Health risk assessment of an excipient in an intravenously administered pharmaceutical product


The client required qualification of the use of a nutrient-related compound as an excipient in an intravenously administered biological.


An international pharmaceutical company.

Project goals

Bibra was asked to give an opinion on whether the presence of the excipient at the intended concentration could pose significant health risks to patients in short- and long-term (prophylactic) treatment.


Bibra initially utilised the in-house TRACE database to identify critical reviews/Expert Opinions on the toxicology of the excipient and these were used as the basis of the assessment. Supplementary detailed searches were conducted to ensure that no critical intravenous data were overlooked. For the risk assessment, bibra divided the patient population into those receiving acute treatment and those receiving lifelong prophylactic treatment. A detailed analysis of systemic effects was undertaken with regard to both treatment regimens.

Project outcome

From the available data bibra was able to identify a number of critical human studies demonstrating that, at the intended acute exposures, short-lived dose-dependent effects on the blood might occur. Comparison of long-term exposure levels with expert-derived tolerable values (adjusted for route of administration) allowed bibra to conclude that the excipient is unlikely to pose a significant health risk to the generality of patients.

Bibra project team

James Hopkins



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