Agitation process for preparing a carbetocin drug product
US11844764B2 · kind B2 · utility
Assignee
Inventors
Key dates
| Filing date | Mar 2, 2022 |
| Grant date | Dec 19, 2023 |
| Priority date | — |
| Expiry date | Mar 2, 2042 |
Classification
- Technology area (CPC A)Human Necessities
- CPC primaryA61K47/38
- WIPO fieldPharmaceuticals
- WIPO sectorChemistry
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 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.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.