Details for Patent: 8,912,193
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Title: | Dry powder inhaler and system for drug delivery |
Abstract: | A breath-powered, dry powder inhaler, a cartridge, and a pulmonary drug delivery system are provided. The dry powder inhaler can be provided with or without a unit dose cartridge for using with the inhaler. The inhaler and/or cartridge can be provided with a drug delivery formulation comprising, for example, a diketopiperazine and an active ingredient, including, peptides and proteins such as insulin and glucagon-like peptide 1 for the treatment of diabetes and/or obesity. The dry powder inhaler is compact; can be provided in various shapes and sizes, colors, and comprises a housing, a mouthpiece, a cartridge placement area, and a mechanism for opening and closing the medicament cartridge. The device is easy to manufacture, provides a pre-metered single unit dose, it is relatively easy to use, and can be reusable or disposable. |
Inventor(s): | Smutney; Chad C. (Watertown, CT), Kinsey; P. Spencer (Sandy Hook, CT), Sahi; Carl R. (Coventry, CT), Adamo; Benoit (Mount Kisco, NY), Polidoro; John M. (Coventry, CT), McLean; Scott (Waterbury, CT), Overfield; Dennis (Fairfield, CT), Kraft; Kelly S. (Poughqaug, NY), Somerville; Karla (Corona, CA) |
Assignee: | MannKind Corporation (Valencia, CA) |
Filing Date: | Jun 18, 2013 |
Application Number: | 13/921,104 |
Claims: | 1. Fumaryl diketopiperazine (FDKP) microparticles comprising a trans-FDKP isomer content of about 45% to about 63%. 2. The FDKP microparticles of claim 1 having a trans-FDKP isomer content of about 52% to about 63%. 3. The FDKP microparticles of claim 1 having a trans-FDKP isomer content of about 50% to about 56%. 4. The FDKP microparticles of claim 1 having a trans-FDKP isomer content of about 54% to about 56%. 5. The FDKP microparticles of claim 1 wherein the FDKP microparticles comprise a drug. 6. The FDKP microparticles of claim 5 having a trans-FDKP isomer content of about 50% to about 56%. 7. The FDKP microparticles of claim 5 wherein the drug is insulin. 8. The microparticles of claim 7 wherein the insulin content is about 3 to about 4 U/mg. 9. A dry powder comprising the microparticles of claim 1. 10. The dry powder of claim 9, wherein the microparticles have a trans-FDKP isomer content of about 53% to about 63%. 11. A method of treating diabetes comprising administering the microparticles of claim 7 to a person in need thereof. 12. FDKP microparticles having improved aerodynamic performance that have been prepared by a process comprising: determining the trans-FDKP isomer content; wherein the microparticles have a trans-FDKP isomer content of about 45% to about 65%. 13. The FDKP microparticles of claim 12 having a trans-FDKP isomer content of about 50% to about 63%. 14. The FDKP microparticles of claim 12 having a trans-FDKP isomer content of about 54% to about 56%. 15. An FDKP composition comprising a trans isomer content of about 45% to about 56%. 16. Microparticles comprising the FDKP composition of claim 15. 17. The FDKP microparticles of claim 16, wherein the trans-FDKP content of the microparticles is about 45% to about 54%. 18. The FDKP microparticles of claim 16 having a trans-FDKP isomer content of about 50% to about 56%. 19. The FDKP microparticles of claim 16 having a trans-FDKP isomer content of about 53% to about 56%. 20. The FDKP microparticles of claim 5 having a manufacturing specification in a range of about 53% to about 63% trans-FDKP isomer content, based upon the total content of FDKP. 21. The method of claim 11 wherein said microparticles are administered using an inhalation system for delivering a dry powder medicament to a pulmonary tract, comprising a dry powder inhaler configured to have at least two inlet apertures, wherein a first inlet aperture is in communication with a first air flow pathway and a second inlet aperture is in communication with a second air flow pathway, and the first airflow pathway and the second airflow pathway converge in a substantially perpendicular manner during an inhalation maneuver, and wherein said inhalation system has a total resistance to flow in a dosing configuration ranging in value from 0.065 to about 0.200 (IkPa)/liter per minute. |