Formulation, Development and Evaluation of Fast Disintegrating Thin Film of Esomeprazole Magnesium Trihydrate

摘要

ABSTRACT The objective of present study was to prepare and evaluate orally fast dissolving film of Esomeprazole magnesium trihydrate for the effective management of peptic ulcers to prevent excess amount of acid secretion in the stomach. Drug Esomeprazole was identified using DSC, FTIR and XRD. To improve the water solubility beta cyclodextrin complex of drug in 1:1 milimolar ratio was prepared. Solubility of drug in complex was found to be 7.67±0.52 mg/ml, represents the complex formation between drug and beta cyclodextrin. 21 batches of fast dissolving film of beta cyclodextrin complex were prepared by using different type of film forming agent, different concentration of film forming agent, different type of plasticizers, and different concentration of plasticizer agent. On evaluation, HPMC E15 and propylene glycol was optimized. Most of the films were homogeneous, transparent, colorless, flexible and easily peel out. The prepared films were subjected to characterization for weight variations, thickness, disintegration time, dissolving time, drug release pattern, % moisture loss etc.  On drug release kinetic mode study, optimized fast dissolving film following Higuchi model.  The scanning electron photomicrograph of the film showed smooth surface with some little pores and without any scratches or transverse striations which is an indication of uniform distribution of drug particles and fast disintegration. Films were stored at different temperature did not show any changes in the physical appearance. Clear, transparent and homogeneous films remained throughout the 90 days but at accelerated temperature conditions, some part of film was breakdown during Peeling out. Keywords:  Esomeprazole Magnesium trihydrate, Oral films, Solvent casting, Propylene glycol, Pharmacokinetics, HPMC E15.