Feasibility study of manufacturing coated tablet lipase from Yarrowia lipolytica

Many studies have provided evidence to use microbial enzyme lipase such as Yarrowia lipolytica lipase as substitute of pancreatic lipase. However Y. lipolytica lipase lowest resistance at acid pH (1 to 2) limits its application in pharmaceutical industries. In order to improve Y. lipolytica lipase resistance to low acid pH, our study was devoted more particularly to coating lipase tablets by Eudragit L30D-55. Lipase tablets were evaluated for weight uniformity, enzyme content, friability, hardness, according to European pharmacopeia. In vitro release was studied using pH 1.2 acidic buffer and pH 6.8 phosphate buffer. Study revealed that the prepared tablets were able to sustain enzyme release into the intestine. Y. lipolytica lipase tablet was compared to Creon 150 mg (commercial drug). After 3 h incubation, coated tablets did not release lipase at pH 1.2 but was disintegrated totality at pH 6.8 same as Creon 150 mg at 17 min. After 8, 12 and 24 months storage at 25 and 37°C, enzyme tablets retain their enzymatic activity and proprieties. Key words: Tablet, creon, Eudragit L30D-55, in vitro release.