Patent ID: 8545882

Claim:
A sustained release pharmaceutical composition in unit dosage form comprising a core comprising one or more medicaments selected from the group consisting of guaifenesin, clarithromycin, dextromethorphan, theophylline, divalproex sodium, diclofenac sodium, niacin, ferrous sulfate, verapamil, levodopa, isosorbide mononitrate, carbidopa, and naproxen and a hydrophobic material as a sustained release agent, and optionally a lubricant, and optionally an excipient and optionally an adjuvant, the one or more medicaments being present in said composition in an amount greater than about 25% by weight of the pharmaceutical composition said hydrophobic material containing 10 or more carbon atoms and having a melting point ranging from at least about 40° C. to about 100° C., and being present in an amount ranging from about 3% to less than about 20% by weight of the pharmaceutical composition and in an amount by weight less than that of the one or more medicaments, and wherein said composition excludes any ingredient in the core that causes the disintegration of the unit dosage form, said pharmaceutical composition being prepared by blending said medicament and hydrophobic material and optionally said lubricant and optionally said excipient and optionally said adjuvant at a temperature below that of the melting point of the hydrophobic material to form a substantially homogenous and uniform blend, and forming therefrom the sustained release pharmaceutical composition in unit dosage form, said pharmaceutical composition being formed in the absence of thermal infusion or melting the hydrophobic material or utilizing a high shear mixer or by heating to temperatures slightly below the melting point of the hydrophobic material.