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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Format: | Article |
Language: | English |
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SpringerOpen
2017-06-01
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Series: | AAPS Open |
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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. |
first_indexed | 2024-12-10T08:50:30Z |
format | Article |
id | doaj.art-52d6414477bd4595aa7de045c8ea834a |
institution | Directory Open Access Journal |
issn | 2364-9534 |
language | English |
last_indexed | 2024-12-10T08:50:30Z |
publishDate | 2017-06-01 |
publisher | SpringerOpen |
record_format | Article |
series | AAPS Open |
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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