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Claims for Patent: 7,943,178

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Claims for Patent: 7,943,178

Title:Methods and compositions for delivering peptides
Abstract: Methods are provided for purifying peptides and proteins by incorporating the peptide or protein into a diketopiperazine or competitive complexing agent to facilitate removal one or more impurities, from the peptide or protein. Formulations and methods also are provided for the improved transport of active agents across biological membranes, resulting for example in a rapid increase in blood agent concentration. The formulations include microparticles formed of (i) the active agent, which may be charged or neutral, and (ii) a transport enhancer that masks the charge of the agent and/or that forms hydrogen bonds with the target biological membrane in order to facilitate transport. In one embodiment, insulin is administered via the pulmonary delivery of microparticles comprising fumaryl diketopiperazine and insulin in its biologically active form. This method of delivering insulin results in a rapid increase in blood insulin concentration that is comparable to the increase resulting from intravenous delivery.
Inventor(s): Steiner; Solomon S. (Mount Kisco, NY), Woods; Rodney J. (New Hampton, NY), Sulner; Joseph W. (Paramus, NJ)
Assignee: MannKind Corporation (Valencia, CA)
Application Number:12/635,380
Patent Claims: 1. A method for delivering a peptide to a patient in need thereof, comprising administering to said patient a delivery formulation for said peptide comprising an effective amount of said peptide complexed with a diketopiperazine derivative, wherein said delivery formulation is prepared by complexing said peptide with microparticles of said diketopiperazine derivative by the steps of: a) providing pre-formed microparticles of diketopiperazine in a suspension comprising a solvent; b) adding said peptide to said suspension; and c) removing solvent from said suspension; wherein said diketopiperazine derivative has the formula 2,5-diketo-3,6-di(4-X-aminobutyl)piperazine, wherein X is selected from the group consisting of fumaryl, succinyl, maleyl, and glutaryl, and wherein said microparticles release said peptide upon dissociation.

2. The method of claim 1 wherein the composition is in a dry powder form administered to the lungs via inhalation.

3. The method of claim 1 wherein the patient is a Type II diabetic.

4. The method of claim 3 wherein the composition is administered concurrently with, or less than 20 minutes prior to, the patient eating a meal.

5. The method of claim 1 wherein said solvent is an aqueous solvent.

6. The method of claim 1 wherein said solvent is removed by lyophilizing or freeze drying.

7. The method of claim 1 wherein said peptide is glucagon.

8. A composition for administration of a peptide to a patient, wherein said composition comprises a peptide and a diketopiperazine derivative and is prepared by complexing said peptide with microparticles of said diketopiperazine derivative by the steps of: a) providing pre-formed microparticles of diketopiperazine in a suspension comprising a solvent; b) adding said peptide to said suspension; and c) removing solvent from said suspension; and wherein said diketopiperazine derivative has the formula 2,5-diketo-3,6-di(4-X-aminobutyl)piperazine, wherein X is selected from the group consisting of fumaryl, succinyl, maleyl, and glutaryl.

9. The composition of claim 8, wherein said microparticles release said peptide upon dissociation.

10. The composition of claim 8, wherein the peptide is glucagon.

11. A composition for the administration of a peptide to a patient comprising a peptide complexed with a diketopiperazine.

12. The composition of claim 11, wherein the peptide is glucagon.

13. A method for making a composition comprising a peptide and a diketopiperazine derivative comprising: a) complexing said peptide with microparticles of said diketopiperazine derivative by the steps of: i) providing pre-formed microparticles of said diketopiperazine derivative in a suspension comprising a solvent; ii) adding said peptide to said suspension; and iii) removing solvent from said suspension; and wherein said diketopiperazine derivative has the formula 2,5-diketo-3,6-di(4-X-aminobutyl)piperazine, wherein X is selected from the group consisting of fumaryl, succinyl, maleyl, and glutaryl.

14. The method of claim 13, wherein said microparticles release said peptide upon dissociation.

15. The method of claim 13, wherein said solvent is an aqueous solvent.

16. The method of claim 13 wherein said solvent is removed by lyophilizing or freeze drying.

17. The method of claim 13 wherein X is fumaryl.

18. The method of claim 13 wherein said peptide is insulin.

19. The method of claim 13 wherein said peptide is glucagon.

20. The method of claim 1 wherein X is fumaryl.

21. The method of claim 1 wherein said peptide is insulin.

22. The composition of claim 8 wherein X is fumaryl.

23. The composition of claim 8 wherein said peptide is insulin.
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