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Claims for Patent: 6,395,304

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Claims for Patent: 6,395,304

Title: Apparatus and method for preparing microparticles
Abstract:Apparatus and method for preparing microparticles. An emulsion is formed by combining two phases in a static mixing assembly. The static mixing assembly preferably includes a preblending static mixer and a manifold. The emulsion flows out of the static mixing assembly into a quench liquid whereby droplets of the emulsion form microparticles. The residence time of the emulsion in the static mixing assembly is controlled to obtain a predetermined particle size distribution of the resulting microparticles.
Inventor(s): Lyons; Shawn L. (Cincinnati, OH), Wright; Steven G. (Madeira, OH)
Assignee: Alkermes Controlled Therapeutics Inc. II (Cambridge, MA)
Application Number:09/828,849
Patent Claims: 1. A method of preparing microparticles, comprising:

preparing a first phase, the first phase comprising an active agent, a polymer, and a solvent;

preparing a second phase;

pumping the first phase and the second phase through a first static mixer to form an emulsion;

flowing the emulsion through a plurality of static mixers; and

combining an outflow of the plurality of static mixers with an extraction liquid for extracting the solvent from the emulsion to form microparticles.

2. The method of claim 1, wherein a diameter of the first static mixer is greater than a diameter of each of the plurality of static mixers.

3. The method of claim 1, wherein the pumping step is performed wherein the first phase is pumped at a first flow rate and the second phase is pumped at a second flow rate greater than the first flow rate.

4. The method of claim 3, wherein a ratio of the second flow rate to the first flow rate is from about 4:1 to about 5:1.

5. The method of claim 3, wherein the flowing step is performed by flowing a portion of a total flow rate through each of the plurality of static mixers, wherein the total flow rate is the sum of the first flow rate and the second flow rate.

6. The method of claim 5, wherein the plurality of static mixers is two.

7. The method of claim 1, wherein the plurality of static mixers is configured in series to provide a plurality of sequential flow streams.

8. The method of claim 1, wherein the plurality of static mixers is configured to provide a plurality of parallel flow streams.

9. The method of claim 1, wherein the step of preparing the first phase comprises:

dissolving the active agent in a first solvent to form an active agent solution;

dissolving the polymer in a second solvent to form a polymer solution; and

blending the active agent solution and the polymer solution.

10. The method of claim 9, wherein the active agent is selected from the group consisting of risperidone, 9-hydroxyrisperidone, and pharmaceutically acceptable salts thereof.

11. The method of claim 10, wherein the first solvent is benzyl alcohol.

12. The method of claim 10, wherein the polymer is poly(d,l-lactide-co-glycolide) having a molar ratio of lactide to glycolide in the range of from about 85:15 to about 50:50.

13. The method of claim 12, wherein the second solvent is ethyl acetate.

14. A method of preparing microparticles, comprising:

preparing a first phase, the first phase comprising an active agent, a polymer, and a solvent;

preparing a second phase;

combining the first phase and the second phase in a first static mixer to form an emulsion, the emulsion forming an outflow of the first static mixer;

dividing the outflow of the first static mixer to form at least two flow streams;

flowing each of the at least two flow streams through a separate second static mixer; and

combining the at least two flow streams with an extraction liquid for extracting the solvent from the emulsion to form microparticles.

15. The method of claim 14, wherein a diameter of the first static mixer is greater than a diameter of each separate second static mixer.

16. The method of claim 14, wherein the step of preparing the first phase comprises:

dissolving the active agent in a first solvent to form an active agent solution;

dissolving the polymer in a second solvent to form a polymer solution; and

blending the active agent solution and the polymer solution.

17. The method of claim 16, wherein the active agent is selected from the group consisting of risperidone, 9-hydroxyrisperidone, and pharmaceutically acceptable salts thereof.

18. The method of claim 17, wherein the first solvent is benzyl alcohol.

19. The method of claim 16, wherein the polymer is poly(d,l-lactide-co-glycolide) having a molar ratio of lactide to glycolide in the range of from about 85:15 to about 50:50.

20. The method of claim 19, wherein the second solvent is ethyl acetate.

21. The method of claim 14, wherein the at least two flow streams have substantially equal flow rates.

22. Microparticles prepared by the method of claim 1.

23. Microparticles prepared by the method of claim 14.
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