Excipient function

Apte and Katdare (29) aver that new mechanisms in the form of guidelines and procedures are needed to regulate the functionality of new and emerging excipients. In the examples below, the pharmacological effectiveness of a drug can be influenced by the excipient. These new excipients may be antigens, viral vectors, microbial products, or other complex proteins. Their pharmacological activities are not completely independent of their excipient functionality and straddle the line between excipients and APIs. For example, paclitaxel bound to albumin (30) (Abraxane) improves breast cancer therapy. 

Table 2 Particle Properties Influencing Excipient Functionality...

Con function both drug or excipient Function as oxcipiont 0 Function drug... 

Can function as both drug or excipient Functions as excipient Functions as drug... 

Pharmaceutical excipient Function Pharmaceutical excipient Function... 

Pharmaceutical excipients are increasingly considered important quality attributes of a drug product. They have an effect not only on product manufacturability, but also on product stability. The physical characterization of excipients has received the most attention, as discussed earlier. Excipient functionality testing and multisource excipient equivalence have been reviewed in the literature.21 However, chemical impurity profiles of excipients have not, in general, received similar attention. 

Rios M. 2006. Debating excipient functionality. Pharm. Technol. 30(9) 50-60. 

TABLE 14.1 Excipient Function Class, Unit Percentage Weight, Names and Nominal Individual-Excipient-to-Drug (or IE/D) Ratios by Assuming a Formulation Unit of 200 mg Total Weight, Containing 10 jig API... 

Schoneker D. 2007. Excipient Functionality an IPEC Americas Perspective. American Association of Pharmaceutical Scientists Annual Meeting and Exposition, San Diego, CA, November 11-15, 2007. 

Excipients function to provide compactibility, lubrication, flow properties, disintegration efficiency, wetting, etc. Poor choice of excipients may give rise... 

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