STARCH-BASED MICROPARTICLES FOR THE RELEASE OF AGENTS DISPOSED THEREIN
The invention provides starch-based microparticles with high loading capacity for the stabilization and/or controlled release of one or more agents, for example, a pharmaceutical, a taste masking agent, a flavoring agent, or a combination thereof, disposed within the microparticles, and to methods of making and using such microparticles.
1 . A method of producing microparticles that stabilize and/or control the release of an agent disposed therein, the method consisting essentially of
(a) creating an aquesous dispersion comprising a mixture of from about 5% w/w to about 20% w/w of cross-linked high amylose starch and the agent to be released at a temperature less than 60° C.; and
(b) spray drying the mixture of step (a) in a spray dryer to produce microparticles having a mean diameter of from about 1 μm to about 200 μm, wherein the microparticles stabilize or control the release of the agent disposed therein.
2 . The method of claim 1 , wherein the microparticles have a mean diameter in the range from about 5 μm to about 150 μm.
3 . The method of claim 1 , wherein the mixture provided in step (a) comprises from about 7% w/w to about 15% w/w of cross-linked high amylose starch.
4 . The method of claim 1 , wherein the agent comprises from about 5% to about 50% (w/w) of the microparticles produced in step (b).
5 . The method of claim 4 , wherein the agent to be released comprises from about 10% to about 45% (w/w) of the microparticles produced in step (b).
6 .- 7 . (canceled)
8 . The method of claim 1 , wherein, in step (a), the agent is melted prior to mixing with the cross-linked high amylose starch.
9 . The method of claim 1 , wherein, in step (a), the agent is mixed with a dispersing agent prior to mixing with the cross-linked high amylose starch.
10 . The method of claim 8 , wherein, in step (a), the dispersion further comprises a surface active agent.
11 . (canceled)
12 . The method of claim 1 , wherein, in step (a), the dispersion further comprises a viscosity reducing agent.
13 .- 14 . (canceled)
15 . The method of claim 12 , wherein the viscosity reducing agent is a polyvinylpyrrolidone-vinyl acetate copolymer.
16 . The method of claim 12 , wherein the ratio of the cross-linked high amylose starch to the viscosity reducing agent is from about 80:20 (w/w) to about 40:60 (w/w).
17 . The method of claim 16 , wherein the ratio of the cross-linked high amylose starch to the viscosity reducing agent is about 60:40 (w/w).
18 . The method of claim 1 , wherein the mixture provided in step (a) is substantially free of pectin.
19 . The method of claim 1 , wherein, in step (b), the spray dryer has an air inlet temperature in the range of from about 125° C. to about 250° C. and an air outlet temperature in the range of from about 50° C. to about 100° C.
20 . The method of claim 1 , wherein the agent is a pharmaceutical, a taste masking agent, or a flavoring agent.
21 .- 25 . (canceled)
26 . A composition of microparticles produced by the method of claim 1 .
27 .- 38 . (canceled)
39 . A method of providing controlled release of an agent, the method comprising orally administering to a subject the microparticles of claim 26 .
40 . (canceled)