26-12-2013 дата публикации
Номер: US20130344143A1
Принадлежит:
The preferred exemplary embodiments in the present application provide formulations and methods for the delivery of drugs, particularly drugs of abuse, having an abuse-relevant drug substantially confined in the core and a non-abuse relevant drug in a non-core region. These formulations have reduced potential for abuse. In the formulation, preferably the abuse relevant drug is an opioid and the non-abuse relevant drug is acetaminophen or ibuprofen. More preferably, the opioid is hydrocodone, and the non-abuse relevant analgesic is acetaminophen. In certain preferred embodiments, the dosage forms are characterized by resistance to solvent extraction; tampering, crushing or grinding. Certain embodiments of the inventions provide dosage forms that provide an initial burst of release of drug followed by a prolonged period of controllable drug release. 1. A pharmaceutical composition having a core and a non-core layer , comprising:(a) hydrocodone, a pharmaceutically acceptable salt or a hydrate thereof, and(b) acetaminophen or ibuprofen,wherein at least 75% all of the hydrocodone, pharmaceutically acceptable salt or hydrate thereof is in the core,wherein the acetaminophen or the ibuprofen is the non-core layer, andwherein the composition is adapted so as to be useful for oral administration to a human 3,2, or 1 times daily.2. The composition of claim 1 , wherein greater than 90% of the hydrocodone claim 1 , pharmaceutically acceptable salt or hydrate thereof is in the core.3. The composition of claim 1 , wherein substantially all of the hydrocodone claim 1 , pharmaceutically acceptable salt or hydrate thereof is in the core.4. (canceled)5. The composition of claim 1 , further wherein the core further comprises acetaminophen or ibuprofen.6. The composition of claim 1 , wherein when administered to the human patient the pharmaceutical composition produces a plasma profile characterized by a Cmax for hydrocodone from about 0.6 ng/mL/mg to about 1.4 ng/mL/mg and a Cmax for ...
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