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AssigneeSomerset Therapeutics, LLC
InventorsRahul Kalhapure, Prem Sagar Akasapu, Veerappan Subramanian, Ilango Subramanian
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The present invention relates to a process for preparation of an insoluble corticosteroid and a soluble corticosteroid composition by moist heat sterilization and homogenization. In particular, the invention relates to a process for the preparation of a sterilized suspension of betamethasone acetate and betamethasone sodium phosphate, wherein the process comprises sterilizing a slurry of the betamethasone acetate by moist heat sterilization or autoclaving in about 30% to about 70% of water to a temperature of about 115° C. to about 128° C. for about 15 minutes to about 60 minutes under nitrogen atmosphere. The suspensions prepared by using the current invention exhibited good physical and chemical stability. Compositions related thereto are also disclosed.
A process for preparing a sterile injectable suspension of an insoluble corticosteroid and a soluble corticosteroid, wherein the process comprises:
A process for preparing a sterile injectable suspension of betamethasone acetate and betamethasone sodium phosphate, wherein the process comprises:
Dependencies are inferred from the claim text.