Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
DC CAFC
First Claim
Patent Images
1. Rifaximin in polymorphic form δ
- , wherein the rifaximin polymorphic form δ
has x-ray powder diffraction pattern peaks at about 5.7°
±
0.2, 12.1°
±
0.2, and 17.0°
±
0.2 2-θ
.
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Abstract
Crystalline polymorphous forms of the rifaximin (INN) antibiotic named rifaximin δ and rifaximin ε useful in the production of medicinal preparations 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 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.
-
Citations
44 Claims
-
1. Rifaximin in polymorphic form δ
- , wherein the rifaximin polymorphic form δ
has x-ray powder diffraction pattern peaks at about 5.7°
±
0.2, 12.1°
±
0.2, and 17.0°
±
0.2 2-θ
. - View Dependent Claims (2, 3, 4, 5, 6, 7, 19, 20, 21)
- , wherein the rifaximin polymorphic form δ
-
8. Rifaximin in polymorphic form ε
- , wherein the rifaximin polymorphic form ε
has x-ray powder diffraction pattern peaks at about 8.2°
±
0.2, 12.4°
±
0.2, and 16.3°
±
0.2 2-θ
. - View Dependent Claims (22, 23)
- , wherein the rifaximin polymorphic form ε
-
9. A method of treating bacterial activity in the gastrointestinal tract of a subject, comprising administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of rifaximin δ
- , thereby reducing the bacterial activity in the gastrointestinal tract, wherein the rifaximin polymorphic form δ
has x-ray powder diffraction pattern peaks at about 5.7°
±
0.2, 12.1°
±
0.2, and 17.0°
±
0.2 2-θ
. - View Dependent Claims (10, 11, 12, 13)
- , thereby reducing the bacterial activity in the gastrointestinal tract, wherein the rifaximin polymorphic form δ
-
14. A method of treating bacterial activity in the gastrointestinal tract of a subject, comprising administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of rifaximin ε
- , thereby reducing the bacterial activity in the gastrointestinal tract, wherein the rifaximin polymorphic form ε
has x-ray powder diffraction pattern peaks at about 8.2°
±
0.2, 12.4°
±
0.2, and 16.3°
±
0.2 2-θ
. - View Dependent Claims (15, 16, 17, 18)
- , thereby reducing the bacterial activity in the gastrointestinal tract, wherein the rifaximin polymorphic form ε
-
24. A medicinal preparation for oral administration having antibiotic activity, the medicinal preparation comprising a therapeutically effective amount of rifaximin in polymorphic form δ
- and pharmaceutically acceptable excipients wherein the rifaximin polymorphic form δ
has x-ray powder diffraction pattern peaks at about 5.7°
±
0.2, 12.1°
±
0.2, and 17.0°
±
0.2 2-θ
. - View Dependent Claims (25, 26, 27, 28, 29, 30, 31, 32)
- and pharmaceutically acceptable excipients wherein the rifaximin polymorphic form δ
-
33. A medicinal preparation for oral administration having antibiotic activity, the medicinal preparation comprising a therapeutically effective amount of rifaximin in polymorphic form ε
- and pharmaceutically acceptable excipients wherein the rifaximin in polymorphic form ε
has x-ray powder diffraction pattern peaks at about 8.2°
±
0.2, 12.4°
±
0.2, and 16.3°
±
0.2 2-θ
. - View Dependent Claims (34, 35)
- and pharmaceutically acceptable excipients wherein the rifaximin in polymorphic form ε
-
36. A medicinal preparation for topical administration having antibiotic activity, the medicinal preparation comprising a therapeutically effective amount of rifaximin in polymorphic form δ
- and pharmaceutically acceptable excipients wherein the rifaximin polymorphic form δ
has x-ray powder diffraction pattern peaks at about 5.7°
±
0.2, 12.1°
±
0.2, and 17.0°
±
0.2 2-θ
. - View Dependent Claims (37, 38, 39, 40, 41, 42, 43, 44)
- and pharmaceutically acceptable excipients wherein the rifaximin polymorphic form δ
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, Confortini, Donatella, Barbanti, Maria, Braga, Dario
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Primary Examiner(s)KIFLE, BRUCK
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Application NumberUS13/950,642Publication NumberTime in Patent Office313 DaysField of Search540/456, 514/254.11, 514/393US Class Current514/254.11CPC Class CodesA61K 31/437 the heterocyclic ring syste...A61K 9/0053 Mouth and digestive tract, ...A61P 31/00 Antiinfectives, i.e. antibi...A61P 31/04 Antibacterial agentsC07B 2200/13 Crystalline forms, e.g. pol...C07D 491/22 in which the condensed syst...C07D 498/22 in which the condensed syst...
