The aim of the present investigation was to formulate and evaluate of Colon Targeted Suppository of Mesalazine. The attempts have been made to increase the dissolution of BCS class IV drug Mesalazine using Cocoa butter, Polyethylene Glycol 6000, Polyethylene Glycol 9000 as base which was prepared by Fusion Method. Base combinations was prepared. Total three formulations of each combinations of base (Cocoa butter: Polyethylene Glycol 6000 and Cocoa butter: Polyethylene Glycol 9000) were prepared in the ratio of 1:9 to 9:1.Cocoa butter was taken alone and used as standard. These base combinations were evaluated for optimization of base using parameters like melting point and liquefaction time. The optimized base (Cocoa butter: Polyethylene Glycol 6000 with ratio of1:9 and Cocoa butter: Polyethylene Glycol 9000 with ratio of1:9) was then formulated into Colon Targeted Suppository of Mesalazine. Polyethylene glycol 400 was added in combination of bases which was used as plasticizer to increase its flexibility which was added in the concentration of 15, 30 and 45%. Displacement value was then calculated to formulate suppository. These formulated colon targeted Mesalazine suppository were evaluated with parameters such as weight variation, hardness, melting point, liquefaction time, content uniformity, and dissolution test. The F3 batch was selected as optimized formulation and was found superior. The F3 formulation shows high drug release of 94.31% and less dissolution time of 30 minutes from six formulation batches; Hence showing better results than other formulations. When F3 formulation was compared with marketed formulation, it gives highest percent drug release than marketed formulation. The results of stability studies showed that F3 has no significant change in drug content, melting point, hardness, liquefaction time and dissolution profile of suppositories after storing them for 90 days at refrigeration temperature.
Mesalazine, Ulcerative Colitis, Colon Targeted Drug Delivery System, Suppository
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