Modified release formulations of at least one form of tramadol

Details Modified release formulations of at least one form of tramadol Modified release formulations of at least one form of tramadol

A - Human Necessities

61

K

A61K 9/22 (2006.01) A61K 9/28 (2006.01) A61K 9/32 (2006.01) A61K 9/36 (2006.01) A61K 31/135 (2006.01) A61K 9/20 (2006.01)

Patent

CA 2476201

The present invention provides for a modified release pharmaceutical composition comprising at least one form of tramadol selected from the group consisting of tramadol, enantiomers thereof, pharmaceutically acceptable salts thereof and combinations thereof, the composition exhibiting an in vitro dissolution profile (measured using the USP Basket Method at 75 rpm in 900 ml 0.1 N HCl at 37 ~C) such that after 2 hours, from about 0 % up to about 30 % (by weight) of the at least one form of tramadol is released, after 4 hours, from about 5 % to about 22 % (by weight) of the at least one form of tramadol is released, after 6 hours, from about 15 % to about 38 % (by weight) of the at least one form of tramadol is released, after 8 hours, more than about 40 % (by weight) of the at least one form of tramadol is released.

L'invention concerne une composition pharmaceutique à libération modifiée, qui comprend au moins une forme de tramadol sélectionnée dans le groupe constitué par tramadol, des énantiomères de celui-ci, des sels pharmaceutiquement acceptables de celui-ci et des combinaisons de ceux-ci. Cette composition présente un profil de dissolution <i>in vitro</i> (mesuré à l'aide du procédé dit <= USP Basket >=, à 75 rpm dans 900 ml 0,1 N HCl à 37 ·C) de sorte qu'après 2 heures, d'environ 0 % à environ 30 % (en poids) de la ou des forme(s) de tramadol est/sont libérée(s) ; après 4 heures, d'environ 5 % à environ 22 % (en poids) de la ou des forme(s) de tramadol est/sont libérée(s) ; après 6 heures, d'environ 15 % à environ 38 % (en poids) de la ou des forme(s) de tramadol est/sont libérée(s) ; après 8 heures, plus de 40 % environ (en poids) de la ou des forme(s) de tramadol est/sont libérée(s).

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