CPC A61K 31/473 (2013.01) [A61K 9/0053 (2013.01); A61K 9/0065 (2013.01); A61K 9/1676 (2013.01); A61K 9/2013 (2013.01); A61K 9/2018 (2013.01); A61K 9/2027 (2013.01); A61K 9/2031 (2013.01); A61K 9/2054 (2013.01); A61K 9/2072 (2013.01); A61K 9/2077 (2013.01); A61K 9/2095 (2013.01); A61K 9/28 (2013.01); A61K 9/284 (2013.01); A61K 9/288 (2013.01); A61K 9/2846 (2013.01); A61K 9/2866 (2013.01); A61K 9/4808 (2013.01); A61K 9/5047 (2013.01); A61K 9/5073 (2013.01); A61K 9/5078 (2013.01); A61K 9/5084 (2013.01); A61K 31/4745 (2013.01); A61K 45/06 (2013.01); C07D 455/06 (2013.01); C07B 2200/05 (2013.01)] | 18 Claims |
1. A solid oral dosage form comprising 6 mg of d6-tetrabenazine and between about 5% and about 30% by weight of the dosage form of a sustained-release polymer comprising a poly(ethylene oxide) polymer or a hydroxypropyl methylcellulose (HPMC) polymer having a viscosity of less than 4,000 cPs,
wherein oral administration of the oral dosage form to a human results in a ratio of fed to fasted AUCinf of a total combined amount of deuterated dihydrotetrabenazine of >1 to 1.2; and
wherein oral administration of the oral dosage form to a human in a fed state, results in
an AUCinf in plasma of a total combined amount of deuterated dihydrotetrabenazine of about 132 hr*ng/mL; or
a Cmax in plasma of a total combined amount of deuterated dihydrotetrabenazine of about 15.5 ng/mL.
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