Richard Y Ho

US Patent:

20050084531, Apr 21, 2005

Filed:

Oct 14, 2004

Appl. No.:

10/965034

Inventors:

Jatin Desai - Plainsboro NJ, US
Roger Stanko - South Plainfield NJ, US
Ronald Miller - Langhorne PA, US
Richard Ho - Murray Hill NJ, US

International Classification:

A61K009/24
A61K009/32
A61K033/14

US Classification:

424471000, 424679000

Abstract:

A tablet core containing a water-soluble, preferably highly water-soluble, active ingredient is coated for sustained release with an aqueous-based coating of an ethyl acrylate-methyl methacrylate copolymer. The amount of copolymer applied, on a dry basis, being about 0.5% to about 2% by weight, based on the total weight of the coated tablet. The coated tablet is dried for not more than about 30 minutes, preferably for about 10 to about 15 minutes, at about 50 C. Notwithstanding the greatly shortened drying time and/or low percentage of copolymner applied, the coated tablet surprisingly exhibits a substantially stable dissolution profile. Tablets containing potassium chloride and coated in accordance with the invention surprisingly exhibit a dissolution profile comparable to that afforded by potassium chloride tablets coated for sustained release with an organic solvent-based coating.