.

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

Claims for Patent: 6,720,453

« Back to Dashboard

Claims for Patent: 6,720,453

Title: Formoterol tartrate polymorph
Abstract:A method of preparation of a highly pure salt of R,R-formoterol L-tartrate is disclosed. The process provides the most thermodynamically stable polymorph by recrystallization of a novel polymorph.
Inventor(s): Tanoury; Gerald J. (Hudson, MA), Senanayake; Chris H. (Shrewsbury, MA), Kessler; Donald W (Groton, MA)
Assignee: Sepracor Inc. (Marlborough, MA)
Application Number:10/238,204
Patent Claims: 1. A crystalline solid consisting of greater than 99.5% by weight of (R,R)-formoterol L-tartrate and less than 0.5% by weight of chemical impurities other than formoterol L-tartrate; said chemical impurities including less than 0.2% by weight (based on total crystalline solid) of a compound of formula 7 ##STR12##

said (R,R)-formoterol L-tartrate being at least 95% in the polymorphic form of a thermodynamically stable third polymorph (A) having peaks at the diffraction degrees with the intensity shown below in an x-ray powder diffraction pattern:

2. A method for preventing bronchoconstriction or inducing bronchodilation in a mammal comprising administering to said mammal a therapeutically effective amount of the solid R,R-formoterol L-(+)-tartrate of claim 1.

3. A pharmaceutical composition comprising a pharmaceutically acceptable carrier and the solid R,R-formoterol L-(+)-tartrate of claim 1.

4. An aerosol pharmaceutical composition according to claim 3.

5. An oral pharmaceutical composition according to claim 3.

6. An oral pharmaceutical composition according to claim 5 in the form of a tablet, capsule or syrup.

7. A dry powder pharmaceutical composition for inhalation according to claim 4.

8. A crystalline solid consisting of greater than 99.5% by weight of (R,R)-formoterol L-tartrate and less than 0.5% by weight of chemical impurities other than formoterol L-tartrate; said chemical impurities including less than 0.1% by weight (based on total crystalline solid) of a compound of formula 8 ##STR13##

said (R,R)-formoterol L-tartrate being at least 95% in the polymorphic form of a thermodynamically stable third polymorph (A) having peaks at the diffraction degrees with the intensity shown below in an X-ray powder diffraction pattern:

9. A crystalline solid according to claim 8, consisting of greater than 99.5% by weight of (R,R)-formoterol L-tartrate and less than 0.5% by weight of chemical impurities other than formoterol L-tartrate; said chemical impurities including 0.05% by weight (based on total crystalline solid) or less of a compound of formula 8.

10. A method for preventing bronchoconstriction or inducing bronchodilation in a mammal comprising administering to said mammal a therapeutically effective amount of the solid R,R-formoterol L-(+)-tartrate of claim 8.

11. A pharmaceutical composition comprising a pharmaceutically acceptable carrier and the solid R,R-formoterol L-(+)-tartrate of claim 8.

12. An aerosol pharmaceutical composition according to claim 10.

13. An oral pharmaceutical composition according to claim 10.

14. An oral pharmaceutical composition according to claim 12 in the form of a tablet, capsule or syrup.

15. A dry powder pharmaceutical composition for inhalation according to claim 10.
« 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