Claims for Patent: 11,160,786

Summary for Patent: 11,160,786

Title:	Rapid disperse dosage form
Abstract:	A high dose rapidly dispersing three-dimensionally printed dosage form comprising a high dose of water soluble drug in a porous matrix that disperses in water within a period of less than about 15 seconds is disclosed. Also disclosed are methods of preparing the dosage form and of treating a condition, disease or disorder that is therapeutically responsive to the drug.
Inventor(s):	Jules Jacob, Norman COYLE, Thomas G. WEST, Donald C. Monkhouse, Henry L. SURPRENANT, Nemichand B. Jain
Assignee:	Aprecia Pharmaceuticals LLC
Application Number:	US15/478,870
Patent Claims:	1. A rapidly dispersible solid dosage form comprising a three-dimensionally-printed, porous, uncompressed and bound matrix, the matrix comprising 50-80% wt of water soluble drug, 3-35% wt of a disintegrant selected from the group consisting of microcrystalline cellulose (MCC), cross-linked polyvinylpyrrolidone, croscarmellose, sodium starch glycolate, and a combination thereof, glycerin in an amount ranging from 0.05-5% by weight of the matrix, and 0.5-20% wt of water soluble, aqueous fluid soluble, partially water soluble or partially aqueous fluid soluble binder, wherein the matrix comprises particles bound by at least one of the binder and the water-soluble drug, wherein the matrix disperses in about 15 sec or less in a volume of about 15 ml or less of water or saliva, and wherein the matrix has sufficient hardness to endure handling and storage. 2. The dosage form of claim 1, wherein the matrix further comprises 0.005 to about 5.0% wt of antioxidant. 3. The dosage form of claim 1, wherein the matrix comprises 0.1% or less of an oxidative degradant of the drug after being stored at 21° C. for six months at 75% RH. 4. The dosage form of claim 1. wherein the matrix comprises an interior and an exterior and the exterior of the matrix is harder than the interior of the matrix. 5. The dosage form of claim 2, wherein: the matrix further comprises one or more surfactants, and optionally one or more of the following: one or more glidants, one or more flavorants, and one or more preservatives. 6. The dosage form of claim 5 wherein a) the one or more surfactant is present in an amount ranging from about 0.05 to about 1% wt based upon the final weight of the dosage form; b) the one or more antioxidant is present in an amount ranging from 0.005 to about 5.0% wt based upon the final weight of the dosage form; c) the one or more glidants is present in an amount ranging from about 0.1 to about 2.0% wt, based upon the final weight of the dosage form; and d) the matrix comprises about 250 to about 1000 mg of the drug. 7. The dosage form of claim 1, wherein the dosage form comprises the 60-70% wt of the water soluble drug, 20-25% wt of the disintegrant, 10-15% wt of the binder, 0.5-2% wt sweetener, 0.1-1.5% wt glidant, 0.1-5% wt of the glycerin, 0.05-1.5% wt surfactant, and 0-0.5% wt flavor, wherein the binder is water soluble, aqueous fluid soluble, partially water soluble or partially aqueous fluid soluble. 8. The dosage form of claim 1, wherein the hardness of the matrix ranges from about 2 to about 6 kp. 9. The dosage form of claim 1, wherein the dosage form is preservative free. 10. The dosage form of claim 1, wherein the dosage form has a shelf-life of at least one year. 11. The dosage form of claim 1, wherein the matrix comprises about 250 mg to about 1000 mg of the drug. 12. The dosage form of claim 1, wherein the dosage form comprises not more than 10% wt and not less 0.1% moisture as determined by loss on drying at 120° C. 13. The dosage form of claim 1, wherein the drug is present in a form selected from the group consisting of hydrate, hemi-hydrate, crystalline, amorphous, anhydrate or a combination thereof. 14. The dosage form of claim 5, wherein the matrix comprises an interior and an exterior and the exterior of the matrix is harder than the interior of the matrix. 15. The dosage form of claim 1, wherein the hardness of the matrix ranges from about 3 to about 9 kp. 16. The dosage form of claim 1, wherein the binder is introduced into the bound matrix by way of printing fluid used to form the matrix. 17. The dosage form of claim 1, wherein the binder is introduced into the bound matrix by way of bulk powder used to form the matrix. 18. The dosage form of claim 1, wherein the bound matrix comprises 15 to 50 printed incremental layers and the thickness of an incremental layer ranges from 0.008 to 0.012 inches. 19. The dosage form of claim 1, wherein the dosage form has a diameter ranging from 13-14 mm to about 20-25 mm and a height ranging from 5-6 mm to about 8-10 mm.