Agitation process for preparing a carbetocin drug product

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United States of America Patent

PATENT NO 11844764
APP PUB NO 20230014640A1
SERIAL NO

17684742

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ATTORNEY / AGENT: (SPONSORED)

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Abstract

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The present disclosure includes a method of making an improved carbetocin drug product. The disclosed method for making an improved carbetocin drug product comprises agitating a carbetocin preparation containing an aqueous solution of carbetocin and one or more excipients for a period of time to initiate the formation of aggregate-forming solids and filtering off the aggregates that form before further processing the remaining carbetocin into a final drug product. The present disclosure also relates to an improved carbetocin drug product, wherein the drug product is substantially free of aggregate-forming solids. The disclosed carbetocin drug product can be used for the treatment of a neurodevelopmental disorder, such as Präder-Willi syndrome. Additionally, the disclosed carbetocin drug product shows content uniformity of carbetocin over long periods of time before and after one or more freeze/thaw cycles, provides enhanced convenience and patient compliance, and/or are highly concentrated.

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Patent Owner(s)

Patent OwnerAddress
ACADIA PHARMACEUTICALS INC12830 EL CAMINO REAL SUITE 400 SAN DIEGO CA 92130

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Inventor(s)

Inventor Name Address # of filed Patents Total Citations
Bryant, Christopher Burr Ridge, US 24 118
Holcomb, Ryan E Fort Collins, US 8 4
Manning, Mark C Johnstown, US 23 610

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