FORMULATION AND IN-VITRO EVALUATION OF SUSTAINED RELEASE MATRIX TABLET OF DICYCLOMINE HYDROCHLORIDE BY USING HYDROPHILIC POLYMERSAbstract
The objective of the present study was to develop Sustained release matrix tablets of Dicyclomine hydrochloride to reduce the dosing frequency to twice daily thereby increasing patient compliance and therapeutic efficacy. Twelve batches of tablets were fabricated using hydrophilic polymer guar gum alone or in combination with xanthan gum and pectin. All the batches were formulated by wet granulation and evaluated for thickness, weight variation, hardness, drug content uniformity, swelling index and in – vitro drug release profile. The results obtained were satisfactory and complied with the Pharmacopoeial specifications. From the twelve batches, B9 formulation had better control over release rate and can increase patient compliance through twice daily dosing. In- vitro drug release for B9 formulation containing 1:3 drug: polymer (guar gum and pectin) ratio was found to be 18.21% at the end of 2nd hour and 81.26% at the end of 11th hour. The dissolution data was fitted into various models to determine the mechanism of drug release. Kinetics of drug release of the optimized batch showed that zero order model was best fit for release of Dicyclomine hydrochloride from prepared dosage form. The optimised formulations B9 were found to be stable upto three months of stability testing at 40oC / 75% RH.
Kiran Joshi *, Shashikant Dhole and Anjali Doltode
Department of Pharmaceutics, Modern College of Pharmacy (for Ladies), Moshi, Pune, Maharashtra, India
31 October, 2013
14 January, 2014
11 March, 2014