Crystalline microspheres and the process of manufacturing the same
The present invention relates to microspheres comprising a core material, wherein the microsphere is perfectly spherical and has a moisture content less than 1%, and the method of manufacturing the same. The present invention is useful in the manufacture of sustained and modified release active pharmaceutical ingredient (API) microspheres, as a free flowing excipient for mini-tablets and in the manufacture of API dispersions.
1. A microsphere comprising a core material, wherein the microsphere has a circularity greater than 0.95, an aspect ratio greater than 0.95, and lacks porosity.
2. The microsphere of claim 1 , wherein the microsphere has a mean particle size from about 10 μm to about 500 μm.
3. The microsphere of claim 2 , wherein the microsphere has a mean particle size from about 10 μm to about 20 μm.
4. The microsphere of claim 3 , wherein the microsphere has a moisture content of 0.5% or less.
5. The microsphere of claim 1 , wherein the microsphere has a particle size distribution of 2.8 or less.
6. The microsphere of claim 5 , wherein the microsphere has a particle size distribution of 2.0 or less.
7. The microsphere of claim 5 , wherein the microsphere has a particle size distribution of 1.5 or less.
8. The microsphere of claim 5 , wherein the microsphere has a particle size distribution of 1.0.
9. The microsphere of claim 1 , wherein the microsphere has a surface with ridges of 10 μm or less.
10. The microsphere of claim 1 , wherein the microsphere has a skeletal density from about 1.4595 g/cc to about 1.4651 g/cc.
11. The microsphere of claim 1 , wherein the microsphere has a moisture content of 0.5% or less.
12. The microsphere of claim 11 , wherein the microsphere has a moisture content of 0.1% or less.
13. The microsphere of claim 11 , wherein the microsphere has a moisture content of 0.0%.
14. The microsphere of claim 1 , wherein the microsphere is water soluble.
15. The microsphere of claim 1 , wherein the microsphere comprises a single core material.
16. The microsphere of claim 15 , wherein the single core material is mannitol.
17. The microsphere of claim 1 , wherein the microsphere comprises a 100% crystalline core.
18. The microsphere of claim 1 , wherein the microsphere further comprises an active pharmaceutical ingredient.
19. The microsphere of claim 1 , wherein the core material is a polyol.
20. The microsphere of claim 19 , wherein the polyol is mannitol.
21. The microsphere of claim 1 , wherein the microsphere lacks internal voids.
22. A composition comprising the microsphere of claim 1 .
23. The composition of claim 22 further comprising an active pharmaceutical ingredient.
24. A microsphere comprising a core material, wherein the microsphere has a circularity greater than 0.95, an aspect ratio greater than 0.95, and a moisture content of 0.5% or less.