CJM Medical Limited, 233 Banstead Road, Banstead, Surrey SM7 1RB, United Kingdom.
Int J Pharm. 2012 Oct 1;435(1):22-6. doi: 10.1016/j.ijpharm.2012.03.052. Epub 2012 Apr 3.
From our own experience we have seen that over the past 60 years topical delivery of drugs with its advantages and disadvantages has become much more widely understood and much more is now known about the disposition of drugs in the skin. Today, pharmaceutical scientists produce dermatological vehicles which are tailored to patients' needs and better appreciate how the formulation may affect rates of drug delivery, and ultimately, efficacy and safety. The guidelines for developing a New Chemical Entity (NCE) to be administered by the topical route are rather straightforward. What appears to be less well understood are the pathways for development, and the regulatory routes for topical formulations of a known established Active Pharmaceutical Ingredient (API) either in a new formulation, at a different concentration, or with APIs where topical administration is an alternative route of administration. This article provides guidance, on the regulatory routes which can help achieve marketing approval in Europe for topical formulations, with particular emphasis on clinical development. Some comments on NCE's will be given, and further detail is provided in cases where the topical route is a new method of administration for delivering a known API.
从我们自己的经验来看，我们已经看到，在过去的 60 年里，药物的局部给药具有其优缺点，现在已经被更广泛地理解，并且对药物在皮肤中的处置方式也有了更多的了解。如今，制药科学家们生产出了针对患者需求定制的皮肤科给药载体，并且更好地了解了制剂如何影响药物递送的速度，最终影响疗效和安全性。通过局部途径给药的新型化学实体（NCE）的开发指南相当简单。然而，人们似乎不太理解的是，对于一种已确定的有效药物成分（API）的局部制剂，无论是新制剂、不同浓度还是用于局部给药的 API，其开发途径和监管途径是什么。本文提供了有关监管途径的指导，这些途径可以帮助在欧洲获得局部制剂的营销批准，特别强调了临床开发。本文还对 NCE 进行了一些评论，并在局部给药是提供已知 API 的新给药途径的情况下，提供了更详细的信息。
