PROCESSES FOR PRODUCING COMPOSITIONS WITH IMPROVED SAFETY PROFILE HAVING LIPASE ACTIVITY AND COMPOSITIONS SUITABLE FOR PHARMACEUTICAL USE

Abstract: processes are described for producing solid or semi-solid compositions, in particular solid oral compositions for pharmaceutical use, comprising treating an enzyme or enzyme-mixture with lipase-activity and a surfactant-component at defined process parameters. said processes are suited for diminishing undesired biological contamination, e.g. viral contamination, of the said enzyme or enzyme-mixture while maintaining its desired biological activities, e.g. enzymatic activities. the process is suitable for industrial use. also described are solid or semi-solid compositions comprising an enzyme or enzyme-mixture having lipase activity, a surfactant-component and a polymeric additive, optionally comprising further auxiliaries. said compositions can preferably be obtained by the processes as described herein. further described are pharmaceutical compositions comprising the solid or semi-solid compositions as described herein.

Inventor(s): George SHLIEOUT, Christopher RUPP, Joerg BREITENBACH, Frauke-Regina RUEFFER, Frithjof SCZESNY

CPC Classification: A61K38/54 (PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms ; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles ; soap compositions ))

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