College of Pharmacy and Health Sciences, St. John's University, Queens, NY, USA.
College of Pharmacy and Health Sciences, St. John's University, Queens, NY, USA.
Int J Pharm. 2020 Nov 30;590:119944. doi: 10.1016/j.ijpharm.2020.119944. Epub 2020 Oct 2.
Prescription opioid abuse also known as opioid epidemic has been an ever-growing problem in the United States. It has been associated with numerous emergencies and mortality with significant burden on healthcare system. Amongst various approaches proposed by FDA, development of an abuse deterrent formulation is one of the key strategies to address this opioid crisis. Existing abuse deterrent technologies have several deficiencies which enable abusers to manipulate/bypass it. The proposed study aims to develop and optimize an abuse-deterrent immediate release bilayer film (ADRIFT). A novel material with distinct process engineering was employed to achieve immediate drug release with nasal/intravenous abuse deterrent properties. Drug layer (DL) composed of a rapidly soluble film forming polymer - polyvinyl alcohol (PVA) while various solvent system and biocompatible polymers were screened to incorporate sodium polyacrylamide starch (KPX) in abuse deterrent layer (AL). Mechanical analysis of ADRIFT suggested that individual excipients played significant role in improving the mechanical strength of ADRIFT. Spontaneous formation of highly viscous gels in different solvents and resistance to mill into fine powder support the injection and snorting abuse deterrent potential, respectively. Immediate release (>85% release) was achieved in < 30mins, indicating that there was no interference between either of the layers towards their specific purposes. Hence, our novel yet simple ADRIFT oral film technology could potentially be useful in manufacturing immediate release abuse-deterrent formulation of opioid drugs.
处方类阿片类药物滥用也称为阿片类药物泛滥在美国是一个日益严重的问题。它与许多急症和死亡率有关，给医疗系统带来了巨大的负担。在美国食品药品监督管理局提出的各种方法中，开发一种防止滥用的配方是解决阿片类药物危机的关键策略之一。现有的防止滥用技术有几个缺陷，使滥用者能够操纵/绕过它。拟议的研究旨在开发和优化一种防止滥用的即时释放双层膜（ADRIFT）。采用了一种具有独特工艺工程的新型材料，以达到具有鼻内/静脉内滥用阻止特性的即时药物释放。药物层（DL）由一种快速溶解的成膜聚合物 - 聚乙烯醇（PVA）组成，同时筛选了各种溶剂系统和生物相容性聚合物，将聚丙烯酸钠淀粉（KPX）纳入防止滥用层（AL）。ADRIFT 的机械分析表明，各个赋形剂在提高 ADRIFT 的机械强度方面发挥了重要作用。不同溶剂中高度粘性凝胶的自发形成以及抵抗研磨成细粉分别支持注射和鼻吸滥用阻止潜力。即时释放（>85%释放）在<30 分钟内实现，表明两个层之间没有相互干扰。因此，我们新颖而简单的 ADRIFT 口腔薄膜技术可能有助于制造阿片类药物的即时释放防止滥用配方。
