| abstract |
The present invention relates to solid, semi-solid or liquid formulations comprising a water-soluble antioxidant which prevents or reduces the generation of formic acid and/or formyl species in the dosage form during manufacture and/or during shelf-life storage. The formulations of the invention prevent or reduce the formation of N-formyl impurities (and gelatin cross-linking) during manufacturing and/or during shelf-life storage. |