Processes for the production of polymorphic forms of rifaximin

Organic compounds -- part of the class 532-570 series – Organic compounds – Unsubstituted hydrocarbyl chain between the ring and the -c-...

Reexamination Certificate

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Reexamination Certificate

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07923553

ABSTRACT:
Crystalline polymorphous forms of rifaximin (INN) antibiotic named rifaximin α and rifaximin β, and a poorly crystalline form named rifaximin γ, useful in the production of medicinal preparations containing rifaximin for oral and topical use and obtained by means of a crystallization carried out by hot-dissolving the raw rifaximin in ethyl alcohol and by causing the crystallization of the product by addition of water at a determinate temperature and for a determinate period of time, followed by a drying carried out under controlled conditions until reaching a settled water content in the end product, are the object of the invention.

REFERENCES:
patent: 4341785 (1982-07-01), Marchi et al.
patent: 4557866 (1985-12-01), Cannata et al.
patent: 7045620 (2006-05-01), Viscomi et al.
patent: 0 161 534 (1989-09-01), None
patent: 2009/108730 (2009-09-01), None
Rossi, C. et al., “NMR Investigation of a New Semisynthetic Bioactive Compound,” Bulletin of Magnetic Resonance, 1996, vol. 18, No. 1-2, pp. 87-90.
Viscomi, G. et al., “Crystal Forms of Rifaximin and Their Effect on Pharmaceutical Properties,” CrystEngComm, 2008, 10, 1074-1081.
Italian Product Label for NORMIX (rifaximin), Apr. 23, 1985.

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