Журнал разработки лекарств
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Commercial Abuse-Deterrent Dosage Forms: Clinical Status

David J Mastropietro and Hossein Omidian

Abuse of prescription medications is being combated with the advent of novel formulations designed to prevent or discourage tampering and misuse. The ability of these abuse-deterrent and tamper-resistant formulations to impact abuse, and the test methods used to determine their lowered abuse potential is becoming more important. There are three main reasons for the need to access these formulations, a) to determine if a formulation itself can impact abuse of a product, b) for standardized methods that can be used to support product labeling, and c) to evaluate both new and generic products for tamper-equivalence. The object of this review is to provide an overview and evaluation of the various types of premarketing tamper and abuse studies performed both in-vitro and by experienced abusers when evaluating a product’s deterrence to abuse. To find and assess abuse liability studies of FDA approved products, a database search using Medline and Google Scholar with keywords “abuse deterrent”, and “tamper resistant” was used along with information obtained from product innovator websites and regulatory documents from the FDA regarding each product. Results from our investigation revealed that studies evaluating of a products abuse deterrent properties could be separated into three main categories based on the state the product is in during the study. The three main categories are 1) solid state studies, 2) solution state studies, and 3) aerosol state studies. For each category, various study examples are discussed and assessed for factors that will have significant impact on the way the study is evaluated.