Preparation of amorphous form of indiplon
AssigneeMai De Ltd.
InventorsLe Huang, Hui Huang
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Abstract
The present invention is directed to amorphous form of indiplon, to processes for preparing said amorphous form, to pharmaceutical compositions containing the same, and to method of treatment using the same. Additionally, the present invention also relates to the preparation of solid amorphous dispersion of indiplon and a carrier which includes PVP and solid PEG etc.
Claims15
An amorphous form of N-Methyl-N-[3-[3-[2-thienylcarbonyl]pyrazolo[1,5-a]pyrimidin-7-yl]phenyl]acetamide (indiplon).
A process for preparing amorphous form of N-Methyl-N-[3-[3-[2-thienylcarbonyl]pyrazolo[1,5-a]pyrimidin-7-yl]phenyl]acetamide (indiplon) by distillation, comprising following steps:
- a) dissolving indiplon starting material in dichloromethane, acetone, acetonitrile or a straight or branched chain C1-C4 alcohol solvent or mixtures thereof;
- b) removing the solvent by distillation;
- c) drying the product to afford the amorphous form of indiplon.
A process for preparing amorphous form of N-Methyl-N-[3-[3-[2-thienylcarbonyl]pyrazolo[1,5-a]pyrimidin-7-yl]phenyl]acetamide (indiplon) by spray drying, comprising following steps:
- a) dissolving the starting material indiplon in a solvent under heating;
- b) removing the solvent by spray drying;
- c) drying the product to obtain the amorphous form of indiplon.
A pharmaceutical composition comprising a therapeutically effective amount of amorphous indiplon and pharmaceutical acceptable excipients.
The use of amorphous form of indiplon or solid amorphous dispersion of indiplon for the treatment of insomnia, chronicle insomnia or sleep disorder.
Dependencies are inferred from the claim text.