PRELIMINARY EVALUATION OF MESALAMINE SUPPOSITORIES USING SAL FAT AS NOVEL BASE

Abstract

Conventional immediate release rectal suppositories of Mesalamine were prepared by using Sal fat as a novel and cost effective suppository base. The prepared suppositories were evaluated for in- vitro drug release by comparison with suppositories formulated using cocoa butter as standard base. Four formulations were prepared by incorporating different combinations of Sal fat, emulsifying wax and tween 80. Methyl paraben and propyl paraben were used as preservatives. All the suppositories were evaluated for different parameters like micro and macro melting range, softening and liquefaction temperature and time, hardness and disintegration time. In-vitro drug release studies were carried out by USP type I apparatus. The prepared suppositories were also subjected to stability testing. The prepared suppositories were within the permissible limits of all the physical parameters. In-vitro drug release studies of optimized formulation showed more than 70% of drug release within 20 min and maximum release of 94.81% within 30 min of the dissolution studies. The drug release studies were found to be comparable to the suppositories prepared by using cocoa butter as standard base. Stability studies also revealed satisfactory results. Thus the overall study and results suggested that Sal fat can be used as economical suppository base as well as cost effective excipient for other pharmaceutical formulations.