Claims for Patent: 5,656,296

Summary for Patent: 5,656,296

Title:	Dual control sustained release drug delivery systems and methods for preparing same
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%.
Inventor(s):	Khan; Sadath U. (Randolph, NJ), Ying; Phyllis (Morristown, NJ), Nesbitt; Russell U. (Somerville, NJ), Fawzi; Mahdi B. (Flanders, NJ), Weiss; Jay (East Brunswick, NJ)
Assignee:	Warner-Lambert Company (Morris Plains, NJ)
Application Number:	08/476,490
Patent Claims:	1. A dual control sustained release drug delivery system where the release of drug is essentially unaffected by high-fat food consumption 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 selected from the group consisting of acrylic resin dispersions consisting of polyacrylamide, polyacryldextran, polyalkyl cyanoacrylate, polymethacrylate, methacrylic resin copolymer, and mixtures thereof present in an amount from about 40% to about 80%; (b) a water-soluble film forming polymer present in an amount from about 20% to about 60%. 2. The drug delivery system according to claim 1, wherein the medicament in the core is present in an amount from about 70% to about 90%%, by weight of the core composition. 3. The drug delivery system according to claim 1, wherein the medicament in the core is selected from the group consisting of procainamide hydrochloride and sodium meclofenamate. 4. The drug delivery system according to claim 3, wherein the medicament in the core is procainamide hydrochloride. 5. The drug delivery system according to claim 1, wherein the edible material in the core is present in an amount from about 5% to about 30%, by weight of the core composition. 6. The drug delivery system according to claim 1, wherein the edible material in the core is selected from the group consisting of carnauba wax, hydrogenated vegetable oils, and stearic acid. 7. The drug delivery system according to claim 6, wherein the edible material in the core is carnauba wax. 8. The drug delivery system according to claim 1, wherein the water-insoluble polymer in the coating layer is present in an amount from about 50% to about 75%, by weight of the coating layer composition. 9. The drug delivery system according to claim 1, wherein the water-insoluble polymer in the coating layer is methacrylic resin copolymer. 10. The drug delivery system according to claim 1, wherein the water-soluble film forming polymer in the coating layer is present in an amount from about 25% to about 50%, by weight of the coating layer composition. 11. The drug delivery system according to claim 1, wherein the water-soluble film forming polymer is a cellulose derivative selected from the group consisting of hydroxypropylcellulose, hydroxypropylmethylcellulose, hydroxypropylmethylcellulose phthalate, sodium carboxymethylcellulose, and mixtures thereof. 12. The drug delivery system according to claim 12, wherein the water-soluble film forming polymer is hydroxypropyl cellulose. 13. The drug delivery system according to claim 1, wherein the weight ratio of core composition to coating layer composition is from about 94:6 to about 98:2, respectively. 14. A method for preparing a dual control sustained release drug delivery system where the release of drug is essentially unaffected by high-fat food consumption which comprises a core and a porous coating layer over the core, which comprises the steps of: (1) providing the following ingredients: (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 selected from the group consisting of acrylic resin dispersions consisting of polyacrylamide, polyacryldextran, polyalkyl cyanoacrylate, polymethacrylate, methacrylic resin copolymer, and mixtures thereof present in an amount from about 40% to about 80%; (b) a water-soluble film forming polymer present in an amount from about 20% to about 60%; (2) melting the edible material from step (1)(A)(b) and admixing the medicament from step (1)(A)(a) to form a molten mixture; (3) cooling and milling the mixture from step (2) and compressing milled mixture to form tablet cores; (4) admixing the ingredients from step (1)(B) in water to form a porous coating layer suspension; and (5) coating the tablet cores from step (3) with the coating layer suspension from step (4) to form the dual control sustained release drug delivery system. 15. A medicated sustained release composition which comprises a pharmaceutically acceptable carrier, and a therapeutically effective amount of a drug delivery system where the release of drug is essentially unaffected by high-fat food consumption which comprises a core and a 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 selected from the group consisting of acrylic resin dispersions consisting of polyacrylamide, polyacryldextran, (b) a water-soluble film forming polymer present in an amount from about 20% to about 60%.