Aquesons Films Coating Stuied of Sustabined Release Niciotine Acid Fellets: An In-Vitro Evalutiion

Abstract

Numerous batches of nicotinic acid (niacin) pellets were coated to determine the optimum level of Surelease® coating which would exhibit in-vitro release patterns suitable for BID dosing. Various levels of Surelease, with and without the incorporation of a hydrophilic material, were studied. It was expected that a significantly high level of Surelease would be needed to obtain the desired in-vitro dissolution release rate for the water soluble drug. However, a coating level of 1.2% Surelease coating was found to have an in-vitro dissolution profile approximating that of a BID product. Scanning electron microscopic examination has shown that the surface of coating is smooth and uniform with the coating thickness of about 2 μm. The 2 months stability data showed no significant changes in the dissolution profiles.