Diversion - And/Or Abuse-Resistant Compositions And Methods For Making The Same

摘要

A composition formulated for diversion- and/or abuse-resistance, includes at least one active pharmaceutical ingredient (API), each present in an acidic form, a first compound capable of coupling to the acidic form of the API to form a complex, where the resulting complex is resistant to separation by conventional separation methods, and a second compound capable of preferentially coupling to the first compound to thereby release the API from the complex.

主权项

1. A composition comprising:
(a) at least one acid salt of an active pharmaceutical ingredient (API) with the structure of Structure I where R1 is H or OH; R2 is H or CH3; R3 is H or CH3; R4 is H, OH or OCH3; R5 is H, OH or OCH3; and R6 is H or OCH3; (b) a first compound coupled to the acid salt of the API to form a water-insoluble complex, and enabling the first compound to undergo oxidization under basic conditions, to form a fine particulate precipitate; and (c) a second compound in an amount sufficient for coupling to the first compound in an aqueous environment, whereby the acid salt of the API is released from the complex.