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Gaurav Laxmikant Deshpande* and Satish Vasudeo Shirolkar


Digestive enzyme supplements are used to treat enzyme deficiencies. Plant-based enzymes, such as papain from papaya, serve as effective digestive aids in the breakdown of proteins. The aim of this study is to develop multi-particulate drug delivery system for digestive enzyme papain. Multi-particulate systems offer advantage with respect to predictable and even distribution and transportation through GI track. Characterization of papain was carried out by physical properties, melting point, FT-IR spectroscopy, drug qualitative stability study and assay of papain was performed by using Hammersten-type casein as substrate. Multi-particulate systems of papain have been attempted using microcrystalline cellulose (MCC) and calcium hydrogen phosphate (dihydrate) as main excipients. Dough of papain with excipients was prepared and passed through sieve no. 16 (B.S.S.). The extrudates were spheronised using spheronizer. Optimization of process was done by factorial design using speed (RPM) and time (min.) for spheronisation as independent variables at three levels. For papain containing MCC-DCP pellets effect of speed and time was studied on percentage yield, pellet size, bulk density, tapped density, Carr‟s index, Hausner ratio, angle of repose, hardness, disintegration time, and percentage drug content. Relationship between dependent and independent variables was established using Design Expert® 10.

Keywords: Multi-particulate systems, digestive enzyme, papain, pellets, extrusionspheronisation, factorial design.

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