Abstract

FORMULATION AND EVALUATION OF ELEMENTARY OSMOTIC PUMP OF METOCLOPRAMIDE HCL

Panchaxari Dandagi*, Shridhar Shedbal and Taufik Kazi

Abstract

Metoclopramide Hydrochloride belongs to the class of antidopaminergic and gastrointestinal agents that exerts preventive action against emesis. It exhibits burst effect owing to its high solubility causing fluctuations in the plasma level. The drug shows extrapyramidal side effects on account of its short half-life and frequent dosing. The objective of this study was to develop an elementary osmotic pump of the drug for slow-constant and pH independent release. Metoclopramide core tablets were prepared by direct compression method consisting of osmogens and hydroxypropyl methylcellulose (HPMC K100M) in varying concentrations. It was followed by dip coating with cellulose acetate coating polymer, drilling of the orifice to produce osmotic tablets and were evaluated for various parameters. From the data obtained, all the formulations showed the weight gain of about 5-7% and approximately 0.2 mm increase in thickness was observed after coating of tablets. F3 formulation exhibited the highest drug release of about 91.90% up to 20 h. Amount of osmogen and concentration of hydroxypropyl methylcellulose effected the drug release. Scanning electron microscopy revealed that the coat was intact and devoid of pores after the dissolution and diameter of the orifice was found to be 0.3 mm. The optimized formulation exhibited zero order release showing non-Fickian diffusion which was evident from the kinetic modelling. Once a day elementary osmotic tablets of Metoclopramide HCl thus formulated produces constant drug delivery with zero order kinetics which could be an effective way of surmounting the disadvantages of conventional forms.

Keywords: Metoclopramide Hydrochloride, Osmotic system, Elementary osmotic pump, Osmogens, Cellulose acetate, Scanning electron microscopy, Zero order.