.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for Patent: 8,404,704

« Back to Dashboard

Details for Patent: 8,404,704

Title:Use of polymorphic forms of rifaximin for medical preparations
Abstract: The present invention relates to Rifaximin polymorphic forms .alpha., .beta. and .gamma., to their use in medicinal preparations for the oral or topical route and to therapeutic methods using them.
Inventor(s): Viscomi; Giuseppe Claudio (Bologna, IT), Campana; Manuela (Bologna, IT), Confortini; Donatella (Bologna, IT), Barbanti; Miriam (Bologna, IT), Calanni; Fiorella (Bologna, IT)
Assignee: Alfa Wassermann S.p.A. (Alanno (PE), IT)
Filing Date:Mar 04, 2011
Application Number:13/041,348
Claims:1. A method of preparing a pharmaceutical composition having controlled systemic absorption of rifaximin, said method comprising combining two or more polymorphs of rifaximin selected from the group consisting of Form .alpha., Form .beta., and Form .gamma. wherein the amount of absorption of said rifaximin is modulated by adjusting the relative proportions of Form .alpha., Form .beta., and Form .gamma. rifaximin to form a mixture of rifaximin polymorphs and combining the mixture with a pharmaceutically acceptable excipient or carrier, wherein the rifaximin Form .alpha. has x-ray powder diffraction pattern peaks at about 7.4.degree.; 19.7.degree.; 21.0.degree. and 22,1.degree. 2-.theta., wherein the rifaximin Form .beta. has x-ray powder diffraction pattern peaks at about 5.4.degree.; 9.0.degree.; and 20.9.degree. 2-.theta., and wherein the rifaximin Form .gamma. has x-ray powder diffraction pattern peaks at about 5.0.degree., 7.1.degree., and 8.4.degree. 2-.theta.,

2. A method of preparing a pharmaceutical composition, said method comprising selecting a mixture of two or more rifaximin polymorphs, wherein said two or more rifaximin polymorphs are two or more of Form .alpha., Form .beta., and Form .gamma., and combining a therapeutically effective amount of said mixture with a pharmaceutically acceptable excipient or carrier, wherein the rifaximin Of the obtained pharmaceutical composition has a controlled systemic absorption determined by the relative proportions of and Form .alpha., Form .beta., Form .gamma. rifaximin, and wherein the rifaximin Form .alpha. has x-ray powder diffraction pattern peaks at about 7.4.degree.; 19.7.degree.; 21.0.degree. and 22.1.degree. 2-.theta., wherein the rifaximin Form .beta. has x-ray powder diffraction pattern peaks at about 5.4.degree. ; 9.0.degree. ; and 20.9.degree. 2-.theta.; and wherein the rifaximin Form .gamma. has x-ray powder diffraction pattern peaks at about 5.0.degree. , 7.1.degree., and 8.4.degree. 2-.theta..

3. The method of claim 2, wherein when rifaximin Form .alpha. is present, rifaximin Form .alpha. is characterized as having water content of less than 4.5%; wherein when rifaximin Form .beta. is present, rifaximin Form .beta. is characterized as having a water content of greater than or equal to 4.5%; and wherein when rifaximin Form .gamma. is present, rifaximin Form .gamma. is characterized as having a water content from about 0% to about 2%.

4. The method of claim 3, wherein the rifaximin Form .alpha. as a water content of between 0% and about 3%.

5. The method of claim 3, wherein the rifaximin Form .beta. has a water content between about 4.5% to about 40%.

6. The method of claim 3, wherein the rifaximin Form .beta. has a dissolution rate of from about 0.001 to about 0.016 mg/min/cm.sup.2.

7. The method of claim 3, wherein the rifaximin Form .gamma. has a dissolution rate of from about 0.1 to about 0.16 mg/min/cm.sup.2.

8. The method of claim 2, wherein the excipient is one or more of a diluting agent, binding agent, lubricating agent, disintegrating agent, absorption accelerating agents, wetting agents, absorbents, coloring agent, flavoring agent or sweetening agent.

9. The method of claim 8, wherein the pharmaceutical composition is formulated as liquid preparation.

10. The method of claim 8, wherein the pharmaceutical composition is formulated as topical preparation.

11. The method of claim 8, wherein the pharmaceutical composition is formulated as a preparation administrable by oral, rectal or vaginal route.

12. The method of claim 10, wherein the pharmaceutical composition is a solid dosage form.

13. The method of claim 11, wherein said solid dosage form is selected from among capsules, tablets, pills, dragees, powders and granules.

14. The method of claim 12, wherein said solid dosage form is administrable by an oral route and wherein said solid dosage form is selected from among coated tablets, uncoated tablets, soft gelatin capsules, hard gelatin capsules, sugar-coated tablets, lozenges, wafer sheets, pellets and powders in sealed containers.

15. The method of claim 13, wherein the pharmaceutical composition is formulated for treating a subject suffering from or susceptible to a bowel disorder and packaged with instructions to treat a subject suffering from or susceptible to a bowel disorder.
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc