Pharmaceutical compositions comprising polymorphic forms α, β, and γ of rifaximin
DC CAFC
First Claim
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1. A solid pharmaceutical composition comprising rifaximin in polymorphic Form α
- and a pharmaceutically acceptable excipient or carrier, wherein the rifaximin Form α
has x-ray powder diffraction pattern peaks at about 7.4°
;
19.7°
;
21.0° and
22.1°
2-θ
, wherein the rifaximin Form α
has a water content of between 3.0-4.5%.
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Abstract
Crystalline polymorphous forms of rifaximin (INN), referred to as rifaximin α and rifaximin β, and a poorly crystalline form referred to as rifaximin γ, useful in the production of medicaments containing rifaximin for oral and topical use and obtained by means of a crystallization process 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 fixed temperature and for a fixed period of time, followed by a drying under controlled conditions until reaching a precise water content in the end product, are the object of the invention.
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Citations
20 Claims
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1. A solid pharmaceutical composition comprising rifaximin in polymorphic Form α
- and a pharmaceutically acceptable excipient or carrier, wherein the rifaximin Form α
has x-ray powder diffraction pattern peaks at about 7.4°
;
19.7°
;
21.0° and
22.1°
2-θ
, wherein the rifaximin Form α
has a water content of between 3.0-4.5%. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
- and a pharmaceutically acceptable excipient or carrier, wherein the rifaximin Form α
-
9. A solid pharmaceutical composition comprising rifaximin in polymorphic Form β
- and a pharmaceutically acceptable excipient or carrier, wherein the rifaximin Form β
has x-ray powder diffraction pattern peaks at about 5.4°
;
9.0°
; and
20.9°
2-θ and
wherein the rifaximin Form β
has a water content of between 4.5%-5.0%. - View Dependent Claims (10, 11, 12, 13, 14)
- and a pharmaceutically acceptable excipient or carrier, wherein the rifaximin Form β
-
15. A solid pharmaceutical composition comprising rifaximin in polymorphic Form γ
- and a pharmaceutically acceptable excipient or carrier, wherein the rifaximin Form γ
has x-ray powder diffraction pattern peaks at about 5.0°
, 7.1°
, and 8.4°
2-θ and
wherein the rifaximin Form γ
has a water content of from between 0% to 1%. - View Dependent Claims (16, 17, 18, 19, 20)
- and a pharmaceutically acceptable excipient or carrier, wherein the rifaximin Form γ
Specification
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Litigation Data
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Current AssigneeAlfasigma S.p.A.
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Original AssigneeALFA Wassermann BV (Alfasigma S.p.A.)
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InventorsViscomi, Giuseppe Claudio, Campana, Manuela, Braga, Dario, Confortini, Donatella, Cannata, Vincenzo, Righi, Paolo, Rosini, Goffredo
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Primary Examiner(s)Kifle, Bruck
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Application NumberUS13/041,347Publication NumberTime in Patent Office410 DaysField of Search514/279US Class Current514/279CPC Class CodesA61K 31/437 the heterocyclic ring syste...A61P 31/00 Antiinfectives, i.e. antibi...C07B 2200/13 Crystalline forms, e.g. pol...C07D 498/22 in which the condensed syst...
