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Formulation and optimization of osmotically controlled release tablets of glipizide: hot melt granulation.

BACKGROUND
The use of water-soluble additives in osmotic release tablets often renders the wet granulation method unsuitable. Hence, it was proposed to investigate the feasibility of preparing granules comprising of osmogen (sodium chloride), alkalizer (sodium carbonate), polyvinyl pyrroidone (Kollidon K 30) and carboxymethyl cellulose sodium (Cekol 30000) by a hot melt technique for obtaining sustained release of glipizide from tablets.


MATERIALS AND METHODS
Dry powder mixture wetted with Tween 80 was sequentially exposed to 45-110 degrees C for obtaining granules. The effect of varying the quantities of osmogen, Cekol 30000 in granules and pore former in the film coating on in vitro release of glipizide was investigated.


RESULTS
Glipizide release increased with an increase in the amount of hydrophilic polymer, osmogen and alkalizer and decreased with increase in the thickness of the coating membrane. Zero-order release independent of stirring rate and media pH through 16 h was observed from tablets of the optimized formulation (glipizide osmotic tablet [GOT] 12). The f2 value of 70.2 indicated similarity in release profiles from this formulation and the marketed extended-release tablet. Accelerated tests (ICH guidelines) revealed stability of GOT 12 tablets.