Dissolution and Uniformity Properties of Ordered Mixes of Micronized Griseofulvin and A Directly Compressible Excipient

Abstract

Ordered mixes of micronized griseofulvin were prepared with a commercially available directly compressible excipient. The excipient consisted of a combination of maltose and dextrose and a particle size fraction of approximately 250-850µ was employed in the mixing studies. Ordered mixes containing 0.25%, 0.5%, and 1% active ingredient were prepared and after thirty minutes of mixing, excellent content uniformity of the mixes was seen. Rapid dissolution of drug from the sugar granules was observed when the drug coated granules were tested using the U.S.P. Paddle Method. The ordered mixing process provided an even coat of the micronized drug onto the granules. As the granules dissolved, particle-particle interactions and aggregation problems with the hydrophobic drug were eliminated. The properties of griseofulvin tablets prepared from these ordered mixes were evaluated and the tablets showed excellent content uniformity and rapid dissolution of griseofulvin from the dosage form.