SYNOPSIS

FORMULATION AND EVALUATION OF MINI-TABLETS IN CAPSULES of ANTI PLATELET CLASS OF DRUG: 

FORMULATION AND EVALUATION OF MINI-TABLETS IN CAPSULES of ANTI PLATELET CLASS OF DRUG BY M.G.AGRAWAL GUIDE BY D. P. AMBHORE A SEMINOR ON SYNOPSIS

INDEX: 

INDEX SR.NO. CONTENT PAGE NO. 1 INTRODUCTION 2 DRUG PROFILE 3 PLAN OF WORK 4 ADVANTAGES 5 LITRATURE REVIEW 6 BIBLOGRAPHY

INTRODUCTION: 

INTRODUCTION Mini tablets are solid dosage form like tablets only difference is, mini tablets are small in size i.e. diameter typically equal to or less than 3 mm, It is also possible to incorporate mini-tabs of different drugs in capsule to treat concurrent diseases or combinations of drugs to improve overall therapeutic outcome, while delivering distinct release rates of each according to disease requirements. . It is possible to incorporate many different mini-tablets, each one formulated individually and programmed to release drug at different sites within the gastrointestinal track, into one capsule. It leads to avoid incompatibility between two API & excipients, combination therapy also possible

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Capsule DEFINITION :-“Capsules are solid preparations with hard and soft shells of various shapes and capacities, usually containing a single dose of active ingredients.” Capsules are tasteless, odorless and can easily be administered. There are attractive in appearance. The drugs having un-pleasant odor and taste are enclosed in a tasteless shell. They can be filled quickly and conveniently. TYPES Hard gelatin capsules Soft gelatin capsules Hard Gelatin Capsules DEFINITION :-“Hard gelatin capsule is also referred to as the dry filled capsule (D.F.C) because in hard gelatin capsule the shell is hard and consist of two sections used for filling dry materials in body capsule.” Soft Gelatin Capsules DEFINITION:- “Soft gelatin capsules are made of gelatin to which glycerin or a polyhydric alcohol such as sorbitol has been added to render the gelatin elastic or plastic like.”

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Antiplatelet drugs are widely-used for the primary and secondary prevention of myocardial infarction (MI), stroke and other cardiovascular events. Several antiplatelet agents, with different mechanisms of action, are commercially available. Combining 2 antiplatelet agents with different mechanisms of action was demonstrated to provide a substantial increase in efficacy

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PLAN OF WORK:- Literature Survey Innovator Product characterization/ market products Preformulation Studies - API characterization - Drug- excipients Compatibility study Development and Optimisation Physical and chemical evaluation of tablet Stabilty Study

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Aim and Objective The objective of present work is To develop and evaluate immediate release film coated tablet of Drug A and delayed release tablet of Drug B in capsule. Comparison of developed product against available market sample with respect to physical and chemical parameters Rationale To get synergistic action by the combination of Drug A and Drug B To avoid incompatibility To get immediate as well as delayed release leads to better drug delivery than innovator product

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ADVANTAGES:- Onset of action Avoid large dosing frequencies Avoid adverse effect due to large dose Easy to take Avoid incompatability Easy to manufacture Cheap rate

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LITERATURE REVIEW:- Karla LaPorte , The minitablets are small enough that they should be easy to swallow, and they have the added benefits of being simple to manufacture and easily scalable for multiple dosage strengths Yolande Anthony , Copovidone , in combination with cetyl alcohol can be spray congealed and used effectively as a binder of poorly compressible, moisture sensitive actives. Gregory W. Albers , Drug B shows two absorption maxima at 235.7 nm and 304.4 nm after acidic hydrolysis. Drug A also absorbs at 235.7 nm but shows no absorption at 304.4 nm in the same condition. Calibration curve for Drug A and Drug B was prepared in the concentration range 4-18 mg/ml (range for which Beer Lambert's law followed) at 235.7 nm and for Drug B at 304.4 nm. Mishra p , Simple two spectrometric method for evaluation of combination of two drug, first based on additivity of absorption and second based on determination of graphical absorion ratio at two wavelength. Willowdale , Formulation, development and evaluation of film coated immediate release minitablets of Drug A Kalvimurthi V , formulation, development and evaluation of extended release mini-tablets of Drug B

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BIBLIOGRAPHY: - Lachman L, Liberman HA, kanig JL. The theory and Practice of industrial Pharmacy, 3 rd , Varghese publishing House Bombay; 1987, 293-331 Lachman L, Liberman HA, Pharmaceutical dosage form: Tablet, Vol.1, Marcel and dekker Publication; 1987, 274-278. Lachman L, Liberman HA, Pharmaceutical dosage form: Capsule, Marcel and dekker Publication; 1987, 171-179 Remingtons , Science and Practice of Pharmacy, 21 st ed , Lipincott and Wilkins publication, 935-965. Bramhankar DM, Jaiswal S B, Biophrmaceutics and pharmacokinetics, 1 st ed , VallabhPrakashan ; 2008, 335-371. Handbook of Pharmaceutical excipients Manual of USP-30 and NF

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www.RxprescriptionDrug-info.net www.usfda.org/patent www.bcsClassification.com Drug info online at www.drugs.com/monograph www.drugbank.com www.freepatent-online.com Research Scholar Research Guide Industrial Guide

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SYNOPSIS SUBMITTED IN PARTIAL FULFILLMENT OF REQUIREMENT, FOR THE DEGREE OF MASTER OF PHARMACY, IN PHARMACEUTICS , IN FACULTY OF MEDICINE, SANT GADGE BABA AMRAVATI UNIVERSITY AMRAVATI

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SUBMITTED BY Mr. MAYUR GAOPALJI AGRAWAL APPEARING M.PHARMACY-2nd DEPARTMENT OF PHARMACEUTICS ANURADHA COLEGE OF PHARMACY, CHIKHLI DIST. BULDHANA AFFILIATED TO SANT GADGEBABA AMRAVATI UNIVERSITY AMRAVATI MAHARASHTRA (INDIA) 2011-2012