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Polymorphs Of Ibrutinib

Abstract: The present invention provides crystalline forms of Ibrutinib and processes for their preparation.

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Patent Information

Application #
Filing Date
27 September 2017
Publication Number
41/2017
Publication Type
INA
Invention Field
CHEMICAL
Status
Email
Parent Application

Applicants

Dr. Reddy’s Laboratories Limited
8-2-337 Road No. 3 Banjara Hills, Telangana, Hyderabad 500 034.

Inventors

1. PEDDY Vishweshwar
Plot No. 341, Vasavi colony, Green Hills Road No: 1, Saroornagar post, Hyderabad- 500035
2. VELAGA Dharma Jagannadha Rao
D. No: 9-4, Pallapu street, Munagapaka village, Vishakapatnam (Dist), Andhra Pradesh - 531033, India.
3. KANNIAH Sundara Lakshmi
101, Periya Kalani Kattu Street, Velapadi, Vellore 632 001, Tamilnadu, India
4. CHENNURU Ramanaiah
Velagala Ponnuru Village Post, Sulluru Pet- 524121, Nellore, Andhra Pradesh, India.
5. RAMAKRISHNAN Srividya
H. No. 1005/2A, SMR Vinay city, Miyapur, Hyderabad, Andhra Pradesh, India 500 049
6. RANGINENI Srinivas
Machinenipalli, Yenmenvetla, Kollapur, Mahabubnagar, Telangana – 509102, India.

Specification

CLAIMS:
We Claim:
1. Crystalline form D1 of Ibrutinib characterized by an X-ray Powder
Diffraction Pattern (PXRD) having peaks at about 10.11, 11.45, 18.47 and
20.89 ± 0.20 degrees 2Ɵ.
2. Crystalline form D1 of Ibrutinib of claim 1, further characterized by PXRD
pattern having additional peaks located at about 5.04, 10.79, 23.10 and
26.60 ± 0.20 degrees 2Ɵ.
3. Crystalline form D1 of Ibrutinib characterized by an X-ray Powder
Diffraction Pattern (PXRD) as shown figure 18.
4. A process for preparing crystalline Form D1 of Ibrutinib, comprising the
steps of:
a. obtaining a solution of ibrutinib in an alcohol;
b. combining the solution of step a) with an anti-solvent; and
c. isolating crystalline form D1 of Ibrutinib.
5. The process of claim 4 wherein, the alcohol is selected from methanol,
ethanol, propanol, isopropanol, butanol, iso-butanol and pentanol.
6. The process of claim 4 wherein, the anti-solvent is water.

Documents

Application Documents

# Name Date
1 201747034226-STATEMENT OF UNDERTAKING (FORM 3) [27-09-2017(online)].pdf 2017-09-27
1 201747034226.pdf 2017-09-28
2 201747034226-COMPLETE SPECIFICATION [27-09-2017(online)].pdf 2017-09-27
2 201747034226-DRAWINGS [27-09-2017(online)].pdf 2017-09-27
3 201747034226-DECLARATION OF INVENTORSHIP (FORM 5) [27-09-2017(online)].pdf 2017-09-27
4 201747034226-COMPLETE SPECIFICATION [27-09-2017(online)].pdf 2017-09-27
4 201747034226-DRAWINGS [27-09-2017(online)].pdf 2017-09-27
5 201747034226-STATEMENT OF UNDERTAKING (FORM 3) [27-09-2017(online)].pdf 2017-09-27
5 201747034226.pdf 2017-09-28