Organic compounds -- part of the class 532-570 series – Organic compounds – Heterocyclic carbon compounds containing a hetero ring...
Reexamination Certificate
2000-06-06
2003-09-02
Rotman, Alan L. (Department: 1625)
Organic compounds -- part of the class 532-570 series
Organic compounds
Heterocyclic carbon compounds containing a hetero ring...
C546S239000
Reexamination Certificate
active
06613906
ABSTRACT:
SUMMARY
This invention relates to a novel crystal form of &agr;,&agr;-dimethyl-4-{1-hydroxy4-{4-(hydroxydiphenylmethyl)-1-piperidinyl}butyl}benzeneacetic acid hydrochloride, a process for its preparation and pharmaceutical formulations thereof.
BACKGROUND
The compound &agr;,&agr;-dimethyl-4-{1-hydroxy-4-{4-(hydroxydiphenylmethyl)-1-piperidinyl}butyl}benzeneacetic acid hydrochloride has been named according to the U.S.A.N. as fexofenadine hydrochloride (“F-HCI”). It is known as the active metabolite of the non-sedating antihistamine terfinadine and is itself marketed in the United States as a non-sedating antihistamine. F-HCI and its preparation are described, for example, in U.S Pat. No. 5,578,610, which is here incorporated by reference. Anhydrous and hydrated crystal forms of F-HCI identified as Forms I, II, III and IV are described in WO 95/31437.
The present invention relates to a novel F-HCI crystal modification, hereinafter designated as Form A, which is distinguished from previously known crystal forms by physical and spectroscopic properties such as melting point, x-ray powder diffraction pattern, solid state NMR spectrum and infrared spectrum. The Form A crystal modification of F-HCI is prepared in an advantageously environmentally friendly manner.
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patent: WO 95/00480 (1995-01-01), None
patent: WO 95/31437 (1995-04-01), None
patent: WO 99/47693 (1999-09-01), None
patent: WO 00/21510 (2000-04-01), None
patent: WO 00/71124 (2000-11-01), None
Davies Julian Anthony
Gano James E.
Covington Raymond
Dohmann George R.
Geneva Pharmaceuticals Inc.
Lopez Gabriel
Rotman Alan L.
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