Rapidly dispersible dosage form of oxcarbazepine
AssigneeAprecia Pharmaceuticals LLC
InventorsJules Jacob, Kelly Caputo, Micael Guillot, Kenneth J. Sultzbaugh, Thomas G. West
Life of this patent
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Abstract
A high dose orodispersible dosage form of oxcarbazepine is provided. Drug-containing particles of oxcarbazepine are included within a porous bound matrix. The dosage form disperses in saliva or water in less than 15 sec and it has sufficient hardness to withstand handling and storage. It can be used to treat diseases or disorders that are therapeutically responsive to oxcarbazepine or a derivative thereof.
Claims14
A rapidly dispersible solid dosage form comprising a porous non-compressed three-dimensionally printed bound matrix comprising:
- drug-containing particles having an average, median or mean effective particle size and comprising a first grade of oxcarbazepine (OXC) particles having an average, median or mean first native particle size, a second grade of OXC particles having an average, median or mean second native particle size, at least one disintegrant, at least one surfactant, and at least one binder;
- at least one disintegrant;
- and
- at least one binder;
- wherein
- the dosage form disperses in 15 sec or less when placed in 15 ml of aqueous fluid;
- and
- the ratio of average, median or mean effective particle size to average, median or mean, respectively, first native particle size ranges from a ratio that is greater than 1:1 to the ratio 5:1, and the ratio of average, median or mean effective particle size to average, median or mean respectively, second native particle size is 20:1 to 50:1.
A rapidly dispersible three-dimensionally printed porous non-compressed bound matrix comprising:
- a first grade of OXC particles having an average, median or mean first native particle size, a second grade of OXC particles having an average, median or mean second native particle size, at least one sweetener, at least one binder, at least one disintegrant, at least one surfactant, and at least one glidant;
- wherein
- the matrix comprises particles bound by binder;
- the matrix disperses in less than 15 sec in a volume of 15 ml of aqueous fluid;
- the OXC particles are included in drug-containing particles having an average, median or mean effective particle size and comprising the OXC particles and at least one pharmaceutical excipient as carrier;
- the content of OXC in the matrix ranges from 35-60% wt based upon the total weight of the matrix;
- and
- the ratio of average, median or mean effective particle size to average, median or mean, respectively, first native particle size ranges from a ratio that is greater than 1:1 to the ratio 5:1, and the ratio of average, median or mean effective particle size to average, median or mean respectively, second native particle size is 20:1 to 50:1.
Dependencies are inferred from the claim text.