Formulation and Development of a Compression Coated, Matrix Based, Tablet of Verapamil HCl using Design of Experiments

Compression coating provides a unique platform for formulating modified release products in a way the dosage form can successfully be targeted to localize the release of the drug in any desired portion of the GIT without the additional step of film coating. The current work focuses on the development and optimization of modified release Verapamil Hydrochloride tablets using compression coating. The effect of various concentrations of different grades HPMC polymers, like, K4M, K15M and K100M on the release profile was studied in DOE environment. The results of the DOE provide an optimized range of the three polymers which could potentially give the targeted release profile for all drugs which have solubility profiles similar to Verapamil HCl. Three batches of optimized formulation were loaded on to accelerated stability studies at 40° C/75% RH in HDPE containers and the 3 months stability data indicates that there is no significant change in either the potency of the dosage form or its in vitro dissolution profile.