Claims for Patent: 11,077,055

Summary for Patent: 11,077,055

Title:	Orally disintegrating compositions
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.
Inventor(s):	Moses-Heller; Sheera (Atlit, IL)
Assignee:	Dexcel Pharma Technologies Ltd. (Or-Akiva, IL)
Application Number:	15/238,109
Patent Claims:	1. 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%. 2. The orally disintegrating tablet of claim 1, wherein the disintegrant comprises cross-linked polyvinylpyrrolidone. 3. The orally disintegrating tablet of claim 1, wherein the enteric coating layer over the subcoating layer further comprises triethyl citrate. 4. The orally disintegrating tablet of claim 1, having a hardness of at least 20 Newtons. 5. The orally disintegrating tablet of claim 4, having a hardness of about 30 to about 70 Newtons. 6. The orally disintegrating tablet of claim 1, having a friability of not more than 1%.