Sign In to Follow Application
View All Documents & Correspondence

Solid State Forms Of Asciminib Salts And Procesess Thereof

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.

Get Free WhatsApp Updates!
Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
08 September 2023
Publication Number
11/2025
Publication Type
INA
Invention Field
CHEMICAL
Status
Email
Parent Application

Applicants

Dr. Reddy’s Laboratories Limited
House No. 8-2-337 Street Road No. 3, Banjara Hills, City Hyderabad, State Telangana, Country India. Pin Code 500034

Inventors

1. Nekkanti Satish Chowdary
House No. Flat No: 203 Street Apurva Elite Block A, Kranthi Nagar, Bachupally City Hyderabad State Telangana Country India Pin Code 500090
2. Sharmistha Pal
House No. NE 320, IISc Quarters Street Indian Institute of Science City Bangalore State Karnataka Country India Pin Code 560012

Specification

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.

Documents

Application Documents

# 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