Abstract
AbstractThe formulation of drug substances with excipients capable of forming a matrix structure is an approach which has been successfully applied to sustain medicament release following oral administration. Investigations of materials which possess matrix forming properties have been limited to a few polymeric substances such as polyvinyl chloride, polyethylene, acrylic copolymers, and cellulose derivatives 1-5 Calcium sulfate dihydrate, dibasic calcium phosphate dihydrate, and tribasic calcium phosphate have previously been used as fillers/diluents in the formulation of solid dosage forms. All three diluents exhibit poor solubility in media of pH 1.1 and are practically insoluble in media of pH 4.0 to 7.5. In addition, when blended with one of three drug candidates and compressed these materials sustain drug release via a matrix diffusional process at higher pH corresponding to that of the human intestine. These findings led to an investigation of these calcium diluents as matrix forming agents in sust...
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