Dry powder inhaler and system for drug delivery
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.
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.