Regulatory Considerations for Alcohol-Induced Dose Dumping of Oral Modified-Release Formulations

Regulatory Considerations for Alcohol-Induced Dose Dumping of Oral Modified-Release Formulations

[...]the requirement for robustness in-vitro at an ethanol concentration of 40% seems likely to be more relevant to abuse-deterrence, while a concentration of 20% is likely a more realistic approximation for accidental ADD. [...]in-vitro results in 40% hydro-alcoholic media as required by regulatory...

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Veröffentlicht in:Pharmaceutical Technology 2015-10, Vol.39 (10), p.40
Hauptverfasser: Friebe, Thomas P, Asgarzadeh, Firouz, Gray, Ann, Hughes, Kevin, Hebestreit, Johann-Philipp, Rosiaux, Yvonne, Yunis, Mahmud, Faham, Amina
Format: Artikel
Sprache:eng
Schlagworte:
Alcohol
Alcoholic beverages
Beverages
Drug dosages
Ethanol
Narcotics
Patients
Pharmaceutical industry
Physiology
Polymers
Regulatory agencies
Stomach
Working groups
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Zusammenfassung:[...]the requirement for robustness in-vitro at an ethanol concentration of 40% seems likely to be more relevant to abuse-deterrence, while a concentration of 20% is likely a more realistic approximation for accidental ADD. [...]in-vitro results in 40% hydro-alcoholic media as required by regulatory authorities do not necessarily predict in-vivo behavior.
ISSN:1543-2521
2150-7376