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Claims for Patent: 8,389,470

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Claims for Patent: 8,389,470

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:12/985,197
Patent Claims: 1. A composition comprising microparticles that include insulin bound to, and coated onto, a 2,5-diketo-3,6-di(4-fumaryl-aminobutyl)piperazine wherein the composition is suitable for pulmonary inhalation.

2. The composition of claim 1 wherein the composition produces a rapid onset of insulin action when administered to a human so that Tmax.sub.[INS] is achieved about 13 minutes after inhalation.

3. The composition of claim 1 wherein the composition produces a rapid onset of insulin action when administered to a human so that peak biological action, measurable as Tmax.sub.GIR, is achieved about 39 minutes after inhalation.

4. The composition of claim 1 wherein the composition is provided as a dry powder.

5. A method of delivering insulin to a human comprising: administering a composition comprising insulin bound to a complexing agent to said human by pulmonary inhalation, wherein the complexing agent is not a cyclodextrin.

6. The method of claim 5 wherein the composition produces a rapid onset of insulin action such that Tmax.sub.[INS] is achieved about 13 minutes after inhalation.

7. The method of claim 5 wherein the composition produces a rapid onset of insulin action such that peak biological action, measurable as Tmax.sub.GIR, is achieved about 39 minutes after inhalation.

8. The method of claim 5 wherein the complexing agent is a diketopiperazine derivative.

9. The method of claim 8 wherein the 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.

10. The method of claim 9 wherein the diketopiperazine derivative is 2,5-diketo-3,6-di(4-fumaryl-aminobutyl)piperazine.

11. The method of claim 5 wherein the composition is provided as a dry powder.
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