Amorphous form of erlotinib hydrochloride and its solid...

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...

Reexamination Certificate

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C544S293000

Reexamination Certificate

active

07625911

ABSTRACT:
The present invention relates to novel amorphous form of [6,7-Bis(2-methoxy-ethoxy)-quinazolin-4-yl]-(3-ethynyl-phenyl) (erlotinib hydrochloride), to solid amorphous dispersion of erlotinib hydrochloride and a carrier such as PVP or solid PEG, to processes for their preparations, to pharmaceutical compositions containing them and to method of treatment using the same. The amorphous form or solid amorphous dispersion of erlotinib hydrochloride obtained in this invention is useful in preparing pharmaceutical dosage forms.

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Corrigan, D.J. et. al., “Amorphous spray-dried . . . ”, J. Pharm. Pharmacol., 1984, vol. 36, pp. 217-221.
Duncan, Q.M. et. al., “The relevance of the amorphous state . . . ”, Intl. J. of Pharmaceutics, 1999, vol. 179, pp. 179-207.
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