Crystalline levosalbutamol sulphate and polymorphic forms...

Organic compounds -- part of the class 532-570 series – Organic compounds – Amino nitrogen containing

Reexamination Certificate

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C514S686000

Reexamination Certificate

active

07915451

ABSTRACT:
The invention provides three polymorphic forms of crystalline levosalbutamol sulphate designated herein as Forms I, II and III.Crystalline levosalbutamol sulphate Form I is characterised by a powder XRD pattern with peaks at 10.8, 11.9, 13.0, 18.3, 28.5±0.2 degrees 2 theta.Crystalline levosalbutamol sulphate Form II is characterised by a powder XRD pattern with peaks at 8.7, 9.6, 15.2, 15.7, 19.1, 27.2, 30.7±0.2 degrees 2 theta.Crystalline levosalbutamol sulphate Form III is characterised by a powder XRD pattern with peaks at 5.5, 6.9, 7.3, 18.7±0.2 degrees 2 theta.Processes for making the new polymorphic forms and pharmaceutical compositions comprising them are also provided.

REFERENCES:
patent: 5545745 (1996-08-01), Gao et al.
patent: 6585958 (2003-07-01), Keller et al.
patent: 6995286 (2006-02-01), Hamied et al.
patent: 7005629 (2006-02-01), Flem
patent: 7579505 (2009-08-01), Rao et al.
patent: 2002/0076382 (2002-06-01), Kaplan et al.
patent: WO 2004/052835 (2004-06-01), None

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