A review of in vivo and in vitro aspects of alcohol-induced dose dumping

Abstract This review provides a comprehensive list of in vivo and in vitro studies that have investigated alcohol induced dose dumping (AIDD) in modified release dosage forms. Of the numerous classes of drugs commercially available as modified release products, opioids, centrally acting drugs, and d...

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Main Authors: Susan D’Souza, Stephen Mayock, Alger Salt
Format: Article
Language:English
Published: SpringerOpen 2017-06-01
Series:AAPS Open
Subjects:
Online Access:http://link.springer.com/article/10.1186/s41120-017-0014-9
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author Susan D’Souza
Stephen Mayock
Alger Salt
author_facet Susan D’Souza
Stephen Mayock
Alger Salt
author_sort Susan D’Souza
collection DOAJ
description Abstract This review provides a comprehensive list of in vivo and in vitro studies that have investigated alcohol induced dose dumping (AIDD) in modified release dosage forms. Of the numerous classes of drugs commercially available as modified release products, opioids, centrally acting drugs, and drugs with a narrow therapeutic index present high risks from dose dumping, despite being formulated in a manner that releases drug in a tailored or delayed fashion. Awareness of AIDD has led to the withdrawal of a few marketed products by Regulatory Agencies, and black box warnings on others. Since then, significant effort has focused on proving the robustness of a formulation when co-ingested with alcohol. Patient risk is deemed to be low if the formulation and its performance is unimpaired by the presence of 0–40% alcohol under in vivo and in vitro conditions.
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spelling doaj.art-52d6414477bd4595aa7de045c8ea834a2022-12-22T01:55:36ZengSpringerOpenAAPS Open2364-95342017-06-013112010.1186/s41120-017-0014-9A review of in vivo and in vitro aspects of alcohol-induced dose dumpingSusan D’Souza0Stephen Mayock1Alger Salt2Tesaro Inc.Collegium Pharmaceutical Inc.H&A Scientific, Inc.Abstract This review provides a comprehensive list of in vivo and in vitro studies that have investigated alcohol induced dose dumping (AIDD) in modified release dosage forms. Of the numerous classes of drugs commercially available as modified release products, opioids, centrally acting drugs, and drugs with a narrow therapeutic index present high risks from dose dumping, despite being formulated in a manner that releases drug in a tailored or delayed fashion. Awareness of AIDD has led to the withdrawal of a few marketed products by Regulatory Agencies, and black box warnings on others. Since then, significant effort has focused on proving the robustness of a formulation when co-ingested with alcohol. Patient risk is deemed to be low if the formulation and its performance is unimpaired by the presence of 0–40% alcohol under in vivo and in vitro conditions.http://link.springer.com/article/10.1186/s41120-017-0014-9Alcohol induced dose dumping (AIDD)In vitroIn vivoRegulatoryOpioidsCentrally acting drugs
spellingShingle Susan D’Souza
Stephen Mayock
Alger Salt
A review of in vivo and in vitro aspects of alcohol-induced dose dumping
AAPS Open
Alcohol induced dose dumping (AIDD)
In vitro
In vivo
Regulatory
Opioids
Centrally acting drugs
title A review of in vivo and in vitro aspects of alcohol-induced dose dumping
title_full A review of in vivo and in vitro aspects of alcohol-induced dose dumping
title_fullStr A review of in vivo and in vitro aspects of alcohol-induced dose dumping
title_full_unstemmed A review of in vivo and in vitro aspects of alcohol-induced dose dumping
title_short A review of in vivo and in vitro aspects of alcohol-induced dose dumping
title_sort review of in vivo and in vitro aspects of alcohol induced dose dumping
topic Alcohol induced dose dumping (AIDD)
In vitro
In vivo
Regulatory
Opioids
Centrally acting drugs
url http://link.springer.com/article/10.1186/s41120-017-0014-9
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