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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA. Annexure-II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION 1 NAME OF THE STUDENT AND ADDRESS (IN BLOCK LETTERS) SOWJANYA .A. S J. S. S COLLEGE OF PHARMACY S S NAGAR,MYSORE-15 2 NAME OF THE INSTITUTION J .S. S COLLEGE OF PHARMACY. 3 COURSE OF STUDY AND SUBJECT DATE OF ADMISSION TO COURSE TOPIC OF DISSERTATION WORK MASTER OF PHARMACY IN INDUSTRIAL PHARMACY 4 5 6 7 BRIEF RESUME OF THE INTENDED WORK 6.1 Need for the study 6.2 Review of literature 6.3 Objectives of the study MATERIALS AND METHODS. 7.1 Source of data Laboratory based study. 7.2 Method of collection of data (Including sampling procedure, if any) Laboratory investigations. 7.3 Does study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly. 7.4 Has ethical clearance been obtained from your institution in case of 7.3. 8 LIST OF REFERENCES 0 8– 06 – 2007 PREPARATION AND EVALUATION OF BLEND OF HPMC AND EUDRAGIT MICROPARTICLES LOADED WITH DILTIAZEM HYDROCHLORIDE FOR CONTROLLED RELEASE --- Enclosed------ Enclosed------ Enclosed---- --- Enclosed---- --- Enclosed---- ----NO----- -----NOT APPLICABLE---- -- Enclosed---- 9 Signature of candidate 10 Remarks of the guide 11 Name and designation of 11.1 Guide Dr. D. V. GOWDA Professor, Dept. of Pharmaceutics, J .S. S College of pharmacy, MYSORE-15 11.2 Signature 11.3 Head of Department 11.4 Signature 12 12.1 Remarks of the Principal Signature Dr. H .G. SHIVAKUMAR Professor & Head, Dept. of Pharmaceutics, J. S. S College of pharmacy, MYSORE-15 TITLE: FORMULATION AND EVALUATION OF BLEND OF HPMC AND EUDRAGIT MICROPARTICLES LOADED WITH DILTIAZEM HYDROCHLORIDE FOR CONTROLLED RELEASE. 6.0 BRIEF RESUME OF THE NEEDED WORK 6.1 NEED FOR THE STUDY In the past decade various conventional dosage forms are in use for the treatment of various diseases. Because of the short half lives of the conventional dosage forms they fail to achieve and maintain the drug at blood level in the body within the therapeutic range. Hence, it is often necessary to take this type of dosage form several times a day. This yields an discomfort and non compliance to the patients. To overcome this problem, number of attempts has been made recently in developing drug delivery systems which are capable of controlling the rate of drug delivery in the body for a long period of time Recently controlled release microparticles has been gaining importance because of its ability to decrease the frequency of dosing and maintain the drug level at plasma for extended period of time and less toxic effects. Diltiazem Hydrochloride is an antihypertensive and antianginal drug having quite extensive first pass metabolism and shorter elimination half-lives .Due to this it should be given more frequently .The aim of the present study is to prepare microparticles of Diltiazem hydrochloride for controlled release by using a blend of polymers of HPMC and Eudragit using phase separation method. 6.2 REVIEW OF LITERATURE Kristmundsdottir, et al1., have prepared microparticles of Diltiazem HCl by spray drying technique using acrylate methacrylate copolymers and reported that the formation of type of microspheres and microcapsules purely depends on the solvent used for the preparation and also their release rate can be controlled by choice of polymer and production conditions during spray drying. Muge Kilicarslan, et al., 2 have formulated Verapamil HCl loaded microspheres with solvent evaporation method and studied effect of drug/ polymer ratio on properties of Verapamil HCl loaded microspheres. They reported that the variation in drug/polymer ratios might have an influence on the physical characteristics of the microspheres and the increasing amount of polymer might be result in decreased drug dissolve. Anurag sood, et al., 3 have performed the Drug release evaluation of Diltiazem CR preparations and they observed the marketed differences in dissolution characteristics of different dissolution media of variable pH and elucidated the mechanism of drug release based on the best fit of release data. B.K.Kim, et al 4., have studied antihypertensive drug filodipine microspheres prepared by solvent evaporation method using acryl ate methacrylate copolymers and concluded that the release profiles and encapsulation efficiencies depended strongly on the structure of polymers used in the preparation of the microspheres. Jung-Hwa Lee, et al5., have prepared microspheres of water soluble drugs by w/o/w double emulsion solvent diffusion method using anionic acrylic acid resin and surfactants and reported release profile of drug largely depends on PHof the medium used. Nilofer Yuk sel, et al6., have prepared microspheres of Nicardipine HCL by solvent evaporation method using acrylic polymers eudragit RS and L and they investigated that the interaction between the Nicardipine hydrochloride and polymers in molecular level with their blends by using different methods and concludes that Nicardipine and acrylic polymers blend preparation of controlled release microspheres retard and enhance drug release rate at different ph solutions. P.M.Satturwar, et al7., have developed a novel method for the preparation of eudragit RL microcapsules. The technique is based on the principle of solvent evaporation using Diclofenac sodium as a model drug for micro encapsulation .The prepared microspheres obtained are uniform and free flowing particles and the release rate was more sustained by increasing the polymer concentration and reported rapid and convenient method for the preparation of eudragit RL microcapsules. M.Hombreiro-perez, et al 8., have prepared matrix type of microparticles comprising a solid dispersion of drug with an amino acryl ate copolymer and ethyl cellulose binary blend for controlled release of poorly water soluble drug Nifidipine and evaluated their properties using different methods. 6.3 OBJECTIVES OF THE STUDY 1. To prepare microparticles of Diltiazem hydrochloride by using phase separation method. 2. To characterize the prepared microparticles for micromeritic properties. 3. To evaluate the prepared microparticles for polymer drug compatibility by FTIR and DSC, Surface morphology by SEM. 4. To carry out invitro release studies and compared with commercially available oral preparation. 5. To perform stability studies of the prepared microparticles. 6.4 METHOD OF PREPARATION Coacervation phase separation technique will be selected for the preparation of microparticles. 7.0 MATERIALS AND METHODS 7.1 SOURCE OF DATA A. Journals and publications. B. Internet and Medline C. Laboratory based study DRUG TO BE USED IN THE FORMULATION Diltiazem hydrochloride MATERIALS Eudragit HPMC Solvents Other excipients etc., EVALUATION 1. Drug polymer compatibility studies by FTIR and DSC 2. Surface morphology by SEM 3. Drug loading capacity 4. Invitro release studies 5. Stability studies 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 NO 7.4 Has ethical clearance been obtained from your institution in case of 7.3? Not applicable REFERENCES 1. Kristmundsdottir T, Gudmundsson O S, Ingvarsdottir K. Release of Diltiazem from Eudragit microparticles prepared by spray drying. Int .J. Pharm. 1996; 137:159-65. 2. Muge Kilicarslan and Tames Baykara. The effect of the drug /polymer ratio on the properties of the Verapamil HCl loaded microspheres. Int. J .Pharm. 2003; 252; 99-109. 3. Anurag sood and Ramesh panchagnula.Drug release evaluation of Diltiazem controlled Release preparations.Int. J. Pharm.1998; 175:95-107. 4. Kim BK, Hwang S J,Park JB,Park HJ. Preparation and characterization of drug loaded polymethacrylate microspheres by an emulsion solvent evaporation method. J microencapsulation. 2002; 19: 811-22. 5. Jung-Hwa Lee, Tae Gwan Park, Hoo-Kyun choi. Effect of formulation and processing variables on the characteristics of microspheres for water soluble drugs prepared by w/o/w double emulsion solvent diffusion method.Int .J. Pharm. 2000; 196: 75-83. 6. Nilofer Yuk sel, Teoman Tincer , Tamer Baykara. Interaction between nicardipine hydrochloride and polymeric microspheres for a controlled release system. Int. J. Pharm. 1996; 140: 145-54. 7. Satturwar PM, Mandagode P M. A Novel method for preparation of Eudragit RL microcapsules.J Microencapsulation.2002; 19:407-13. 8. Hombreiro-perez M, Siepmann J. Non-degradable microparticles containing a hydrophilic and /or lipophillic drug: preparation, characterization and drug release modeling. J.controlled release 2003;88:413-28 9. Thomas wai-y-P.Lie, Joseph R Robinson, Remington: The Science and Practice of Pharmacy, 2000, 1, 20, 903-29. 10. Lean Lachman, Herbert A.Lieberman, Joseph L kanig. The Theory and Practice of Ind.Pharmacy.1987, 3: 430-56. 11. Controlled Drug Publication. Indian Pharmacopoeia.1996; 1:256-57.