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Claims for Patent: 6,537,586

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Claims for Patent: 6,537,586

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:10/109,641
Patent Claims: 1. A method of preparing microparticles, comprising: combining a first phase and a second phase to form an emulsion, wherein the first phase comprises an active agent, a polymer, and a solvent; 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 the step of combining the first phase and the second phase comprises: pumping the first phase at a first flow rate and pumping the second phase at a second flow rate greater than the first flow rate.

3. The method of claim 2, wherein a ratio of the second flow rate to the first flow rate is from about 4:1 to about 5:1.

4. The method of claim 2, 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.

5. The method of claim 4, wherein the plurality of static mixers is two.

6. The method of claim 1, further comprising: 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.

7. The method of claim 6, wherein the active agent is selected from the group consisting of risperidone, 9-hydroxyrisperidone, and pharmaceutically acceptable salts thereof.

8. The method of claim 7, wherein the first solvent is benzyl alcohol.

9. The method of claim 7, 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.

10. The method of claim 9, wherein the second solvent is ethyl acetate.

11. Microparticles prepared by the method of claim 1.

12. A method for controlling particle size distribution of microparticles, comprising: combining a first phase and a second phase in a static mixing assembly to form an emulsion, wherein the first phase comprises an active agent, a polymer, and a solvent; flowing the emulsion into an extraction liquid for extracting the solvent from the emulsion to form microparticles; and adjusting a residence time of the emulsion in the static mixing assembly to obtain a predetermined particle size distribution of the resulting microparticles, wherein the residence time is equal to a length of the static mixing assembly divided by an average velocity of the emulsion through the static mixing assembly.

13. The method of claim 12, wherein the adjusting step is carried out to increase the residence time, thereby narrowing particle size distribution.

14. The method of claim 12, wherein the adjusting step is carried out to decrease the residence time, thereby broadening particle size distribution.

15. The method of claim 12, wherein the static mixing assembly comprises a plurality of individual static mixers configured so that the emulsion flows sequentially through the plurality of individual static mixers.

16. The method of claim 12, wherein the static mixing assembly comprises: a first static mixer; and a manifold that includes a plurality of static mixers, the manifold in fluid communication with the first static mixer.

17. The method of claim 16, wherein a diameter of the first static mixer is greater than a diameter of each of the plurality of static mixers in the manifold.

18. The method of claim 12, wherein the residence time is from about three seconds to about four seconds.

19. The method of claim 16, wherein the residence time is from about three seconds to about four seconds.

20. The method of claim 12, wherein the adjusting step is carried out by changing the length of the static mixing assembly.

21. The method of claim 16, wherein the plurality of static mixers in the manifold are configured to provide a plurality of parallel flow streams.

22. Microparticles prepared by the method of claim 12.
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