Patent ID: 8092831

Claim:
An oral pharmaceutical tablet consisting essentially of: (a) a delayed release pseudoephedrine sulfate or hydrochloride tablet and (b) an immediate release coating applied to said delayed release pseudoephedrine tablet that allows for the immediate release of a therapeutic amount of pseudoephedrine sulfate or hydrochloride and a therapeutic amount of an antihistamine selected from the group consisting of loratadine and descarboethoxy loratadine; wherein the delayed release pseudoephedrine tablet consists of: (a) a compressed immediate release core consisting essentially of: (i) 10-30% based upon the total weight of the compressed core of pseudoephedrine sulfate or hydrochloride; (ii) 65-90% based upon the total weight of the compressed core of a filler; (iii) 0.1-2% based upon the total weight of the compressed core of a glidant; and (iv) 0.1-2% based upon the total weight of the compressed core of a lubricant; and (b) a delayed release coating on said compressed immediate release core consisting essentially of: (i) 15-60% based upon the total weight of the delayed release coating of a combination of at least two pH dependent polymers selected from the group consisting of zein, methacrylic acid copolymers, cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose acetate succinate, cellulose acetate trimellitate and polyvinyl acetate phthalate; (ii) 3-15% based upon the total weight of the delayed release coating of a plasticizer; and (iii) 30-75% based upon the total weight of the delayed release coating of an anti-adherent wherein the delayed release coating delays the release of the pseudoephedrine sulfate or hydrochloride from the immediate release core until the delayed release tablet reaches an environment where the pH is higher than 6; and wherein the immediate release coating comprises: (a) a pseudoephedrine immediate release coating comprising: (i) a therapeutic amount of pseudoephedrine sulfate or hydrochloride; and (ii) a water soluble or rapidly dispersible binder; and (b) a separate antihistamine immediate release coating comprising: (i) a therapeutic amount of loratadine or descarboethoxy loratadine, (ii) a water soluble or rapidly dispersible binder, and (iii) a surfactant.