Risk based in vitro performance assessment of extended release abuse deterrent formulations

详细信息    查看全文

• 作者：Xiaoming Xu^a ; Abhay Gupta^a ; Manar Al-Ghabeish^a ; Silvia N. Calderon^b ; Mansoor A. Khan^a ; ^c ; ^{mkhan@pharmacy.tamhsc.edu" class="auth_mail" title="E-mail the corresponding author}
• 关键词：Abuse deterrent formulation ; Opioid analgesics ; Evaluation matrix ; Drug abuse ; manipulation ; Mode of abuse ; Syringeability ; Injectability
• 刊名：International Journal of Pharmaceutics
• 出版年：2016
• 出版时间：16 March 2016
• 年：2016
• 卷：500
• 期：1-2
• 页码：255-267
• 全文大小：2965 K

文摘

High strength extended release opioid products, which are indispensable tools in the management of pain, are associated with serious risks of unintentional and potentially fatal overdose, as well as of misuse and abuse that might lead to addiction. The issue of drug abuse becomes increasingly prominent when the dosage forms can be readily manipulated to release a high amount of opioid or to extract the drug in certain products or solvents. One approach to deter opioid drug abuse is by providing novel abuse deterrent formulations (ADF), with properties that may be viewed as barriers to abuse of the product. However, unlike regular extended release formulations, assessment of ADF technologies are challenging, in part due to the great variety of formulation designs available to achieve deterrence of abuse by oral, parenteral, nasal and respiratory routes. With limited prior history or literature information, and lack of compendial standards, evaluation and regulatory approval of these novel drug products become increasingly difficult. The present article describes a risk-based standardized in-vitro approach that can be utilized in general evaluation of abuse deterrent features for all ADF products.