.

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: 6,906,028

« Back to Dashboard

Details for Patent: 6,906,028

Title: Stable insulin formulations
Abstract:The present invention provides a monomeric insulin analog formulation stabilized against aggregation in which the buffering agent is either TRIS or arginine. The stable formulations of the present invention are useful for treating diabetes, and are particularly advantageous in treatment regimes requiring lengthy chemical and physical stability, such as, in continuous infusion systems.
Inventor(s): DeFelippis; Michael Rosario (Indianapolis, IN), Dobbins; Michael Allen (Lebanon, IN), Frank; Bruce Hill (Indianapolis, IN), Li; Shun (Indianapolis, IN), Rebhun; Dawn Marie (Indianapolis, IN)
Assignee: Eli Lilly and Company (Indianapolis, IN)
Filing Date:Oct 03, 2002
Application Number:10/264,176
Claims:1. A method for treating diabetes comprising administering an effective dose of a solution formulation, the solution formulation comprising a physiologically tolerated buffer selected from the group consisting of 2-amino-2-hydroxymethyl-1,3-propanediol and arginine; a monomeric insulin analog; zinc; a phenolic preservative; and an isotonicity agent, wherein the solution formulation is administered using a continuous infusion system.

2. The method of claim 1, wherein the solution formulation is a stable formulation.

3. The method of claim 1, wherein the buffer is 2-amino-2-hydroxymethyl-1,3-propanediol.

4. The method of claim 1, wherein the monomeric insulin analog is Asp.sup.B28 -human insulin.

5. The method of claim 1, wherein the monomeric insulin analog is Lys.sup.B28 Pro.sup.B29 -human insulin.

6. The method of claim 1, wherein the pH of the formulation is between pH 7.0 and pH 8.0 when measured at a temperature of 22.degree. C.

7. The method of claim 1, wherein the concentration of the monomeric insulin analog is between about 1.2 mg/mL and about 50 mg/mL.

8. The method of claim 7, wherein the concentration of the monomeric insulin analog is between about 3.0 mg/mL and about 35 mg/mL.

9. The method of claim 4, wherein the concentration of Asp.sup.B28 -human insulin is between about 1.2 mg/mL and about 50 mg/mL.

10. The method of claim 9, wherein the concentration of Asp.sup.B28 -human insulin is between about 3.0 mg/mL and about 35 mg/mL.

11. The method of claim 5, wherein the concentration of Lys.sup.B28 Pro.sup.B29 -human insulin is between about 1.2 mg/mL and about 50 mg/mL.

12. The method of claim 11, wherein the concentration of Lys.sup.B28 Pro.sup.B29 -human insulin is between about 3.0 mg/mL and about 35 mg/mL.

13. A method for treating hyperglycemia comprising administering an effective dose of a solution formulation, the solution formulation comprising a physiologically tolerated buffer selected from the group consisting of 2-amino-2-hydroxymethyl-1,3-propanediol and arginine; a monomeric insulin analog; zinc; a phenolic preservative; and an isotonicity agent, wherein the solution formulation is administered using a continuous infusion system.

14. The method of claim 13, wherein the solution formulation is a stable formulation.

15. The method of claim 13, wherein the buffer is 2-amino-2-hydroxymethyl-1,3-propanediol.

16. The method of claim 13, wherein the monomeric insulin analog is Asp.sup.B28 -human insulin.

17. The method of claim 13, wherein the monomeric insulin analog is Lys.sup.B28 Pro.sup.B29 -human insulin.

18. The method of claim 13, wherein the pH of the formulation is between pH 7.0 and pH 8.0 when measured at a temperature of 22.degree. C.

19. The method of claim 13, wherein the concentration of the monomeric insulin analog is between about 1.2 mg/mL and about 50 mg/mL.

20. The method of claim 19, wherein the concentration of the monomeric insulin analog is between about 3.0 mg/mL and about 35 mg/mL.

21. The method of claim 16, wherein the concentration of Asp.sup.B28 -human insulin is between about 1.2 mg/mL and about 50 mg/mL.

22. The method of claim 21, wherein the concentration of Asp.sup.B28 -human insulin is between about 3.0 mg/mL and about 35 mg/mL.

23. The method of claim 17, wherein the concentration of Lys.sup.B28 Pro.sup.B29 -human insulin is between about 1.2 mg/mL and about 50 mg/mL.

24. The method of claim 23, wherein the concentration of Lys.sup.B28 Pro.sup.B29 -human insulin is between about 3.0 mg/mL, and about 35 mg/mL.
« Back to Dashboard

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

How are People Using DrugPatentWatch?

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