Compressible-Coated Pharmaceutical Compositions and Tablets and Methods of Manufacture
First Claim
Patent Images
1. A pharmaceutical composition comprising compressible-coated microparticles comprising:
- a. drug particles comprising a drug and/or a pharmaceutically acceptable salt, ester, polymorph, or solvate thereof;
b. at least one modified-release membrane layer comprising a water-insoluble polymeric material disposed over the drug particles; and
c. a compressible coating layer comprising a non-polymeric sweetener.
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Abstract
There is provided a method for preparing a pharmaceutical composition comprising compressible coated, taste-masked and/or controlled-release coated drug-containing particles, rapidly-dispersing microgranules comprising a disintegrant and a sugar alcohol, a saccharide, or a mixture thereof, and other optional, pharmaceutically acceptable excipients wherein the orally disintegrating tablet (ODT) or rapidly dispersing tablet (RDT) composition having acceptable tableting, organoleptic, and pharmacokinetic properties.
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Citations
27 Claims
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1. A pharmaceutical composition comprising compressible-coated microparticles comprising:
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a. drug particles comprising a drug and/or a pharmaceutically acceptable salt, ester, polymorph, or solvate thereof; b. at least one modified-release membrane layer comprising a water-insoluble polymeric material disposed over the drug particles; and c. a compressible coating layer comprising a non-polymeric sweetener. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 24, 25, 27)
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23. A method for treating or preventing a gastrointestinal disorder comprising administering to a patient in need thereof a taste-masked composition comprises the steps of:
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a. applying one or more polymeric membranes onto drug particles containing a drug and/or a pharmaceutically acceptable salt, solvate, polymorph, or ester thereof, with a desired particle size distribution; and b. a compressible coating with a non-polymeric material disposed over the modified-release coated drug particles of step (a); c. producing rapidly dispersing granules with an average particle size of not more than 400 μ
m, comprising a sugar alcohol, a saccharide, or a mixture thereof, and a super disintegrant with an average particle size of not more than 30 μ
m, by granulating said mixture at a ratio of from 99/1 to 90/10 using water as a granulating fluid and drying in a fluid bed dryer or in a tray drying;d. blending compressible coated taste-masked drug particles from (b), rapidly dispersing microgranules from (c) and additional excipients comprising one or more flavoring agents, one or more colorants, a sweetener, additional disintegrant, and a diluent such as microcrystalline cellulose; and e. compressing the blend from (d) into orally disintegrating tablets using a rotary tablet press equipped with an external lubrication system, wherein (1) one or more said taste-masking layers effectively mask the taste of said drug and/or the pharmaceutically acceptable salt, ester, or solvate thereof, (2) said orally disintegrating tablet rapidly disintegrates in the oral cavity of a patient into a smooth, easy-to-swallow suspension containing taste-masked particles exhibiting non-gritty mouthfeel and no aftertaste. - View Dependent Claims (26)
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Specification