Tamper-resistant oral opioid agonist formulations

Details Tamper-resistant oral opioid agonist formulations Tamper-resistant oral opioid agonist formulations

A - Human Necessities

61

K

A61K 31/485 (2006.01) A61K 9/00 (2006.01) A61K 9/02 (2006.01) A61K 9/16 (2006.01) A61K 9/20 (2006.01) A61K 9/28 (2006.01) A61K 9/48 (2006.01) A61K 9/50 (2006.01) A61K 9/70 (2006.01)

Patent

CA 2400567

Disclosed is an oral dosage form comprising (i) an opioid agonist in releasable form and (ii) a sequestered opioid antagonist which is substantially not released when the dosage form is administered intact, such that the ratio of the amount of antagonist released from said dosage form after tampering to the amount of said antagonist released from said intact dosage form is about 4:1 or greater, based on the in-vitro dissolution at 1 hour of said dosage form in 900 ml of Simulated Gastric Fluid using a USP Type II (paddle) apparatus at 75 rpm at 37 degrees C wherein said agonist and antagonist are interdispersed and are not isolated from each other in two distinct layers.

L'invention porte sur une forme posologique comprenant: (i) un agoniste de l'opioïde sous forme libérable, et (ii) un antagoniste séquestré de l'opioïde n'étant pratiquement pas libéré lorsque la forme posologique est administrée intacte. Ainsi le rapport entre la quantité d'antagoniste libérée par la forme posologique après infraction et la quantité de ce même antagoniste libérée par une forme intacte est-il d'environ 4:1 ou plus. Cela se base sur la dissolution in-vitro à une heure de la forme posologique dans 900 ml de fluide gastrique simulé à 37 DEG C dans un appareil USP Type II (à palettes) tournant à 75 tours/minute. Lesdits agoniste et antagoniste sont imbriqués et non isolés l'un de l'autre sans deux couches distinctes.

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