CRYSTALLINE MICROSPHERES AND THE PROCESS FOR MANUFACTURING THE SAME
The present invention relates to microspheres and compositions comprising a plurality of microspheres, wherein the microspheres are perfectly spherical and have 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 - 29 . (canceled)
30 . A microsphere comprising a core material, wherein the microsphere has a circularity greater than 0.98 and an aspect ratio greater than 0.98.
31 . The microsphere of claim 30 , wherein the microsphere has a mean particle size from about 10 μm to about 500 μm.
32 . The microsphere of claim 31 , wherein the microsphere has a mean particle size from about 10 μm to about 20 μm.
33 . The microsphere of claim 32 , wherein the microsphere has a moisture content of 0.5% or less.
34 . The microsphere of claim 30 , wherein the microsphere has a particle size distribution of 2.8 or less.
35 . The microsphere of claim 34 , wherein the microsphere has a particle size distribution of 2.0 or less.
36 . The microsphere of claim 30 , wherein the microsphere has a surface with ridges 10 μm or less.
37 . The microsphere of claim 30 , wherein the microsphere has a skeletal density from about 1.4595 g/cc to about 1.4651 g/cc.
38 . The microsphere of claim 30 , wherein the microsphere has a moisture content of 0.5% or less.
39 . The microsphere of claim 30 , wherein the microsphere is water soluble.
40 . The microsphere of claim 30 , wherein the microsphere comprises a single core material.
41 . The microsphere of claim 40 , wherein the single core material is mannitol.
42 . The microsphere of claim 30 , wherein the microsphere comprises a crystalline core.
43 . The microsphere of claim 30 , wherein the microsphere further comprises an active pharmaceutical ingredient.
44 . The microsphere of claim 30 , wherein the core material is a polyol.
45 . The microsphere of claim 44 , wherein the polyol is mannitol.
46 . The microsphere of claim 30 , wherein the microsphere lacks porosity.
47 . The microsphere of claim 30 , wherein the microsphere lack internal voids.
48 . A composition comprising the microsphere of claim 30 .
49 . The composition of claim 48 further comprising an active pharmaceutical ingredient.