Modified Release Formulations Containing Drug - Ion Exchange Resin Complexes

摘要

An aqueous liquid suspension containing a coated drug-ion exchange resin complex comprising a core composed of an amphetamine complexed with a pharmaceutically acceptable ion-exchange resin and an uncoated amphetamine-ion exchange resin complex is provided. The coated amphetamine-ion exchange resin complex is in admixture with a polymer to form a matrix. Methods of making the coated complex and the liquid suspension are described.

主权项

1. A product comprising an aqueous pharmaceutical liquid suspension suitable for oral ingestion comprising:
(i) a particulate drug-ion exchange resin complex-matrix comprising a pharmaceutically acceptable drug 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, 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 barrier coating applied as an aqueous dispersion, wherein said cured 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 barrier coating, whereby said 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.