MICRONIZATION: AN EFFICIENT TOOL FOR DISSOLUTIONENHANCEMENT OF DIENOGEST

Dienogest is orally active synthetic progesterone. In this study, Dienogest Oral Tablet 2 mg is being developed for use as in therapy of endometriosis, hysteromyoma and uterine leiomyoma. Micronization is a process involves reducing the size of the solid drug particles to 1 to 10 microns commonly by use of attrition methods (Fluid energy or Air Jet Mill). Micronization technique is a cost effective technique for improving the dissolution of Dienogest, a poorly soluble drug. Particle size reduction was realized by Air Jet Milling. Micronization of Dienogest enhanced its dissolution rate in multimedia compared to nonmicronized material. Dienogest Oral Tablets are commercially available in Germany and other European market dissolved similarly to micronized Dienogest, but significantly higher than the nonmicronized Dienogest. The results suggest that micronization technique for the preparation of rapidly dissolving formulations of Dienogest, and could potentially lead to improvement in the bioavailability of oral Dienogest product.