Acura Pharmaceutical Technologies, Inc., Culver, IN 46511, USA.
Am J Drug Alcohol Abuse. 2013 Sep;39(5):284-90. doi: 10.3109/00952990.2013.821476.
The personal and societal effects of methamphetamine abuse are well documented. The ease of accessibility to methamphetamine and the quality of the "high" it produces makes the drug highly desired by its abusers. Over time, many methamphetamine users will also become methamphetamine cooks, where pseudoephedrine in over-the-counter cold products is converted to methamphetamine through a simple, albeit extremely dangerous, process. New laws limiting access to these products have had limited success. No existing commercial pseudoephedrine products offer significant impediments to slow or limit the extraction and conversion of pseudoephedrine in clandestine methamphetamine laboratories.
A new pseudoephedrine 30 mg tablet product using Impede technology (Nexafed®) to deter methamphetamine production has recently been introduced into the marketplace. Using methods designed to mimic clandestine laboratory processes, the ability of this product to disrupt extraction and conversion of pseudoephedrine to methamphetamine yet provide therapeutic effectiveness was evaluated.
Impede™ technology tablets limited the extraction and/or conversion of pseudoephedrine to methamphetamine when compared to a commercially marketed pseudoephedrine product (Sudafed®). Nexafed® tablets were also shown to be bioequivalent to the same control product, thus ensuring therapeutic equivalence.
With the advent of new pseudoephedrine products in the marketplace with features to limit the extraction and conversion of pseudoephedrine to methamphetamine, new tools are now available to minimize the clandestine manufacture of the drug and potentially limit its social impact.
甲基苯丙胺滥用对个人和社会造成的影响已有充分的记录。甲基苯丙胺容易获取，而且其产生的“快感”质量很高，这使得该药物深受使用者的青睐。随着时间的推移，许多甲基苯丙胺使用者也会成为甲基苯丙胺制造者，将非处方感冒药中的伪麻黄碱通过一个简单但极其危险的过程转化为甲基苯丙胺。限制这些产品获取的新法律收效甚微。现有的商业伪麻黄碱产品并没有对在秘密的甲基苯丙胺实验室中缓慢提取和限制伪麻黄碱转化为甲基苯丙胺造成明显的阻碍。
最近市场上推出了一种使用 Impede 技术（Nexafed®）的新型 30 毫克伪麻黄碱片剂产品，以阻止甲基苯丙胺的生产。使用旨在模拟秘密实验室工艺的方法，评估了该产品阻止伪麻黄碱提取和转化为甲基苯丙胺的能力，同时又提供治疗效果。
与市售的伪麻黄碱产品（Sudafed®）相比，Impede™技术片剂限制了伪麻黄碱向甲基苯丙胺的提取和/或转化。Nexafed®片剂也被证明与相同的对照产品具有生物等效性，从而确保了治疗等效性。
随着市场上具有限制伪麻黄碱提取和转化为甲基苯丙胺功能的新型伪麻黄碱产品的出现，现在有了新的工具来最大限度地减少秘密制造该药物，并可能限制其社会影响。
