Rajiv Gandhi University of Health Sciences



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA

4th ‘T’ Block, Jayanagar, Bangalore - 560 041

ANNEXURE – II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

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|1.0 |Name of the Candidate |Binish Khan |

| |and Address: | |

| | |D-194,Okhla,Abul Fazal Enclave, |

| | |New Delhi-110025 |

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|2.0 |Name of the Institution: |Al-Ameen College of Pharmacy, |

| | |Hosur Road, Bangalore – 560 027. |

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|3.0 |Course of Study and Subject: |M. Pharm – Pharmaceutics |

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|4.0 |Date of Admission: |November – 2011 |

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|5.0 |Title of the Topic: |

| |“Design and Evaluation of mucoadhesive antifungal vaginal hydrogel of miconazole nitrate for candidiasis” |

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|6.0 |Brief resume of the intended work: |

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| |– Need for the study: |

| |Vaginitis is the inflammation of the vagina which can result in discharge, itching, pain and often an irritation or infection of the vulva. The |

| |three main kinds of vaginitis are: bacterial vaginosis (BV), vaginal candidiasis and trichomoniasis. Candidiasis or thrush is a fungal infection |

| |(mycosis) of any of the Candida species (all yeasts), of which Candida albicans is most common. It is a yeast infection and is also known |

| |as candidosis, moniliasis, andoidiomycosis1. |

| |Candidiasis infects the mouth, vagina, skin, stomach, and urinary tract. About 75% of women get a vaginal yeast infection during their lifetime, |

| |and 90% of all people with HIV/AIDS develop candida infection. If it grows excessively from colon and vagina it penetrates the lining of the |

| |colon and spreads into the bladder, vagina, small intestine, blood, lymph, brain, lung and other areas of the body2. Symptoms are body aches and |

| |pains, fatigue, athlete’s foot, diarrhea, bloating, vaginal infections, skin rashes, patches, and blisters in the groin, between fingers and |

| |toes, and under the breasts, vaginal itching and irritation with a white discharge resembling cottage cheese2,3. It is estimated that 1/3rd of |

| |the population is suffering from candida albicans overgrowth2. |

| |The goals of pharmacotherapy in vaginitis are to reduce morbidity, prevent complications, and eradicate the infection. Drugs used for infectious |

| |causes of vaginitis may be applied topically or may require oral or parenteral administration. |

| |The antifungal agents used to treat vaginitis are imidazole derivatives that exert a fungicidal effect by altering permeability of the fungal |

| |cell membrane. The mechanism of action also may involve alteration of RNA and DNA metabolism or an intracellular accumulation of peroxides toxic |

| |to fungal cell. Intravaginal and topical therapy with a variety of antifungals (eg, clotrimazole, miconazole, terconazole, tioconazole) is highly|

| |effective. |

| |Miconazole is an anti-fungal medication used either on the skin or in the vagina for fungal infections. It prevents fungal organisms from |

| |producing vital substances required for growth and function. It interacts with 14-α demethylase, a cytochrome P-450 enzyme necessary to convert |

| |lanosterol to ergosterol. Ergosterol is an essential component of the fungal cell membrane, inhibition of its synthesis increases cellular |

| |permeability causing leakage of cellular contents. Miconazole exhibits half life of 24.1 hours and has poor water solubility. The common dosage |

| |is 5 - 10 g for 7 to 14 days or 100 mg twice a day for 5 days4. |

| |For vaginal yeast infections, medications available over the counter include creams and suppositories. Most treatments last from 2 - 3 days to 2 |

| |weeks3,5 . The main disadvantages of vaginal suppository are that it is less patient complaint, mucosal irritation and erratic and undesired |

| |absorbtion6. Creams and ointments are messy, uncomfortable and leak out of the vagina. Thus there is need to develop better dosage forms for |

| |antifungals used in the treatment of vaginitis. |

| |Gels are semi-solid, three-dimensional, polymeric matrices comprising small amounts of solid, dispersed in relatively large amounts of liquid, |

| |yet possessing more solid-like character7. Gels that contain water are called hydrogels, while that containing an organic liquid are called |

| |organogels. Hydrogels include the matrix of water - soluble materials such as cellulose derivatives and natural gums. Mucoadhesive polymers of |

| |natural, semisynthetic or synthetic origin are able to form hydrogels8,9. Mucoadhesion is the attachment of the drug along with a suitable |

| |carrier to the mucous membrane. When drug particles are directly dispersed in mucoadhesive gel, the mucoadhesive polymer will be absorbed onto |

| |the particle surface and the contact time of drug particles with mucous membranes will further increase10. |

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| |Vaginal gels optimize safety, efficacy and acceptability. They possess a higher biocompatibility and bioadhesivity and can be rapidly |

| |eliminated through normal catabolic pathways which decreases the risk for irritative or allergic host reaction at the application |

| |site.9. |

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| |Mucoadhesive gel prepared by bioadhesive polymer has the property of increasing the time of retention. The disadvantage of the drug of poor water|

| |solubility can be improved by formulating the drug to a gel of mucoadhesive polymers as well as permeation enhancer. Bioadhesive polymer and |

| |permeation enhancer increases the time of contact and permeation which increases the bioavaibility, reduces dosing frequency and causes fast |

| |onset of action11,12,13,14,15 |

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| |In the present research work an attempt will be made to formulate, optimize and evaluate antifungal vaginal hydrogel of miconazole by using |

| |mucoadhesive polymers. Such a gel is proposed to increase the adhesion time of the drug at the site of application and hence might increase the |

| |permeation and bioavailabilty of the drug. |

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| |6.2 REVIEW OF LITERATURE |

| |J. das Neves et al., (2006) studied the vaginal anatomy histology, physiology and discussed about gels as vaginal drug delivery systems. They did|

| |pharmaceutical characterization of vaginal gels by evaluation of drug release and permeation studies, by doing mechanical studies on it, by |

| |toxicological evaluation, mucoadhesion and vaginal retension and distribution. They also discussed about the excipients used in gels. Discussed |

| |about clinical usage and potential of vaginal gels. Summarized acceptability of gels for vaginal administration and concluded that although most |

| |of the times regarded as an alternative to more conventional routes of drug delivery, vaginal drug administration has proven to be useful and |

| |even advantageous in some particular cases. In these review they summarized the continuing interest, and discussed the current research in this |

| |field 7. |

| | |

| |Krishna S el al., (2012) provided a review article on vagina as drug delivery system. In the article they discussed various polymers which are |

| |used in hydrogel which provide bioadhesive property to the vaginal formulations, so that the formulation remains vaginal tissues for proper time.|

| |The main objective of the review was to summarize various vaginal drug delivery systems with an special emphasis an vaginal physiology, factors |

| |affecting the vaginal drug absorption, mechanism of vaginal epithelium drug absorption including the advances in the current approaches in |

| |vaginal drug delivery systems. The article also gave the advantages of vaginal drug delivery system and a summary on classification of |

| |intravaginal drug delivery systems8. |

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| |Amit A et al., (2011) presented a review describing mucoadhesion, mucoadhesive polymers, uses of these polymers in designing different types of |

| |mucoadhesive drug delivery systems, permeation enhancers, types and their properties. The review explained that the mucoadhesive systems remain |

| |in close contact with the absorption tissue, the mucous membrane, releasing the drug at the site of action leading to increase in bioavailability|

| |(both local and systemic effects). Extending the residence time of a dosage form at a particular site and controlling the release of drug from |

| |the dosage form are useful especially for achieving controlled plasma level of the drug as well as improving bioavailability. Mucoadhesive |

| |polymers are water-soluble and water insoluble polymers, which have swellable networks, jointed by cross-linking agents. These polymers possess |

| |optimal polarity to make sure that they permit sufficient wetting by the mucous and optimal fluidity that permits the mutual adsorption and |

| |interpenetration of polymer and mucous takes place12. |

| |Noha A. N. et al., (2002) evaluated mucoadhesive patches containing 10 mg miconazole nitrate. They prepared the patches with ionic polymers, |

| |sodium carboxymethyl cellulose (SCMC) and chitosan, or non-ionic polymers, polyvinyl alcohol (PVA), hydroxyethyl cellulose (HEC) and |

| |hydroxypropylmethyl cellulose (HPMC). They obtained convenient bioadhesion, acceptable elasticity, swelling and surface pH. They concluded that |

| |the mucoadhesive patches containing miconazole nitrate using anionic (SCMC), cationic (chitosan) and non-ionic (PVA, HEC, HPMC) polymers showed |

| |satisfactory mucoadhesive characteristics. Optimum release behaviour was shown with patches containing 10% w/v PVA and 5% w/v PVP. PVA patches |

| |improved uniform and effective miconazole levels in vitro and in vivo (>5 h) without being drastically influenced by ageing.14 |

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| |Claudia Valenta (2004) gave a review on the use of mucoadhesive polymers in vaginal delivery. It stated that currently available dosage forms |

| |have several limitations, therefore novel concepts and dosage forms are needed. Mucoadhesive polymers play a major role. The anatomy and |

| |physiology of the vagina is discussed and highlights the most important studies based on mucoadhesive polymer-systems like poly (acrylates), |

| |chitosan, cellulose derivatives, hyaluronic acid derivatives, pectin and traganth, starch, poly(ethylene glycol), sulfated polysaccharides, |

| |carrageenan, Na-alginate and gelatine. According to the review mucoadhesive polymers are very promising candidates for systemic and local vaginal|

| |drug delivery. Most of the existing dosage forms are based on the synthetic pol (acrylates) but in the near future natural compounds such as |

| |chitosan or carrageenan and new derivatives will gain more significance15. |

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| |Jung Y.C. et al., (2001) formulated clotrimazole (CT) in mucoadhesive thermosensitive gels (MTG) to develop more effective treatment for vaginal |

| |candidasis. They prepared Several MTG formulations composed of poloxamers (P) 407, 188, and polycarbophil (PC). Evaluated their mucoadhesive |

| |strength, did antifungal activity test, determined the work required to expel each formulation from a syringe, performed in vitro release |

| |studies, performed cellular viability studies and inoculated rats. Their results suggested that CT-containing vaginal MTG would be useful for |

| |effective and convenient for the treatment of vaginal candidasis with reduced dosing interval. And the cell viability and morphology data |

| |support the safety of MTG gels for vaginal application16. |

| | |

| |Rahamatullah S. et al., (2010) gave a detailed article on mucoadhesive drug delivery system. The review article aims to provide an overview of |

| |the various aspects of mucoadhesion, mucoadhesive materials, factors affecting mucoadhesion, evaluating methods, and finally various mucoadhesive|

| |drug delivery systems (buccal, nasal, ocular, gastro, vaginal, and rectal). They concluded that mucoadhesive dosage forms offer prolonged contact|

| |at the site of administration, low enzymatic activity, and patient compliance. The formulation of mucoadhesive drug delivery system depends on |

| |the selection of suitable polymer with excellent mucosal adhesive properties and biocompatibility17. |

| | |

| |Farhan J.A., (2008) developed an acid buffering bioadhesive vaginal (ABBV) gel for the treatment of mixed vaginal infections. Different |

| |bioadhesive polymers were evaluated on the basis of their bioadhesive strength, stability and drug release properties. The drugs clotrimazole |

| |(antifungal) and metronidazole (antiprotozoal as well as antibacterial) were used in the formulation along with Lactobacillus spores to treat |

| |infections. The developed bioadhesive gel was found to have prolonged ex vivo retention. The in vitro results of antimicrobial activity suggest |

| |that the acid buffering bioadhesive gel was more efficacious than the commercial formulation tested18. |

| | |

| |Jung Y.C et al., (2002).Formulated and evaluated various rheological properties of clotrimazole gels for predicting their performance in vagina. |

| |Two kinds of thermo sensitive and mucoadhesive formulations were composed of poloxamer 407 (P407, 15%), polycarbophil (0.2%), and different |

| |amounts of P188 (15 vs. 20%).Their steady shear behaviour,gelation temperature,gelation time, viscoelastic properties, dynamic mechanical |

| |analysis were obtained.The results indicated that the rheological evaluation at the physiologic conditions needs to be preceded to develop more |

| |effective in situ-gelling vaginal formulation and the difference in the composition of the thermosensitive and mucoadhesive gel formulations |

| |might lead to a dramatic change in the rheological behaviors. Results suggested that the rheological analysis in the physiological conditions |

| |would be a powerful tool for the prediction of gel behavior and drug efficacy after intravaginal application19. |

| | |

| |Constantia E. K., (2002) designed and evaluated a new bioadhesive vaginal drug delivery system for clotrimazole. Chitosan, a cationic biopolymer |

| |derived by deacetylation of chitin, was modified by the introduction of thioglycolic acid. The water uptake, dsintegration behavior, bioadhesive |

| |properties and the release of clotrimazole from were studied. Results showed that by the introduction of thiol groups the bioadhesive properties |

| |of chitosan could be significantly improved. The addition of clotrimazole further increased bioadhesion on mucosal tissue. The article concluded |

| |that the new chitosan–TGA conjugates are very promising vehicles for the vaginal application of clotrimazole in treatment of mycotic |

| |infections20. |

| | |

| |Esra B. et al., (2009) studied strategies to prolong the intravaginal residence time of drug delivery systems. Approaches for prolonging the |

| |residence time based on mucoadhesion, are in- situ sol-to-gel transition and mechanical fixation. An overview on mucoadhesive drug delivery |

| |systems and in-situ gelling systems for mechanical fixation is provided, the techniques to evaluate the potential of the systems for prolonged |

| |vaginal residence time are described and important polymers used in vaginal mucoadhesive gels are given21. |

| | |

| |A Madgulkar et al., (2009) developed buccal adhesive tablet of miconazole nitrate with prolonged antifungal activity and performed optimization |

| |and ex-vivo disposition studies. They also compared the formulation with the marketed gel. The drug concentrations above the minimum inhibitory |

| |concentration were achieved immediately from both formulations but the gel showed initially fast drug release. Drug permeation across buccal |

| |mucosa was minimum from both tablet as well as marketed gel22. |

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| |Füsun A. (2009) gave a comprehensive review of the patents related to mucoadhesive vaginal drug delivery systems. Also confirmed that the vaginal|

| |route is appropriate for bioadhesive drug delivery systems in order to retain drugs. The article mentioned the most commonly used mucoadhesive |

| |polymers capable of forming hydrogels are synthetic polyacrylates, polycarbophil, chitosan, cellulose derivatives (hydroxyethycellulose, |

| |hydroxypropylcellulose and hydroxypropylmethylcellulose), hyaluronic acid derivatives, pectin, tragacanth, carrageenan and sodium alginate23. |

| | |

| |Ganure A.L. et al., (2011) in their abstract described the formulation and evaluation of gel containing chitosan (1%),various thickening agents |

| |like hydroxyethylcellulose (1%, w/w), sodium carboxy methyl cellulose (1%, w/w), hydroxy propyl cellulose (1%, w/w), methyl cellulose (1%, w/w), |

| |hydroxy propyl methyl cellulose (1% w/w), magnesium aluminum silicate (1%, w/w) and clotrimazole (1%, w/w) as a drug. The studies indicated that |

| |with increased concentrations of chitosan relative drug release were decreased. The study showed that chitosan (1%) and hydroxyl ethyl cellulose |

| |(6%) gel containing clotrimazole produced better spreadability and consistency as compared to marketed product and standard carbopol gel24. |

| |Phyllis L.C., et al., (1998) evaluated recent advances in understanding of clinical relevance, diagnosis and treatment of vaginal infections and |

| |determined an efficient and effective method of evaluating this problem. The study showed that use of topical therapies are effective and have |

| |lesser side effects as compared to the systemic medication. The study mentioned that for women with infrequent yeast vagintitis over the counter |

| |preparations of miconazole and clotrimazole for 7 days are appropriate treatments and should be used as first line therapy25. |

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| |OBJECTIVE OF STUDY |

| | |

| |In the present research work an attempt will be made to formulate, optimize and evaluate antifungal vaginal hydrogel of miconazole. The gel will |

| |be prepared in order to increase the adhesion time of the drug at the site of application and hence to increase the permeation and bioavailabilty|

| |of the drug. |

| | |

| |SPECIFIC OBJECTIVES |

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| |Screening of polymers for mucoadhesive hydrogel formulation |

| |To formulate optimized vaginal mucoadhesive hydrogel of miconazole nitrate |

| |To evaluate mucoadhesive hydrogel of miconazole nitrate for technological properties |

| |To study the in-vitro release of the developed formulation. |

| |To study ex-vivo bioadhesive strength by using fresh hairless goat skin |

| |To compare the in vitro release of the formulation with the present marketed preparation. |

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| |Materials and Methods: |

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| |7.1 Source of Data: |

| |1) Review of Literature from |

| |a) Journals - such as |

| |AAPS PharmSciTech. |

| |International Journal of Pharmaceutical Sciences |

| |Indian Journal of Pharmaceutical Sciences |

| |Pharmaceutical development and technology |

| |Science Direct. |

| |Pubmed |

| |Acta Pharm |

| |Journal of Applied Sciences Research |

| |Stamford Journal of Pharmaceutical Sciences |

| |b) Internet Browsing. |

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| |7.2 - Method of Collection of Data: |

| |Literature survey |

| |Preformulation studies |

| |Standardization of method of estimation of miconazole nitrate |

| |Evaluation of drug excipients interaction by IR and DSC |

| |Screening of polymers (Chitosan, Sodium CMC, PVP,Carrageen,Agar and Guar Gum) for hydrogel formulation. |

| |Preparation of hydrogel of miconazole nitrate using selected polymers |

| |Evaluation of hydrogel for weight variation, drug content, content uniformity, swelling index, mucoadhesive strength and mucoadhesive time. |

| |Evaluation of rheological parameters. |

| |In-vitro release studies of prepared formulation and data analysis. |

| |To study ex-vivo bioadhesive strength by using fresh hairless goat skin |

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| |7.3 - Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, Please describe |

| |briefly. |

| |Not applicable |

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| |7.4 – Has ethical clearance been obtained from your Institution in case of 7.3 |

| |Not applicable |

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| |Bibliography |

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| |URL: (cited on 2012 march 7) |

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| |URL: (cited on 2012 may 3) |

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| |URL: (cited on 2012 march 8) |

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| |URL: (cited on 2012 March 15) |

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| |URL: (cited on 2012 may 1) |

| | |

| |Stephan WH. Suppositories.Biomaterials. 2002;535 |

| |URL: |

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| |J. das Neves, M.F. Bahia. Gels as vaginal drug delivery systems. Int J Pharm. 2006;318:1-14 |

| | |

| |Krishna SV, Ashok V, Chatterjee A. A review on vaginal drug delivery systems. IJBPAS. 2012;1(2):152-167 |

| | |

| |Afaf A R. Formulation and evaluation of bioadhesive gels containing miconazole nitrate. J. Appl. Sci. Res. 2008;4(9):1052-1065 |

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| |Tangri P, Madhav NVS. Oral mucoadhesive drug delivery systems: a review. Int J Biopharm. 2011;2(1):36-46. |

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| |Amit A, Ajazuddin, Swarna, Mukesh S, D K Tripathi. Polymers and Permeation Enhancers: Specialized Components of Mucoadhesives. S. J. Pharm. Sci. |

| |2011;4(1):91-95 |

| | |

| |Pradeep K D, Joydeep D, V S Tripathi. Chitin and chitosan:Chemistry,properties and applications. J Sci Ind. 2004;63:20-31 |

| | |

| |Luana P, Valeria A, Lorena V, Cinzia P, Maurizio R, Carlo R. Chitosan and a modified chitosan as agents to improve performances of mucoadhesive |

| |vaginal gels. Biomaterials. 2008;66:141–145 |

| | |

| |Noha AN, Fatma A. Ismail, Nabila A. Boraie, Lobna MM. Mucoadhesive buccal patches of miconazole nitrate in vitro/in vivo performance and effect |

| |of ageing. Int. J. Pharm. 2003;264:1–14 |

| | |

| |Claudia V. The use of mucoadhesive polymers in vaginal delivery. Adv Drug Deliv Rev. 2005;57:1692–1712 |

| | |

| |Jung YC, Yu-Kyoung O, Han-gon C, Yang BK, Chong-Kook K. Prolonged antifungal effects of clotrimazole-containing mucoadhesive thermosensitive gels|

| |on vaginitis. J. Controlled Release. 2002;82:39–50 |

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| |Rahamatullah S, Thakur RRS, Martin JG, A David W, Ryan FD. Mucoadhesive drug delivery systems. J Pharm Bioallied Sci. 2011;3(1):89–100. |

| | |

| |Farhan JA, Mohd Aftab A, Zeenat I K, Roop KK, Mushir. Development and in vitro evaluation of an acid buffering bioadhesive vaginal gel for mixed |

| |vaginal infections. Acta Pharm. 2008;5:407–419 |

| | |

| |Jung YC, Yu-Kyoung O, Han-gon C, Yang BK, Chong-Kook K. Rheological evaluation of thermosensitive and mucoadhesive vaginal gels in physiological |

| |conditions. Int. J. Pharm. 2002:241:155–163 |

| | |

| |Constantia EK, Claudia V, Martina L, Andreas BS. Design and in vitro evaluation of a novel bioadhesive vaginal drug delivery system for |

| |clotrimazole. J. Controlled Release. 2002;81:347–354 |

| | |

| |Esra B, Zeynep AS, Sinem YK, Andreas BS. Strategies to Prolong the Intravaginal Residence Time of Drug Delivery Systems. J Pharm Pharmaceut Sci. |

| |2009;12(3):312–336 |

| | |

| |A Madgulkar, S Kadam, V Pokharkar. Development of buccal adhesive tablet with prolonged antifungal activity: Optimization and ex vivo deposition |

| |studies. Indian J Pharm Sci. 2009;71:290-4 |

| | |

| |Füsun A. Mucoadhesive Vaginal Drug Delivery Systems. Recent Patents on Drug Delivery & Formulation. 2009;3:193-205 |

| | |

| |Ganure AL, Patel PK, Dangi AA. Preparation and in-vitro evaluation of Chitosan loaded Clotrimazole Gel. IJPI’s JPC. 2011;1:2 |

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| |Phyllis LC, Donna F, Robert HF. Evaluation and Management of Vaginitis. J Gen Intern Med. 1998;13:335-346 |

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|8.0 | |

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|9.0 |Signature of the Candidate |( BINISH KHAN) |

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|10.0 |Remarks of the Guide: |Recommended |

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|11.0 |Name and Designation of: | |

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| |11.1 Institutional Guide: |Dr. ROOPA S. PAI |

| | |Professor |

| | |Department of Pharmaceutics |

| | |Al-Ameen college of Pharmacy |

| | |Bangalore- 560 027 |

| | | |

| |11.2 Signature: | |

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| | |Dr. V. KUSUM DEVI |

| | |Professor and Head |

| |11.3 Head of the Department: |Department of Pharmaceutics |

| | |Al-Ameen College of Pharmacy |

| | |Bangalore- 560 027 |

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| |11.4 Signature: | |

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|12.0 |12.1 Remarks of the Chairman and Principal |Forwarded to the University for scrutiny |

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| | |Prof. B. G. SHIVANANDA |

| | |Principal |

| |12.2 Principal: |Al-Ameen College of Pharmacy, |

| | |Hosur Road, Bangalore – 560 027 |

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