Claims for Patent: 9,463,160

Summary for Patent: 9,463,160

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. The dosage form 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 (West Orange, NJ), Kumar; Sandeep (Trenton, NJ), Monkhouse; Donald C. (Radnor, PA)
Assignee:	Massachusetts Institute of Technology (Cambridge, MA)
Application Number:	10/200,029
Patent Claims:	1. A rapid release drug delivery system comprising: a non-compressed solid matrix having a three dimensionally printed architecture, the matrix comprising a bulk powder material, a water soluble binder and at least one active ingredient, and the active ingredient being present in one or more predetermined printed pattern within the matrix, wherein the matrix disperses in about 90 seconds or less upon contact with moisture thereby releasing the active ingredient, the matrix has a hardness of about 1 to about 20 kp, and the drug delivery system has a porosity of 10%-90%, wherein the matrix is prepared according to the process comprising: a) providing one or more layers comprising a mixture of bulk powder material and a water soluble binder; b) according to the one or more predetermined patterns, applying binding fluid to the one or more layers using a three-dimensional printing technique, the binding fluid comprising a pharmaceutically acceptable solvent and at least one active ingredient, or comprising a mixture of a pharmaceutically acceptable solvent and at least one active ingredient and water soluble pharmaceutically acceptable binder; and c) evaporating the solvent to provide a rapidly dispersing non-compressed solid matrix. 2. A rapid release drug delivery system comprising at least one active ingredient in a dispersing non-compressed solid matrix harboring the at least one active ingredient, the matrix comprising a bulk powder material and a water soluble binder, wherein the matrix has a structure of layers with programmed placement of binder printed within each layer, wherein the matrix is dispersed within a time period of about ninety seconds or less upon contact of the matrix with moisture thereby releasing the at least one active ingredient, the matrix has a hardness of about 1 to about 20 kp, and wherein the drug delivery system has a porosity of 10%-90%, wherein the matrix is prepared according to a process comprising: a) providing one or more layers comprising a mixture of bulk powder material and at least one active ingredient; b) according to the one or more predetermined patterns, applying binding fluid to the one or more layers using a three-dimensional printing technique, the binding fluid: comprising a mixture of water soluble binder and pharmaceutically acceptable solvent; or comprising a mixture of at least one active ingredient, pharmaceutically acceptable solvent and water soluble binder, and c) evaporating the solvent to provide the dispersing non-compressed solid matrix. 3. A pharmaceutical composition comprising: a dispersing non-compressed solid matrix comprising a bulk powder material, a water soluble binder material and one or more active ingredients, wherein: at least one of the binder material and/or the one or more active ingredients are three-dimensionally printed within the matrix according to one or more predetermined patterns, wherein the matrix has a hardness of about 1 to about 20 kp, the pharmaceutical composition has a porosity of 10%-90%, and the composition disperses within about ninety seconds upon contact of said composition with moisture, wherein: a) the matrix is made according to a process comprising: a1) providing one or more layers comprising a mixture of bulk powder material and water soluble binder material; a2) according to the one or more predetermined patterns, applying binding fluid to the one or more layers using a three-dimensional printing technique, the binding fluid comprising a mixture of at least one active ingredient, pharmaceutically acceptable solvent and water soluble binder, and a3) evaporating the solvent to provide the dispersing non-compressed solid matrix; or b) the matrix is made according to a process comprising: b1) providing one or more layers comprising a mixture of bulk powder material and at least one active ingredient; b2) according to the one or more predetermined patterns, applying binding fluid to the one or more layers using a three-dimensional printing technique, the binding fluid comprising a mixture of water soluble binder and pharmaceutically acceptable solvent; or comprising a mixture of water soluble binder, pharmaceutically acceptable solvent and at least one active ingredient; and b3) evaporating the solvent to provide a rapidly dispersing non-compressed solid matrix. 4. The pharmaceutical composition of claim 3, wherein the matrix has three dimensionally printed compositional gradients. 5. The pharmaceutical composition of claim 3, wherein the water soluble binder comprises a pharmaceutically acceptable, substantially water-soluble substance having the capacity to adhere to and bind together the particles of said bulk powder material, to maintain the three-dimensional shape of said matrix in the absence of moisture and to permit said composition to exhibit hardness and friability characteristics adequate for storage and handling. 6. The pharmaceutical composition of claim 3 wherein the bulk powder material comprises a pharmaceutically acceptable compound and further comprises one or more binders, one or more actives, or one or more excipients. 7. The pharmaceutical composition of claim 3 wherein the dispersing matrix consists essentially of lactose and polyvinyl pyrrolidone and one or more of the active ingredients dispersed in said matrix; wherein: said one or more of the active ingredients dispersed in said matrix is a taste masking agent, and wherein the binder material is printed in a predetermined pattern within the matrix. 8. The pharmaceutical composition of claim 3, wherein the moisture is a bodily fluid. 9. The pharmaceutical composition of claims 3, wherein the composition comprises two different active ingredients. 10. The pharmaceutical composition of claim 3, wherein the composition possesses a bulk density of ranging from about 150 mg/mL to about 1300 mg/mL. 11. The pharmaceutical composition of claim 3, wherein bulk powder material is selected from the group consisting of spray-dried lactose, fructose, sucrose, dextrose, sorbitol, mannitol, xylitol, microcrystalline cellulose and a combination thereof. 12. The pharmaceutical composition of claim 3, wherein the water soluble binder is selected from the group consisting of arabinogalactan, polyvinylpyrrolidone, sorbitol, mannitol, xylitol and a combination thereof. 13. The pharmaceutical composition of claim 3, wherein the one or more active ingredients is selected from the group consisting of chloropheniramine maleate, pseudoephedrine hydrochloride, diphenhydramine hydrochloride, doxylamine succinate, dextromethorphan hydrobromide, acetaminophen, or mixtures thereof. 14. The pharmaceutical composition of claim 3, wherein each of the bulk powder material and binder comprises a water soluble compound. 15. The pharmaceutical composition of claim 14, wherein the bulk powder material and binder comprise the same water soluble compound. 16. The pharmaceutical composition of claim 15, wherein the water soluble compound comprises polyvinyl pyrrolidone. 17. The pharmaceutical composition of claim 3, wherein the active ingredient is a taste masking agent, a salivary gland stimulant, a breathe refresher, or a nasal decongestant. 18. The pharmaceutical composition of claim 3, wherein the composition disrupts in less than about sixty seconds upon contact of said composition with moisture. 19. The pharmaceutical composition of claim 3, wherein the composition disrupts in less than about thirty seconds upon contact of said composition with moisture. 20. The pharmaceutical composition of claim 3, wherein the composition disrupts in less than about fifteen seconds upon contact of said composition with moisture. 21. The pharmaceutical composition of claim 3, wherein the composition disrupts in less than about ten seconds upon contact of said composition with moisture. 22. The pharmaceutical composition of claim 3, wherein the composition disrupts within five seconds upon contact of said composition with moisture. 23. The pharmaceutical composition of claim 3, wherein the composition has a porosity ranging from about 30% to about 70%. 24. The pharmaceutical composition of claim 3, wherein the composition possesses a bulk density ranging from about 400 mg/mL to about 1000 mg/mL. 25. The pharmaceutical composition of claim 3, wherein the composition disrupts in less than about thirty seconds upon contact of said composition with moisture; the composition has a porosity ranging from about 30% to about 70%; and the composition possesses a bulk density ranging from about 400 mg/mL to about 1000 mg/mL. 26. The drug delivery system of claim 1, wherein the matrix disrupts in less than about thirty seconds upon contact of said system with moisture; the matrix has a porosity ranging from about 30% to about 70%; and the matrix possesses a bulk density ranging from about 400 mg/mL to about 1000 mg/mL. 27. The drug delivery system of claim 2, wherein: the matrix disrupts in less than about thirty seconds upon contact of said system with moisture; the matrix has a porosity ranging from about 30% to about 70%; and the matrix possesses a bulk density ranging from about 400 mg/mL to about 1000 mg/mL. 28. The pharmaceutical composition of claim 4, wherein: the matrix disrupts in less than about thirty seconds upon contact of said composition with moisture; the matrix has a porosity ranging from about 30% to about 70%; and the matrix possesses a bulk density ranging from about 400 mg/mL to about 1000 mg/mL. 29. The pharmaceutical composition of claim 5, wherein: the matrix disrupts in less than about thirty seconds upon contact of said composition with moisture; the matrix has a porosity ranging from about 30% to about 70%; and the matrix possesses a bulk density ranging from about 400 mg/mL to about 1000mg/mL. 30. The drug delivery system of claim 1, wherein the matrix has a hardness of about 3 to about 10 kp. 31. The drug delivery system of claim 2, wherein the matrix has a hardness of about 3 to about 10 kp. 32. The pharmaceutical composition of claim 4, wherein the matrix has a hardness of about 3 to about 10 kp. 33. The pharmaceutical composition of claim 5, wherein the matrix has a hardness of about 3 to about 10 kp. 34. The pharmaceutical composition of claim 3, wherein the matrix has a hardness of about 3 to about 10 kp.