Health risk assessment of three leachables

Client

A pharmaceuticals company

Background

After 2 years of storage, three leachables were detected in a drug product that is administered by inhalation to patients aged as young as 6 years. Bibra was asked to assess whether the leachables might pose any significant health risks to the patients.

Project goals

To provide the client with a high-quality, scientifically robust report assessing the potential impact on the health of patients using the drug for the anticipated treatment time (repeated intermittent dosing for up to about 6 months).

Approach

Little or no toxicological information was identified for any of the structures, so they were submitted to Toxtree analysis. One leachable contained a Toxtree alert for mutagenicity and, in the absence of any mutagenicity study data, was assumed to be a potential mutagen. By comparing the estimated exposure with the standard TTC exposure that experts (e.g. EFSA/EMA/ICH/PQRI) view as tolerable for mutagens, it was concluded that the leachable would not pose any intolerable health risks in respect of non-threshold toxicity. None of the leachables would pose any significant threshold toxicity health risks. The assessment also made use of toxicity information on the likely metabolites of the extractables. Overall, bibra was able to confidently conclude that none of these three leachables, at the detected concentrations and estimated resultant exposures, would pose any significant risk to patient health.

Bibra project leader

Pete Watts

Leachables assessments

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