Patent ID: 8337890

Claim:
An orally ingestable, modified release, solid composition comprising particulates which provide at least an 8 hour release profile, said composition comprising: (i) a particulate matrix comprising a particulate drug-ion exchange resin complex and a water insoluble polymer or copolymer, or a hydrophilic polymer, said particulate matrix capable of passing through a number 40 mesh screen, said drug-ion exchange resin complex comprising a pharmaceutically acceptable drug bound to a pharmaceutically acceptable water insoluble ion exchange resin to form said drug-ion exchange resin complex, said ion exchange resin being irregularly shaped and selected from (A) a copolymer comprising styrene and divinylbenzene and (B) a copolymer comprising sytrene and divinylbenzene having quaternary ammonium functional groups, wherein said water insoluble polymer or copolymer, or hydrophilic polymer, is present in an amount of about 3% to about 30% by weight, based on the weight of said drug-ion exchange resin complex defined in (i), and (ii) a cured, high tensile strength, water permeable, water insoluble, non-ionic polymeric diffusion modified release barrier coating over said particulate drug-ion exchange resin complex—water insoluble polymer or copolymer, or hydrophilic polymer matrix defined in (i), said cured barrier coating applied as an aqueous dispersion and comprising (a) about 75% w/w to about 90% w/w polyvinylacetate polymer (b) a stabilizer, and (c) about 2.5 to about 20% w/w of plasticizer effective to enhance the tensile strength of said cured barrier coating, whereby said cured coating provides a modified release profile to the drug in said drug-ion exchange resin complex in said matrix.