Enteric spherules diastase in enzyme preparations.

Enteric diastase spherules were prepared using cellulose acetate phthalate and eudragit RS-100 by emulsion solvent removal method. Factors that could affect the size shape and diastatic activity were studied. The studied factors include pH of aqueous media, temperature of dispersion media and concentration of surface active agent. Prepared enteric diastase spherules were investigated for stability and diastatic activity at different temperatures and pH in various buffer systems, in the presence and absence of pepsin, a gastric enzyme. Eudragit RS-100 based spherules were noted to be spherical and uniform in shape with an appreciable level of diastatic activity. However, diastase was observed to be released from such a system in a slow but controlled manner. Eudragit RS-100 was found to provide more stabilization to the diastase than the stabilization provided by cellulose acetate phthalate. The spherules when tested in in vitro and in situ were recorded to exhibit diastatic activity at 99 per cent potency level (based on an actually incorporated amount of diastase). The study reveals that enteric or pH sensitive diastase releasing systems hold promise and potential in the therapeutic application of digestive enzyme(s).