Hydrated form of erlotinib free base and a process for preparation of erlotinib hydrochloride polymorph form a substantially free of polymorph form B

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United States of America Patent

PATENT NO 8471012
APP PUB NO 20120022256A1
SERIAL NO

13221986

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ATTORNEY / AGENT: (SPONSORED)

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Abstract

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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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Patent Owner(s)

Patent OwnerAddress
HETERO DRUGS LIMITEDHETERO HOUSE 8-3-166/71 ERRAGADDA HYDERABAD ANDHRAPRADESH 500 018

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Inventor(s)

Inventor Name Address # of filed Patents Total Citations
Muralidhara, Reddy Dasari Hyderabad, IN 111 109
Parthasaradhi, Reddy Bandi Andra Pradesh, IN 145 158
Raji, Reddy Rapolu Hyderabad, IN 102 111
Rathnakar, Reddy Kura Hyderabad, IN 139 178
Srinivas, Rao Thungathurthy Andhra Pradesh, IN 1 0

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