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Claims for Patent: 8,853,231

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Claims for Patent: 8,853,231

Title:Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Abstract: Crystalline polymorphous forms of rifaximin (INN), referred to as rifaximin .alpha. and rifaximin .beta., and a poorly crystalline form referred to as rifaximin .gamma., 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.
Inventor(s): Viscomi; Giuseppe Claudio (Bologna, IT), Campana; Manuela (Bologna, IT), Braga; Dario (Bologna, IT), Confortini; Donatella (Bologna, IT), Cannata; Vincenzo (Bologna, IT), Righi; Paolo (Bologna, IT), Rosini; Goffredo (Bologna, IT)
Assignee: Alfa Wassermann S.p.A. (Alanno (PE), IT)
Application Number:13/679,602
Patent Claims: 1. A pharmaceutical composition comprising a polymorphic form of rifaximin together with a pharmaceutically acceptable carrier, wherein the polymorphic form is form .alpha., having x-ray powder diffraction pattern peaks at about: 7.4.degree., 7.9.degree., and 11.8.degree.; or 7.4.degree., 8.8.degree., and 11.8.degree.; or 7.4.degree., 10.5.degree., and 11.8.degree.; or 7.4.degree., 11.1.degree., and 11.8.degree.; or 7.4.degree., 11.8.degree. and 12.9.degree.; or 7.4.degree., 11.8.degree. and 17.6.degree.; or 7.4.degree., 11.8.degree. and 19.7.degree.; or 7.4.degree., 11.8.degree. and 21.4.degree.; or 7.4.degree., 11.8.degree. and 22.1.degree., or 7.4.degree.,11.1.degree., and 12.9.degree.; or 7.4.degree., 11.1.degree., and 19.7.degree.; or 7.4.degree., 12.9.degree., and 19.7.degree.; or 11.1.degree., 11.8.degree., and 19.7.degree.; or 11.1.degree., 19.7.degree., and 21.4.degree.; or 11.1.degree., 19.7.degree., and 22.1.degree., or 11.8.degree., 12.9.degree., and 19.7.degree.; or 11.8.degree., 19.9.degree., and 22.1.degree., 2.theta..

2. The pharmaceutical composition of claim 1, wherein after administration of the pharmaceutical composition to a patient, an observed plasma concentration of rifaximin in the patient is negligible.

3. The pharmaceutical composition of claim 1, wherein the composition further comprises an excipient.

4. The pharmaceutical composition of claim 2, wherein the excipient is selected from the group consisting of a diluting agent, a binding agent, a lubricating agent, a disintegrating agent, a coloring agent, a flavoring agent, and a sweetening agent.

5. The pharmaceutical composition of claim 2, wherein the composition is for oral use and is in a form selected from the group consisting of coated or uncoated tablets, hard or soft gelatin capsules, sugar-coated pills, lozenges, wafer sheets, pellets, and powders in sealed packet.

6. The pharmaceutical composition of claim 2, wherein the composition comprises one or more of colloidal silicon dioxide, hydroxypropyl methylcellulose, cellulose, microcrystalline cellulose, propylene glycol, sodium starch glycolate.

7. A pharmaceutical composition comprising a polymorphic form of rifaximin together with a pharmaceutically acceptable carrier, wherein the polymorphic form is form .beta., having x-ray powder diffraction pattern peaks at about: 5.4.degree., 6.4.degree., and 7.0.degree., or 5.4.degree., 6.4.degree., and 7.8.degree.; or 5.4.degree., 6.4.degree., and 9.0.degree.; or 5.4.degree., 6.4.degree., and 10.4.degree.; or 5.4.degree., 6.4.degree., and 13.1.degree., or 5.4.degree. and 7.0.degree., and 14.4.degree.; or 5.4.degree., 10.4.degree., and 18.3.degree.; or 5.4.degree., 10.4.degree., and 20.9.degree.; or 5.4.degree., 10.4.degree., and 17.1.degree., or 6.4.degree., 7.0.degree., and 10.4.degree.; or 6.4.degree., 7.8.degree. and 10.4.degree.; or 6.4.degree., 9.0.degree. and 10.4.degree.; or 6.4.degree., 10.4.degree., and 14.4.degree.; or 10.4.degree., 13.1.degree., and 14.4.degree.; or 10.4.degree., 17.1.degree., and 17.9.degree.; or 10.4.degree., 17.9.degree., and 18.3.degree.; or 10.4.degree., 17.9.degree., and 20.9.degree.; or 10.4.degree., 18.3.degree., and 20.9.degree.; or 14.4.degree., 17.1.degree., and 18.3.degree.; or 17.1.degree., 18.3.degree., and 20.9.degree.; or 14.4.degree., 17.1.degree., and 20.9.degree., 2.theta..

8. The pharmaceutical composition of claim 7, wherein after administration of the pharmaceutical composition to a patient, an observed plasma concentration of rifaximin in the patient is negligible.

9. The pharmaceutical composition of claim 7, further comprising an excipient.

10. The pharmaceutical composition of claim 9, wherein the excipient is selected from the group consisting of a diluting agent, a binding agent, a lubricating agent, a disintegrating agent, a coloring agent, a flavoring agent, and a sweetening agent.

11. The pharmaceutical composition of claim 7, wherein the composition is for oral use and is in a form selected from the group consisting of coated or uncoated tablets, hard or soft gelatin capsules, sugar-coated pills, lozenges, wafer sheets, pellets, and powders in sealed packet.

12. The pharmaceutical composition of claim 10, wherein the composition comprises one or more of colloidal silicon dioxide, hydroxypropyl methylcellulose, cellulose, microcrystalline cellulose, propylene glycol, sodium starch glycolate.

13. A pharmaceutical composition comprising a polymorphic form of rifaximin together with a pharmaceutically acceptable carrier, wherein the polymorphic form is form .gamma., having x-ray powder diffraction pattern peaks at about 5.0.degree., 7.1.degree., and 8.4.degree. 2.theta. and an intrinsic dissolution rate of about 0.14 mg/min/cm.sup.2.

14. The pharmaceutical composition of claim 13, wherein after administration of the pharmaceutical composition to a patient, an observed plasma concentration of rifaximin is of about 670 ng/ml.

15. The pharmaceutical composition of claim 14, wherein the composition further comprises an excipient.

16. The pharmaceutical composition of claim 15, wherein the excipient is selected from the group consisting of a diluting agent, a binding agent, a lubricating agent, a disintegrating agent, a coloring agent, a flavoring agent, and a sweetening agent.

17. The pharmaceutical composition of claim 14, wherein the composition is for oral use and is in a form selected from the group consisting of coated or uncoated tablets, hard or soft gelatin capsules, sugar-coated pills, lozenges, wafer sheets, pellets, and powders in sealed packet.

18. The pharmaceutical composition of claim 16, wherein the composition comprises one or more of colloidal silicon dioxide, hydroxypropyl methylcellulose, cellulose, microcrystalline cellulose, propylene glycol, sodium starch glycolate.
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