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Details for Patent: 9,114,072

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Details for Patent: 9,114,072

Title:Dosage form exhibiting rapid disperse properties, methods of use and process for the manufacture of same
Abstract: A rapidly dispersing dosage form is described, which releases its active ingredients within a period of less than about ninety seconds. These dosage forms exhibit a three-dimensional shape that is retained for adequate storage but is readily dispersed in the presence of excess moisture. Also disclosed are methods of administration of a medicament and a process for the preparation of rapidly dispersing dosage forms.
Inventor(s): Yoo; Jaedeok (Princeton, NJ), Kumar; Sandeep (Newbury Park, CA), Monkhouse; Donald C. (Radnor, PA)
Assignee: Massachusetts Institute of Technology (Cambridge, MA)
Filing Date:Feb 09, 2012
Application Number:13/369,473
Claims:1. A process for preparing a pharmaceutical rapidly dispersing non-compressed solid matrix comprising one or more active ingredients and bound particles of bulk material, the process comprising: a) providing one or more layers of powdered bulk material comprising a mixture of a pharmaceutically acceptable compound, one or more active ingredients and a water soluble pharmaceutically acceptable binder; b) applying a first binding fluid, comprising a pharmaceutically acceptable solvent or a mixture of a pharmaceutically acceptable solvent and a water soluble pharmaceutically acceptable binder which is the same as or different than the binder in the powdered bulk material, to the one or more layers of bulk material using three-dimensional printing technique; and c) evaporating the solvent to provide a rapidly dispersing non-compressed solid matrix having a three-dimensional shape, wherein the solid matrix: 1) is able to maintain its three dimensional shape in the absence of moisture; 2) is able to exhibit hardness and friability characteristics adequate for storage and handling; and 3) is dispersed completely within a time period of less than about ninety seconds upon contact of said solid matrix with water in an environment of use.

2. The process of claim 1, wherein steps (a) and (b) are repeated to provide a solid matrix comprising plural layers of bound particles of bulk material.

3. The process of claim 1, wherein step (b) further comprises: Step i) reapplying the first binding fluid to the same one or more layers of step (b) to form a bottom section; Step ii) providing one or more layers of the powdered bulk material onto the bottom section; Step iii) applying a second binding fluid, comprising a pharmaceutically acceptable solvent or a mixture of a pharmaceutically acceptable solvent and a water soluble pharmaceutically acceptable binder which is the same as or different than the binder in the powdered bulk material, to the one or more layers of Step ii) to form one or more middle sections; Step iv) providing one or more layers of the powdered bulk material onto the one or more middle sections; and Step v) applying a third binding fluid, comprising a pharmaceutically acceptable solvent or a mixture of a pharmaceutically acceptable solvent and a water soluble pharmaceutically acceptable binder which is the same as or different than the binder in the powdered bulk material, to the one or more layers of Step iv) to form a top section, and reapplying the third binding fluid to the same one or more layers of the instant step.

4. The process of claim 3, wherein the first and third binding fluids are each a mixture of a pharmaceutically acceptable solvent and a water soluble pharmaceutically acceptable binder.

5. The process of claim 3, wherein the top and bottom sections have increased hardness and reduced friability as compared to the one or more middle sections.

6. The process of claim 3, wherein the second binding fluid is a mixture of a pharmaceutically acceptable solvent and a water soluble pharmaceutically acceptable binder, which further comprises one or more active ingredients.

7. The process of claim 1, wherein the first binding fluid is applied at a first application rate to form a bottom section, and the process further comprises: Step i) providing one or more layers of the powdered bulk material onto the bottom section; Step ii) applying a second binding fluid, comprising a pharmaceutically acceptable solvent or a mixture of a pharmaceutically acceptable solvent and a water soluble pharmaceutically acceptable binder which is the same as or different than the binder in the powdered bulk material, at a second application rate to the one or more layers of Step i) to form one or more middle sections; Step iii) providing one or more layers of the powdered bulk material onto the one or more middle sections; and Step iv) applying a third binding fluid, comprising a pharmaceutically acceptable solvent or a mixture of a pharmaceutically acceptable solvent and a water soluble pharmaceutically acceptable binder which is the same as or different than the binder in the powdered bulk material, at a third application rate to the one or more layers of Step iii) to form a top section; wherein the first and third application rates are slower than the second application rate.

8. The process of claim 7, wherein the first, second or third binding fluid further comprises one or more active ingredients.

9. The process of claim 8, wherein the water soluble pharmaceutically acceptable binder in the powdered bulk material is the same as the water soluble pharmaceutically acceptable binder in the binding fluid.

10. The process of claim 8, wherein the one or more active ingredients in the bulk material is the same as the one or more active ingredients in the binding fluid.

11. The process of claim 1, wherein the first binding fluid is applied with one or more printheads.

12. The process of claim 11, wherein the printhead is a continuous jet printhead that applies the first binding fluid at a scan rate of 0.5 to 3 m/sec using a droplet size of 15 to 150 .mu.m in diameter and a flow rate of 0.2 to 3 mL/min.

13. The process of claim 12, wherein the thickness of each layer is 100-300 .mu.m.

14. The process of claim 11, wherein the printhead is a drop-on-demand printhead that applies the first binding fluid at a scan rate of 0.1 to 1 m/sec using a droplet size of 50 to 500 .mu.m in diameter and a flow rate of 0.2 to 3 mL/min.

15. The process of claim 14, wherein the thickness of each layer is 100-500 .mu.m.

16. The process claim 1, wherein the applying step is performed according to one or more predetermined patterns.

17. The process of claim 16, wherein two or more of the predetermined patterns are different.

18. The process of claim 1, wherein the providing step and applying step are repeated to provide a solid matrix comprising 5 to 50 layers of bound particles of bulk material.

19. The process of claim 1, wherein the solid matrix has a porosity ranging from about 10% to about 90% and a bulk density ranging from about 150 mg/mL to about 1300 mg/mL.

20. The process of claim 1, wherein the solid matrix has a hardness ranging from 1 kp to 20 kp.

21. The process of claim 1, wherein the solid matrix has a friability of less than about 25%.

22. The process of claim 1, wherein the powdered bulk material further comprises a water soluble carbohydrate.

23. The process of claim 19, wherein the solid matrix has a porosity ranging from about 30% to about 70% and a bulk density ranging from about 400 mg/mL to about 1000 mg/mL.
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