.

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: 7,312,196

« Back to Dashboard

Details for Patent: 7,312,196

Title:Formulations for amylin agonist peptides
Abstract: The present invention is concerned with a pharmaceutical formulation comprising an amylin agonist and optionally a buffer, a tonicifier or stabilizer, and a preservative in a container, for example, a vial, prefilled cartridge, prefilled syringe or disposable pen. This formulation may be in liquid, gel, solid or powdered form for delivery, for example, via nasal, pulmonary, oral, sublingual, buccal, transdermal, or parenteral routes. Formulation with biocompatible polymers and release modifiers, such as sugars, can facilitate controlled release after injection, minimizing the number of administrations to a patient. These formulations maintain stability upon storage under refrigerated or room temperature conditions. Such formulations can be further combined with insulin for administration to a patient.
Inventor(s): L'Italien; James (Del Mar, CA), Stetsko; Gregg (San Diego, CA)
Assignee: Amylin Pharmaceuticals, Inc. (San Diego, CA)
Filing Date:May 31, 2002
Application Number:10/159,779
Claims:1. A liquid pharmaceutical formulation comprising about 0.5 to 1.0% (w/v) of an amylin agonist, a pharmaceutically acceptable excipient and a liquid vehicle comprising water or an aqueous/organic solvent mixture or suspension, wherein said formulation comprises about 1.0 to 10% (w/v) of a carbohydrate or a polyhydric alcohol, about 0.02 to 0.5% (w/v) of an acetate, phosphate, citrate or glutamate buffer, and wherein the pH of said formulation is about 3.5 to about 5.0.

2. The formulation of claim 1, wherein the pH of said formulation is about 3.8 to about 4.2.

3. The formulation of claim 1 which is substantially isotonic.

4. The formulation of claim 1 , wherein said amylin agonist is pramlintide.

5. The formulation of claim 1, wherein said polyhydric alcohol is mannitol, sorbitol, inositol, glycerol, xylitol, propylene/ethylene glycol copolymer. PEG 8000, PEG 400, PEG 4000, PEG 200, PEG 1450 or PEG 3350.

6. The formulation of claim 1, wherein said polyhydric alcohol is mannitol.

7. The formulation of claim 1, wherein said carbohydrate is mannose, ribose, trehalose, maltose, glycerol, inositol, lactose, sucrose, fructose, galactose, or arabinose.

8. The formulation of claim 1, wherein said formulation further comprises a surfactant.

9. The formulation of claim 8, wherein said surfactant is polyoxyethylene (20) sorbitan monooleate, 3-[(3-cholamidopropyl) dimethylammonio]1-propanol sulfonate, polyoxyethylene (23) lauryl ether, poloxamer or a non-ionic surfactant.

10. The formulation of claim 8, further comprising a preservative.

11. A method for treating diabetes in a patient in need of such treatment comprising administering a therapeutically effective amount of the formulation of claim 1 to the patient in need of such treatment.

12. The method of claim 11 wherein insulin is admixed with said formulation prior to administration.

13. The method of claim 12 wherein the admixing step is simultaneous, or concerted and sequential with administration.

14. The formulation of claim 1 for administration to a subject, wherein the formulation is administered in the form selected from the group consisting of a parenteral controlled release delivery, oral delivery, a microcapsule delivery, a microsphere, an implant delivery, and a polymer matrix delivery.

15. A liquid suspension formulation comprising about 0.5 to 90% (w/v) of an amylin agonist, about 1.0 to 10% (w/v) of a carbohydrate or a polyhydric alcohol; and about 0.02 to 0.5% (w/v) of an acetate, phosphate, citrate or glutamate buffer, and a liquid vehicle, wherein the formulation has a pH of about 3.5 to about 5.0.

16. The formulation of claim 1 formulated for nasal or pulmonary delivery.

17. The formulation of claim 1 formulated for controlled release injectable delivery.

18. The formulation of claim 1 formulated for transdermal delivery.

19. A formulation comprising about 0.5 to 1.0% (w/v) of an amylin agonist, insulin, and a pharmaceutically acceptable emulsifier, wherein said formulation comprises about 0.1 to 10% (w/v) of a carbohydrate or a polyhydric alcohol and wherein the pH of said formulation is about 3.0 to about 7.0.

20. The formulation mixture of claim 19 for use with an insulin pump device.

21. The formulation of claim 19, wherein the emulsifier is an oil.

22. The formulation of claim 19, wherein the insulin is glargine.

23. The formulation of claim 1, wherein the amylin agonist is stable for at least 30 days at room temperature.

24. The formulation of claim 15, wherein said amylin agonist is pramlintide.

25. The formulation of claim 19, wherein said amylin agonist is pramlintide.

26. The formulation of claim 1, further comprising a penetration enhancer or a stabilizer.

27. The formulation of claim 19, further comprising at least one pharmaceutically acceptable excipient selected from the group consisting of a penetration enhancer and a stabilizer.

28. The formulation of claim 1 for administration to a subject, wherein the formulation is administered in a form for controlled release delivery.
« 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