Design and statistical optimization of solubility modulated monolithic osmotic tablet of metformin hydrochloride (SCOT)

Research Article

Rashmi Sharma, Saroj Jain, Rav

Abstract

This research paper deals with design, optimization and evaluation of SCOT of metformin hydrochloride. A full factorial design was employed to optimize the amount of solubility modulating agent (X1) and % PEG in CA (X2) and % wt. build up (X3) as independent variables that influence the drug release. SCOT tablets of metformin were prepared by wet granulation method and evaluated for cumulative % drug release at 2,8,16 hours as dependent variable. Fabricated SCOT tablets were evaluated for weight variation, thickness, hardness, friability, and in-vitro release studies. Sodium chloride as solubility modulating agent retards the drug release. The % wt. buildup had effect on drug release due to Increase in coating weight from (2-5%) which retards drug release due to increase in thickness of semi permeable membrane. The values of independent and dependent variables were subjected to least square fit analysis to establish a full model. The prediction profiler and counter plot was generated at the concentration of in dependent variables X1(10.2 mg/tab), X2 (5) and X3 (3.5%) for maximized response. The drug release from developed formulation was found independent of pH and agitation intensity. The in-vitro release of fabricated osmotic tablet was compared with marketed osmotic and matrix tablet. The in-vitro release kinetics of fabricated osmotic tablet was found similar to marketed osmotic tablet as both followed zero-order release kinetics, While Matrix tablets exhibited Higuchi model.

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