Prescription Opioid Formulation to Deter Extraction, Injection, Insufflation, and Smoking

项目总结/摘要： 在美国，目前阿片类药物的处方比人还多。的数量 药物过量造成的死亡继续增加，60%以上涉及处方类阿片。作为 因此，仅今年一年，估计就有42 000人因毒品流行而丧生。一开始， 暂时缓解疼痛可能会转变为需要增加剂量或更有效手段的成瘾 让药物进入人体系统因此，患者已经开发了用于处理 处方药，以准备用于替代给药途径，如注射，吹入，或 smoking.然而，这些替代给药途径可能导致药物的不安全血清水平 导致吸毒过量因此，我们建议开发一种新的抗滥用配方， 设计独特，以防止滥用处方药。该提案将在2个目标中执行。的 第一个目标将侧重于ADF公式的开发，设计方面特别侧重于 通过吹气、吸烟、注射和服用多种药丸滥用。在目标2中，我们将重点验证 根据FDA滥用预防计划概述的程序， 阿片类药物-评价和标签指南。我们的研究计划将导致一部小说的发展 ADF配方，可抵抗广泛的篡改，从而产生更安全的配方和药丸 设计

PROJECT SUMMARY/ABSTRACT: In the United States, there are currently more prescriptions for opioids than there are people. The number of deaths caused by drug overdoses continues to increase, with more than 60% involving prescription opioids. As a result, an estimated 42,000 people will be lost to the drug epidemic this year alone. What often begins as a temporary relief of pain can transition into an addiction that requires increased doses or a more efficient means of getting the drug into the person's system. Thus, patients have developed methods for processing the prescription pills to prepare them for alternative routes of administration such as injection, insufflation, or smoking. However, these alternative routes of administration can cause unsafe blood serum levels of the drug and lead to an overdose. Therefore, we propose to develop a novel abuse deterrent formulation (ADF) that will be uniquely designed to prevent abuse of the prescription pill. The proposal will be performed in 2 aims. The first aim will focus on the development of the ADF formulation with design aspects specifically focused on abuse through insufflation, smoking, injection and taking multiple pills. In Aim 2 we will focus on validating the design by putting the pill through a rigorous test following the procedures outlined by the FDA Abuse-Deterrent Opioids-Evaluation and Labeling guidelines. Our proposed studies will result in the development of a novel ADF formulation that will be resistant to a wide range of tampering, resulting in a safer formulation and pill design.