Preparation, characterization, and stability of new prostaglandin E2 gel for local administration.

A new gel delivery system for the local application of prostaglandin E2 consists of drug incorporated in the matrix of a cross-linked starch polymer. The properties of the starch powder provide a stabilizing milieu for the labile prostaglandin E2 and, by addition of saline, a ready-to-use gel for immediate local administration. The gel offers advantages over existing preparations in terms of chemical and microbiological stability, homogeneity, and dosage safety. This report outlines the pharmaceutical aspects involved in the development of the delivery system.