MEDICAMENT-CONTAINING HOLLOW PARTICLE
The invention provides a particle composed of a shell and a hollow, wherein the shell contains a medicament and a polymer, and a volume ratio of the hollow relative to the whole particle is 1%-50%. The invention also provides a process for preparation of the hollow particle, which includes a step of granulating a powder mixture containing a medicament and a polymer, while spraying a solvent capable of dissolving the polymer.
1 . (canceled)
2 . An orally administered pharmaceutical composition, comprising:
a plurality of hollow particles each comprising a shell surrounding the hollow having 1%-50% of a particle volume, the shell having a thickness of not less than 10 μm and comprising a polymer and a medicament which is released from the hollow particles after oral administration to a subject.
3 . The pharmaceutical composition of claim 2 , wherein the hollow particles each comprise 0.1 wt %-96 wt % of the medicament per 100 wt % of the hollow particle.
4 . The pharmaceutical composition of claim 3 , wherein the hollow particles each comprise 10 wt %-96 wt % of the medicament per 100 wt % of the hollow particle.
5 . The pharmaceutical composition of claim 4 , wherein the hollow particles each comprise 50 wt %-96 wt % of the medicament per 100 wt % of the hollow particle.
6 . The pharmaceutical composition of claim 5 , wherein the hollow particles each comprise 60 wt %-96 wt % of the medicament per 100 wt % of the hollow particle.
7 . The pharmaceutical composition of claim 2 , wherein the polymer is at least one polymer selected from the group consisting of a water-soluble polymer, a water-insoluble polymer, an enteric polymer, a gastric soluble polymer and a biodegradable polymer.
8 . The pharmaceutical composition of claim 7 , wherein the polymer is a water-soluble polymer.
9 . The pharmaceutical composition of claim 2 , wherein each of the hollow particles has an aspect ratio of 1.0-1.5.
10 . The pharmaceutical composition of claim 2 , wherein each of the hollow particles has a particle shell strength of not less than 2.0 MPa.
11 . The pharmaceutical composition of claim 2 , wherein the hollow has a diameter of not less than 10 μm.
12 . The pharmaceutical composition of claim 2 , wherein at least one pharmaceutically acceptable additive selected from the group consisting of filler, binder, sweetening agent, corrigent, smell masking agent, flavor, fluidizer, antistatic agent, colorant, disintegrant, lubricant, plasticizer, and anticoagulant are in admixture with the medicament and the polymer.
13 . The pharmaceutical composition of claim 12 , wherein the pharmaceutical composition has a medicament content of 0.1-95.9 wt % per 100 wt %, an additive content of 0.1-95.9 wt % and a polymer content of 4-40 wt % per 100 wt % of the hollow particle.
14 . The pharmaceutical composition of claim 13 , wherein the medicament content is 1 wt. %-95.9 wt % per 100 wt % of the hollow particle.
15 . The pharmaceutical composition of claim 14 , wherein the medicament content is 10 wt. %-95.9 wt % per 100 wt % of the hollow particle.
16 . The pharmaceutical composition of claim 15 , wherein the medicament content is 50 wt. %-95.9 wt % per 100 wt % of the hollow particle.
17 . The pharmaceutical composition of claim 16 , wherein the medicament content is 60 wt. %-95.9 wt % per 100 wt % of the hollow particle.
18 . The pharmaceutical composition of claim 2 in a capsule.
19 . The pharmaceutical composition of claim 2 in the form of a tablet.
20 . The pharmaceutical composition of claim 2 , wherein the hollow particles have an average particle size of 50 μm-1000 μm and a particle size distribution width as defined by D90/D10 of not greater than 6.0.
21 . The pharmaceutical composition of claim 20 , wherein the particle size distribution width as defined by D90/D10 is not greater than 5.0.
22 . The pharmaceutical composition of claim 21 , wherein 0.1 wt %-96 wt % of the medicament is included per 100 wt % of the hollow particle.
23 . The pharmaceutical composition of claim 22 , wherein 10 wt %-96 wt % of the medicament is included per 100 wt % of the hollow particle is not less than 10%.
24 . The pharmaceutical composition of claim 23 , wherein 50 wt %-96 wt % of the medicament is included per 100 wt % of the hollow particle.
25 . The pharmaceutical composition of claim 24 , wherein 60 wt %-96 wt % of the medicament is included per 100 wt % of the hollow particle.
26 . The pharmaceutical composition of claim 2 , wherein each of the hollow particles further has an external coating.
27 . The pharmaceutical composition of claim 6 , wherein each of the hollow particles further has an external coating.
28 . The pharmaceutical composition of claim 21 , wherein each of the hollow particles further has an external coating.