FORMULATION AND EVALUATION OF BUCCOADHESIVE SUSTAINED-RELEASE DISCS OF GLIPIZIDE

Document Type : Original Article

Authors

Department of Industrial Pharmacy, Faculty of Pharmacy, Assiut University, Assiut, Egypt

Abstract

Glipizide is an oral hypoglycemic agent used in the treatment of type II diabetes mellitus. It is characterized by its poor aqueous solubility and delayed absorption with concomitant food intake. The objective of the present study was to enhance the absorption rate of glipizide and avoid its side effects on stomach by formulating it into buccoadhesive sustained release disc formulations. The discs were prepared by direct compression method. Hydroxypropyl methylcellulose (HPMC 15000), was used as the main hydrophilic matrix forming polymer either alone or in combinations in two ratios (3:2 & 4:1) with various mucoadhesive polymers namely; Sodium alginate (NaAlg), Sodium carboxymethyl cellulose (SCMC), Hydroxyethyl cellulose (HEC), Hydroxypropyl cellulose (HPC) and Chitosan. The discs were evaluated for weight variation test, thickness, diameter, drug content, hardness, friability, swelling index, surface pH, in-vitro bioadhesion, in-vitro release studies and in-vivo bioavailability studies. Invitro release studies demonstrated that formulation F8 which contains HPMC / SCMC (40%: 10%) has sustained the drug release up to 8 hrs which was considered an optimum pattern of drug release. The kinetic studies revealed that all formulations follows zero order release kinetics except F3, F4 and F11 which fitted well in first order release model. Bioavailability parameters including Cmax, Tmax, and AUC0–24 h of F8 and the commercial oral tablets of glipizide (Minidiab® 5 mg) were compared. The selected formulation F8 produced higher Cmax and extended Tmax (P<0.05).
 
 

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