NOVEL PHARMACEUTICAL FORMULATIONS
The present invention relates to new extended release pharmaceutical compositions and methods of use thereof for the treatment of disorders.
1 . An extended-release pharmaceutical formulation comprising, in a solid dosage form for oral delivery of between about 100 mg and about 1 g total weight:
between about 2 and about 18% of an active ingredient that is tetrabenazine;
between about 70% and about 96% of one or more diluents selected from the group consisting of mannitol powder, spray dried mannitol, microcrystalline cellulose, lactose, dicalcium phosphate, tricalcium phosphate, starch, pregelatinized starch, compressible sugars, silicified microcrystalline cellulose, and calcium carbonate;
between about 1% and about 10% of a water-soluble binder selected from the group consisting of polyvinylpyrrolidone, hydroxypropylcellulose (HPC), hydroxypropylmethylcellulose (HPMC), ethylcellulose (EC), corn starch, pregelatinized starch, gelatin, and sugar; and
between about 0.5 and about 2% of a surfactant selected from the group consisting of polysorbate, sodium lauryl sulfate, and docusate sodium.