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US 11,077,055 B2Granted
Orally disintegrating compositions
AssigneeDexcel Pharma Technologies Ltd.
InventorSheera Moses-Heller
Life of this patent
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Abstract
An orally disintegrating dosage form of a proton pump inhibitor, methods for its production and use thereof are provided. The dosage form includes a plurality of pellets containing a proton pump inhibitor admixed with a disintegrant to afford rapid disintegration in the oral cavity after administration.
Claims6
An orally disintegrating tablet comprising (i) enteric coated active cores comprising a therapeutically effective amount of lansoprazole;
- and (ii) at least one pharmaceutically acceptable excipient comprising a disintegrant in an amount of about 2% to about 15% by weight of the total composition, wherein the enteric coated active cores together with the at least one pharmaceutically acceptable excipient are compressed into the form of a tablet,
- the enteric coated active cores comprising:
- (a) inert seeds comprising sugar spheres in an amount of about 2% to about 10% by weight of the total composition;
- (b) a drug coating layer over the inert seeds, wherein the drug coating layer comprises lansoprazole in an amount of about 3% to about 9% by weight of the total composition, mannitol, and meglumine in an amount of about 1% to about 5% by weight of the total composition;
- (c) a subcoating layer over the drug coating layer, wherein the subcoating layer comprises hydroxypropyl methylcellulose in an amount of about 5% to about 15% by weight of the total composition;
- and
- (d) a single enteric coating layer over the subcoating layer, wherein the enteric coating layer comprises hydroxypropyl methylcellulose phthalate in an amount of about 10% to about 25% by weight of the total composition, and cetyl alcohol,
- wherein the tablet substantially disintegrates in the oral cavity of a subject in need thereof within less than about 60 seconds after administration and provides a delayed release profile of the lansoprazole, and
- wherein in vitro drug release in 15 minutes at 0.1N HCl and 40% ethanol is less than about 20%.
6 more elements
Dependencies are inferred from the claim text.