CONTRIBUTION OF WAXES ON GRANULATION AND COMPRESSION OF NONCOMPRESSABLE DRUG (1)PARTICLE SIZE DISTRIBUTION AS A TOOL FOR STUDYING THE GRANULATION PROCESS.

Abstract

Granulation of noncompressible drug is essential for tabletting process. Known granulation techniques are dry ganulation, wet granulation and melt granulation technique (thermoplastic granulation). Melt granulation is obtained through the addition of a binder which melts or softens at relatively low temperature. After melting, the binder acts as a binding liquid. The binders used for melt granulation are stearic acid and glyceryl monostearate. Different concentrations of the granulating substances were mixed with paracetamol powder (Non compressible model drug) at room temperature using Hobart’s mixer. The temperature was increased gradually to 80 C and then decreased again to room temperature while stirring. The products were spherical granules with some concentrations of the granulating agent added. To clear the pure effect of the added granulating agents, the same procedure was also carried out using paracetamol alone. Sieve analysis of all products was carried out as a tool to compare the granulating agent efficacy of the added waxy substances. Different physical parameters (Bulk density, True density, Compressibility % and Flowability) were measured. The results indicated that there are changes in the powder characters as a result of addition either SA or GMS. The physical parameters indcated that the folwability of all products is not improved as a result of addition of the granulating agent but the products are, in most cases, granules with either irregular or smoth surfaces. The results encourage trying to apply this technique for large-scale process for compression of noncompressable drug. Also preparation of tablets and studying the drug release are the subject of the next work.