Abuse-deterrent dosage forms

摘要

Abuse-deterrent dosage forms (e.g., orally administered dosage forms, transdermal dosage forms, suppositories, etc.), processes for formulating pharmaceutical dosage forms comprising an active agent susceptible to abuse (e.g., an opioid agonist, a benzodiazepine, a stimulant) such that the resulting dosage forms are abuse-deterrent are described. Also described are methods of deterring abuse of pharmaceutical dosage forms.

主权项

1. An abuse-deterrent dosage form comprising an active agent susceptible to abuse and a tonicity-increasing agent, wherein
the tonicity-increasing agent is in an effective amount to provide a hypertonic solution, suspension or gel comprising the active agent upon contact of the dosage form with from 2 ml to 5 ml of a solvent, the hypertonic solution, suspension or gel has an osmotic pressure of from about 380 mOsmol/L to about 10000 mOsmol/L, a viscosity of less than about 8 cP and is sufficiently hypertonic to deter abuse, the abuse-deterrent dosage form is an abuse-deterrent transdermal dosage form, the active agent susceptible to abuse is an opioid agonist, the solvent comprises water, saliva and/or nasal secretions, and the tonicity-increasing agent is the only abuse-deterrent agent in the dosage form.