Alcohol induced dose dumping in modified release formulations in vivo and in vitro studies:  Comprehensive review

Jasu Rajan; Vasu Rajan; Bhupinder Kaur

doi:10.53730/ijhs.v6nS3.8295

Authors

Jasu Rajan University Institute of Pharma Sciences, Chandigarh University, Mohali, 140301, India
Vasu Rajan University Institute of Pharma Sciences, Chandigarh University, Mohali, 140301, India
Bhupinder Kaur University Institute of Pharma Sciences, Chandigarh University, Mohali, 140301, India

Keywords:

alcohol induced dose, modified release, in vivo, in vitro studies

Abstract

Various case studies based on alcohol-induced dose dumping in modified release dosage forms both in vivo and in vitro have been studied in this review, as well as a study of numerous factors impacting it, polymers that can be used to prevent it, and a perspective of regulatory authorities. The drug from various modified release dosage forms is released in such a way that the release of the drug is tailored or delayed especially for drugs that are having a therapeutic index in a very narrow range or are opioids. These types of drugs possess a very high risk of dose dumping if co-administered with alcohol. Since the problem of alcohol-induced dose dumping (AIDD) has been caught by the regulatory agencies some of the formulations come with black box warnings and some are even withdrawn from the market. It’s been set as a benchmark by the regulatory agencies that if the formulation withstands 0-40% alcoholic condition under in-vitro release tests then the modified release formulations can be classified rugged against the dose duping.

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