Rapidly Dispersible Dosage Form of Topiramate

摘要

A taste-masked rapidly dispersible dosage form of topiramate is provided. Wax coated particles of topiramate are included within a porous bound matrix. The topiramate retains its taste-masked form after dispersion in the mouth of a subject even though the particles are not coated with a polymeric material. The dosage form disperses in saliva or water in less than 2 min even though it has a high content of wax. It can be used to treat diseases or disorders that are therapeutically responsive to topiramate or a derivative thereof.

主权项

1) A taste-masked rapidly dispersible dosage form comprising a three-dimensionally printed solid porous non-compressed bound matrix comprising:
taste-masked wax-coated particles of drug comprising at least one waxy material and having a drug-to-waxy material weight ratio ranging from 20:80 to 50:50, wherein the waxy material is not an ionic polymer or copolymer, an acrylate polymer or copolymer, a methacrylate polymer or copolymer, or an enteric polymer or copolymer; at least one water soluble, aqueous fluid soluble, partially water soluble or partially aqueous fluid soluble binder selected from the group consisting of water soluble synthetic polymer, polyvinlypyrrolidone, hydroxypropylmethylcellulose, copovidone, pregelatinized cornstarch, hydroxypropylcellulose, lactose, fructose, sucrose, dextrose, sorbitol, mannitol, xylitol and a combination thereof; and at least one surfactant selected from the group consisting of polysorbate, poloxamer, sodium laurel sulfate, and a combination thereof; and wherein, the dosage form disperses in less than 90 sec when placed in aqueous fluid and the drug remains taste-masked.