Invention Grant
- Patent Title: Hydrated form of erlotinib free base and a process for preparation of erlotinib hydrochloride polymorph form a substantially free of polymorph form B
- Patent Title (中): 埃洛替尼游离碱的水合形式和盐酸埃罗替尼多晶型的制备方法基本上不含多晶型B
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Application No.: US13900647Application Date: 2013-05-23
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Publication No.: US08669265B2Publication Date: 2014-03-11
- Inventor: Bandi Parthasaradhi Reddy , Kura Rathnakar Reddy , Rapolu Raji Reddy , Dasari Muralidhara Reddy , Thungathurthy Srinivas Rao
- Applicant: Hetero Research Foundation
- Applicant Address: IN
- Assignee: Hetero Drugs Limited
- Current Assignee: Hetero Drugs Limited
- Current Assignee Address: IN
- Agency: Cantor Colburn LLP
- Main IPC: A61K31/517
- IPC: A61K31/517
Abstract:
The present invention provides a novel and stable hydrated form of erlotinib free base, and a process for its preparation thereof. The present invention also provides a process for preparation of erlotinib hydrochloride crystalline polymorph a substantially free of polymorph B. The present invention further relates to erlotinib hydrochloride crystalline particles having mean particle size (D50) ranging from about 4 μm to 15 μm and 90 volume-% of the particles (D90) ranging from about 14 μm to 30 μm, to the methods for the manufacture of said crystalline particles, and to pharmaceutical compositions comprising said crystalline particles.
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