Rapid disperse dosage form
AssigneeAprecia Pharmaceuticals LLC
InventorsJules Jacob, Norman Coyle, Thomas G. West, Donald C. Monkhouse, Henry L. Surprenant, Nemichand B. Jain
Life of this patent
Estimating the term…
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.
Claims24
A rapidly dispersible solid dosage form comprising a three-dimensionally printed, porous, bound matrix comprising 50-80% wt of levetiracetam (LEV), 3-35% wt of disintegrant selected from the group consisting of microcrystalline cellulose (MCC), cross-linked polyvinylpyrrolidone, croscarmellose, sodium starch glycolate, and a combination thereof, and 0.5-20% wt of water-soluble binder, wherein the matrix comprises particles bound by at least one of the water-soluble binder and the LEV, wherein the matrix disperses in about 15 sec or less in a volume of about 15 ml or less of water or saliva.
A rapidly-dispersible uncompressed dosage form consisting of a porous bound-particle matrix of 5 to 50 incremental layers having a layer thickness ranging from 0.005 inches to 0.015 inches, the matrix comprising, by weight:
- 60% to 70% levetiracetam (LEV) particles, the LEV particles consisting of LEV, and 5% to 15% binder, wherein:
- the matrix comprises up to 1000 mg of LEV;
- the matrix disperses in about 15 sec or less in a volume of about 15 ml or less of water or saliva;
- and
- and at least 75% of the LEV dissolves in about 2 minutes or less when placed in an aqueous fluid.
Dependencies are inferred from the claim text.