the COVID-19 pandemic. Predisposing factors such as Diabetes mellitus (DM) as well as use of corticosteroids in COVID-19 patients act as a key role for the surge of the disease. However, the epidemiological factors, site of the infections, demographic details, morbidity and mortality of the patients were not well documented, so we undertook the study to review the published original articles, case series, and case report on mucormycosis associated with COVID-19 with predisposing factors such as DM and the use of corticosteroids, Methods: On analysis of 30 articles from India as well as from other countries. Results: After analysis of the available data, it was found that mucormycosis is predominantly seen in males in the age of 50±5. The common site of the infection was rhino-orbital mucormycosis followed by rhino orbital cerebral. Pre-existing DM was the most significant risk factor followed by corticosteroid treatment along with hospitals supplying oxygen to patients. The hospital environment also play a significant role for the sudden rise of the disease. Conclusion: To overcome this severe situation in the future, there is a need to maintain optimal hyperglycemia in the population, avoid overuse of corticosteroids, and proper hospital infection control (HIC) program in order to reduce the burden of fatal mucormycosis.
EnglishMucormycosis, COVID-19, Diabetes Mellitus, Corticosteroid, HIC, Oxygen
Introduction:
Severe acute respiratory syndrome Coronavirus -2 (SARS-CoV-2) Infections has been associated with a wide range of opportunistic infection. 1Bacterial, as well as fungal infections, were reported in patients with coronaviral diseases. Mucormycosis one such opportunistic infection which shows sudden rise in covid 19-second wave in India.2 There are several mechanisms that appears to be facilitating Mucorales spores to germinate in people with COVID-19 is an environment of low oxygen (hypoxia), diabetes high glucose (diabetes, metabolic acidosis, diabetic keto-acidosis [DKA]), high iron levels (increased ferritins) and decreased phagocytic activity of white blood cells (WBC) due to immunosuppression (SARS-CoV-2 mediated, steroid-mediated or background co-morbidities) along with several other shared risk factors including prolonged hospitalization with or without mechanical ventilators. 3
It has been found that the prevalence of mucormycosis is nearly 80 times higher in India in compare with other developed countries in COVID 19 era this might be due to the presence of highest number of diabetic patients in Indian population with this long-term use of corticosteroids were also considered as important risk factor for the sudden spike of mucormycosis in Indian population.3,4,5,6
These findings need to be re-look in the context of COVID19 pandemic hence we conduct a systemic review of published case report/ case series of mucormycosis in people with COVID19 who have DM and are treated with corticosteroids.
Methods:
A systematic literature search of Medline, PubMed, and Google Scholar was done using the term “COVID-19 and Mucormycosis, SARS COV-2 and Mucormycosis, Zygomycosis, Phycomycosis, Mucorales, COVID-19 and Diabetes mellitus. On the basis of title and available abstract, articles were included for the selected topics. For the study only those articles have included their abstracts in English. Of the published articles, 38 original articles and 12 reviewed were excluded in which studies were mainly focused on COVID 19 and mucormycosis.
Overall30original articles/case report was found in Medline, PubMed, and Google Scholar. Of the total of 30 articles 14 were from India where overall 75 mucormycosis cases were documented.
Diabetic mellitusand corticosteroid as risk factors:
Sharmaet al. studied mucormycosis cases in COVID 19 patients where they found 21 patients were diabetic and all the patients were under Steroid treatment, on analysis of the prognosis they have found all of them were recovered from COVID 19 as well as mucormycosis.7
Yet in another study by Moorthyetal. from Bangalore of 17 COVID 19 patients with mucormycosis found 15 patients were diabetic and also under steroid treatment. The mortality rate was 40% which were high in comparison to other studies.8
Another study in Iran by Pakdel F et al. was reported fifteen cases of rhino-orbital mucormycosis in COVID-19 patients. The median age of patients was 52 years (range 14-71) and 66% were male. The median interval time between COVID-19 disease and diagnosis of mucormycosis was seven (range: 1-37) days. Among all, 13 patients (86%) had diabetes mellitus, while 7 patients (46.6%) previously received intravenous corticosteroid therapy. Five patients (33%) underwent orbital exenteration, while seven (47%) patients died from mucormycosis. Six patients (40%) received combined anti-fungal therapy and none that received combined anti-fungal therapy died.9
Another study in USA by Dallalzadehetal. reported one confirm cases of mucormycosis in COVID-19 patients with DM and Steroid were act as an important risk factor. 10
There were many other case studies/ series from India reported that Diabetic mellitus and Steroid treatment were two important risk factors of mucormycosis in COVID 19 infected patients which all are summarize in table 1.
On analysis of the pooled data from all the studies showed mucormycosis was predominantly seen in males and mean age were 50±5years, the common site of the infection was rhino-orbital mucormycosis followed by rhino orbito cerebral. Pre-existing DM was the most significant risk factors followed by corticosteroid treatment. While considering the mortality rate the pooled data shows about one in three patients were expired due to mucormycosis.
Discussion:
Mucormycosis is extremely rear in healthy populations but can be coupled with an immunocompromised condition such as malignancies, organ transplantation prolonged neutropenia, immunosuppressive and corticosteroid therapy, iron overload, AIDS, even with malnutrition and uncontrolled DM. Mucormycosis can infect in nose, sinuses, orbit, central nervous system (CNS), lung (Upper &Lower respiratory Tract), gastrointestinal tract (GITract), skin, jaw bones, joints, heart, kidney and mediastinum, but rhino-orbital- cerebral mucormycosis is the commonest variety seen in clinical practice worldwide. 11 Based on our literature study it’s revealed that it appears by the intersection of two crises: one is the use of corticosteroid in COVID 19 patients and the other of poorly controlled DM in the settings of a pandemic. In addition to this an alternation iron metabolism occurs in severe COVID 19 which lead to cause hyper ferritin emic syndrome, studies have shown that high ferritin levels lead to excess intracellular iron that generates reactive oxygen species resulting in tissue damage. Cytokines, especially IL-6, due to severe infection and DKA, stimulate ferritin synthesis and downregulate iron export resulting in intracellular iron overload, further exacerbating the process.12 The resultant tissue damage leads to the release of free iron into circulation.13 Iron overload and excess free iron seen in academic states are one of the keys and unique risk factors for MCR.14 However more details study is required to conclude whether high ferritin level is directly involved in mucormycosis or whether its act as a modulator of the diseases. 15
It has been observed that in the second wave of COVID 19 there was huge demand for‘ industrial oxygen’ to address the lack of oxygen supply chain for medical use. Hence, proper handling and sanitization of oxygen gas cylinders in hospital/home use is of utmost importance. The hospital environment also plays a vital role in mucormycosis as it found Fungal pathogens are present in bed bars and headers, taps, bedside table and other places of hospitals. This problem can be suppressed by proper hospital infection control measures adopting hand washing measures by healthcare workers and decontaminating high-contact hospital surfaces. There is another factor that may also played an important role such as reusable oxygen humidifiers in the transmission of potential nosocomial pathogens via the generation of aerosol particles, for they reach deep into the lung immediately after inhalation, care should be taken for appropriate maintenance of reusable ones. Besides, clean distilled water should be used in humidifiers during oxygen therapy in COVID-19 patients.30
People requiring oxygen support at home should ensure the use of clean distilled water in oxygen concentrators. Overuse of steam inhalation, as well as non-humidified oxygen, can lead to damage of the respiratory mucosa, allowing easy penetration of the fungal spore inCOVID-19 positive individuals. Continued use of facemasks would reduce the chances of re-infection with SARS-CoV-2 and minimize the risk of inhalation of fungal spores. However, reusing the same masks for 2–3 weeks may increase the risk of acquiring mucormycosis.
Conclusion
It is found that uncontrolled diabetes mellitus, inappropriate steroid therapy, self-medication, and a high load of fungal spores in the hospital environment were responsible for mucormycosis in the COVID-19 era. So, there are needed to make efforts to maintain hyperglycemia, proper use of corticosteroids in patients with COVID-19 and hospital sanitization in order to reduce the burden of fatal mucormycosis.
Acknowledgment: I am grateful to the Government of Uttar Pradesh for providing the
Infrastructure to conduct the study.
Source of funding: NIL
Conflict of Interest: Nil
Authors’ Contribution: All authors contributed equally towards the data collection, data analysis & compilations
Englishhttp://ijcrr.com/abstract.php?article_id=4601http://ijcrr.com/article_html.php?did=4601Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-5241EnglishN2022September24Healthcare
Impact of COVID-19 Risk Communication on Knowledge and Mental Status of Food Handlers’: A Cross-Sectional Study in a Tertiary Care Setting
English0510Karpaga Priya PEnglish Nanditha VenkatesanEnglish Sahana KathimandaEnglish Gouri Kumari PadhyEnglish Mohan KumarEnglish https://doi.org/10.31782/IJCRR.2022.141802
Introduction: The mental health impact of COVID-19 among food handlers working in food establishments/canteens of Dedicated COVID Health Centers and Hospitals are unrecognized. Aim/Objectives: This was an analytical cross-sectional study conducted among all the food handlers working in food establishments/canteens of a tertiary care hospital in central India using a pre-designed, pre-tested proforma that included Depression, Anxiety and Stress Scale 21 (DASS 21). Results: Out of 76 study subjects, 9 (11.8%) had some form of mental illness; 7(9.2%) had depression, 3(3.9%) had anxiety and 1(1.3%) had stress. It was observed that study subjects traveling to the worksite in their own vehicle (OR=5.75, 95% CI=1.29- 25.72), difficulty with transport during lockdown (OR=14.75, 95%CI=3.07-70.92) and those with active complaints (OR=16.25, 95%CI=2.25-117.10) were at increased risk of some form of mental illness in comparison to their counterparts (pEnglishCOVID-19, Risk communication, Food handlers, Mental health, Knowledge, India
Introduction
Covid-19 is now a global pandemic.1 The challenges and concerns regarding direct and indirect health, economic and social consequences are many. Also, the multitude of target populations compounds the prevention, control and risk communication efforts. Healthcare professionals, police personnel and sanitary workers are called COVID warriors or frontline soldiers battling COVID-19.2At the same time there is an unrecognized workforce behind these frontline workers keeping them in good health and supporting the fight against COVID-19.
Currently, the Dedicated COVID Health Centers (DCHC) and Dedicated COVID Hospitals (DCH) are predominantly the tertiary care hospitals/teaching hospitals in the State in addition to District Hospitals (DH).3 The tertiary care/teaching hospitals across the country are mostly residential for doctors through provision of hostels and quarters. With the lockdown in place the only source of food and refreshments for them are the food establishments/canteens in these hospitals and residential hostels/quarters. Also, these food establishments/canteens are obliged to provide food to those admitted in hospitals including patients admitted in COVID-19 isolation wards and/or critical care units. In a study conducted by Singh A et al among food handlers in food establishments of five teaching hospitals of North India, it was found that there are eight food handlers per hundred doctors/medical students.4
The mental health impacts of crisis situations to mankind are well known.5 It was reported during the severe acute respiratory syndrome(SARS) outbreak of 2002 that 93.5% of frontline workers experienced mental trauma, 45.7% had stress, 45% had emotional distress, 37.2% had diminished social life and 60% had depression.6In a study conducted by Lai J et al. during the current COVID-19 pandemic, a considerable proportion of frontline workers reported symptoms of depression (50.4%), anxiety (44.6%), insomnia (34.0%), and distress (71.5%). Nurses, frontline health care workers especially women and those working in Wuhan, China, reported more severe degrees of mental health symptoms.7 Thus during times of crisis psychiatric morbidities range from persistent depression, anxiety, stress, panic attacks, psychomotor excitement, psychotic symptoms, delirium, and even suicidality.
The identified literature reports the negative impact of COVID-19 on individuals’ mental health especially those involved directly or indirectly with COVID-19 mitigation efforts. Stressors include threat and risk of contagion, perception of safety, information overload versus the unknown, confinement and quarantine, financial loss and job insecurity as well as stigma and social exclusion.8Moderating factors that aggravate or mitigate COVID-19’s effects on employees mental health can be organizational, institutional and individual.9 The organizational factors include the occupational role and working environment of the employee, availability of occupational safety and health management measures in place and availability of teleworking systems. The institutional factors include programs that aim to support employees financially and psychologically during and after the pandemic. The individual factors encompass socio-demographic factors (gender, age and education), the history of the individual’s mental illness, and the perception of physical health vulnerability.10
In an article published by Human Resource Executive, it was reported that the majority (88%) of the workers experienced moderate to extreme stress over the past month. Importantly, it was noted that, almost two-thirds (62%) of workers with stress lost at least 1 hour a day in productivity and 32% lost at least 2 hours a day due to COVID-19-related stress. These findings indicate that work-related or workplace stress not only affect employees but their implications or consequences are for employers as well.11
With this background, the present study was carried out to assess the mental health status of food handlers working in a tertiary care hospital in central India. In addition, the knowledge of food handlers in relation to the COVID-19 pandemic and other factors associated with mental health status were studied.
Materials and methods
This is an analytical cross-sectional study conducted among all the food handlers working in food establishments/canteens of a tertiary care hospital in central India. It is a Dedicated COVID Care Hospital/Medical college, involved in COVID-19 screening, diagnosis and treatment. The hospital has 4 canteens in total. There are different classes of workers in a canteen; from the manager, cook, server, and cleaner to the owner. All were included in our study. Those who refused consent to answer the questions were excluded. The data was collected by personal interviews during the months of June and July 2020. The respective canteen in charge was contacted and the nature of the study was explained. After obtaining their permission, the canteen staff were interviewed ensuring privacy. The data was collected after clearance from the Institutional Ethics Committee, All India Institute of Medical Sciences, Raipur.
The study was carried out using a pre-designed, pre-tested proforma made using Google forms for the ease of data collection. The proforma was made quantitative and included three sections namely demographic factors, knowledge assessment and Depression, Anxiety and Stress Scale 21 (DASS 21). DASS 21 instrument developed by Lovibond and Lovibond is used to assess subjective depression and anxiety and stress signals in participants. It is easy to administer, quick to score and is freely available with a sensitivity and specificity of 78–89% and 71–76% respectively. Each interview lasted for not more than 20-30 minutes. After the interview, the participant’s gap in knowledge was addressed appropriately. The data from Google forms were transferred to Microsoft Excel and analyzed using SPSSv23. Appropriate statistical tests were applied.
Results:
The mean age of the study population was 25.6+7.1 years [Median= 23 years, Range= 30 (18 to 48 years)]. Enrollment was found to be higher for females 41 (53.9%) as compared to males 35 (46.1%) and the majority, 73 (96.1%) were literate. The mean duration of current employment of the study subjects was 12.9+14.4 months (Median= 8 months) and the mean duration of work hours per week was 62.7+17.9 hours (Mode= 70 hours per week). Most of the study subjects, 59 (77.6%) were from Chhattisgarh and of those from Chhattisgarh, 30 (50.8%) are from Raipur. The distance between the worksite and the accommodation site of the study subjects was 3.7+3.6 kilometers. The primary mode of transport for the majority of the study subjects was on foot (Figure 1).
Out of 76 study subjects, 9 (11.8%) had some form of mental illness; 7 (9.2%) had depression, 3(3.9%) had anxiety and 1(1.3%) had stress. It was observed that study subjects traveling to the worksite in their own vehicle (OR=5.75, 95%CI=1.29-25.72), study subjects having difficulty with transport during lockdown (OR=14.75, 95%CI=3.07-70.92) and those with active complaints (OR=16.25, 95%CI=2.25-117.10) were at increased risk of some form of mental illness in comparison to their counterparts (pEnglishhttp://ijcrr.com/abstract.php?article_id=4602http://ijcrr.com/article_html.php?did=4602
1. The Lancet Infectious Diseases. COVID-19, a pandemic or not? Lancet Infect Dis. 2020 Apr; 20(4):383. Available from: https://www.thelancet.com/journals/laninf/article/PIIS1473- 3099(20)30180-8/fulltext
2. Covid 19 Warriors. COVID warriors. Available from: https:// covidwarriors.gov.in/(Last accessed on August 8, 2020)
3. Ministry of Health & Family Welfare, Government of India. Final Guidance on Management of Covid cases. Available from: https://www.mohfw.gov.in/pdf/Final Guidance on MangaementofCovidcasesversion2.pdf (Last accessed on August 8, 2020)
4. Singh A, Katyal R, Chaudhary V, Narula K, Upadhayay D, Singh SP. An epidemiological study on the predictors of the health status of food handlers in food establishments of teaching hospitals of North India. Indian J Occup Environ Med. 2015 Sep 1;19(3):145-150.
5. Pfefferbaum B, North CS. Mental Health and the Covid-19 Pandemic. N Engl J Med. 2020 Aug 6;383(6):510–512.
6. Lin C, Peng Y, Wu Y, Chang J, Chan C, Yang D. The psychological effect of severe acute respiratory syndrome on emergency department staff. Emerg Med J EMJ. 2007 Jan;24(1):12–7.
7. Lai J, Ma S, Wang Y, Cai Z, Hu J, Wei N, et al. Factors Associated With Mental Health Outcomes Among Health Care Workers Exposed to Coronavirus Disease 2019. JAMA Netw Open. 2020 Mar 23;3(3).e203976
8. COVID-19: Global pandemic may increase stress exponentially. 2020 Apr 29; Available from: https://www.icrc.org/en/document/covid19-global-pandemic-may-increase-stress (Last accessed on August 8, 2020)
9. Hamouche S. COVID-19 and employees’ mental health: stressors, moderators and agenda for organizational actions. Emerald Open Res. 2020 Apr 20;2.15
10. Centers for Disease Control and Prevention. Corona Virus Disease (COVID-19). Communities, Schools, Workplaces, & Events Employees: How to Cope with Job Stress and Build Resilience During the COVID-19 Pandemic. 2020. Available from: https:// www.cdc.gov/coronavirus/2019-ncov/community/mental health-non-healthcare.html (Last accessed on August 8, 2020)
11. How Has COVID-19 Affected Mental Health, Severity of Stress Among Employees?. AJMC. Available from: https://www.ajmc. com/view/undefined (Last accessed on August 8, 2020)
12. Le HT, Nguyen DN, Beydoun AS, Le XTT, Nguyen TT, Pham QT, et al. Demand for Health Information on COVID-19 among Vietnamese. Int J Environ Res Public Health. 2020 Jun;17(12). 4377
13. Parikh PA, Shah BV, Phatak AG, Vadnerkar AC, Uttekar S, Thacker N, et al. COVID-19 Pandemic: Knowledge and Perceptions of the Public and Healthcare Professionals. Cureus J Med Sci. 2020 May 15;12(5). e8144
14. Awareness program on Covid-19 for police. Nashik News - Times of India. The Times of India. 2020. Available from: https://timesofindia.indiatimes.com/city/nashik/awarenessprogramme-on-covid-19-for-police/article show/75435679.cms (Last accessed on August 8, 2020)
15. Lin Y, Huang L, Nie S, Liu Z, Yu H, Yan W, et al. Knowledge, Attitudes and Practices (KAP) related to the Pandemic (H1N1) 2009 among Chinese General Population: a Telephone Survey. BMC Infect Dis. 2011 May 16;11.
16. Lau LL, Hung N, Go DJ, Ferma J, Choi M, Dodd W, et al. Knowledge, attitudes and practices of COVID-19 among income-poor households in the Philippines: A cross-sectional study. J Glob Health;10(1).011007
17. Rehman U, Shahnawaz MG, Khan NH, Kharshiing KD, Khurs heed M, Gupta K, et al. Depression, Anxiety and Stress Among Indians in Times of Covid-19 Lockdown. Community Ment Health J. 2021 Jan;57(1):42-48
18. Vaughan E, Tinker T. Effective Health Risk Communication About Pandemic Influenza for Vulnerable Populations. Am J Public Health. 2009 Oct;99(S2): S324–32.
19. WHO. Mental health and psychosocial considerations during the COVID-19 outbreak.Available from: https://www.who.int/ docs/default-source/coronavirus/mental-health-considerations.pdf?sfvrsn=6d3578af_2(Last accessed on August 8, 2020)
Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-5241EnglishN2022September24Healthcare
Comparative Study of Dental Education between South Asian and Southeast Asian Countries - An Empirical Analysis
English1116Kajal AgarwalEnglish Prashanthy M.R.English Bharathwaj V.V.English Sindhu R.English Dinesh DhamodharEnglish Prabu DEnglish Rajmohan M.English Suganya P.English https://doi.org/10.31782/IJCRR.2022.141803
Introduction: Dentistry is the field that brings back one’s smile. It is this field that teaches about the importance of oral hygiene. Dental education varies in all Southeast Asian and South Asian countries. Aim: To compare dental education concerning fee structure, dentist population ratio, and year of graduation between South Asian and Southeast Asian countries. Methodology: This study was conducted to the comparison of dental education in South Asian and Southeast Asian countries. Southeast Asian countries were classified as Group A and South Asian countries were classified as Group B. Data was retrieved from manual and electronic databases using search engines (Pubmed, google scholar, Web of Science). In this study, the keywords were Dentistry, Southeast Asian, South Asian, Dental colleges, and Dentist population ratio used in the search. Result: This study determined the difference between dental education, dentist population ratio, and the dentist’s average salary among Group A and B. The number of Dental colleges was the maximum in India (71%) among all other Group A and B. Conclusion: Nevertheless South Asia had a plethora of colleges, and high-paying dental jobs were possible only in Southeast Asian countries. Hence substantial numbers of dental colleges with proper apportionment and job contentment is obligatory for better treatment outcome of patients.
EnglishDentistry, Dentist, South East Asian, South Asian, Dentist population ratio, Dental colleges, Fees structure
INTRODUCTION:
Asia is divided into several peripheral coastal regions, namely East Asia, South Asia, Southeast Asia, and the Middle East. Southeast Asia is a vast region of Asia situated to the east of the Indian subcontinent and south of China. It consists of two distinct portions, mainland Southeast Asia and insular Southeast Asia. Southeast Asian countries were classified as Group A which included Singapore, Malaysia, Thailand, Vietnam, Philippines, Cambodia, Indonesia, Brunei, Laos, Myanmar and Timor Leste. Southeast Asia stretches 4,000 miles at its greatest extent from northwest to southeast and includes 5,000,000 square miles (13,000,000 square kilometers) of land and sea. Currently, Southeast Asia's population is approaching half-billion or one-twelfth of the world's total.1
Dental education in Southeast Asian countries highlights the high-quality dental services for dental graduates and dental practitioners' free movement. The Southeast Asian Nations (ASEAN) Dental Councils had proposed the Common Major Competencies for ASEAN General Dental Practitioners to support undergraduate dental education.2
South Asia extends south from the central part of the continent to the Indian Ocean. The western boundary is the desert region where Pakistan shares a border with Iran. South Asian were classified as Group B which included Sri Lanka, India, Bangladesh, Bhutan, Nepal, Pakistan, and the Maldives.3
People in developing countries were burdened excessively by oral diseases, such as periodontal diseases, dental caries, etc. Such conditions were aggravated by poverty, poor living conditions, ignorance concerning health education, and lack of government funding and policy to provide sufficient oral health care workers. World Health Organization (WHO) and the FDI World Dental Federation had identified the problems and developed strategies. However, acceptable goals and standards of oral health have to be agreed upon.4 It contains human resource indicators that provide us with an overview of the availability of trained and specialized medical, dental, nursing, and paramedical workforces in the country. It also provides information regarding regional distribution and disparities.
The number of dental schools and the total number of dentists had increased in the past two decades, but the dentist/population ratio was decreased.5 However, to serve the need for this massive population's oral health care, India had organized many dental educational institutes. Also, the dental field and educational sector had grown up during the past decades.6
Dentistry is a health science department that involves analysis, prognosis, and prevention of surgical and non-surgical ailments of the oral cavity. 7 The majority of dental infections and therapies were carried out to stop or deal with the most typical oral conditions such as tooth decay, periodontal illness, etc. Dental education aims to prepare students to be competent enough to meet public oral health needs. In the region of South Asian and Southeast Asia, the population's living and health conditions reflect the unequal distribution of dental health determinants and the disparity in the means to compensate for this inequality. The present study aims to compare dental education concerning fee structure, dentist population ratio, and year of graduation between group A and group B.
Methodology
This study was conducted to the comparison of dental education between South Asian and Southeast Asian countries. Southeast Asian countries were classified as Group A which included Singapore, Malaysia, Thailand, Vietnam, Philippines, Cambodia, Indonesia, and Myanmar. South Asia was classified as Group B which included Sri Lanka, India, Bangladesh, Bhutan, Nepal, Pakistan, and the Maldives. Data were retrieved from the manual and electronic databases using search engines (Pubmed, Google Scholar, Web of Science). The total number of institutes, years of education for both undergraduates and postgraduates, fee structure, and the total dentist population ratio for different countries were the main source of the data collected. The Southeast Asian, dental colleges, South Asian, postgraduates, undergraduates, and dentist population ratio were keywords used to retrieve the data. Articles related to dental education in group A and group B were only included other than native languages were excluded. Documents like Letters, Meeting abstracts were excluded.
RESULTS:
The present study aimed to analyze dental education's current situation in group A and group B. Information regarding the total number of colleges in each country, undergraduate and postgraduate in dental colleges and duration of the course, entire fee structure of different colleges in different countries, were obtained and tabulated to provide an insight about dentistry in group A and group B.
Table 1 depicts the average fee structure, duration of the course, and the total dentist population ratio in other countries. Cambodia had the lowest dentists population ratio to other Group A. The duration of the course was almost the same for every country.
Table 2 reported the average fee structure and the total dentist population ratio in other countries. The duration was the same for all the countries except the Maldives for undergraduates. The Post-graduation course duration was 3 years in all groups B, whereas in Srilanka, the course duration was one year.
Table 3 showed that the distribution and comparison of a dentist's average salary per month in group A and group B. In group A, the dentists were highly paid in Singapore. On the contrary, the least was spent in Myanmar. While in group B, the dentists were highly paid in Maldives and least paid in Bangladesh.
Figure 1 showed that the total dentist ratio population in Group A. Cambodia had the least dentist-population ratio, while Myanmar being the highest dentist-population ratio.
Figure 2 showed that the total dentist population ratio in Group B. Pakistan had the least dentist population ratio, while India being the highest dentist population ratio.
Figure 3 showed that the distribution of the total number of dental colleges in Group A. According to the figure, Myanmar (2), Cambodia (2), and Singapore (3) had a low number of dental colleges. On the contrary, Indonesia (30) had a high number of dental colleges.
Figure 4 shows the distribution of the total number of dental colleges in Group B. According to the figure, Bangladesh (35), Bhutan, Sri Lanka, and the Maldives had two dental colleges, Afghanistan (3), Nepal (13), and Pakistan (43) had the number of dental colleges. In contrast, India (318) had the highest number of dental colleges all over the world.
DISCUSSION
The current study reported a comparison of dental education in Group A and Group B. All the nations are dissimilar in cultural, social, and ecological aspects and their caste, ideology, and religion, with differentiating community needs in rural and urban structures. The number of dentists available for people varied in different countries.
The present study stated that India had the highest number of dental colleges among all other countries. In Group A, Indonesia had 30 colleges, Thailand had 11, Malaysia and Philippines had 10, and Vietnam had 8, whereas Singapore, Cambodia, and Myanmar had the lowest with 3 and 2 dental colleges. In Group B, India had the highest with 318 dental colleges, Pakistan had 43, Nepal had 13, the Maldives, Bhutan, and Srilanka had 2, Afghanistan had 3, and Bangladesh had 35 dental colleges.
This study stated the average salary of a dentist per month. The dentist's pay was too less in Myanmar while in Singapore was highly paid. All the other countries had mediocre salaries paid to dentists. Data obtained for the duration of the course for both undergraduates and postgraduates were mostly five years for undergraduates and 3years for postgraduates, respectively, except the Maldives, Myanmar, and the Philippines had 6years courses for undergraduates. On the contrary, Cambodia had no post-graduation dental course.
This study reported that India (71%) had the highest percentage of dental colleges distribution among South-Asian countries (group B), followed by Pakistan (10%). Bhutan and Bangladesh had the lowest percentage of dental institutions (2%). Among Southeast Asian countries (group A), the highest percentage of dental colleges were in Indonesia (36%), and the lowest number was in Singapore (4%). According to each country's population, there was no proper distribution of dental colleges to meet people's dental demands, especially in group A. At present, India has the highest number of dental colleges in the world.7
The dentist population ratio was a widely accepted measure of workforce outcomes. 8 To analyze the dentist population ratio of Group A, the ratio was 1:119000 and 1:43000 in Cambodia and Vietnam, respectively. In descending order, the dentist population ratio in other Group A followed the Indonesia dentist population ratio was 1:25000, the Philippines had 1:20,000, Thailand had 1:7000, and Malaysia had 1:6,000. In Singapore, the ratio was 1:10000, and in Myanmar had 1:3695.
World Health Organization recommends a Dentist Population ratio of 1:7500.9 It should be noted that most of the countries did not meet the recommended ratio given by the World Health Organization (WHO). The reasons for such an excess supply of dentists were poor (or) no workforce planning, reliance on faulty statistics, mushrooming of dental colleges, and inefficient regulatory bodies. The problem lies behind the distribution of dental colleges than the number of dentists. The number of dental colleges varied for all countries.
Major drawbacks would be the unequal distribution of dentists in all the areas, lack of systemic planning and allocation, and booming of dental colleges in all the countries. In rural areas, the dentist population ratio was less compared to urban areas. Due to unemployment and low income, most dentists in Group A and Group B moved to western countries. The reasons for dentist migrations were complex and included the lure of better remuneration, professional development, career growth, better working and living conditions. Political and economic forces also influenced the decision to migrate. A high population-to-provider ratio does not explain levels of untreated disease, potential demand, or sufficient demand. Therefore, it reveals little information about the criticality of intervention or the character of intervention. Pakistan had produced more than ten thousand dentists, but most of them left the country for a better future.10
The students pursuing a Bachelor's degree fail to follow a Master's degree due to the excessive fee, which has created a scenario in which some dentists intend to seek alternate professions. 11,12 The predominant migration pattern in the region was the movement of dentists from middle- to high-income countries. Dentists from India, Malaysia, Sri Lanka, and Bangladesh were more likely to migrate to high-income countries in the region, and have a Commonwealth connection.13 Dental colleges also have decreased their investment in physical plant and faculty numbers. Most of the dentists in all the countries had migrated to western countries due to unemployment and low salary provided by the dentist in Group A and Group B.14,17,18,20To achieve universal health coverage, improved oral health care delivery with a skilled and motivated dental health workforce was necessary. Human resource shortages hinder the scale-up of health services and limit the capacity to absorb additional financial resources. Kasbah etal. the study reported that the efficiency of dental education was better in Saudi Arabia due to implementing the newer method Mini clinical evaluation exercise.21 A clear understanding of the dental health-workforce situation is very critical to develop effective policies. Shobana et al. study reported that the implementation of some ethical values and principles motivates them to get an awareness of education.22 The government authorities should conduct an awareness campaign to bring awareness about dental hygiene among the public.
There was gross inadequacy in dentists' availability and significant inequalities in their distribution between the different countries. In terms of health outcomes, poorly performing countries had a more substantial shortfall in dentists' number. The respective countries' regulatory bodies should reinforce the dentist's employment opportunities with dignified salaries and better living standards to retain qualified dentists from migrating to other foreign countries. Dental graduates among group A and group B prefer to pursue higher education in western countries. Many dentists are also deviating from their profession and choosing different parts such as insurance companies, hospital administration-related jobs, and medical coding because of the less pay scale available for dentists.
The Dental Council must be taken into action for the proper and equal distribution of dental colleges all around the Asian region according to the oral health care needs of the people. The existing framework appealing would prompt catastrophic outcomes unless intruded with the crisis without laxity to spare the profession's veneration.
LIMITATION
The major limitation encountered during the study was obtaining information about various dental colleges; the dentist population ratio in three countries of Southeast Asia and South Asian countries was not retrieved. Details regarding the number of colleges, population, and average salary of a dentist were available while regarding dental seats accessible in different colleges was not existing on any platform.
CONCLUSION
In today's world, oral health has become a significant factor to be considered. Oral hygiene habits are equally as crucial as other habits. Every year, the number of dentists is increasing, but people are still not aware of the importance of oral health. Socially appropriate strategies must be developed to target oral health issues. Nevertheless, South Asia had a plethora of colleges, and high-paying dental jobs were possible only in Southeast Asian countries. Hence substantial numbers of dental colleges with proper apportionment and job contentment is obligatory for better treatment outcome of patients.
ACKNOWLEDGEMENT: Nil
CONFLICT OF INTEREST: Nil
FUNDING: Nil
Kajal Agarwal- concept and study design, data collection
Prashanth M.R- Concept and study design. Data collection, and manuscript write up
Bharathwaj V.V- formulated the write-up
Sindhu R- Performed the analysis and interpretation
Dinesh Dhamodhar- Data analysis and interpretation
Prabu D- Provided revised scientific content to the manuscript
Rajmohan M- Correction done
Suganya- Data collection
Englishhttp://ijcrr.com/abstract.php?article_id=4603http://ijcrr.com/article_html.php?did=4603Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-5241EnglishN2022September24Healthcare
Role of Allergic Rhinitis in Cognitive Functions and Psychological Condition of Children Aged 8-16 years
English1720Ipsa KujurEnglish Mamata PandaEnglish Suryakanta SwainEnglish Bishwajit MishraEnglish Smruti Dash MohapatroEnglish Manisha PatroEnglishhttps://doi.org/10.31782/IJCRR.2022.141804
Introduction: Allergic rhinitis (AR) is defined as a symptomatic disorder of the nose induced after coming in contact to allergens by an immunoglobulin E(IgE) mediated inflammation. Allergic rhinitis is one of the commonest chronic allergic diseases in school age group. AR is clinically diagnosed and its symptoms are watery nose, nasal obstruction, itching and sneezing.AR is divided into intermittent or persistent disease according to the duration of active symptoms. The severity of AR can be classified as mild, moderate or severe according to the level of disturbance of the daily activities. Around 20-30% of the population suffers from AR and the majority of them show symptoms from 6-7 years of age. Objectives/Aim: To evaluate the role of symptomatic allergic rhinitis in cognitive functioning of a child and the effect of allergic rhinitis on the psychological condition of affected children. Methodology: A prospective observational study was carried out in the OPD/IPD of HI-TECH Medical college and hospital from 1st September 2019-31st October 2021.150 children were evaluated in this period special questionnaire regarding the quality of life in rhinitis patients for psychological well-being and their cognitive ability like verbal memory, memory retrieval, working memory, information processing, color word interference and cognitive flexibility was evaluated with the help of computerized Visual verbal learning test(VVLT) and Stroop colour word test(SCWT). Results: In the study we found out that there was a significant association with age in years with working memory/memory retrieval/colour word interference/cognitive flexibility, with p less than 0.05. The psychological status of children was assessed by the questionaries and was found to be affected due to regular medications leading to inattentive behavior, absence from school, stress on parents due to high burden of disease, shame because of the persistent nature of the disease and feeling drowsy throughout on medications. Conclusion: Allergic rhinitis affects the psychological well-being of a child and decreases cognitive ability but there is no cognitive impairment drastically.
EnglishAllergic rhinitis, cognitive function, psychological condition, visual verbal learning test, Stroop colour word test, questionaries on allergic rhinitis
INTRODUCTION:
Allergic rhinitis (AR) is a common chronic disease.1. ISAAC phase 1 revealed that in India 12.5% of children in the age group of 6-7 years and18.6%in the age group of 13-14 years had nasal symptoms related to allergic rhinitis.ISAAC phase 3 revealed an elevation in nasal symptoms to 12.9% and 23.6 % in 6-7- and 13-14-year age groups respectively.4ARis often underestimated. Not only physical manifestations but mental problems, reduce the quality of life (QOL).6,9Allergic rhinitis can have a negative impact on scholastic performance and work performance which contributes to the experience of stress and agony in children.3 Children with allergic rhinitis report increased sleep disturbances secondary to allergic symptoms and increased daytime fatigue which affects school performance.5Michael S Blaiss wrote an article on behalf of the allergic rhinitis in school children consensus group in 2004.2The group concluded that allergic rhinitis symptoms can have considerable harmful effects on absenteeism, presenteeism(inattention, distraction, lack of concentration), cognitive impairment(difficulty in the use of speech, visual perception and construction, calculation ability, information processing and execution etc), poor school performance, behaviour and psychosocial problems in school children.10 Symptomatic allergic patients are significantly slower in processing particular data than non-symptomatic patients. 8 Remembering things and making decisions along with basic functions such as speed directly influences most aspects of daily activities. Consequently, slow thinking and motor action may impose difficulty on the child in an attempt to maintain a certain performance. This causes fatigue and increased susceptibility to distraction. This increases stress in a family system like parent-child conflict, parental sleep disruption, increased parenting stress etc. Therefore, it affects both the child and the parents. Now the question arises if cognition and psychosocial well-being is compromised then to what extent
MATERIALS AND METHODS
This study will be done at Hi-Tech Medical college and hospital Bhubaneswar. The study will cover children aged from 8-16 years. Patient particulars like age, sex, and address will be noted. Detailed history including the age of onset of illness, duration of illness (seasonal or perineal), family history of atopy, previous anti-allergy treatment and history of scholastic performance will be recorded. Four aspects of cognitive development will be measured. To assess VERBAL MEMORY, Visual Verbal Learning Test (VVLT) will be carried out.15 words will be shown and the child will be asked to remember the words shown to him/her. This procedure will be repeated 5 times. A number of words recalled immediately shows WORKING MEMORY. Then after 20 minutes, words remembered show long-term memory(MEMORY RETRIEVAL). To test the information processing of the child, the Stroop-Colour-Word Test (SCWT) will be carried out. The test will involve three cards showing colour names(SCWT1), coloured figures (SCWT2) and names of the colour written in different coloured ink from the name of the colour it is suggesting (SCWT 3). On the first and second cards, the colour names and figures showing the same colour, no incongruity have to be read aloud as quickly as possible, which shows the speed of INFORMATION PROCESSING. On the third card, the amount of time required to discard irrelevant but important information (reading of colour name)will be recorded. The difference between SCWT3 and the mean of SCWT1 and SCWT2 will reflect “COLOUR WORD INTERFERENCE”, which shows COGNITIVE FLEXIBILITY. The results from the above test will be represented using appropriate tables, graphs and diagrams. The psychological condition of the patient will be evaluated using a customised questionnaire.
RESULTS:
The below graphs and tables give us the interpretation that allergic rhinitis patients have a slower working memory, memory retrieval is poor and cognitive flexibility is affected in comparison with normal kids. The significant p-value is set as 0.05. But there isn’t a major change seen in the children in comparison to non-allergic kids. The effect in the psychological domain is far more than in the cognitive domain due to various reasons.
DISCUSSION:
Cognitive impairment (also known as intellectual disability) is a term used when an individual has some kind of shortcomings in mental function and in domains such as communication, self-help and social interaction. These shortcomings will cause a hindrance in the learning and development of a child. The affected child will be slower than a typical child. It is diagnosed with the help of standardized tests of intelligence and adaptive behaviour. Children going through cognitive problems such as low attention, poor memory or lack of inhibition may later suffer mental health issues as teenagers and young adults.7 Allergic rhinitis is one of the major reasons because of why children miss school in childhood days. Due to rhinorrhoea, headache, sleepless nights, difficulty in concentrating, sleeping pattern problems and lethargy, short-term memory problems are seen in children. The consequences of symptomatic allergic rhinitis can extend to adult life affecting the quality of life in all its aspects. Allergic rhinitis causes emotional problems in children causing them to be depressed and ashamed of themselves, hence decreasing their performance in school.
CONCLUSION
Symptomatic allergic rhinitis disturbs day-to-day life due to signs and symptoms experienced and due to grave impact on mental health. Some investigations and tests have been run to gauge the effect on cognitive functions objectively. But still remains uncertain if it leads to an objective reduction in cognitive functions of the affected child. The psychological condition of the affected patients was significantly impaired.
ACKNOWLEDGEMENT-DR PANDA MAMATA, ASSOCIATE PROFESSOR, DEPT.OF PAEDIATRICS
DR MISHRA BISHWAJIT, ASSOCIATE PROFESSOR, DEPT.OF PAEDIATRICS
DR SWAIN SURYAKANTA, PROFESSOR AND HOD, DEPT.OF PAEDIATRICS
DR DASH MOHAPATRA SMRUTI, MBBS,3rd YEAR POSTGRADUATE, DEPT.OF PAEDIATRICS
DR PATRO MANISHA, MBBS,3rd YEAR POSTGRADUATE, DEPT.OF PAEDIATRICS
SOURCE OF FUNDING-NONE
CONFLICT OF INTEREST-NONE
AUTHORS CONTRIBUTIONS- DR IPSA KUJUR: Integrity of the data and accuracy of the data analysis; study of concept and design; critical revision of the manuscript for important intellectual content; study supervision.
DR. MAMATAPANDA: Study concept and design; acquisition, analysis or interpretation of the data; study supervision
DR BISHWAJIT MISHRA AND DR SURYAKANTA SWAIN: Acquisition, analysis or interpretation of the data; study supervision
DR SMRUTI DASH MOHAPATRA: critical revision of the manuscript for important intellectual content
DR MANISHA PATRO: Drafting of the first manuscript
ETHICAL CLEARANCE: INSTITUTIONAL ETHICS COMMITTEE,HI TECH MEDICAL COLLEGE AND HOSPITAL; No.HMCH/IEC/2021/124, dated 6 10 2021
Englishhttp://ijcrr.com/abstract.php?article_id=4604http://ijcrr.com/article_html.php?did=4604
1. Kremer B, den Hartog HM, Jolles J. Relationship between allergic rhinitis, disturbed cognitive function and psychological well-being, clinical exp allergy 2002;32:1310-1315
2. Blaiss MS. Cognitive, social and economic costs of allergic rhinitis, allergy asthma proc 2000;21:7-13
3. Elias M, Chandramani P, Alok S, Impact of allergic rhinitis in school going children, Asia Pac Allergy 2012;2-93-100
4. Lindsay CR. A comprehensive study of the effects of allergic rhinitis on the performance and conduct behavior of school-aged children, 2008
5. Treatment of allergic rhinitis is associated with improved attention performance in children: The allergic rhinitis cohort study for kids. www.plosone.org, October 2014, volume 9, issue 10
6. Allergic rhinitis and school performance, J Investig Allergol Clin Immunol 2009; Vol19, Suppl.1:32-39
7. Change of cognitive function and learning ability in allergic rhinitis. The Korean academy of asthma, allergy and clinical immunology symposium 2.
8. Allergic rhinitis, De shazo RD, Kemp SF.Clinical manifestations and epidemiology of allergic rhinitis(rhinosinusitis). uptodate. com.2008
9. ISAAC Steering committee. Worldwide variation in the prevalence of symptoms of asthma, allergic rhinitis and atopic eczema: ISAAC. Lancet1998; 351:1225-1232
10. Simons FE. Learning impairment and allergic rhinitis. Allergy Asthma Proc. Jul-Aug 1996; 17:185-9. doi: 10.2500/108854196778996895.
Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-5241EnglishN2022September24Healthcare
Identification and Mitigation of Risks using Quality Risk Assessment Tools for Formulation Development of Pazopanib HCl Extrudates by using HME Technique: A Systematic QbD Approach
English2128Amit GuptaEnglish Rashmi DahimaEnglishhttps://doi.org/10.31782/IJCRR.2022.141805
Introduction: Pharmaceutical development ensures to design a valued product and robust manufacturing process to consistently deliver intended performance. It is necessary to recognize that quality cannot be tested into drug products but it should be built in during formulation design and development. Pazopanib HCl is a protein kinase inhibitor molecule approved by USFDA and European agencies for the treatment of renal cell carcinoma (RCC) patients and other renal malignancies, but it has very poor aqueous solubility and drug release. Therefore, it is essential need to improve the solubility and in vitro dissolution characteristics. Objective/Aim: The main objective of this study was to prepare stable Pazopanib HCl extrudates (PZP-Ex) by using the Quality by Design (QbD) approach. Method: Pazopanib HCl extrudates (PZP-Ex) was manufactured using hot melt extrusion technique. Initially, the quality target product profile (QTPP) and critical quality attributes (CQAs) were identified, and then risk assessment was done using a heat map and failure mode and effect analysis (FMEA) approach. A full factorial design (FFD) was used to study the impact of two continuous variables i.e., level of polymer, milling speed and one categorical (milling screen type) factor on particle size distribution (PSD), disintegration time and dissolution of extrudates. Results: The significance (p) value for studied response variables i.e., percent retention on 40 mesh ASTM sieve (420 µ), disintegration time and percent drug release in 15 min were 0.006, 0.0243 and 0.0355 respectively from the actual by a predicted plot which signifies that the model is significant. The polymer-to-drug ratio has a significant impact on drug release and disintegration time of extrudates. Conclusion: Pazopanib HCl extrudates were successfully prepared by HME technique. Critical formulation and process parameters such as polymer to drug ratio, milling screen size and milling speed were optimized using FFD.
EnglishCQAs, FMEA, Heatmap, QbD, QTPP, Risk management
Introduction
In the 21st century, “Risk Management Principles” are most commonly and effectively employed in various areas of business operations such as finance, safety, public health including biological and pharmaceutical research domain.1 The main objective of pharmaceutical development is to design a quality product and its manufacturing process to deliver consistently the intended performance of the drug product.2
In past decade, the traditional quality by testing (QbT) approach was used to ensure the quality of drug products by checking it against the regulatory specifications.3 Quality by design (QbD) is described in ICH Q8, Q9 and Q10 guidance documents. QbD principles promote systematic, scientific knowledge-based development for continuous improvement of pharmaceutical drug products. The product or process knowledge, risk assessment and its management, quality management system (QMS) along with the use of process analytical technology (PAT) are tools for successful product development.4 Now a days, pharmaceutical industries are more focusing to develop and integrate the quality systems within organizations practices; hence, quality risk management is a valuable and main component of an effective quality system.5
Pazopanib HCl is a potent tyrosine kinase inhibitor that inhibits angiogenesis through the VEGFR receptor and blocks tumor growth. This drug molecule has been used in the treatment of renal cell carcinoma and other malignancies. It is a poorly water soluble and highly permeable class II drug of Biopharmaceutics Classification System (BCS). The recommended maximum daily dose of Pazopanib HCl is up to 800 mg, administered as 4 tablets of 200 mg strength.6 The goal of this study was to identify, ranking and mitigation of process associated risksto the drug product critical quality attributes(CQAs) during the development of Pazopanib HCl HME extrudates using QbD elements and risk management tools.7
It is hypothesized that HME polymer physicochemical properties will have a major impact on the qualities of drug extrudates, since the HME polymer is major component. The aim of the present study was to optimize polymer to drug ratio to get maximum miscibility and obtain a Pazopanib HCl extrudates (PZP-Ex) with faster disintegration time and drug release. The critical process parameters (CPPs) such as milling screen size and milling speed during extrudate preparation and its impact on extrudates PSD, disintegration, and dissolution time were also studied.
Commonly used material such as Affinisol HPMCas HME polymer and poloxamer 188 as plasticizer were used in current study. The outcomes from this study may provide a way forward to other researchers in developing HME extrudates with better compressibility and desired attributes, such as faster disintegration time and dissolution.
Materials and Methods
Materials
Pazopanib HCl active pharmaceutical ingredient was gifted from Sun Pharmaceutical Industries Ltd., Gurgaon, India. The cellulosic polymer Affinisol HPMC HME 15LV was donated by Dupont (Nutrition and Biosciences, USA). Other ingredients such as Poloxamer 188 were obtained from BASF Corporation (Mumbai, India). All other chemicals and solvents used in this study were of analytical grade.
Methods
QbD elements and risk assessment procedure
The main component of product development by QbD are quality target product profile (QTPP), critical quality attributes (CQAs),design of experiments (DoE), risk assessment and control strategy.8 Control strategy is generally defined based on the scientific knowledge gained during product development and experimentation, which establish the relationship between formulation and process variables that must be controlled to develop high quality product.9,10 Quality risk assessment process is utilized for identification, analysis, evaluation and mitigation of risks related to intermediate in process quality assurance (IPQA) and during production check quality assurance.11 A general process flow for quality risk assessment (QRA) are described in figure1.
Preparation of Pazopanib HCl HME Extrudates (PZP-Ex)
The Pazopanib HCl extrudates (PZP-Ex) was manufactured as per below mentioned formula in Table 1. Initially Affinisol HPMC 15 LV polymer, poloxamer 188 and pazopanib HCl drug were mixed in rapid mixer granulator for 5 minutes at slow impeller speed. Then prepared premix was extruded using a hot melt extruder instrument. Hot melt extrusion were carried out using co-rotating twin-screw extruder (Thermo-scientific) fitted with various screws containing kneading elements at 30° and 60 ° orientation. The feed rate of the premix material and the screw speed were kept constant at 2 g/min and 100 rpm respectively. The barrel temperature was kept as (100/180/180/180/180 °C) for different trials. The extrudates were kept at room temperature prior to milling operation. A Quadro Comil (Fitzpatrick) was operated at defined speed with forward knives fitted with suitable size screen to mill the extrudates. The 16 # ASTM (1204 µm) to 20 # ASTM (850 µm) powder fraction was collected and further used for disintegration and dissolution testing.
Heat map
In heat map, the level of risk (low/medium/high) is assigned through colour. Risk coding is based on prior scientific knowledge including experimental outcomes and justification is provided for assigned risk in each cell considering severity. The green colour has been coded for low risk, yellow for medium risk and red for high risk.12
Failure mode and effect analysis (FMEA)
FMEA is an exhaustive technique thatcan help us to determine the potential failure modes and its causes, potential failure effects, severity rank of the failure effect, occurrence rank of the failure, current detection mode and its failure rate. Hence, risk assigned in heat map and FMEA shall be mitigated based on the scientific rationale and through execution of experiments.13 Refer below tables for risk level, RPN range, colour criteria and scoring criteria for failure mode and risk analysis (Table 2, 3).
Experimental trials
DoE approach was employed for systematic optimization of formulation and process variables during Pazopanib HCl extrudates (PZP-Ex) preparation. A full factorial design (FFD) was selected with three factors and two levels (low and high) as shown in Table 4. The polymer-to-drug ratio and milling speed are continuous variables and evaluated at the ratio of 0.5:1 to 2:1 and 1200 -2400 rpm respectively. Whereas, milling screen size is a categorical factor and studied the impact of 40G and 50G milling screens on granule characteristics, disintegration time and percent drug release.
Results
QbD elements and risk assessment procedure
Based on the clinical and pharmacokinetic characteristics as well as the physicochemical characteristics requirements, QTPP and CQAs elements were defined to guide the development of Pazopanib HCl extrudates by HME technique (Table 5).
Preparation of pazopanib HCl HME Extrudates (PZP-Ex)
Pazopanib HCl extrudates were manufactured using hot melt extrusion technique, which are having unit operations such as sifting, mixing, extrusion and milling. Process map are described in below figure (figure 2).
Heat map
Heat map is a systematic approach employed to understand and prioritize the risk elements. In order to evaluate the impact of each variable on DPCQAs, risk coding is done.
In heat map (Table 6), variable location, parameter location and drug product CQAs is listed in the header row. For each variable, the cell is filled with designated colour for the assigned risk and justification updated. The justification is provided based on the severity.
Failure mode and effect analysis (FMEA)
Failure mode and effects analysis is a structured and systematic process to identify potential possible failures in drug product. Initial FMEA for manufacturing process of pazopanib HCl extrudates are summarized in Table 7.
Experimental trials
Based on the initial risk assessment for formulation components, experimental trials were conducted to evaluate the risk of processing steps. The experimental trial matrix and trial outcomes are depicted in table 8. All statistical analysis has been carried out using JMP Software (by SAS, version 16).
The particle size distribution of extrudates was carried out using a sieve shaker and percent retention on 40 mesh sieve size was calculated. The 16 # ASTM (1204 µm) to 20 # ASTM (850 µm) extrudates fraction was collected and further used for disintegration and dissolution testing. The disintegration time is also an important in-process material attribute and were carried out in water (n=6) at 37±20C with a sinker using disintegration test apparatus.A disintegration test of 16-20 # fraction extrudates material was carried out by holding the material in 40# stainless steel sinker. The percent drug release at 15 min time point in pH 6.8 phosphate buffer, 900 ml, type I (basket)was carried out and samples were analyzed using the validated HPLC method.
Statistical Outcomes of Experimental Trials
The DoE trials with responses were analyzed in JMP software (version 16.0) through “fit Model” approach. Based on the ANOVA and regression analysis, p value and R square value were observed from the “Actual predicted plot” for each response and recorded in table 9.
The sorted parameters (Table 10) and prediction profiler (Figure 3) indicated the impact of polymer-to-drug ratio level, milling screen and milling speed and its interaction terms on extrudates characteristics such as particle size distribution, disintegration time and dissolution. The sorted parameters for each term are summarized below:
Impact of polymer to drug ratio: Based on the sorted parameters and prediction profiler (figure 3) it can be concluded that polymer level has significant impact on studied responses and p value was found < 0.05. At optimum polymer to drug ratio (1:1), model predicted the % retention on 40#, DT and dissolution at 15 mins about 38.1%, 99 secs (1 min 39 secs) and 81.3% respectively.
Impact of milling screen size: Based on the p value from the sorted parameter results as shown above in the table 10, milling screen size has significant impact on all the studied responses. As per the prediction profiler, 40G screen size has obtained the finer granules in comparison to the 50G obtained granules.
Impact of milling speed: Based on the sorted parameters it can be concluded that milling speed has no significant impact on studied responses and p value was found > 0.05. However, from prediction profiler it was observed that% drug release decreased by decreasing the milling rpm. This might be due to slight less fine formation at lower milling speed.
Failure mode and effect analysis (FMEA)-Updated:
FMEA was updated based on DoE optimization studies results and risk was reduced to low from high or medium risk.
Discussion
In 2007, Food and Drug Administration (FDA) published guidance on defining a target product profile (TPP). The TPP provides a written statement of the overall intent of drug development program.14 QTPP and CQAs were discussed initially to design and development of Pazopanib HCl extrudates (PZP-Ex). Process map was defined for preparation of extrudates using HME technique. Initially risk was identified for the formula and process variables using risk assessment tools i.e., heat map and FMEA. The assigned risk for each unit operations were mitigated for medium and high risks process steps based on the scientific knowledge gained during the product development and through experimental trials.
In the present study, full factorial design was used for the optimization of formula and process variables and total of 10 experimental trials were executed. The DoE trials with responses were analysed in JMP software (version 16.0) through “fit Model” approach. The p-value signifies whether the model is significant or not. The p value was observed less than 0.05 for all the studied response variables i.e., percent retention on 40 # ASTM sieve, disintegration time and percent drug release in 15 min hence model was significant.
The sorted parameters and p-value are summarized for the study's responses (Table 10). The % dissolution was directly proportional to the polymer level and this might be due to the fact that a higher polymer-to-drug ratio will convert the crystalline drug into an amorphous solid dispersion state. Milling screen size may impact on extrudates granulometry due to aperture size differences between 40G and 50G mesh. 40G screen has small apertures in comparison to 50G screen. Disintegration time is likely to be impacted by the ratio of coarse to fine granules, hence 40G obtained granules show faster disintegration and percent drug release.
Conclusion
In this study, the impact of input variables on studied responses for prepared Pazopanib HCl extrudates by HME technique were successfully optimized. The Pazopanib HCl API was embedded in Affinisol HPMC polymer along with using Poloxamer 188 as a plasticizer. The main goal to carry out risk assessment for Pazopanib HCl extrudates are to reduce the process variations, probability failure rate and manufacturing process defects, thereby obtaining robust unit operations and enhancing manufacturing efficiencies. The polymer-to-drug ratio has a significant impact on drug release and disintegration time of extrudates. The key elements of pharmaceutical QbD were included i.e., QTPP, process design and understanding, CQAs, prior scientific knowledge, risk elements (Heat map and FMEA), DoE screening, and control strategy. Based on the DoE screening study, critical process parameters such as polymer-to-drug ratio, milling screen size and milling speed were optimized and proposed as 2:1, 40G and 1800 rpm respectively.
Acknowledgment: Authors are thankful to BASF, India and Dupont for providing excipients as gift sample. The authors are also grateful to authors/publishers of referenced articles, books and journals.
Source of funding: Nil
Conflict of interest: We declare that we do not have any conflict of interest.
Authors’ Contribution:
Gupta A conceptualized the research work. Also performed experimentation and analysis.
Dahima R performed the statistical data interpretation and contributed to the manuscript writing.
Abbreviations: ANOVA: analysis of variance; BCS: biopharmaceutics classification system; CPPs: critical process parameters; CQAs: critical quality attributes; DoE: design of experiments; DPCQA: during production check quality assurance; FDA: food and drug administration; FFD: full factorial design; FMEA: failure mode and effect analysis; HME: hot melt extrusion HPLC: high-performance liquid chromatography; ICH: international council for harmonization of technical requirements for pharmaceuticals for human use; IPQA: in-process quality assurance; NSAID: non-steroidal anti-inflammatory drug; PAT: process analytical technology; Pazopanib HCl Extrudates: PZP-Ex; QbD: Quality by design; QbT: quality by testing; QRA: quality risk assessment; QTPP: quality target product profile; TPP: target product profile
Englishhttp://ijcrr.com/abstract.php?article_id=4605http://ijcrr.com/article_html.php?did=4605Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-5241EnglishN2022September24Healthcare
A Short Review on "A Novel Approach in Fast Dissolving Film & their Evaluation Studies"
English2934Prajjwal GuptaEnglish Chaya RaniEnglish Kanishka ChauhanEnglish Harsh SisodiaEnglishhttps://doi.org/10.31782/IJCRR.2022.141806
In the case of chronic illnesses, fast-dissolving drug delivery systems were developed as an oral medication administration alternative to traditional dose forms. For masking the taste of unpleasant drugs and enhancing patient compliance, fast-dissolving films are now recommended over traditional tablets and capsules. Fast dissolving films consist of a very thin oral strip that dissolves in less than one minute when placed on the tongue. Customers have responded positively to dissolvable oral thin films in the form of breath strips, which have been on the market for a few years and are used to administer vitamins, vaccines and other medicinal products. In fact, the review goes through the various production methods for film preparation. The current review summarizes the majority of recent patents on fast-dissolving films. A brief analysis of the several factors considered to analyze such films has been carried out. These fast-dissolving films are better to other oral traditional dose forms in terms of delivering drugs and attaining faster therapeutic blood levels in the case of chronic diseases.
EnglishDissolution, Disintegration, Fast dissolving film, Polymer, Surfactants, Types of films
Introduction 1-4
The oral route is the most common route of drug administration delivery until now because it has several benefits over other routes of drug administration. However, the oral drug delivery system still needs to be improved due to various drawbacks related to specific patient groups, such as geriatric, paediatric, and dysplasia patients who suffer from a variety of medical conditions and have difficulty speaking. To improve these drawbacks fast dissolving tablets or orally dissolving film immersed as alternative oral dosage forms. The FDT technology allows tablets to dissolve or disintegrate without the use of extra water in the mouth. The Food and Drug Administration [FDA] defines the FDT formulation as "a solid dosage form containing medicinal compounds that disintegrate fast, generally within seconds, when put on the tongue." The orally fast-dissolving film is a novel drug delivery method for oral administration. It was produced using the technique of a transdermal patch.It consists a very thin oral strip which is placed on the tongue or any oral mucosal tissue, immediately hydrates by soaking saliva, it adheres at the site of application then it fastly disintegrates and dissolves to release the drug into the oral cavity.
Special features of oral dissolving film5,6
A very thin film
Un-obstructive
Fast disintegration and dissolving
Excellent mucoadhesive
Should not leave residue in the mouth
Give a pleasant mouth feel
Available in various sizes and shapes
Quick release
Ideal properties of fast-dissolving films 7
It should have a pleasant flavour and a pleasant tongue feel.
To resist post-manufacturing handling, it should be less friable and have excellent mechanical strength.
The drug's stability and solubility in water and saliva should be good.
It should leave the least amount of residue in the mouth.
It should dissolve rapidly in the mouth, releasing the drug instantly.
It should be compatible with the other ingredients.
Advantages 7,8
Dosing convenience
Water is not Required
No fear of choking
Taste masking
Increased stability
Patient compliance has improved.
Rapid onset of action
Handling and transportation ease
Improved bioavailability for certain active pharmaceutical ingredients
Disadvantages 9,10
As it's hygroscopic, it must be stored in a dry environment.
It also shows the granule's fragile nature.
They need specific packaging in order for the products to be stable and safe.
A high dosage of drug cannot be incorporated into an oral film.
Drugs that are unstable at the pH of the buccal cavity cannot be given.
Oral route cannot be used to deliver drugs that irritate the mucosa.
Only drug with a low dose requirement can be administered.
Taste masking-most medicines have a bitter flavour, which requires the use of a taste masking agent.
Applications of Oral Films in Drug Delivery 11
Oral mucosal transport via buccal, sublingual, and mucosal routes using OTFs might become the efficient delivery technique for therapies that need rapid absorption, such as those for pain, allergies, sleep problems, and central nervous system illnesses.
Topical applications: Using dissolvable films to deliver active ingredients such as analgesics or antimicrobial agents for wound care and other applications may be possible.
Gastro retentive dosage systems: Water-soluble and poorly soluble molecules of varying molecular weights are packed in a film format for dissolvable films, which are being evaluated in dosage forms. The films' dissolution might be triggered by the gastrointestinal tract's pH or enzyme secretions, and might be employed to treat gastrointestinal problems.
Diagnostic devices: Dissolvable films can be loaded with sensitive reagents to allow controlled release when exposed to biological fluids, or they may be used to form isolation barriers for separating different reagents within a diagnostic device to permit a timed reaction.
Classification of fast-dissolving technology 12
Fast dissolve technologies may be divided into three categories for ease of explanation.
Lyophilized systems
Compressed tablet-based systems
Fast dissolving film
Fast dissolving film 13-15
Oral films are one of the most recent advancements in the development of oral disintegrating dosage forms. They are thin, elegant films made of edible water-soluble polymers that come in a variety of sizes and forms, such as square, rectangle, and disc. The stripes might be soft or hard, opaque or translucent. They are meant to disintegrate quickly on the tongue without the need of water. Fast-dissolving films [FDFs] have a significant disintegration-specific surface area.
The films reduce the risk of choking, are easy to handle and administer, and keep a simple and conventional packaging that is simple to manufacture, solving the drawbacks of oral rapid dissolving tablets. Low drug loading capacity and limited taste masking options are two key drawbacks of these dosage forms.
A thin film with a thickness of 1-10 mm and a surface area of 1-20 cm2 of any shape is referred to as a fast-dissolving film. Drugs can be incorporated up to 15 mg in a single dosage. Due to a particular matrix consisting of water-soluble polymers, it dissolves rapidly in saliva and has a low tack for easy handling and application. The system's wet tack and muco-adhesiveness capabilities, on the other hand, are designed to attach the film to the application site when wet. Films are chosen for their flexibility and strength to aid in the manufacturing process, as well as processes such as rewinding, die cutting, and packaging.
The fast-disintegrating film is placed on the patient tongue are mucosal tissue, which gets instantly wetted by saliva. The film rapidly hydrates and sticks to the application site. It then disintegrates and dissolves rapidly, releasing the drug for oral mucosal absorption or stomach absorption when swallowed.
Formulation of fast-dissolving oral films 16
The many types of excipients that are utilised in oral films are listed below chemically inert and approved excipients should be utilised in the formulation of oral films. Depending on the characteristics of the film-forming substance, the development of dosage forms might bring a number of significant challenges. Foaming during film formation as a result of material heating or solvent evaporation, flaking during slitting, and cracking during cutting are all common issues.
Active Pharmaceutical Ingredient 15,16
The drug is incorporated in the film in concentrations ranging from 1 to 30% w/w. Fast-acting films can be used to administer a variety of drugs. Oral strips are thin, flexible films with a surface area of up to 8 cm2 that dissolve in seconds, thus molecules with a high dose and low solubility are not recommended. Antihistamines, anti-diarrheal, anti-depressants, vasodilators, anti-asthmatics, antiemetics, and other medications can be administered as fast-dissolving oral films. Dimenhydrinate can also be used to mask the taste of ODFs. Common examples of drugs incorporated into ODFs are rizatriptan benzoate, salbutamol sulphate, rofecoxib, verapamil, ondansetron, dexamethasone, cetirizine, pilocarpine, tianeptine sodium, indomethacin, etc.
Film forming polymer17
They impart the desired properties into the film, mainly hydrophilic polymers used in the preparation, as the film dissolves rapidly in the oral cavity. The type and amount of polymer employed, for example, pullulan, sodium alginate, pectin, hydroxy propyl cellulose, and hydroxy methyl cellulose, affect the film's toughness.
Film formers fall into the category of water-soluble polymers. In medical and nutraceutical applications, the use of film-forming polymers in dissolvable films has gained a lot of attention. The water-soluble polymers enable the films to disintegrate rapidly, have a pleasant tongue feel, and have acceptable mechanical properties.
By increasing the molecular weight of polymer film bases, the rate of polymer disintegration is reduced. HPMC E-3 and K-3, Methylcellulose A-3, A-6, and A-15, Pullulan, carboxymethylcellulose Cekol 30, Polyvinyl pyrrolidone PVP K-90, Pectin, Gelatine, Sodium Alginate, Hydroxy propyl cellulose, Polyvinyl alcohol, Maltodextrins, and Eudragit are just a few of the water-soluble polymers used as film formers.
Plasticizer 18,19
The plasticizer is an important component that increases the film's flexibility and minimises its brittleness.If the plasticizer is applied inappropriately, it might cause film cracking, fracturing, and peeling. The plasticizer should be added to the formulation in a 0-20 percent concentration range to affect the mechanical characteristics of the film, such as tensile strength and percent elongation. Plasticizers include PEG, glycerol, diethyl phthalate, triethyl citrate, and tributyl citrate.
Surfactant 19
Surfactants are used to solubilize poorly soluble drugs and also to solubilise or wet and disperse the film and release the active ingredients easily. Examples include poloxamer 407, sodium lauryl sulphate, benzalkonium chloride, benzethonium chloride, tweens and spans.
Sweetening agent 20,21
The mouth-dissolving films need to have good taste for patient acceptance and compliance as the films are to be taken without water and they are not swallowed but are required to disintegrate and dissolve in the oral cavity.
Sweeteners used include
a] Natural water-soluble sweetener: xylose, ribose, glucose, sucrose, maltose, sativoside etc.
b] Artificial water-soluble sweetener: sodium or calcium saccharin salts, acesulfame -K etc.
c] Dipeptide-based sweetener: aspartame
Saliva stimulating agent 22
These agents are used to increase saliva production in the mouth, which helps the mouth-dissolving films dissolve faster. Examples include malic acid, citric acid, tartaric acid, lactic acid and ascorbic acid. Citric acid is one of the most preferred ingredients.
Flavouring agents23,24
These are added for patient acceptance and compliance. The flavours selected are determined by the patients; age, the type of drug, and the taste of the drug to be masked. Synthetic flavour oils, oleoresin, and extracts produced from various sections of plants such as fruits, leaves, and flowers can all be used as flavouring agents. One can use a single flavour or a mixture of flavours. Essential oil or water-soluble extract of menthol, strong mints like sweet mint, spearmint, peppermint, wintergreen, clove, cinnamon, sour fruit flavours like orange, lemon, or sweet confectionary flavours like vanillin, chocolate, or fruit essences like apple, pineapple, cherry, and raspberry all be used as flavouring.
Colouring agent 25
Colours approved by FD & C is used for improving the appearance of film in case the drug is insoluble or for aesthetic appeal. Pigments like titanium dioxide can be used for colouring. The concentration of the colouring agent should not exceed 1% w/w.
Composition of oral thin film
Method of Manufacture of Mouth Dissolving Film
1. Casting and drying
A. Solvent casting
B. Semisolid casting.
2. Freeze-dried wafer
3. Extrusion
A. Hot melt extrusion.
B. Solid Dispersion Extrusion
C. Rolling method.
Solvent casting method26
This method is preferred for fast-dissolving buccal films, in which the water-soluble ingredient is dissolved to form a clear viscous solution, and the drug, along with another excipient, is dissolved in a suitable solvent, then both solutions are mixed and stirred before being cast in a Petri plate and dried.
Semisolid casting 27
In this process, a solution of water-soluble film-producing polymer is initially produced. The resulting solution is combined with an ammonium or sodium hydroxide-prepared solution of an acid-insoluble polymer [e.g., cellulose acetate butyrate, cellulose acetate phthalate]. The appropriate amount of plasticizer is applied, resulting in a gel mass. Finally, the gel mass is cast in the film or ribbon using a heat-controlled drum. The film is between 0.015 and 0.05 inches thick. A 1:4 ratio of acid-insoluble polymer to film-forming polymer should be used.
Freeze-dried wafer 28
It's also known as Lyophilisation or Cryodesiccation because it involves dehydrating water and lowering surrounding pressure to allow water in a substance to sublime straight from the solid to the gaseous phase. Lyophilization produces an extremely porous preparation with a high specific surface area that dissolves quickly and has increased absorption and bioavailability.
Hot melt extrusion29
In this procedure, the API is combined with the carrier, and a stable granular mass is produced and dried. So that the granules stay in the extruder for 3-4 minutes, the screw speed should be about 15 rpm. 80°C [zone 1], 115°C [zone 2], 100°C [zone 3], and 65°C [zone 4] are the recommended processing temperatures [zone 4]. The extrudate [T= 65°C] is squeezed into a cylindrical calendar to form a film. In this solvent-free method, low molecular weight and low viscosity polymers are chosen.
Solid Dispersion Extrusion
Solid dispersion is prepared by immiscible components and drugs. Finally, the solid dispersion is shaped into film by means of dies.
Rolling method30
In this approach, a drug solution or suspension is made with rheological considerations in mind. As a solvent, water or a combination of water and alcohol is employed. The carrier is rolled with a drug-containing suspension or solution. The films are cured on rollers before being cut into the desired shapes and sizes.
Evaluation parameters of fast-dissolving films
Physical Appearance
The mouth-dissolving films were checked visually for uniformity, clarity and tackiness.
Weight and thickness
Cut the films into 2cm X 2cm squares and weigh them using an electric scale. The average weight and standard deviation were obtained after three films were individually weighted. The thickness of the films was measured with a micrometre in three locations, with an average of three readings from three films and a standard deviation recorded.
Surface pH23
The pH was determined by putting the electrode of a pH metre in contact with the surface after placing the film on a glass petri-plate and moistening it with 0.5ml of phosphate buffer. The standard deviation was calculated using an average of three measurements from three films.
Drug content31
Each formulation must have three film units put in a separate 100 ml volumetric flask, 100 ml of solvent added, and the flasks constantly swirled for 24 hours. The solution must be filtered, diluted properly, and then measured at a particular wavelength in a UV spectrophotometer. As a final reading, the average of drug content of the three films must be used.
Folding Endurance31
Using a sharp blade, cut three films of each composition to the required size. Folding endurance should be assessed by folding the film in the same spot over and over until it breaks. The value of folding endurance is determined by the number of time the film can be folded at the same location without breaking.
Tensile Strength
Tensile strength is the maximum stress applied to a point at which the strip specimen break. It is calculated by the formula,
Tensile strength = Load at failure × 100 / Strip thickness × strip width
Disintegration Test32
The visual technique should be used to determine the in-vitro disintegration time of film strip. The film strip should be swirled every 10 seconds in a glass Petri dish with 10-25 ml of distilled water at 37°C. The moment at which the film begins to shatter or disintegrate was recorded as the disintegration time. The time it took for the disintegration to occur was measured.
In-vitro dissolution studies
To assess drug release, the simulated salivary fluid should be used as the dissolving media. The dissolution profile of rapid-release films was measured in a beaker with 30 ml of simulated salivary fluid [pH 6.8] as a dissolving medium and kept at 37 0.5°C. At 100 rpm, the medium was agitated. At 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10-minute intervals, aliquots [5 ml] of the dissolving media were removed and replaced with fresh medium. At specified nm, samples were spectrophotometrically analysed. All of the samples were subjected to three trials, with the average value taken. At various time intervals, the percentage of the drug dissolved was recorded and plotted against time.
Stability studies 33
The fast-dissolving films' stability should be tested under a variety of environmental circumstances. For stability experiments, the film was wrapped in aluminium foil and kept for 90 days at 2-8°C [45 percent RH], 25-30°C [60 percent RH], and 45-50°C [75 percent RH] in a stability chamber. During the stability investigation, the patches were characterised for drug content and other characteristics.
Discussion
In this review article, we have discussed the detailed study on fast dissolving film & their unique features, Ideal properties, advantages, disadvantages, applications, types of films, formulations of fast-dissolving oral films, active pharmaceutical ingredients used in the preparation of oral films, methods for the manufacturing of oral films & evaluation parameters of fast dissolving films.
Conclusion
Recently As a dosage form for mouth fresheners, fast-dissolving films have gained appeal. Meanwhile, pharmaceutical companies have noticed the technology's promise for delivering medical goods and have created many OTC items utilising it. The fast-dissolving thin film has received little attention in the literature, but it appears to be an appropriate dose form for usage in young children, particularly geriatric and paediatric patients. They combine the increased stability of a solid dosage form with the ease of use of a liquid dosage form. The availability of goods on the market is limited due to a lack of consistent techniques for preparation and analysis.
Acknowledgement: Authors acknowledge the immense help received from the scholars whose articles are cited and included in references of this manuscript. The authors are also grateful to the authors/editors/publishers of all those articles, journals and books from where the literature for this article has been reviewed and discussed.
Source of funding: None
Conflict of Interest: none
Authors’ Contribution:
Prajjwal Gupta: His contribution to this review article is that he compiles the total study based on fast-dissolving films & their parameters.
Chaya Rani: Her contribution to this review article is that she does the literature review on evaluation parameters of fast-dissolving films.
Kanishka Chauhan: Her contribution to this review article is that she does the literature review on the introduction & classification of fast-dissolving films.
Harsh Sisodia: His contribution to this review article is that he does the literature review on methods of preparation of oral films.
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