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Modified release formulations of tramadol and uses thereof

  • US 20070184115A1
  • Filed: 12/18/2006
  • Published: 08/09/2007
  • Est. Priority Date: 12/30/2005
  • Status: Abandoned Application
First Claim
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1. A first once daily controlled-release dosage form comprising tramadol comprising at least one means for controllably releasing the tramadol such that said first once daily controlled-release dosage form exhibits an in-vitro release rate such that after about 2 hours from about 0 to about 22% by weight of tramadol is released, after about 4 hours from about 5 to about 30% by weight of tramadol is released, after about 6 hours, from about 15 to about 38% by weight of tramadol is released, and after about 8 hours, more than about 40% by weight of tramadol is released, and when said first once daily controlled-release dosage form is administered to a patient in need of such administration under fed or fasted conditions and is bioequivalent according to FDA guidelines to a second orally administrable dosage form comprising the same dose of tramadol also suitable for once daily administration in the fed or fasted state.

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