Amorphous form of daclatasvir and its salts and process for preparation thereof
AssigneeCadila Healthcare Limited
InventorsSanjay Jagdish DESAI, Sandipan Prabhurao BONDGE, Naitik Bharatbhai PATEL, Chirag Vasantbhai PATEL, Sandip Kiritkumar UPADHYAY
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Abstract
This relates to an amorphous form of daclatasvir and its salts and process for preparation thereof. In particular, it relates to an amorphous form of daclatasvir and daclatasvir dihydrochloride. It also relates to pharmaceutical compositions comprising an amorphous form of daclatasvir or daclatasvir dihydrochloride for oral administration for treatment of Hepatitis C virus (HCV).
Claims20
An amorphous solid dispersion comprising daclatasvir dihydrochloride and a polymer.
An amorphous form of daclatasvir dihydrochloride.
An amorphous form of daclatasvir dihydrochloride substantially free from residual solvents.
The process according to claim 8, wherein the solvent comprises one or more of alcohols selected from methanol, ethanol, isopropanol, 2-propanol, 1-butanol, and t-butyl alcohol;
- ketones selected from acetone, butanone, and methyl isobutyl ketone;
- esters selected from ethyl acetate, isopropyl acetate, t-butyl acetate, and isobutyl acetate;
- halogenated hydrocarbons selected from methylene dichloride, ethylene dichloride, and chlorobenzene;
- ethers selected from diethyl ether, dimethyl ether, diisopropyl ether and 1,4-dioxane;
- nitriles selected from acetonitrile, and propionitrile;
- and polar aprotic solvents selected from N,N-dimethylformamide, N,N-dimethylacetamide, N-methylpyrrolidone, dimethyl sulfoxide, and mixtures thereof.
Dependencies are inferred from the claim text.