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Modified release formulations containing drug—ion exchange resin complexes

  • US 9,522,191 B2
  • Filed: 10/07/2014
  • Issued: 12/20/2016
  • Est. Priority Date: 03/16/2006
  • Status: Active Grant
First Claim
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1. An aqueous pharmaceutical liquid suspension suitable for oral ingestion comprising:

  • (i) a particulate drug-ion exchange resin complex-matrix comprising a pharmaceutically acceptable drug which is carbinoxamine bound to a pharmaceutically acceptable water insoluble ion exchange resin to form said particulate drug-ion exchange resin complex, said particulate drug-ion exchange resin complex being in a matrix with a water insoluble polymer or copolymer or a hydrophilic polymer, which polymer or copolymer is present in an amount of about 3% to about 30% by weight, based on the weight of said particulate drug-ion exchange resin complex-matrix, said ion exchange resin being a cation exchange resin, 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 defined in (i), said cured, high tensile strength, water permeable, water insoluble, non-ionic polymeric, modified release, diffusion barrier coating applied as an aqueous dispersion, wherein said cured, high tensile strength, water permeable, water insoluble, non-ionic polymeric, modified release diffusion barrier coating comprises;

    (a) about 75% w/w to about 90% w/w polyvinylacetate polymer;

    (b) a stabilizer comprising polyvinylpyrrolidone, and(c) about 2.5% w/w to about 20% w/w of plasticizer effective to enhance the tensile strength of said cured, high tensile strength, water permeable, water insoluble, non- ionic polymeric, modified release diffusion barrier coating, whereby said cured, high tensile strength, water permeable, water insoluble, non-ionic polymeric, modified release, diffusion barrier coating is over the particulate drug-ion exchange resin complex-matrix and provides a modified release profile to said pharmaceutically acceptable drug in said particulate drug- ion exchange resin complex-matrix.

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