MODIFIED RELEASE FORMULATIONS CONTAINING DRUG-ION EXCHANGE RESIN COMPLEXES
First Claim
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1. An orally ingestable, modified release, composition comprising:
- (i) a particulate drug-ion exchange resin matrix, said drug-ion exchange resin complex comprising a pharmaceutically acceptable, orally ingested drug, bound to a pharmaceutically acceptable water insoluble ion exchange resin to form a drug-ion exchange resin complex, said ion exchange resin being selected from a copolymer comprising styrene with divinylbenzene and a copolymer comprising methacrylic acid with divinylbenzene,wherein said drug-ion exchange resin complex is further in a matrix comprising said drug-ion exchange resin complex and a drug release retardant, wherein said release retardant 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 said drug release retardant comprises a water insoluble polymer or copolymer or a hydrophilic polymer, said drug-ion exchange resin matrix comprising particles of a size capable of passing through a number 40 mesh COMIL screen, and(ii) a cured, high tensile strength, water permeable, water insoluble, non-ionic polymeric diffusion barrier coating over said particulate drug-ion exchange resin matrix defined in (i), said coating applied as an aqueous dispersion, said aqueous based coating dispersion comprising a polyvinylacetate polymer with a stabilizer, and wherein said cured coating further includes an effective amount of plasticizer in said cured, high tensile strength, water permeable, water insoluble, non-ionic polymeric diffusion barrier coating, whereby said cured coating provides a modified release profile to the drug in said drug-ion exchange resin matrix.
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Abstract
A coated drug-ion exchange resin complex comprising a core composed of a drug complexed with a pharmaceutically acceptable ion-exchange resin is provided. The drug-ion exchange resin complex is in admixture with a release retardant. The coating is a polyvinyl acetate polymer and a plasticizer. Methods of making and products containing this coated complex are described.
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Citations
29 Claims
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1. An orally ingestable, modified release, composition comprising:
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(i) a particulate drug-ion exchange resin matrix, said drug-ion exchange resin complex comprising a pharmaceutically acceptable, orally ingested drug, bound to a pharmaceutically acceptable water insoluble ion exchange resin to form a drug-ion exchange resin complex, said ion exchange resin being selected from a copolymer comprising styrene with divinylbenzene and a copolymer comprising methacrylic acid with divinylbenzene, wherein said drug-ion exchange resin complex is further in a matrix comprising said drug-ion exchange resin complex and a drug release retardant, wherein said release retardant 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 said drug release retardant comprises a water insoluble polymer or copolymer or a hydrophilic polymer, said drug-ion exchange resin matrix comprising particles of a size capable of passing through a number 40 mesh COMIL screen, and (ii) a cured, high tensile strength, water permeable, water insoluble, non-ionic polymeric diffusion barrier coating over said particulate drug-ion exchange resin matrix defined in (i), said coating applied as an aqueous dispersion, said aqueous based coating dispersion comprising a polyvinylacetate polymer with a stabilizer, and wherein said cured coating further includes an effective amount of plasticizer in said cured, high tensile strength, water permeable, water insoluble, non-ionic polymeric diffusion barrier coating, whereby said cured coating provides a modified release profile to the drug in said drug-ion exchange resin matrix. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29)
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Specification