Stable high strength pharmaceutical composition of levoleucovorin
US9301922B1 · kind B1 · utility
Assignee
Inventor
Key dates
| Filing date | Apr 30, 2014 |
| Grant date | Apr 5, 2016 |
| Priority date | — |
| Expiry date | Apr 30, 2034 |
Classification
- Technology area (CPC A)Human Necessities
- CPC primaryA61K47/24
- WIPO fieldPharmaceuticals
- WIPO sectorChemistry
Abstract
The administration of levoleucovorin is useful as an antidote to drugs which act as folic acid antagonists and in combination chemotherapy with 5-FU. The most often used calcium salt of levoleucovorin has a limited solubility in water and forms almost insoluble degradation products. Therefore aqueous solutions are unstable and precipitates are resulting. Precipitates in injectable products present an unacceptable safety risk to patients. Stable high strength pharmaceutical aqueous compositions containing calcium salts, magnesium or zinc salts of levoleucovorin and one or more of the compounds sodium gluconate, potassium gluconate, glycerophosphate disodium salt or glycerophosphate dipotassium salt are disclosed.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.