D.O.E. Based Optimization of Compression Coated Tablets

Compression coating provides an 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 Tramadol Hydrochloride tablets using this platform. The innovator product (Ultram ER) is a reservoir based functional film coated tablet system. The disadvantages of this system are that the coating is solvent based and the % weight gain required is in the range of 35 to 47% w/w leading to inordinately long processing time. The aim of the present work was to develop a product with dissolution profile matching to Ultram ER using the compression coating technique. Also, the effect of the concentration and viscosity grades of combination of HPMC polymers 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 Tramadol HCl.