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Claims for Patent: 8,349,294

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Claims for Patent: 8,349,294

Title:Stable metal ion-lipid powdered pharmaceutical compositions for drug delivery and methods of use
Abstract: Microparticle compositions comprising metal ion-lipid complexes for drug delivery are described including methods of making the microparticle compositions and methods of treating certain conditions and disease states by administering the microparticle compositions. The metal ion-lipid complexes can be combined with various drugs or active agents for therapeutic administration. The microparticle compositions of the present invention have superior stability to other microparticle compositions resulting in a microparticle composition with longer shelf life and improved dispersability. The microparticle compositions of the present invention have a transition temperature (T.sub.g) of at least 20.degree. C. above the recommended storage temperature (Tst) for drug delivery.
Inventor(s): Dellamary; Luis A (San Marcos, CA), Riess; Jean (Falicon, FR), Schutt; Ernest G (San Diego, CA), Weers; Jeffry G (Belmont, CA), Tarara; Thomas E (Burlingame, CA)
Assignee: Novartis AG (Basel, CH)
Application Number:12/967,482
Patent Claims: 1. A microparticle for drug delivery wherein the microparticle comprises an active agent and an excipient, wherein the active agent comprises an antibiotic, wherein the excipient comprises a metal ion-lipid complex, wherein the metal ion is chosen from the group consisting of lanthanide metals, actinide metals, group IIa and IIIb metals, transition metals or mixtures thereof, wherein the lipid comprises a phospholipid, and wherein the complex results in a glass transition temperature increase of the microparticle.

2. The microparticle of claim 1 wherein the microparticle has a glass transition temperature of at least 20.degree. C. above a storage temperature for the drug or active agent.

3. The microparticle of claim 1 wherein the phospholipid is chosen from the group consisting of DPPC, DSPC, DMPC, dioctylphosphatidycholine, soy phosphatidylcholine, egg phosphatidylcholine and partially hydrogenated phosphatides and polymerizable phospholipids.

4. The microparticle of claim 1 wherein the presence of the metal ion raises the glass transition temperature of the microparticle at least 2.degree. C. above that of the same microparticle without the metal ion.

5. The microparticle of claim 4 wherein the metal ion is chosen from the group consisting of calcium, zinc, aluminum, iron and magnesium in the form of water soluble salts and mixtures thereof.

6. The microparticle of claim 1 wherein the lipid component is comprised of a mixture of at least two lipids.

7. The microparticle of claim 1 wherein the microparticle has a mean volume aerodynamic particle size of about 0.5 .mu.m to 7 .mu.m.

8. A composition comprising a plurality of microparticles of claim 7.

9. The microparticle composition of claim 8 wherein the microparticles are substantially non-hollow and non-porous.

10. The microparticle composition of claim 9 further comprising a powder modifying agent.

11. The microparticle composition of claim 10 wherein the powder modifying agent is a carbohydrate.

12. The microparticle composition of claim 11 wherein the carbohydrate is selected from the group consisting of lactose, sucrose, hydroxyl ethyl starch; hetastarch, trehalose, mannose and mannitol.

13. A stable microparticle composition for drug delivery wherein the microparticle is comprised of a metal ion-lipid complex formed by the following process: dispersing a phospholipid in water to create a first preparation; suspending a metal compound or salt in water to create a second preparation; adding an antibiotic; combining the first and second preparations; and spray drying the combined preparations to create a stable metal ion-lipid microparticle composition.

14. The microparticle composition of claim 13 wherein the phospholipid is selected from the group consisting of soy phosphatidylcholine, egg phosphatidylcholine, DPPC, DSPC, DMPC, dioctylphosphatidylcholine, and partially and fully hydrogenated phosphatides.

15. The microparticle composition of claim 13 wherein the metal ion is added in the form of calcium salt.

16. The microparticle composition of claim 13 wherein the combined preparation is spray dried with an inlet temperature within the range of 40-100.degree. C. and an outlet temperature within the range of 30-85.degree. C.

17. The microparticle composition of claim 13 wherein the antibiotic is added to one of the preparations selected from the group consisting of the first preparation, the second preparation and the combination of the first and second preparation.

18. The microparticle composition of claim 13 wherein the drug or active agent is added to the formed metal ion-lipid complex.

19. The microparticle composition of claim 13 wherein the antibiotic comprises tobramycin.

20. The microparticle of claim 1 wherein the active agent comprises a plurality of active agents.

21. The microparticle of claim 1 wherein the excipient comprises a plurality of excipients.

22. The microparticle of claim 1 wherein the complex results in a glass transition temperature increase sufficient to stabilitize against water sorption.

23. The microparticle of claim 1 wherein the antibiotic comprises tobramycin.
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