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US 8,062,667 B2Granted
Modified release formulations containing drug-ion exchange resin complexes
AssigneeTris Pharma, Inc.
InventorsKetan Mehta, Yu-Hsing Tu
Life of this patent
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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.
Claims55
An aqueous pharmaceutical suspension composition suitable for oral ingestion comprising:
- (i) a particulate matrix comprising a particulate drug-ion exchange resin complex and a water insoluble polymer or copolymer, or 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 selected from
- (A) a sulfonated copolymer comprising styrene and divinylbenzene, and
- (B) a copolymer comprising styrene 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
- (ii) a cured, high tensile strength, water permeable, water insoluble, non-ionic polymeric diffusion 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) a polyvinylacetate polymer
- (b) a stabilizer, and
- (c) at least an amount of plasticizer effective to enhance the tensile strength of said cured barrier coating, whereby said barrier coating provides a modified release profile to said pharmaceutically acceptable drug in said drug-ion exchange resin complex in said matrix and
- (iii) a pharmaceutically acceptable aqueous suspension base wherein said particulate drug-ion exchange resin complex and said water insoluble polymer or copolymer, or hydrophilic polymer covered with said cured barrier coating as defined in (ii) is suspended in said aqueous suspension base.
7 more elements
An orally ingestible aqueous pharmaceutical suspension composition, comprising:
- (i) a particulate matrix comprising a particulate dextromethorphan-ion exchange resin complex, said dextromethorphan-ion exchange resin complex comprising dextromethorphan bound to a pharmaceutically acceptable water insoluble ion exchange resin, wherein said ion exchange resin is a sulfonated copolymer of styrene and divinylbenzene and wherein said matrix further comprises about 5% to about 20%, based on the weight of said dextromethorphan-ion exchange resin complex, of a water insoluble polymer or copolymer or a hydrophilic polymer, said particulate matrix comprising granules having a size capable of passing through a number 40 mesh screen;
- (ii) a cured high tensile strength, water permeable, water insoluble, non ionic polymeric diffusion barrier coating over said dextromethorphan-ion exchange resin complex and said water insoluble polymer or said hydrophilic polymer defined in (i), said cured barrier coating applied as an aqueous dispersion, and wherein said cured barrier coating comprises polyvinylacetate with a stabilizer comprising polyvinylpyrrolidone in a weight ratio of about 10:1, respectively, and said cured barrier coating further comprising from about 5% to about 10% by weight of a plasticizer based on the dry weight of said cured barrier coating,
- (iii) an uncoated particulate dextromethorphan-ion exchange resin complex wherein said ion exchange resin comprises a sulfonated copolymer of styrene and divinylbenzene and wherein said uncoated dextromethorphan-ion exchange resin complex comprises particles of a size capable of passing through a number 40 mesh screen;
- and
- (iv) a pharmaceutically acceptable aqueous suspension base, wherein said coated particulate dextromethorphan-ion exchange resin complex and said water insoluble polymer or said hydrophilic polymer defined in (ii) and said uncoated particulate dextromethorphan-ion exchange resin complex defined in (iii) are suspended in said base.
2 more elements
Dependencies are inferred from the claim text.