Pharmaceutical parenteral formulation containing carglumic acid
US11103474B2 · kind B2 · utility
Assignee
Inventors
Key dates
| Filing date | Nov 20, 2017 |
| Grant date | Aug 31, 2021 |
| Priority date | — |
| Expiry date | Nov 20, 2037 |
Classification
- Technology area (CPC A)Human Necessities
- CPC primaryA61K9/0019
- WIPO fieldPharmaceuticals
- WIPO sectorChemistry
Abstract
The present invention relates to a pharmaceutical formulation suitable for parenteral administration containing carglumic acid and a buffering agent having a pKa from 5.5 to 9.0 at 25° C.; according to an embodiment, the buffering agent may have a pKa from 7.5 to 8.5, preferably a pKa of about 8.07, such as trometamol. The formulation may also contain at least one bulking agent, such as mannitol. The invention also includes a method for manufacturing a lyophilised sterile formulation by freeze-drying a water solution containing carglumic acid, a buffering agent having a pKa from 5.5 to 9.0 at 25° C., preferably from 7.5 to 8.5, and optionally a bulking agent to obtain a freeze-dried powder.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.