AQUEOUS FILM COATING STUDIES OF SUSTAINED-RELEASE NICOTINIC-ACID PELLETS - AN INVITRO EVALUATION

Numerous batches of nicotinic acid (niacin) pellets were coated to determine the optimum level of Sureleaser 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-mu-m. The 2 months stability data showed no significant changes in the dissolution profiles.