The research is undertaken with an objective to develop pharmaceutically equivalent, stable, cost effective and quality improved formulation of Gastro-Resistant Acamprosate Calcium Tablet BP 333 mg, having all the critical quality attributes within specified limit. The target of developing GastroResistant tablet is accomplished by using a suitable enteric coating polymer and disintegrant for further release optimization. Acamprosate calcium belong to BCS class III is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with Acamprosate calcium should be part of a comprehensive management program that includes counselling. The efficacy of Acamprosate calcium in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning Acamprosate calcium treatment. The efficacy of Acamprosate calcium in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed. Gastro-Resistant tablet of Acamprosate Calcium drug is formulated using wet granulation using Crospovidone and sodium starch glycolate as a disintegrant and microcrystalline cellulose as diluent further coating core tablet with Anionic copolymer of methacrylic acid and acrylic acid ethyl ester to prevent its release in acidic pH. The current study involves preparation and evaluation of Acamprosate Calcium tablets, comparison of dissolution rate of optimized formulation with reference product PrCAMPRAL® tablets marketed in Canada by Mylan Pharmaceuticals ULCand estimation of similarity and difference factors.

Gastro-Resistant tablet, Wet granulation, Similarity Factor, Polymorphism, Stability study.