Rapidly dispersible dosage form of topiramate

A taste-masked rapidly dispersible dosage form comprising:

• a solid porous non-compressed three-dimensionally printed bound matrix comprising:
• spray-congealed taste-masked wax-coated particles comprising drug particles and at least one wax, wherein the spray-congealed taste-masked wax-coated particles have a weight ratio from 20:80 to 50:50, wherein the wax:
• coated particles are prepared by spray congealing a mixture of the drug particles and a molten form of the wax, and wherein the wax 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, polyvinylpyrrolidone, hydroxypropylmethylcellulose, copovidone, pregelatinized cornstarch, hydroxypropylcellulose, lactose, fructose, sucrose, dextrose, sorbitol, mannitol, xylitol and a combination thereof;
• and at least one surfactant independently selected upon each occurrence from the group consisting of polysorbate, poloxamer, sodium lauryl sulfate, and a combination thereof;
• and wherein,
• the dosage form disperses in less than 90 sec when placed in aqueous fluid;
• the total amount of wax-coated particles is from 20% to 50% of the final weight of the dosage form;
• the wax-coated particles have an average or mean particle size of about 60 microns to about 250 microns;
• and
• the drug particles have an average or mean particle size of about 30 microns to 50 microns;
• whereby the drug remains taste-masked.

A taste-masked rapidly dispersible dosage form comprising a three-dimensionally printed solid porous non-compressed bound matrix that disperses in less than 90 sec when placed in aqueous fluid, wherein the non-compressed bound matrix is prepared by a three-dimensional printing process comprising depositing aqueous printing fluid onto one or more layers of bulk powder, said bulk powder comprising:

• taste-masked wax-coated particles comprising drug particles and at least one wax, wherein the taste-masked wax-coated particles have a drug-to-wax weight ratio from 20:80 to 50:50, and wherein the wax 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, polyvinylpyrrolidone, hydroxypropylmethylcellulose, copovidone, pregelatinized cornstarch, hydroxypropylcellulose, lactose, fructose, sucrose, dextrose, sorbitol, mannitol, xylitol and a combination thereof;
• and
• wherein the printing fluid and/or the tasted-masked wax:
• coated particles of drug further comprise at least one surfactant independently selected upon each occurrence from the group consisting of polysorbate, poloxamer, sodium lauryl sulfate, and a combination thereof.

A rapidly dispersible dosage form comprising a three-dimensionally printed solid porous non-compressed bound three-dimensionally printed matrix comprising:

• taste-masked wax-coated particles comprising a mixture comprising drug particles and at least one wax and having a drug-to-wax weight ratio ranging from 20:80 to 50:50, wherein the wax-coated particles have an average or mean particle size of from about 60 microns to about 250 microns;
• 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, polyvinylpyrrolidone, hydroxypropylmethylcellulose, copovidone, pregelatinized cornstarch, hydroxypropylcellulose, lactose, fructose, sucrose, dextrose, sorbitol, mannitol, xylitol and a combination thereof;
• at least one disintegrant;
• and
• at least one surfactant independently selected at each occurrence from the group consisting of polysorbate, poloxamer, sodium lauryl sulfate, and a combination thereof;
• wherein,
• the dosage form disperses in less than 90 sec when placed in aqueous fluid;
• and
• the dosage form comprises plural stacked three-dimensionally printed incremental layers, each layer having a thickness from 0.008 inches to 0.012 inches.