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Details for Patent: 8,877,162

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Details for Patent: 8,877,162

Title:Stable metal ion-lipid powdered pharmaceutical compositions for drug delivery
Abstract: A microparticle for drug delivery comprises an active agent and an excipient, the excipient comprising a metal ion-lipid complex. The metal ion is chosen from the group consisting of lanthanide metals, actinide metals, group IIa and IIIb metals, transition metals or mixtures thereof. The lipid comprises a phospholipid. The complex results in a glass transition temperature increase of the microparticle.
Inventor(s): Dellamary; Luis A. (San Marcos, CA), Reiss; Jean (Falicon, FR), Schutt; Ernest G. (San Diego, CA), Weers; Jeffry G. (Belmont, CA), Tarara; Thomas E. (Burlingame, CA)
Assignee: Novartis AG (Basel, CH)
Filing Date:Dec 06, 2012
Application Number:13/707,563
Claims:1. A microparticle for drug delivery wherein the microparticle comprises an active agent and an excipient, 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 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 1 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. The microparticle of claim 1 wherein the active agent comprises a plurality of active agents.

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

10. A composition comprising a plurality of microparticles of claim 1.

11. A microparticle composition for drug delivery wherein the microparticle is comprised of a metal ion-lipid complex and an active agent in addition to the 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 active agent; combining the first and second preparations; and spray drying the combined preparations to create a metal ion-lipid microparticle composition.

12. The microparticle composition of claim 11 wherein the phospholipid is selected from the group consisting of soy phosphatidylcholine, egg phosphatidylcholine, DPPC, DSPC, DMPC, dioctylphosphatidylcholine, and partially and fully hydrogenated phosphatides.

13. The microparticle composition of claim 11 wherein the metal ion is added in the form of calcium salt.

14. The microparticle composition of claim 11 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.

15. The microparticle composition of claim 11 wherein the active agent 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.

16. The microparticle composition of claim 11 wherein the active agent is added to the formed metal ion-lipid complex.

17. The microparticle of claim 11 wherein the excipient comprises a plurality of excipients.
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