Module 3 2019

Points raised on pharmaceutical development Choice of excipients • Use of SLS in tablet formulations • Justification for preservative or antioxidant content (including over shelf-life) • Excipients of known effect (e.g. sorbitol, benzyl alcohol, ethanol – think about target & special populations)

Questions to ask:

• Is inclusion of the excipient absolutely necessary?

• What are the risks versus the benefits of inclusion?

• Are alternative products marketed that do not contain the excipient?

• Could one excipient impact the biological effect of another? e.g. propylene glycol and ethanol in neonates

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