Crystalline Ertugliflozin Process

Abstract: The present invention relates to a process for the preparation of crystalline Form Gl of Ertugliflozin (I). The invention also relates to crystalline Form Gl obtained by the process of the present invention, the said Form Gl being substantially pure, stable, and characterized by X-ray powder-diffraction pattern comprising of atleast five 29° peaks selected form 4.4, 11.0, 13.1, 15.0, 15.4, 16.6, 18.1, 18.3, 18.7, 20.3, 21.1, 21.7 and 23.9 ± 0.05 20°. The invention further relates to pharmaceutical compositions comprising crystalline Form Gl of Ertugliflozin, useful in the treatment of treatment of type 2 diabetes mellitus.

Patent Information

Application #

Filing Date

23 September 2016

Publication Number

13/2018

Publication Type

INA

Invention Field

CHEMICAL

Status

Email

Parent Application

Applicants

GRANULES INDIA LIMITED

MY HOME HUB, 2ND FLOOR, 3RD BLOCK, MADHAPUR, HYDERABAD, TELANGANA, INDIA-500081.

Inventors

1. PRASADA RAJU VNKV VETUKURI

GRANULES INDIA LIMITED, MY HOME HUB, 2ND FLOOR, 3RD BLOCK, MADHAPUR, HYDERABAD, TELANGANA, INDIA-500081.

2. RAJESH KUMAR RAPOLU

GRANULES INDIA LIMITED, MY HOME HUB, 2ND FLOOR, 3RD BLOCK, MADHAPUR, HYDERABAD, TELANGANA, INDIA-500 081

3. RAJASEKHAR BHUPATHI

GRANULES INDIA LIMITED, MY HOME HUB, 2ND FLOOR, 3RD BLOCK, MADHAPUR, HYDERABAD, TELANGANA, INDIA-500 081

4. KRISHNA PRASAD CHIGURUPATI

GRANULES INDIA LIMITED, MY HOME HUB, 2ND FLOOR, 3RD BLOCK, MADHAPUR, HYDERABAD, TELANGANA, INDIA-500 081

5. GOVERDHAN GILLA

GRANULES INDIA LIMITED, MY HOME HUB, 2ND FLOOR, 3RD BLOCK, MADHAPUR, HYDERABAD, TELANGANA, INDIA-500 081

Specification

The present invention relates to a process for the preparation of crystalline Form Gl of Ertugliflozin (I).

The invention also relates to crystalline Form Gl obtained by the process of the present invention, the said Form Gl being substantially pure, stable, and characterized by X-ray powder-diffraction pattern comprising of atleast five 29° peaks selected form 4.4, 11.0, 13.1, 15.0, 15.4, 16.6, 18.1, 18.3, 18.7, 20.3, 21.1, 21.7 and 23.9 ± 0.05 20°.
The invention further relates to pharmaceutical compositions comprising crystalline Form Gl of Ertugliflozin, useful in the treatment of treatment of type 2 diabetes mellitus.

Documents

Application Documents

#	Name	Date
1	201641032515-FORM-26 [06-11-2017(online)].pdf	2017-11-06
1	201641032515-Other Patent Document-230916.pdf	2016-09-26
2	201641032515-Form 5-230916.pdf	2016-09-26
2	201641032515-REQUEST FOR CERTIFIED COPY [09-10-2017(online)].pdf	2017-10-09
3	201641032515-Form 3-230916.pdf	2016-09-26
3	Correspondence by Agent_Submission Of Form1_15-11-2016.pdf	2016-11-15
4	201641032515-Form 2(Title Page)-230916.pdf	2016-09-26
4	Form1_After Filing_15-11-2016.pdf	2016-11-15
5	201641032515-Form 1-230916.pdf	2016-09-26
6	201641032515-Form 2(Title Page)-230916.pdf	2016-09-26
6	Form1_After Filing_15-11-2016.pdf	2016-11-15
7	201641032515-Form 3-230916.pdf	2016-09-26
7	Correspondence by Agent_Submission Of Form1_15-11-2016.pdf	2016-11-15
8	201641032515-Form 5-230916.pdf	2016-09-26
8	201641032515-REQUEST FOR CERTIFIED COPY [09-10-2017(online)].pdf	2017-10-09
9	201641032515-FORM-26 [06-11-2017(online)].pdf	2017-11-06
9	201641032515-Other Patent Document-230916.pdf	2016-09-26