Modified release formulations containing drug-ion exchange resin complexes

摘要

A particulate, barrier coated drug-anion exchange resin complex comprising a core composed of an acidic drug complexed with a pharmaceutically acceptable ion-exchange resin is provided. The barrier coating contains a polyvinyl acetate polymer and a plasticizer. Methods of making and products containing this coated complex are described.

主权项

1. A powder comprising a particulate drug-anion exchange resin complex comprising:
(a) a pharmaceutically acceptable acidic drug bound to a pharmaceutically acceptable, water insoluble, anion exchange resin to form the particulate drug-anion exchange resin complex, said complex optionally being in a matrix with a water insoluble polymer or copolymer or hydrophilic polymer, wherein said drug is a drug subject to abuse by humans, and (b) a cured, high tensile strength, water permeable, water insoluble, non-ionic, polymeric diffusion barrier coating over the particulate drug-anion exchange resin complex-optional matrix defined in (a), wherein the cured barrier coating comprises:
(i) 70% w/w to 90% w/w polyvinylacetate polymer;(ii) polyvinylpyrrolidone, and(iii) an amount of plasticizer effective to enhance the tensile strength of said cured barrier coating,
wherein the powder may optionally be admixed with an aqueous suspension base for use as an oral suspension.