Abstract: Aspects of the present invention relate to solid state forms of Asciminib salts and processes thereof and pharmaceutical composition thereof. The present application relates to Asciminib oxalate form DC1 and its process. The present application also relates to Asciminib phosphate form DC2 and its process. The present application also relates to Asciminib trifluoroacetate form DC3 and its process.
WE CLAIM:
1) Asciminib oxalate salt.
2) A crystalline form DC1 of Asciminib oxalate, characterized by a PXRD
comprising the peaks at about 9.57, 11.2, 13.8, 18.4, 19.3, 20.1, 21.9, 22.7,
23.6, 24.3, 25.5, 27.5, 30.0, 31.3, 33.3 ± 0.2 2 θ.
3) A process for the preparation of a crystalline form DC1 of Asciminib oxalate, comprising:
a) providing a mixture of Asciminib free base and oxalic acid in presence of a solvent;
b) isolating the crystalline form DC1 of Asciminib oxalate.
4) The process as claimed in claim 3, wherein the solvent is selected from methanol, ethanol,
isopropyl alcohol, n-butanol, tertiary butanol, acetone, ethyl methyl ketone, diethyl ketone,
methyl isobutyl ketone, dichloromethane, chloroform, ethyl formate, methyl acetate, ethyl acetate,
propyl acetate, butyl acetate, methyl propanoate.
5) A crystalline form DC2 of Asciminib phosphate, characterized by a PXRD
comprising the peaks at about 6.4, 8.0, 10.0, 14.4, 14.8, 15.4, 17.9, 18.7, 19.3,
20.1, 21.2, 22.3, 22.7, 24.4, 27.3, 30.6, 31.8, 33.1 ± 0.2 2θ.
6) A crystalline form DC2 of Asciminib phosphate, comprising :
a) providing a solution of Asciminib phosphate in propylene glycol;
b) isolating the crystalline form DC2 of Asciminib phosphate.
7) Asciminib trifluoroacetate salt.
8) A crystalline form DC3 of Asciminib trifluoroacetate, characterized by a
PXRD comprising the peaks at about 7.1, 8.5, 9.6, 11.4, 12.0, 14.4, 15.8, 17.0,
17.5, 18.2, 19.2, 19.6, 20.3, 21.4, 22.0, 23.0, 24.1, 25.5, 26.5, 28.0, 29.0, 30.3,
31.0, 32.4, 35.3 ± 0.2 2θ.
9) A process for the preparation of crystalline form DC3 of Asciminib trifluoro acetate,
comprising:
a) providing a mixture of Asciminib with trifluoro acetic acid in present of a solvent;
b) isolating the crystalline form DC3 of Asciminib trifluoro acetate.
10) A pharmaceutical composition comprising crystalline form DC1 of Asciminib oxalate or
crystalline form DC2 of Asciminib phosphate or crystalline form DC3 of Asciminib trifluoro
acetate with at least one pharmaceutically acceptable excipient.
| # | Name | Date |
|---|---|---|
| 1 | 202341060349-STATEMENT OF UNDERTAKING (FORM 3) [08-09-2023(online)].pdf | 2023-09-08 |
| 2 | 202341060349-PROVISIONAL SPECIFICATION [08-09-2023(online)].pdf | 2023-09-08 |
| 3 | 202341060349-FORM 1 [08-09-2023(online)].pdf | 2023-09-08 |
| 4 | 202341060349-DRAWINGS [08-09-2023(online)].pdf | 2023-09-08 |
| 5 | 202341060349-FORM-5 [05-09-2024(online)].pdf | 2024-09-05 |
| 6 | 202341060349-FORM 3 [05-09-2024(online)].pdf | 2024-09-05 |
| 7 | 202341060349-DRAWING [05-09-2024(online)].pdf | 2024-09-05 |
| 8 | 202341060349-COMPLETE SPECIFICATION [05-09-2024(online)].pdf | 2024-09-05 |