FORMULATION AND EVALUATION OF SUSTAINED RELEASE TABLET OF DICYCLOMINE HYDROCHLORIDE

PHARMACY

The goal of the present study was to Formulate and evaluate Sustained Release tablet of Dicyclomine Hydrochloride to reduce the dosing frequency to twice daily, thereby increasing patient’s compliance and therapeutic efficacy. Sustained release system achieves slow release of drug over prolonged period of time. This system retards the release of therapeutic agent such that its appearance in the circulation is delayed or prolonged and its plasma profile is sustained in duration. Sustained release formulation maintains a uniform blood level of drug with better patient compliance as well as increased efficacy of drug. The Sustained Release Tablets (F1-F9) were prepared by direct compression method and formulated using different concentration of polymers. Combination of polymer, Guar Gum, Xanthan gum, Hydroxyl Propyl Methyl Cellulose (HPMC K15M). FT-IR spectroscopy was done to study the compatibility of the drug with various excipients used in formulation. Formulations were subjected for pre-compression and post compression evaluation. The IR study revealed that there was no chemical interaction between drug and excipients. The tablets were prepared by direct compression method. Pre-compressional parameters i.e. angle of repose, carr’s index, bulk density, tapped density and Hauser’s ratios were studied. These results indicate that powder mixture had good flow characteristics. After evaluation of physical properties like Weight variation, Hardness, Thickness, Friability of tablet, the different formulations were checked for the percentage Drug content, which showed good uniformity. The compressed tablets were evaluated for post compression parameters and showed compliance with pharmacopoeial limits. Dicyclomine HCl is an antispasmodic and anticholinergic which is used for relief colicky pain caused by intestinal muscle spasm in functional bowel /irritable bowel syndrome (IBS). The objective is to formulate and evaluate the Sustained Release tablets of Dicyclomine HCl containing 30 mg. In- vitro drug release was performed with USP dissolution apparatus type-II (paddle type) using with 6.8 pH phosphate buffer by temperature maintaining at 37˚C ± 0.5 ˚C. Based on results among all formulations, F4 formulation containing drug and xanthan gum in ratio of 1:2 showed maximum drug release of 98.108 %. Thus, drug formulation of F4 has enhanced drug release profile.

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