.

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: 7,696,162

« Back to Dashboard

Claims for Patent: 7,696,162

Title:Zinc-free and low-zinc insulin preparations having improved stability
Abstract:The invention relates to a formulation comprising a polypeptide selected from at least one of insulin, an insulin metabolite, an insulin analog, and an insulin derivative; at least one surfactant; optionally at least one preservative; and optionally at least one of an isotonicizing agent, a buffer or an excipient, wherein the formulation is free from or low in zinc. The invention also relates to the production of such insulin preparations and their use as pharmaceutical formulations.
Inventor(s): Boderke; Peter (Frankfurt am Main, DE)
Assignee: Sanofi-Aventis Deutschland GmbH (Frankfurt am Main, DE)
Application Number:12/285,464
Patent Claims: 1. A formulation comprising: Lys(B3),Glu(B29) human insulin; a compound chosen from polysorbate 20, polysorbate 80, and poloxamer 171; and water, wherein the formulation is free from zinc or contains less than 0.2% by weight of zinc based on the insulin content of the formulation.

2. The formulation according to claim 1, wherein the pH is in a range from 6 to 8.5.

3. The formulation according to claim 1, wherein the formulation further comprises tromethamine.

4. The formulation according to claim 1, wherein the formulation further comprises NaCl.

5. The formulation according to claim 1, wherein the formulation further comprises cresol.

6. The formulation according to claim 5, wherein the formulation further comprises tromethamine.

7. The formulation according to claim 6, wherein the formulation further comprises NaCl.

8. The formulation according to claim 1, wherein the compound is polysorbate 20.

9. A method of treating diabetes mellitus comprising administering a formulation comprising: Lys(B3),Glu(B29) human insulin; a compound chosen from polysorbate 20, polysorbate 80, and poloxamer 171; and water, wherein the formulation is free from zinc or contains less than 0.2% by weight of zinc based on the insulin content of the formulation.

10. The method according to claim 9, wherein the pH is in a range from 6 to 8.5.

11. The method according to claim 9, wherein the formulation further comprises tromethamine.

12. The method according to claim 9, wherein the formulation further comprises NaCl.

13. The method according to claim 9, wherein the formulation further comprises cresol.

14. The method according to claim 13, wherein the formulation further comprises tromethamine.

15. The method according to claim 14, wherein the formulation further comprises NaCl.

16. The method according to claim 9, wherein the compound is polysorbate 20.

17. A method of making a formulation comprising Lys(B3),Glu(B29) human insulin; a compound chosen from polysorbate 20, polysorbate 80, and poloxamer 171; and water, wherein the formulation is free from zinc or contains less than 0.2% by weight of zinc based on the insulin content of the formulation; said method comprising: dissolving the Lys(B3),Glu(B29) human insulin in the water, adding the compound chosen from polysorbate 20, polysorbate 80, and poloxamer 171, and optionally adding a final volume of water.

18. The method according to claim 17, wherein the formulation comprises a pH in a range from 6 to 8.5, and the method comprises: dissolving the Lys(B3),Glu(B29) human insulin in the water, adjusting the pH, adding the compound chosen from polysorbate 20, polysorbate 80, and poloxamer 171, and optionally adding a final volume of water.

19. The method according to claim 17, wherein the compound is polysorbate 20.
« 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