Patent ID: 7964216

Claim:
A spaced drug delivery system designed to provide desired control on the disease condition, comprising (a) a first time pulse release composition comprising (i) a core comprising one or more first therapeutically active agent(s) and a swelling agent that swells but does not gel, wherein the swelling agent is selected from the group consisting of sodium starch glycolate, sodium croscarmellose and cross-linked polyvinyl pyrrolidone, and (ii) a coat comprising a mixture of a water insoluble polymer and a water soluble polymer in a weight ratio comprised in a range from 6:3 to 9:3 and in a weight gain ranging from about 2% by weight to about 20% by weight of the core, wherein the coat composition forms a continuous film that surrounds the core, and wherein the water insoluble polymer is ethyl cellulose and the water soluble polymer is hydroxypropyl methylcellulose (HPMC), and (b) a second composition comprising one or more second therapeutically active agent(s), wherein the second therapeutically active agent is released as an immediate pulse upon oral administration of the spaced drug delivery system with initiation of the immediate pulse immediately upon oral administration, and wherein an amount of the swelling agent in the core and a ratio of the water insoluble polymer and water soluble polymers in the coat are selected so as to cause a rupture of the coat upon uptake of water, such that the first therapeutically active agent is released as a delayed pulse, wherein the coat ruptures with initiation of the delayed pulse at a rupture time which is about a predetermined time after oral administration, wherein said predetermined time is in a range of from about 1 hour to about 12 hour, and said rupture time has a reliability such that 36 out of 36 tablets rupture within ±50% of the predetermined time if the predetermined time is in the range of about 1 hour to about 4 hour, and within ±25% of the predetermined time if the predetermined time is in the range of about >4 hour to about 12 hour, when tested by subjecting the tablets to a USP dissolution test using an aqueous media at 37±0.5° C., in USP Type I or Type II apparatus at an rpm selected in a range from about 50 rpm to about 100 rpm, and wherein the first and second therapeutically active agents act on the disease condition by similar or dissimilar, but complementary mechanisms, to control the symptoms of the disease, or a measurable indicator of the disease condition, and further wherein the time of release of the two or more therapeutically active agents is designed to provide desired control on the disease condition, wherein the first composition does not contain the second therapeutically active agent and the second composition does not contain the first therapeutically active agent.