Bristol-Myers Squibb, Company, New Brunswick, New Jersey, 08901.
J Pharm Sci. 2013 Nov;102(11):3867-82. doi: 10.1002/jps.23691. Epub 2013 Aug 23.
Pharmaceutical nanomaterials (NMs) encompass a wide variety of materials including drug nanoparticles (NPs), which can be amorphous or crystalline; or nanoparticulate drug delivery systems, such as micelles, microemulsions, liposomes, drug-polymer conjugates, and antibody-drug conjugates. These NMs are either transient or persistent-depending on whether the integrity of their structure and size is maintained until reaching the site of drug action. Examples of several approved drug products are included as pharmaceutical nanoparticulate systems along with a commentary on the current development issues and paradigms for various categories of NPs. This commentary discusses the preparation of nanoparticulate systems for commercial development, and the biopharmaceutical and pharmacokinetic advantages of these systems. A criterion of criticality is defined that incorporates the structure, in addition to size requirement of pharmaceutical NPs to identify systems that may require special development and regulatory considerations.
制药纳米材料（NMs）涵盖了多种材料，包括药物纳米颗粒（NPs），可以是无定形或结晶的；或纳米颗粒药物递送系统，如胶束、微乳液、脂质体、药物-聚合物缀合物和抗体-药物缀合物。这些纳米材料是瞬态的或持久的-这取决于它们的结构和大小的完整性是否保持到到达药物作用部位。本文还包括了几种已批准的药物产品作为制药纳米颗粒系统的例子，并对各种类别的 NPs 的当前开发问题和范例进行了评论。本文讨论了用于商业开发的纳米颗粒系统的制备，以及这些系统的生物制药和药代动力学优势。定义了一个关键标准，该标准除了制药 NPs 的大小要求外，还包含了结构要求，以确定可能需要特殊开发和监管考虑的系统。
