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Drug Product Development of Highly Potent Compounds for Oral Solids

Roman Messerschmid¹, Ulrich Brauns², Manfred Fiebig¹, Thomas Friedl¹

¹ Department of Pharmaceutical Research and Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach/Riss (Germany)
² Department of Project Management, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach/Riss (Germany)

Corresponding author: Dr. Roman Messerschmid, Boehringer Ingelheim Pharma GmbH & Co. KG, Department of Pharmaceutical Research and Development, 88397 Biberach/Riss (Germany), e-mail: Roman.Messerschmid@boehringer-ingelheim.com

The imperilment of the operator during processing of highly potent compounds into solid oral dosage forms consists of the hazard inhered by the drug substance combined with the exposure for each individual production step carried out under the respective protection measures. In the following the substance classification system for hazard assessment established within Boehringer Ingelheim is presented, based on occupational exposure limits (BIEL = Boehringer Ingelheim Exposure Limits) and a banding strategy in BIEL-categories. Adequate protection measures of the employee are explained for the drug product development depending on substance, formulation and process related characteristics.

Key words Drug product development • Exposure control • Glove box • Highly potent compounds • OEB • OEL