Excipients in pediatric dosage forms and related regulatory aspects with review to propylene glycol

Pediatric formulations often contain excipients with lack of safety and toxicity data based on a unique and daily exposure, duration of treatment and patient acceptability. In the 1980s, US set up regulatory initiatives for the development of pediatric drugs. In 2007, pediatric regulation focused on the development of high quality pediatric formulations for children 0-17 years old entered into force in the EU. The European Medicine Agency (EMA) activities on medicines for children is coordinated by the Pediatric Committee (PDCO), with roles to:

(i) ensure full compliance with pediatric regulation, evaluate and adopt opinions on pediatric investigation plans (PIP) for development of pediatric medicines submitted by pharmaceutical companies and include studies evaluating safety and quality to support the authorization,

(ii) verify that all measures agreed in PIP have been conducted,

(iii) issue waivers supported with evidence that the medicine is unsafe or without significant benefits compared to existing treatments and

(iv) contribute to the development of network of centers with expertise for clinical studies in children (Dunne, 2007).

The US and European Pediatric Formulation Initiatives (USPFI and EUPFI) are coopreating with Food and Drug Administration (FDA) and EMA as observers in order to address safety problems linked to excipients used in children, create platforms for systematic evaluation of excipient’s safety in children and newborns, generate evidence-based database (safety and toxicity aspects of pharmaceutical excipients – STEP) to facilitate access to the data, provide rapid evaluation of the risks due to the use of excipients and improve the decision making during pediatric medicines design.

The aim of the present work was to address the safety and toxicity aspects of the excipient propylene glycol (PG) and the risk associated with its use in pediatric medicines.

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Hristina Pislevikj, Katerina Goracinova, Excipients in pediatric dosage forms and related regulatory aspects with review to propylene glycol, Faculty of Pharmacy, Ss. Cyril and Methodius University, Mother Theresa 47, 1000 Skopje, N. Macedonia, DOI:10.33320/maced.pharm.bull.2022.68.03.123