CARBETOCIN DRUG PRODUCT AND PROCESS FOR PREPARING SAME
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United States of America Patent
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Issued Date -
Mar 21, 2024
app pub date -
Nov 16, 2023
filing date -
Sep 20, 2018
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Abstract
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 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 free/thaw cycles, provides enhanced convenience and patient compliance, and/or are highly concentrated.
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