CPC A61K 31/5375 (2013.01) [A61K 9/2013 (2013.01); A61K 9/2027 (2013.01); A61K 9/2054 (2013.01); A61K 9/209 (2013.01); A61K 9/282 (2013.01); A61K 9/2846 (2013.01); A61K 9/2866 (2013.01)] | 20 Claims |
1. A pharmaceutical product comprising a single dosage form and a label, wherein the single dosage form comprises a first release component and a second release component, wherein the first release component contains 1 mg to 10 mg of reboxetine, and the second release component contains 0.1 mg to 10 mg of reboxetine and is coated with a polymer that delays release of reboxetine in the second release component;
wherein the single dosage form has a property that, when administered to a fasted human subject:
1) the reboxetine in the first release component provides a first local maximum in reboxetine plasma concentration, and
2) the reboxetine in the second release component provides a second local maximum in reboxetine plasma concentration,
wherein the first local maximum in reboxetine plasma concentration occurs about 2 hours to about 6 hours prior to the second local maximum in reboxetine plasma concentration;
wherein reboxetine is the only active pharmaceutical agent; and
wherein the label states that the single dosage form is to be administered once a day.
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