Patent ID: 8491935

Claim:
An orally ingestible aqueous pharmaceutical suspension composition comprising: (A) barrier coated particulates which provide about a twelve hour release profile which comprise (i) a particulate matrix comprising a particulate hydrocodone-cation exchange resin complex and a water insoluble polymer or copolymer or a hydrophilic polymer, said particulate hydrocodone-cation exchange resin complex—(water insoluble polymer or copolymer or hydrophilic polymer) matrix capable of passing through a number 40 mesh screen, said particulate hydrocodone-cation exchange resin complex comprising hydrocodone bound to a pharmaceutically acceptable water insoluble cation exchange resin, wherein said water insoluble polymer or copolymer, or hydrophilic polymer, is present in said particulate hydrocodone-cation exchange resin complex—(water insoluble polymer or copolymer or hydrophilic polymer) matrix in an amount of about 3% to about 30% by weight, based on the weight of said particulate hydrocodone-cation exchange resin complex, and (ii) a cured high tensile strength, water permeable, water insoluble, non ionic polymeric diffusion barrier coating over said particulate hydrocodone-cation exchange resin complex—(water insoluble polymer or copolymer or said hydrophilic polymer) matrix defined in (i), said cured barrier coating applied as an aqueous dispersion, said cured barrier coating comprising: (a) about 70% w/w to about 90% w/w polyvinylacetate polymer, (b) a stabilizer, and (c) about 2.5 to about 20% w/w of plasticizer effective to enhance the tensile strength of said cured barrier coating, whereby said cured coating provides about a twelve hour release profile to the hydrocodone in said particulate hydrocodone-cation exchange resin complex—(water insoluble polymer or copolymer or hydrophilic polymer) matrix), wherein the weight percentage is based on the weight of the cured barrier coating layer; (B) an uncoated particulate drug-cation exchange resin complex of a size capable of passing through a number 40 mesh screen, wherein said uncoated drug-cation exchange resin complex is a dl-chlorpheniramine bound to a pharmaceutically acceptable water insoluble cation exchange resin complex or a dexchlorpheniramine bound to a pharmaceutically acceptable water insoluble cation exchange resin; and (C) a pharmaceutically acceptable aqueous suspension base, wherein said coated particulate hydrocodone-cation exchange resin complex—(water insoluble polymer or copolymer or or hydrophilic polymer) matrix defined in (ii) and said uncoated particulate drug-ion exchange resin complex defined in (B) are suspended in said base.