Safe oral intakes for pharmaceutical excipients

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Client

A manufacturer of pharmaceuticals.

Background

Bibra was asked to consider the available toxicity data on two pharmaceutical excipients, and to propose tolerable oral intakes (i.e. health criteria values (HCVs)) for patients.

Project goals

To perform comprehensive literature searches on both excipients, identifying, where available, key Expert Group pronouncements on toxicity and derivations of oral HCVs. If no suitable HCVs were identified, bibra was asked to derive its own HCVs for each excipient.

Approach

Bibra reviewed and summarised the available toxicity data on each (relatively well-studied) excipient, including a consideration of Expert Group opinions and tolerable intakes. Bibra provided its conclusions on the suitability and magnitude of oral HCVs for the two chemicals.