Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-524122EnglishN-0001November30HealthcarePHARMACOGNOSTIC STUDY OF FLOWER BUDS OF PUNICA GRANATUM L (PUNICACEAE) English0308S. B. BarwalEnglish Sunil A. NirmalEnglish B. B. TaloleEnglish S. C. PalSubhash C. MandalEnglishS. B. Barwal1 , Sunil A. Nirmal*1, B. B. Talole1 , S. C. Pal2 and Subhash C. Mandal3 . 1Department of Pharmacognosy, Pravara Rural College of Pharmacy, Loni, M.S., India. 2Department of Pharmacognosy, NDMVP College of Pharmacy, Nashik. 3 Pharmacognosy and Phytochemistry Research Laboratory, Department of Pharmaceutical Technology, Jadavpur University, Kolkata. *Address for Correspondence: E-mail: nirmalsunil@rediffmail.com ABSTRACT: Punica granatum Linn (Punicaceae) is commonly known as „Dalimb? in Marathi. P. granatum is a dark greenish large deciduous shrub or small tree, about 5-10 m high. In Pharmacognostic study of flower buds of P. granatum, macroscopy, microscopy, physical parameters and extractive values were studied. Flowers are 3.8-5 cm long and as much across, mostly solitary, sometimes apparently axillary and sessile. Calyx-tube companulate, adnate and produced beyond the ovary, coriaceous, lobe are 5-7 and Vulvate. Petals are 5-7, obovate, scarlet, lobes. Stamens are very numerous, inserted on the calyx below the petals at various levels. Anthers are elliptic and deliscing longitudinally. Ovary is inferior, many cells are arranged in 2 concentric circles. Style is long and bent, where as stigma is capitate. Carpals early coalescing and occurring to unequal growth becoming arranged into 2 tiers, 3 in the lower and 5-9 in the upper. These findings will be useful towards establishing pharmacognostic standards on identification, purity, quality and classification of the plant, which is gaining relevance in plant drug research. EnglishPunica granatum, Petals, sepals, Ash value, Extractive value, Moisture Content.INTRODUCTION: Punica granatum Linn. (Punicaceae) is a dark greenish large deciduous shrub or small tree, about 5-10 m in height. It is smooth and gray in colour. Leaves are opposite, 2.5-6.3 cm long, oblong-lanceolate, oblong-obovate, glabrous, entire, minutely pellucid-punctate, shining above, bright green- beneath, base is narrowed and having a very short petiole. Seeds are with a watery outer coat containing pink juice and sometimes red or whitish and a horny inner coat.[1, 2] Traditionally plant is used in the treatment of asthma, diarrheoa, dysentery, tuberculosis and bronchitis. It also used in gargle, anthelmentic, and as an astringent.[1,3] The Pharmacognostic standardization is necessary for the plant as it s a very important plant and proper identification is necessary. Hence present work was carried out, which will help for proper identification of the plant. MATERIAL AND METHODS: Plant Material: Fresh flower buds of P. granatum was collected from Ahmednagar district and authenticated by Mr. Mujumdar, Deputy Director, Botanical survey of India, Koregaon Road, Pune. The herbarium of plant specimen has been deposited at B.S.I., Pune (Voucher no. BSBP1). Qualitative Investigation: External features and organoleptic properties of flower buds, like color, odor, taste, shape and size were studied. [3] Quantitative Investigation: The moisture content, ash and extractive values of the powdered flower bud sample and the quantitative microscopy on the anatomical section of the flower bud was done. [4,5] Phytochemical Evaluation: The preliminary phytochemical investigation was done by the standard chemical tests. [5] RESULTS AND DISCUSSION: Flower buds of plant P. granatum were observed to be 1-3 cm in size and shape and is oblong. Flowers are Scarlet red colored and odorless with acrid taste. The petals are uniform in thickness except in veins. They are 40 mm thick and consist of two layers of epidermis and a single layer of medial cells. The veins of petals have small, collateral vascular bundle and parenchymatous ground tissue. The epidermal cells are squarish in shape and thick walled. The median layers of cells are rectangular and thick walled. The epidermis has radially oblong cells with prominent cuticle (Fig 1A & B). The filaments of the stamens are circular in sectional outline. The vascular elements are seen in central part forming a dark core. The ground tissue of the filament consists of small, circular, thick walled compact parenchyma cells. The staminal filament is 300 mm in diameter. The sepals are 120-150 mm thick. They have thick epidermal layers of radially oblong thick walled cells. The ground tissue is parenchymatous and compact. The ovary wall is 1.5 mm thick. It has outer and inner epidermal layers. The outer epidermis is thick and stomatiferous. The cells are small and squarish in shape. The inner epidermis is slightly wider with radially oblong cells. The vascular strands are scattered in the ovary. The median strands are larger than outer portion, which are smaller and less prominent. The ground tissue consists of numerous layers of circular, thick walled compact parenchyma cells (Fig 1C). The vascular bundles are thick and prominent in its midrib region (Fig 1D). The anthers are dioceous with four chambers. The anthers wall has radially elongated cells with spiral thickenings. This layer is called endothecium. Outer coat of endothecium is a single layer of spindle shaped and these walled cells which constitute the endothecium have disintegrated during pollen development (Fig 1E). The pollen grains are elliptical in outline in polar view with wide vertically elongated aperture and it is 30 to 40 mm in size. In equatorial view, the pollen is circular with three colpi. It is 40 mm in diameter (Fig 2B). The seeds are duel shaped with seed coat. The seed surface is smooth and shining. It is dark brown and nutlike. It is 850 mm long and 450 mm thick at the wider end (Fig 2A). The physical constant evaluation is an important parameter in detecting adulteration or improper handling of the drug. Various ash values are important to determine purity of the drug i.e. the presence or absence of foreign organic matter. Since the plant P. granatum is useful in the traditional medicine for the treatment of some ailment, it is important to standardize it for use as a drug. The pharmacognostic constants for the flower buds of this plant, the diagnostic microscopic features and the numerical standards reported in this work could be useful for the compilation of a suitable monograph for its proper identification. The extracts obtained after extraction was characterized by preliminary phytochemical test for rough ideas of main constituents present in the extracts. Petroleum ether extract showed presence of steroids, triterpene acids and Chloroform extract contain steroids, triterpene acids and alkaloids, while alkaloids, saponins, flavonoids, tannins and carbohydrate were found in Ethanol extract. Aqueous extract showed presence of saponins, flavonoids, tannins and carbohydrate. Englishhttp://ijcrr.com/abstract.php?article_id=2265http://ijcrr.com/article_html.php?did=22651. Kirtikar KR, Basu BD, Indian Medicinal Plants, 2nd Edn, Vol.I, International Book Distributors, Dehradun, 1991, pp. 667-670 2. Anonymous, The Wealth of India, 1st Edn, Vol.V, Council of Scientific and Industrial Research, New Delhi. 2004, pp. 24-26,317-324. 3. Nadkarni KM, Indian Materia Medica, 3rd Edn, Vol.I, Bombay Popular Prakashan, 1982, pp.1031- 1032 4. Indian Pharmacopoeia, 4th Edn , VolII, The controller of publications, New Delhi, 1996,pp. A-53, A-54, A- 89. 5. Khandelwal KR, Practical Pharmacognosy Technique and Experiments, 23rd Edn, Nirali Prakashan, Pune, 2005, pp. 15-29, 149-56.

Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-524122EnglishN-0001November30HealthcarePOTENTIAL OF SOFTWARE SOLUTIONS IN EFFECTIVE PHARMACY MANAGEMENT: A SURVEY English0915Shailini.YEnglish D.SreedharEnglish Manthan JEnglish Prashant MEnglish Ajay.PEnglish N.UdupaEnglish Virendra S. LigadeEnglishPharmacy is a place, a career, and sometimes a business. A pharmacy is a place where licensed pharmacists dispense medicine on receiving a valid prescription written by a legal prescriber. A pharmacy is not a drugstore. Some businesses today do not have pharmacies, but do sell medicines bought without a prescription (over thecounter drugs, or OTCs). A pharmacy can be a free-standing building, or it may be found inside other places like a drugstore, a medical office building, or a hospital Pharmacists are registered by a board of pharmacy, and therefore are designated registered pharmacist. However, this title is only conferred after passing rigorous national, state practice, and law examinations. Pharmacists must always be vigilant for counterfeit prescriptions written by drug abusers who are trying to get narcotics and other controlled substances illegally. Pharmacy also means the practice of pharmacy as a profession. Pharmacy is an information intensive profession. The availability of affordable computers and the advancement of information technology have resulted in our ability to rapidly and effectively access, retrieve, analyze, share, and store large volumes of information pertinent to patient care.     EnglishPharmacy Management System- An Overview ? To facilitate operational efficiency across the chain, managements need to arrange the right-fit, Pharmacy management system. ? Addressing the shortage of pharmacists by streamlining and automating workflow process steps. ? Streamlining operations through data sharing across store locations allowing patients to order / refill their Rx from any store. ? Segmentation of work process for efficient division of labor. ? Systemic data checks to scan impact of drug combinations or drug allergies to ensure patient wellness and provide counseling to improve relationships with the patient ? Enhancing customer satisfaction levels and repeat business through timely and consistent customer service Applications of Software in Pharmacy Management Pharmacy management software is a versatile software solution that cuts down Reports generation time and increases quality and accuracy of the information. Margin on Item(s) or Customer(s), Sales Invoice, Party Ledger, Batch-wise Stock Position Report, Sales Analysis Report, Customer or Supplier Enquiry, Debit Note, Credit Note etc. Software can generate instant up-to-date Balance Sheet, Profit and Loss Statements, Ledgers and information on Batch-wise Stock Position, Area-wise or Collection-boy-wise Outstanding Statements. All these will lead to full utilization of manpower, and enhances business. Objective of the study: ? To understand the spread of Pharmacy management software Research Methodology: ? A Self administered questionnaire survey was used to extract data from Pharmacies from four different regions of the State of Tamilnadu and Karnataka, i.e., Chennai, Coimbatore, Thirunelveli, Vellore and Mangalore. ? The Sample size used for the study was 106 pharmacies. The city included were Thirunelveli,: 23 pharmacies 20 pharmacies of Coimbatore, 30 pharmacies of Chennai and 24 pharmacies of Vellore, and 9 pharmacies of Mangalore. The non probability connivance method of sampling is used for the study. ? The survey was constructed to elicit information in nine primary domains relevant to identifying training needs and system barriers to the expanded use of technology in pharmacy management. ? The parameters used for study were : Computer Experience, Computer Anxiety, Basic Computer Skills, Internet Skills , Database Information, Access to Computers, Anticipated Future Needs ? Questions were limited to the hardware, software, and online resources that were currently available to the Pharmacies. ? The right choice will depend on factors like size, geographical spread and complexities of each organization. Their current state with respect to system sophistication and process standardization are also important considerations. ? Some critical factors that must be considered from the economic and implementation perspectives include: •Effort and cost involved in mounting or purchasing the base version. • Attempt required organizing the base version across a number of stores. •Development of user training modules and ease of transition. •Estimated long term maintenance effort and costs. •Effort and documentation for support team to stay abreast of developments. •Flexibility and ease of enhancements for future business needs. •Ability to run different versions in production, test and development for different environments and different applicationsThe use of software in Pharmacy is at nascent stage in these selected regions. The Wondersoft is generally used followed by Medisoft, Pharmasoft, Wipro, I Soft, Hautomate Softscript. The retail pharmacies need to consider the economics and their commitment to any option prior to undertaking a pharmacy management system initiative. Equally important is conducting a thorough due carefulness exercise to identify challenges and strategies for their mitigation. Choosing the right pharmacy system has been one of the tougher questions faced by pharmacies. However, successes in this area show that it is a critical decision that needs to be evaluated and planned for carefully with a 5- 10 year roadmap in view. Retailers will need to evaluate their specific environment for opportunities, constraints and their long term vision before deciding whether an approach is aligned with their specific objectives Englishhttp://ijcrr.com/abstract.php?article_id=2266http://ijcrr.com/article_html.php?did=2266References: 1. Pharmacy software or pharmacy Management Software, http://www.itbroadway.com/products _esselpharmasoft.html, [cited on Dec 22nd, 2008 at 2.30pm]. 2. Software( PharmacyManagement) PharmacyMarketplace,http://www.p harmacychoice.com/marketplace/cat egory.cfm/listing/Pharmacy_Manage ment_Software,[cited on Dec 27th, 2008 at 5.00pm] 3. http://www.freepatentsonline.com/61 95612.html,[cited on Dec 27th, 2008 at 5.20pm]. 4. Emergis launches next-generation pharmacy management software. http://www.pressreleasepoint.com/e mergis-launches-nextgenerationpharmacy-management-softwareand-connects-sobeys-pharmaciespei-drug,[cited on Jan 8th, 2009 at 8.00pm]. 5. American Journal of Health-System Pharmacy .[cited on Apr 16th, 2009 at 4.30 pm] 6. http://www.knowledgespeak.com/ne wsArchieveviewdtl.asp?pickUpID=5 344and pickUpBatch=809,[cited on Feb 21st, 2009 at 9.00 pm] 7. Kelly, William N, What is Pharmacy, Pharmacy: What it is and how it works, CRC Press Pharmacy education series, 2002 / 36 / 1-14. 8. Symons, Allene. “Drive-throughs, teens create pharmacy shrink challenges.” Drug Store News, Nov. 23, 1998. 9. Agnese, Joseph. “Large Retailers Differentiation Efforts Paying Off.” Supermarkets and Drugstores, Jan. 24, 2008. 10. Frederick, James. “Walgreens? Rx business roars on.” Drug Store News, March 15, 1999. 11. Alexander, Antoinette. “Retail clinics take root in diverse locations.” Drug Store News, April 21, 2008. 12. Davis, Joyzelle. “In-store clinics shake up health care.” Scripps Howard News Service, June 16,2007 13. Hopper, Teresa, Pharmacy Management Software for Pharmacy Technicians, Mosby Publication, June 31, 2007/4/15-39 14. Durgin, Jane M, Pharmacy Practice for Technician, DAA Publication, 2007/I/137-210. 15. Damle, Parag; Puri, Kunal, The Right Pharmacy Management System, Infosy series, May 2007/1-9 16. Desselle, Shane; Zgarrick, David, Pharmacy Management, Mc Graw Hill, 2005/257-290

Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-524122EnglishN-0001November30General SciencesPRESENT SCENARIO OF INDIAN FORESTS AND THE LAWS WHICH SAVE THEM English1623Aarti BagdiEnglishThis study aims at highlighting the issues related to Indian forests and the forest dwellers. “Making laws and implementing those laws” by the country are two different things, but they are quite lacking in context of forests. Forests are the great source of economy to our country, but the rapid destruction is the subject to think on. Who is responsible and how it can be overcome? are the questions which really need an answer. So some emphasis should be led down to save them in terms of Eviction, Depletion and Deforestation. Figures and graphs mentioned in the article facilitate to compare the current situation with the past. Resultant of depleted forests like global warming, heavy soil erosion, extinction of species (eg. Only 1411 tigers are left) are the matters of concern. Our purpose is to motivate the common man if the policy makers are sleeping, to initiate and plant trees to “save our planet” EnglishIndia is a developing Nation with the land area of total 328.7 million ha. of which 142.5 million ha. (43.3%) is under agriculture, Forests cover 76.5 million ha. (23.27%). According to the State of Forest Report (FSI 1997), the actual forest cover is 63.34 million ha (19.27%) of which 26.13 million ha. are degraded, (NFAP 1999). About 300 million tribal and other local people contribute to the “forest people” population of the country, and are the most disadvantaged section of society, subsist from forests. Government is running Programs and Acts to address to the issues and problems related to the “Forests” and “Forest people”. Do the forest recourses and a part of population of tribal people living in forests is safe under these Acts and Policies? Government Forest Policy and Acts Government of India under Ministry of Environment and forest, enunciated a policy called “National Forest Policy”, 1988. Its basic objectives are:- 1. To ensure environmental stability and maintenance of ecological balance. 2. To conserve the natural heritage of nation. 3. To Increase the productivity of the forests. 4. To check soil erosion. 5. To meet the requirement of fuel wood, fodder, minor forest produce and small timber of the rural and tribal populations. 6. To encourage reforestation to increase the forest cover. Secondly, we have National Forestry Action Programme (NFAP) The National Forestry Action Programme is a comprehensive strategic long-term plan for the next 20 years to address the issues underlying major problems of the forestry sector in line with the National Forest Policy, 1988.Its objective is:- 1. To bring one-third area of the country under forest/tree cover. 2. To arrest deforestation for achieving sustainable development of forests. Thirdly, we have Indian Forest Act, 1927, The Indian Forest Act, 1927 was largely based on previous Indian Forest Acts implemented under the British. The first and most famous was the Indian Forest Act of 1878. It provides legal framework for management of forests in the country. In some States, the Act is applicable as it is, while some of the States have enacted their own which in essence, are the adopted versions of the Indian Forest Act 1927. Both the 1878 act and the 1927 one sought to consolidate and reserve the areas having forest cover, or significant wildlife, to regulate movement and transit of forest produce, and duty leviable on timber and other forest produce. It also defines the procedure to be followed for declaring an area to be a Reserved Forest, a Protected Forest or a Village Forest. It defines what is a forest offence, what are the acts prohibited inside a Reserved Forest, and penalties leviable on violation of the provisions of the Act. Reasons behind the reduction of forests in India:- 1. The heavy pressure of population on land. Having about 2.5% of world's geographic area, India at present is supporting 16% of planet's human population and 18% of cattle population. The forest cover has been reducing both in quality and extent. 2. Lack of regeneration. 3. There are serious problems of encroachment, grazing, forest fire, shifting cultivation and illegal felling. Note: Between 1950 and 1980 India lost about 4.3 million ha. of forest land for non-forest use like growth of agriculture, heavy industries and other developmental process. A recent World Bank report estimated that due to degradation and deforestation the loss has been up to one million ha. per year during 1970s to 1980s. Forest people: The Adivasis, the original inhabitants of forests, most of the areas that now come under the Parks and the Protected Areas, appreciate the concern shown by the Congress towards the „needs of the people?. For e.g. “The Nagar Hole national park is now a part of the Nilgiris Biosphere Reserve -- one of the 440 biosphere reserves in 97 countries where the UNESCO is implementing the Man and Biosphere program. Nilgiris was the first internationally designated biosphere reserve in India. Several ethnic groups had inhabited the area from time immemorial. In 2000 there were 11,60,200 permanent inhabitants within the biosphere reserve subsisting on the use of natural resources such as medicinal plants, agriculture and agrihorticulture.” Over 9,000 indigenous people were residing in 58 hamlets, apart from those who lived within the forests, there were more than 23,000 adivasis residing within 5 km distance, all depending on the Nagar Hole forests for their survival called the National Park. Under the UN scheme for the Biosphere Reserve, the forests, the animals, the birds, the agriculture and the human being ought to have been protected for their uniqueness. But the government agencies continued to violate this norm for lucrative business interests. The natural forests were extensively logged and substituted with plantations of teak, eucalyptus and rosewood. Nearly 15 per cent of the area within the National Park is now under plantations. the government agencies continued to violate this norm for lucrative business interests. The natural forests were extensively logged and substituted with plantations of teak, eucalyptus and rosewood. Nearly 15 per cent of the area within the National Park is now under plantations. Evictions: Governments have been systematically pushing out the adivasis to the forest fringes. In 1970s, a total of 1220 families consisting of more than 6000 people were pushed out to locations 1-12 km from their original habitats To help these people who reside in forest areas through out the country, the FPP is under play. The Forest Peoples Programme (FPP) It is a non-governmental organisation, founded in 1990 that aims at: > campaigning for the rights of indigenous forest people. > bridges the gap between policy makers and forest people. > Advocacy, practical projects and capacity building . Forest Peoples Programme (FPP) advocates an alternative vision of how forests should be managed and controlled, based on respect for the rights of the peoples who know them best. FPP works with forest peoples in South America, Central Africa, South and South East Asia, and Central Siberia to help these communities secure their rights, build up their own organisations and negotiate with governments and companies as to how economic development and conservation is best achieved on their lands Suggestions: How to save forests? 1. Use less paper and avoid its misuse. 2. Aware the people about the harmful effects of depletion of forests eg. Global warming, pollution, extinction of species etc. 3. Planting trees on land where forests have been cut down. 4. Use mobile and save paper (IDEA plan for saving paper). 5. Public propaganda should be there regarding the long term advantages of forests. 6. Forest fires should be prevented. 7. Recycle paper usage should be promoted. 8. Act as a volunteer, participate in environmental issues and programs and save the “mute living trees”. 9. Everyone should plant more and more trees. Recent news and Amendments: 1. Tamil Nadu to implement National Forest Policy: to increase the forest cover area in the country to 33 per cent through the multi-pronged approach of Tamil Nadu Afforestation Project. 2. Goa has its own Forest Policy: This state policy will take care of Forests, Forest dwellers, everything in totality. Policy3. NGO for medicinal plants under Forest : Omkar Mission Research Institute is demanding plantation of medicinal plants under target set by Central Govt. to reach 33% forest cover by 2012 following NFP, 1988. Revision of NFP,1988 due to 73 and 74th constitutional amendment: The 29 functions recommend for the decentralization to the Panchayat Raj Institutions listed in the 11th schedule include "Agricultures, Land reforms, Land improvement and management, Minor irrigations, Water management, Watershed development, Animal husbandry, Fisheries, Social and Farm forestry, Non - Timber Forest Produces (NTFPs) and maintenance of community assets, Management of state owned forestlands is not included but may be specifically notified by individual State Governments. Indian Forest Act: The 42nd Constitutional Amendment shifts forests from the “State List” to the “Concurrent List”. The FCA prohibits non-forest use of forest land without the government?s approval. It also advocates “sustainable forest management through participatory approach”, with “due regard to the traditional rights of the tribal people on forest land”. Forest- related provisions in the Constitution of India: according to 48A the “state shall endeavor to protect and improve the environment and safeguard the forest and wildlife of the country”. Article 51A of constitution include fundamental duty of every citizen to protect and improve the natural environment involving forests, lakes, wildlife, rivers, living creatures. Conclusion: All the facts, policies, programs and figures mentioned here are reflecting the current situation of forests and the part of population living their in forests. It is a matter of great concern that forests should be preserved and the eviction of the poor people should be abolished to avoid the upcoming harm to the forests. “It?s not important that how many people are motivated, but it is important that how many implement that motivation in their life.” Besides that, our ministers should also think in the direction more seriously and come up with an “accurate fruitful solution”. Englishhttp://ijcrr.com/abstract.php?article_id=2267http://ijcrr.com/article_html.php?did=22671. “Who drove the policy, changes in forestry sector in India” by Ms Sumana Datta, accessed on 20th Jan 2010. 2. “Indian Forest Act, 1927, National Forest Policy (NFP) 1988, National Forestry Action Programme. (NFAP)”, accessed on 23rd Jan 2010. 3. “Save Forests and Wildlife” Naira Yaqoob, accessed on 30th Jan 2010. 4. “The National Forestry Action Programme”, 5. National Forest Policy ReviewIndia by Indian Institute of Forest Management accessed on 2nd March 2010 6. “Assam Forest Policy 2004” www.envisassam.nic.in/forestpolicy.asp, accessed on 3rd March 2010. 7. The Times of India, Flora and Fauna, Oct?2009, accessed on 3 rd March 2010. 8. THE HINDU, Feb?2008. accessed on 5th March 2010. 9. Expressindia, R. Raghavan, Sep?2007, accessed on 5th March 2010.

Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-524122EnglishN-0001November30TechnologyROLE OF PROCESS ANALYTICAL TECHNOLOGY (PAT) English2432B. Stephen Rathinaraj*English S. SudharshiniEnglish Ganesh Sheshrao BangaleEnglishEnglishIntroduction: According to the FDA, PAT is: "a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and inprocess materials and processes with the goal of ensuring final product quality." The goal of Process Analytical Technology is: "to understand and control the manufacturing process, which is consistent with our current drug quality system: quality cannot be tested into products; it should be built-in or should be by design." Development of technology and updating the current practice in pharmaceutical industry plays a major role in compliance with the regulatory bodies. Validation is the key word in compliance of cGMP. Recently FDA attitude towards process improvement is a key drive of Process analytical technology (PAT.); simply putting from PAT is real time testing and adjustment based on a full understanding of how the components affect the final products. Process analytical technology has been described as the pharmaceutical industries drive to provide real-time information to characterize and control process variation and manufacturing capability. Process analytical technology is a system for designing, analyzing, and controlling manufacturing through timely measurements of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality. It also involves the use of raw material properties, manufacturing parameters, and process monitoring and chemo metric techniques to produce finished products of acceptable quality. PAT will save the pharmaceutical industries money, time, product, and hours in less testing. PAT made us to understand of all of the chemical process and how each of the components will effect the final products, which will leads to overcome the huddles in process production and regulatory compliances by improving the process methodology. Process analytical technology can be applied to bulk formulation, inbound logistics, Active ingredients manufacture, Fill and finish, packing and outbound logistics. The potential benefits of PAT are to provide processes which consistently generate products of predetermined quality in an efficient and expected form. reduction of cycle times using on-, in-, or at-line measurements and controls, prevention of rejection product and waste, real time product release, increased use of automation, cost savings, Regulatory relief, facilitation of continuous processing using small-scale equipment, resulting in improved energy and material use and increased capacity. Mapping and Image Studies:1 On a micron or sub-micron scale, solid samples such as powders, pressed tablets or cast films typically exhibit nonhomogeneous mixing of components. This results in regions that are disproportionately more concentrated in individual components, which can have major impact on stability, delivery and other physical properties of the product. SSCI's powerful analytical techniques provide a wealth of chemical and physical information on specific microscopic regions of solid samples. Some of the most prominent techniques are: Infrared spectrosopy (FTIR) Raman Spectroscopy Near infrared spectroscopy (NIR) X-ray powder diffraction (XRPD) Electron diffraction (EDS) Atomic force microscopy (AFM) and Micro thermal imaging While traditional application of these techniques involves examination of a single location in the sample and subsequent collection of the chemical or physical information from only that isolated area, new imaging techniques involve automated data collection from multiple locations over a large area of the sample. This allows visualization of qualitative distribution, identification of majority or trace components, or more accurate quantitative analysis. Imaging2 Imaging is a general term for collection (usually automated) and analysis of data from a large number of locations on a sample. Collection of the data array can be accomplished in several ways. The two most common methods of collecting data are use of an array detector, where data for the entire image are collected simultaneously, and automated mapping, in which analysis is carried out a number of discrete points. SSCI Inc. makes use of both methods of data collection. SSCI scientists can carry out distribution analyses where each measurement represents an area as small as from 50 um to 1 A depending on the technique. Small particles or domains can be observed that would not be resolved with single analysis of the entire area. Distribution of a single component is easily visualized. Investigation of interfacial interactions is possible by observing differences between adjacent pixels. The array can be processed repeatedly, observing different chemical or physical signatures. Use of these techniques can produce any number of diagnostic presentations of the total sample area. Imaging over a large area provides a more representative analysis of the sample for quantitative applications. Each pixel of the image provides a full spectrum that can be compared to spectral databases of known compounds for specific identification. Trace particles as small as a single pixel can provide a pure spectrum of a contaminant that would be undetectable in a single analysis of the entire sample area. Individual spectra from each pixel allow quantitative distribution within the area analyzed. Reprocessing provides a more accurate quantitative analysis of the bulk material. FTIR Imaging FTIR is well accepted as a methodology for chemical and structural analysis of organic products, providing a unique "fingerprint" spectrum of each molecule. The resulting spectrum is also diagnostic for subtle changes in the chemical or physical properties of the sample. Each FTIR spectrum represents an area of the sample as small as 10 um, and distribution of a single component is easily visualized. With proper selection of conditions, FTIR can overcome limitations of Raman and NIR. FTIR is often limited by the presence of water or the need to sample through glass, either of which produces significant spectral interferences. SSCI scientists have extensive experience analyzing solid-state composition in final dosage form. composition in final dosage form. Raman Mapping3 As with FTIR, Raman spectra are unique, allowing unambiguous chemical identification. Raman is highly sensitive to the local molecular environment such as changes in crystal structure or subtle chemical modifications, but Raman does not suffer the material limitations inherent to infrared spectroscopy since both glass and water exhibit minimal Raman spectral interferences. Each Raman spectrum represents an area as small as 1 um. Raman occasionally suffers from fluorescence, a sampledependent spectral interference. NIR imaging Near infrared spectroscopy offers many of the advantages of FTIR and Raman, but overcomes some of the limitations. NIR offers the same advantage over FTIR as Raman, in that neither glass nor water interferes with the analysis. Each NIR spectrum represents an area as small as 1 um. NIR spectra result from absorption of overtones and combination bands from the mid infrared region, therefore, chemical or physical differences detected by FTIR also affect NIR data. NIR occasionally suffers from a lack of spectral specificity that is available with FTIR or Raman. X-Ray Powder Diffraction Mappin X-ray diffraction addresses an entirely different aspect of solid analysis and provides highly reliable analysis of the solid-state form of a material. An XRPD mapping study can, for example, provide information about the solid form composition at different regions in a tablet or identify the presence of a trace amount of a particular solid form. Each diffractogram represents an area as small as 50 um. XRPD offers limited chemical information as compared to FTIR, Raman or NIR. EDS Imaging4 Energy dispersive spectrometry (EDS) combines the advantages of scanning electron microscopy (SEM) and elemental analysis. Samples interrogated by SEM can be analyzed for elemental content by EDS under similar conditions of magnification and sampling environment. Each point represents an area as small as 1A . AFM and Micro Thermal Imaging AFM and micro thermal techniques offer physical resolution of surface structure as small as 1 A and present a topographical representation of the sample surface with much greater resolution than SEM. Contact and noncontact AFM provide topographical imaging of the surface of conductive and non-conductive materials, as well as surfaces that are soft and pliable. Micro thermal imaging adds a significantly different dimension, imaging the sample based upon differences in thermal conductivity of the materials on the surface Stability, Solubility, Dissolution Stress testing can reveal differences in the physical and chemical stabilities of various solid forms. Modes or rates of degradation can often be associated with particular solid forms such as polymorphs or solvates, since certain lattice types and modifications are more prone to degradation than others. We conduct high-temperature, highhumidity, and light-exposure degradation studies to identify and quantitate physical and chemical changes (XRPD and HPLC, respectively). Our cGMP degradation studies can determine both the chemical stability and the solid-state stability of your drug substance, drug product, or chemical. Dissolution rates often vary considerably with solid form. Dissolution tests are often used to ensure that production processes are under control. We determine dissolution rates and equilibrium solubilities using intrinsic and non-intrinsic methods P.A.T. and Pharmaceutical Quality by Design Process Analytical Technology (PAT) is a system for designing, analyzing, and controlling manufacturing processes based on 1) an understanding of the scientific and engineering principals involved and 2) identification of the variables which affect product quality. The PAT initiative is consistent with the current FDA belief that quality cannot be tested into products, but should be builtin or by design. According to the FDA draft guidance, the desired state of pharmaceutical manufacturing is that: ? Product quality and performance are ensured through the design of effective and efficient manufacturing processes ? Product and process specifications are based on a mechanistic understanding of how formulation and process factors affect product performance ? Quality assurance is continuous and real time ? relevant regulatory policies and procedures are tailored to accommodate the most current level of scientific knowledge ? risk-based regulatory approaches recognize both the level of scientific understanding and the capability of process control related to product quality and performance The primary goal of PAT is to provide processes which consistently generate products of predetermined quality. In so doing, improved quality and efficiency are expected from: ? reduction of cycle times using on-, in-, or at-line measurements and controls ? prevention of reject product and waste ? real time product release ? increased use of automation ? facilitation of continuous processing using small-scale equipment, resulting in improved energy and material use and increased capacity Building Quality into Products5 Effective PAT implementation is founded on detailed, science-based understanding of the chemical and mechanical properties of all elements of the proposed drug product. In order to design a process that provides consistent product, the chemical, physical, and biopharmaceutical characteristics of the drug and other components of the drug product must be determined. Although the science of analyzing for chemical attributes such as identity and purity is mature, certain physical attributes such as solid form, particle size, and particle shape are more difficult to analyze and control. SSCI is uniquely experienced to address this aspect of PAT. Given a compound of interest, our scientists routinely: ? Determine the solid forms attainable and their relevance to manufacture and use ? Select the optimum solid form ? Develop analytical methods to verify the presence of, and quantify the concentration of, the selected form in API ? Investigate the physical properties of the solid such as particle size, particle shape, stability, ease of drying, filterability, solubility, dissolution rate, etc. ? Develop a manufacturing process that consistently provides the desired form of the API having the desired physical characteristics ? Aid in setting API specifications ? Determine excipient compatibility ? Aid in formulation design ? Develop drug product manufacturing strategies that are consistent with the solid properties of the API ? develop analytical methods to verify the presence of, and quantify the concentration of, the selected form in drug product ? aid in setting drug product specifications SSCI scientists have extensive experience solving solid-state problems in drug products. Process Control6 Once the properties of the drug product components are understood, the processing variables that control the relevant properties must be identified. Identification of these variables necessarily requires a multivariate approach. From a solid-state point of view, PAT implementation involves the design of manufacturing processes based on a thorough scientific understanding of the solid-state properties and stability of the components of the drug product at critical points throughout manufacturing. Then, measurement and control of the critical parameters integrates a broad spectrum of analytical technologies interfaced to production plant control networks and incorporated into standard procedures. SSCI works with clients to establish specific process understanding and design process analytical control strategies. Building upon the current SSCI reputation for meticulous cGMP pharmaceutical research and analysis, SSCI can assist clients in all aspects of PAT implementation, including: ? Process understanding through advanced solid-state research ? identification of critical control variables using multivariate techniques ? Development and validation of appropriate analytical methods for measuring critical control variables ? Transfer of analytical methods to on-, in-, or at-line use ? Consultation and assistance in method validation and use after transfer Potential Regulatory Impact7 FDA presentations indicate their anticipation that PAT implementation will eventually change the regulatory process. Documentation of quality by design during the pre-IND meeting, the end of phase II meeting, and in regulatory submissions will allow early review and analysis of the CMC section of an NDA by the FDA. Addressing issues of concern and further quality by design can result in classification of the drug substance and drug process manufacturing process as low-risk. In some cases, this approach is expected to result in a less comprehensive or eliminated preapproval inspection. While these procedural changes will not happen overnight, they present a possibility for more rapid regulatory approval and reduced time to market. We invite your queries on this important development in the pharmaceutical industry. We believe our extensive experience in cGMP solid-state research and analysis will help you meet the PAT challenges today and for the future. Conclusion: As can be seen in the above discussion, the use of PAT techniques can be a huge benefit to those who choose to use the technology. Process analytical technology provides better knowledge of raw materials, manufacturing parameters and their impact on finished product quality. This will result in more robust process, better products, more uniform dissolution results, and a huge cost savings for the manufacturer. The challenge that dissolution scientists face is to become familiar with this next generation of pharmaceutical testing and its potential application. Englishhttp://ijcrr.com/abstract.php?article_id=2268http://ijcrr.com/article_html.php?did=2268References: 1. Eriksson, L., Johansson, E., KettanehWold, N. and Wold, S., "Multi- and Megavariate Data Analysis, Principles and Applications." 1st Edition, Umetrics Academy, June 07, 2001, ch 3-4. 2. Brown, S., presented at InCINC'94 "Has the 'Chemometrics Revolution' ended? Some views on the past, present and future of chemometrics." Department of Chemistry and Biochemistry, University of Delaware 3. Wold, S., presented at InCINC'94 "Chemometrics; what do we mean with it, and what do we want from it?" Institute of Chemistry, Umea University, Umea, Sweden. 4. Zackrisson, G., Ostling, G., Skagerberg, B., Anfält, T., "Accelerated Dissolution Rate Analysis (ACDRA) for controlled release drugs. Application to Roxiam." Journal of Pharmaceutical & Biomedical Analysis, Vol. 13, No. 4/5, 377-383, 1995. 5. Adams, E., Maesschalck, R., De Spiegeleer, B., Vander Heyden, Y., Smeyers-Verbeke, J., Massart, D., "Evaluation of dissolution profiles using principal component analysis." International Journal of Pharmaceutics, 212, 41-53, 2001. 6. Adams, E., Walczak, B., Vervaet, C., Risha, P., Massart, D., "Principal component analysis of dissolution data with missing elements." International Journal of Pharmaceutics, 234, 169-178, 2002. 7. Kirsch, J., Drennen, J., "Determination of film coated tablet parameters by near infrared spectroscopy." Journal of Pharmaceutical and Biomedical Analysis, 13, 1273-1281, 1995.

Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-524122EnglishN-0001November30HealthcareQUANTITATIVE ANALYSIS OF FLUTAMIDE IN BULK DRUG AND ITS PHARMACEUTICAL DOSAGE FORM BY USING HPLC English3342S.Sudharshini1EnglishKumar ChoudhuryEnglishBhupendra shresthaEnglishA simple, rapid and reproducible high performance reverse phase liquid chromatographic method has been developed for quantitative estimation of Flutamide in tablets using a C-8 column and UV detection at 294nm. The isocratic elution was used to quantify the analyte. The samples were chromatographed on C-8 column and the mobile phase was Acetonitrile: Water (50:50, v/v) was pumped at 1 mL/min. The method was linear between 10- 125µg mL-1 , statistically validated for its linearity, precision and accuracy. The intra-and - inter day variation was found to be less than 1% showing high precision of the assay method. It was found that the excipients in the commercial tablets did not interfere with the method. EnglishFlutamide, High performance liquid chromatography (HPLC), AcetonitrileKey words: Flutamide, High performance liquid chromatography (HPLC), Acetonitrile Introduction Flutamide1-3 is an acetanilide, nonsteroidal compound with orally active antiandrogenic properties. It exerts its antiandrogenic action by inhibiting androgen uptake and/ or nuclear binding of androgen in target tissues. It is used, usually with gonadorelin analogues; in the palliative treatment of prostatic carcinoma. It is freely soluble in Acetone, Ethyl acetate, Methyl alcohol. Englishhttp://ijcrr.com/abstract.php?article_id=2269http://ijcrr.com/article_html.php?did=2269