Formulation and Evaluation of Different Polymer-Coated Spherules from Granules

Abstract

Abstract: A novel spheronization technique is reported here for forming spherules from granules using FDA-approved excipients and common pharmaceutical unit operations. Aspirin is used as a drug to check stability during the process. Spherules are made by “bed coating during sliding” (BCDS) of granules. The spherules provide an opportunity to modify their surface properties by polymer film coating. It improves the functional properties such as appearance, drug release, and integrity of particles during the processing of spherules. Spherules with two size ranges (sieves no 22 and 44) are compared. These spherules are further coated with polymers to show the adaptability of the process. Microscopical evaluation reveals that several edges (90° and 45°) are less for spherules compared to granules. The angle of Repose and packing parameters appeared excellent. Different polymer coating drugs give different release profiles as per the properties of the polymeric drugs. This is a versatile platform delivery system for developing advanced drug delivery systems (ADDS). However, the stability of aspirin is affected by the wet process may be because aspirin is a hydrolytically labile drug. Granules and pellets are not necessarily spherical. Coated spherules can also be an option for coating as against to coating the tablet.