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Abstract

DESIGN AND DEVELOPMENT OF MODIFIED RELEASE TABLETS OF GLIPIZIDE CONSIDERING THE CURRENT REGULATORY REQUIREMENT OF TESTING IN HYDRO-ALCOHOLIC MEDIA

Sangani Hardik*, Dholakia Mansi, Rana Hardik, Thakkar Vaishali T., Gandhi Tejal R.

ABSTRACT

Objective: The objective of the present study was to assess the interaction between alcohol and prepared matrix tablet of glipizide containing gelucire 43/01 and polyethylene oxide incorporating QbD approach. Experimental Work: Matrix sustained release tablet was prepared using gelucire 43/01 and poly ethylene oxide as release retardant polymers and glipizide was selected as a model drug. Matrix tablet was prepared by hot melt granulation technique. Central composite design was applied to obtain optimized batch using concentration of gelucire and concentration of polyethylene oxide as independent variables and drug release at 2h, 6h and 10h were selected as dependent variables. All the batches were evaluated for post and pre-compressional parameters. Optimized batch was evaluated for influence of hydro alcoholic media on drug release. Result and Discussions: The resulting formulation produced robust tablets with optimum pre and post compressional parameter. Optimized batch was selected from the central composite design which contains 19.2% concentration of gelucire and 4.5 % concentration of polyethylene oxide. The optimized batch gives similar drug release to marketed formulation. As the concentration of alcohol increases from 5 to 40%, the drug release also increases but did not shown dose dumping effect. It is just due to higher solubility of glipizide in alcohol. Conclusion: The robust matrix formulation was formulated using gelucire and polyethylene oxide which shows similar drug release to marketed formulation. Also, significant change in dissolution was not observed when exposed to hydro alcoholic media for 12 hr. The present study demonstrated the effect of alcohol employing the concept of design of experiments.

Keywords: Glipizide, gelucire 43/01, PEO 301, hydro alcoholic media, sustained release.


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