Amorphous salt of a macrocyclic inhibitor of HCV
The amorphous form of the sodium salt of the macrocyclic inhibitor of HCV of formula: as well as processes for manufacturing this salt.
1. A process for preparing a sodium salt of the compound in solid amorphous form comprising:
(a) preparing a mixture of the compound of formula I in dichloromethane and aqueous sodium hydroxide; and
(b) spray-drying a mixture of (a) in a spray-drying apparatus; wherein said compound is of formula I:
wherein the aqueous sodium hydroxide is from about 7.5N to about 12.5N sodium hydroxide solution in water.
2. The process of claim 1 wherein step a) comprises mixing a sodium hydroxide solution in water with the said solvent and subsequently adding the compound of formula I.
3. The process of claim 2 , wherein in step a) the compound of formula I is allowed to form a solution.