Inventors:
Sadath U. Khan - Randolph NJ
Phyllis Ying - Morristown NJ
Russell U. Nesbitt - Somerville NJ
Mahdi B. Fawzi - Flanders NJ
Jay Weiss - East Brunswick NJ
Assignee:
Warner-Lambert Company - Morris Plains NJ
International Classification:
A61K 924
Abstract:
The present invention pertains to a dual control sustained release drug delivery system which comprises a core and a porous coating layer over the core, wherein the coated core comprises (A) a core comprising in percentages by weight of the core composition (a) a medicament present in an amount from about 60% to about 90%; (b) an edible material having a melting point from about 25. degree. C. to about 100. degree. C. selected from the group consisting of (i) fatty acids having an iodine value from about 1 to about 10, (ii) natural waxes, (iii) synthetic waxes, and (iv) mixtures thereof, present in an amount from about 5% to about 40%; and (B) a porous coating layer over the core comprising in percentages by weight of the coating layer composition (a) a pH-independent water-insoluble polymer present in an amount from about 40% to about 80%; and (b) a water-soluble film forming polymer present in an amount from about 20% to about 60%.