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Details for Patent: 6,921,527

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Details for Patent: 6,921,527

Title: Composition for pulmonary administration comprising a drug and a hydrophobic amino acid
Abstract:According to the subject invention, dispersible dry powder pharmaceutical-based compositions are provided, including methods for their manufacture and dry powder dispersion devices. A dispersible dry powder pharmaceutical-based composition is one having a moisture content of less than about 10% by weight (% w) water, usually below about 5% w and preferably less than about 3% w; a particle size of about 1.0-5.0 .mu.m mass median diameter (MMD), usually 1.0-4.0 .mu.m MMD, and preferably 1.0-3.0 .mu.m MMD; a delivered dose of about >30%, usually >40%, preferably >50%, and most preferred >60%; and an aerosol particle size distribution of about 1.0-5.0 .mu.m mass median aerodynamic diameter (MMAD), usually 1.5-4.5 .mu.m MMAD, and preferably 1.5-4.0 .mu.m MMAD. Such compositions are of pharmaceutical grade purity.
Inventor(s): Platz; Robert M. (Half Moon Bay, CA), Patton; John S. (Portola Valley, CA), Foster; Linda (Sunnyvale, CA), Eljamal; Mohammed (Tripoli, LB)
Assignee: Nektar Therapeutics (San Carlos, CA)
Filing Date:Jan 31, 2003
Application Number:10/355,578
Claims:1. A dispersible dry powder composition for pulmonary delivery, said composition comprising a therapeutically effective amount of a drug and a hydrophobic amino acid, Wherein about 95% of the mass of the dry powder composition has a particle size of less than 10 .mu.m.

2. The dry powder composition of claim 1, further comprising a pharmaceutically acceptable carrier.

3. The dry powder composition of claim 1, wherein the hydrophobic amino acid is selected from the group consisting of tryptophan, tyrosine, leucine, and phenylalanine.

4. The dry powder composition of claim 1, substantially free from penetration enhancers.

5. The dry powder composition of claim 2, wherein the carrier comprises human serum albumin.

6. The dry powder composition of claim 2, wherein the carrier comprises a carbohydrate bulking agent.

7. The dry powder composition of claim 1, wherein about 80% of the mass of the dry powder composition has a particle size of less than 5 .mu.m.

8. The dry powder composition of claim 1, wherein the drug is a macromolecule.

9. The dry powder composition of claim 1, wherein the drug is a non-macromolecule.

10. The dry powder composition of claim 3, wherein said hydrophobic amino acid is lecuine.

11. The dry powder composition of claim 1, wherein said dry powder composition particles having an aerosol particle size distribution of from about 1.0 to 5.0 .mu.m MMAD.

12. The dry powder composition of claim 1, wherein the dry powder is characterized by a delivered dose of greater than about 30%.

13. The dry powder composition of claim 8, wherein the macromolecule is selected from the group consisting of insulin, interleukin 1 receptor, parathyroid hormone, alpha-1 antitrypsin, calcitonin, interferon, low molecular weight heparin, and nucleic acids.

14. A unit dosage form for pulmonary delivery of a pharmaceutical drug, said unit dosage form comprising a dispersible dry powder composition, comprising a therapeutically effective amount of the pharmaceutical drug in combination with a hydrophobic amino acid according to any one of claims 1, 2, 3, 10, or 11.

15. A spray-dried, dispersible dry powder composition for pulmonary delivery, said composition comprising a therapeutically effective amount of a drug and a hydrophobic amino acid, where about 95% of the mass of the dry powder composition has a particle size of less than 10 .mu.m.
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