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Abstract

A multiparticulate milnacipran composition for oral administration has been developed. The formulation is made by complexing milnacipran with an ion-exchange resin in the form of small particles, typically less than 150 microns. Multiparticulate formulations may be any one or more of the following types of particles are formulated into a final dosage form: immediate release particles, prepared by coating drug-containing particles with the polymer that is insoluble in the neutral medium of saliva, but dissolves in the acid environment of the stomach; enteric coated particles, prepared by coating drug-containing particles with the polymer that is insoluble in the acidic environment of the stomach but dissolves in the neutral environment of the small intestines; extended release particles, prepared by coating drug-containing particles with a polymer that forms water insoluble but water permeable membrane; enteric coated-extended release particles, prepared by coating extended release drug particles with a second, enteric coating; delayed release particles, prepared by coating drug-containing particles with a polymer that is insoluble in the acidic environment of the stomach and the environment of the upper small intestines, but dissolves in the lower small intestines or upper large intestines. The various drug-containing particles described above can be further formulated into a number of different final dosage forms including, but not limited to, a liquid, liquid suspension, gel, capsule, soft gelatin capsule, tablet, chewable tablet, crushable tablet, rapidly dissolving tablet, or unit of use sachet or capsule for reconstitution.

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First Claim