Mohammed Maniruzzaman,Saumil Kiritkumar Bhatt,Anwar Ali,Arun Jangra
申请号:
GB201601063
公开号:
GB2546513A
申请日:
2016.01.20
申请国别(地区):
GB
年份:
2017
代理人:
摘要:
The invention relates to a process of preparing a salt of an active pharmaceutical ingredient, the process comprising providing a blend of an active pharmaceutical ingredient (e.g. ibuprofen, phenytoin diclofenac) and a salt forming substance (i.e. a base, e.g. sodium/potassium hydroxide, sodium/potassium carbonate) mixing the blend, optionally in the presence of added water, to react the active pharmaceutical ingredient with the salt forming substance to provide the salt of the active pharmaceutical ingredient wherein when the active pharmaceutical ingredient is acidic, the salt forming substance is a base and the pKa difference between the acidic active pharmaceutical ingredient and the base is greater than 3 or when the active pharmaceutical ingredient is basic, the salt forming substance is an acid and the pKa difference between the basic active pharmaceutical ingredient and the acid is greater than 3. Also the invention relates to the salts of active pharmaceutical ingredients obtainable from said process which may be directly compressed to form a tablet/capsule or further blended with a lubricant to form same.