FORMULATION AND DEVELOPMENT OF ENTERIC COATED pH DEPENDENT COMPRESSION COATED TABLETS OF MESALAMINE

In the present investigation an attempt was made to reduce the side effect of anti inflammatory drug in G.I.Tract, to prevent ulcerative colitis and to improve the patient compliance by developing delayed release (DR) tablet of Mesalazine. Lactose-based placebo tablets were coated using meth acrylic acid copolymers Eudragit S100 by spraying from aqueous and organic system & Instacoat IEN-II-218 by spraying from organic system. The coated tablets were tested in vitro for their suitability for pH dependent colon targeted oral drug delivery. The same coating formulations were then applied on tablets containing mesalazine as a model drug and evaluated for in vitro dissolution rates under various conditions. The disintegration data obtained from the tablets demonstrate that disintegration rate of the studied tablets is dependent on: (i) the polymer used to coat the tablets, (ii) pH of the disintegration media, and (iii) the coating level of the tablets. The Dissolution studies performed on the mesalazine tablets. The results also demonstrated that a Eudragit S100 can be successfully used for aqueous & organic system to coat tablets for colon targeted delivery of drug. For colon targeted delivery of drugs the proposed a Eudragit S100 can be successfully used for aqueous & organic system is superior than tablets coated with Instacoat IEN-II-218. Among the ten formulations, F9 best matched formulation with respect to market product. Optimized formulation was found stable during accelerated stability study for 3 months at 400C/75% RH.