Nema Sandeep, Brendel Ronald J
Pfizer, Chesterfield Parkway W, Chesterfield, MO 63017.
PDA J Pharm Sci Technol. 2011 May-Jun;65(3):287-332. doi: 10.5731/pdajpst.2011.00634.
This review article is a current survey of excipients used in approved injectable products. Information provided includes concentration ranges, function, frequency of use, and role in dosage form. This article is an update of a paper published more than a decade ago (reference 11). Since then many new products have been approved. Safety concerning excipients has evolved as the scientific community continues to learn about their usage. New excipients are being used in early phases of clinical trials to support novel therapeutic entities like RNAi, aptamers, anti-sense, fusion proteins, monoclonal antibodies, and variant scaffolds. Because these excipients are not inert, various pharmacopoeias are responding with monographs or informational chapters addressing excipient functionality. The final sections of this article discuss new excipients, serving specific needs that traditional excipients are unable to provide and for which safety studies are necessary to support a novel excipient for marketing applications.
Excipients are added to parenteral dosage forms to serve a variety of functions including stabilization and as vehicles. This review article is a survey of excipients used in approved injectable products. Information provided includes excipient concentrations, functional roles, and frequency of use. This article is an update of an article originally published over a decade ago. Since then new products have been approved and safety concerns have evolved as the scientific community has learned about the usage of excipients. In addition, new excipients are being used in early phases of clinical trials to support novel therapeutic entities such as RNAi, aptamers, anti-sense, fusion proteins, monoclonal antibodies, and variant scaffolds. Because these excipients are not inert, various pharmacopoeias are responding with monographs or informational chapters addressing excipient functionality. The final sections of this article discuss new excipients, serving specific needs that traditional excipients are unable to provide and for which safety studies are necessary to support a novel excipient for marketing applications.
这篇综述文章是对已批准注射用产品中使用的辅料的当前调查。提供的信息包括浓度范围、功能、使用频率以及在剂型中的作用。本文是十多年前发表的一篇论文（参考文献11）的更新。从那时起，许多新产品已获批准。随着科学界不断了解辅料的使用情况，有关辅料的安全性也在不断演变。新辅料正被用于临床试验的早期阶段，以支持诸如RNA干扰、适配体、反义、融合蛋白、单克隆抗体和变异支架等新型治疗实体。由于这些辅料并非惰性物质，各种药典正在通过专论或信息章节来回应辅料的功能。本文的最后部分讨论了新辅料，这些新辅料满足了传统辅料无法提供的特定需求，并且需要进行安全性研究以支持新型辅料用于市场应用。
辅料被添加到肠胃外剂型中以发挥多种功能，包括稳定作用以及作为载体。这篇综述文章是对已批准注射用产品中使用的辅料的调查。提供的信息包括辅料浓度、功能作用和使用频率。本文是一篇十多年前最初发表的文章的更新。从那时起，新产品已获批准，并且随着科学界了解辅料的使用情况，对安全性的关注也在演变。此外，新辅料正被用于临床试验的早期阶段，以支持诸如RNA干扰、适配体、反义、融合蛋白、单克隆抗体和变异支架等新型治疗实体。由于这些辅料并非惰性物质，各种药典正在通过专论或信息章节来回应辅料的功能。本文的最后部分讨论了新辅料，这些新辅料满足了传统辅料无法提供的特定需求，并且需要进行安全性研究以支持新型辅料用于市场应用。
