A questionnaire survey on the barriers regarding pharmaceutical excipients during pediatric drug development.

It is unclear whether there have been any problems caused by excipients in the development of pediatric drugs. In this study, we investigated the current issues caused by excipients in developing pediatric formulations. The current issues and challenges related to excipients in pediatric drug development and the sources of information on excipients were investigated through a questionnaire sent to the 38 pharmaceutical companies that are members of the Japan Pharmaceutical Manufacturers Association. Twelve pharmaceutical companies with experience in developing pediatric formulations faced difficulties due to uncertain information on the suitability of excipients for pediatrics, and four companies faced difficulties due to different regulations on excipients in different countries. Uncertainty about the maximum acceptable dose and regulatory differences between countries were also cited as barriers. Regarding excipient databases, the United States Food and Drug Administration Inactive Ingredients Database and the European Safety and Toxicity of Excipients for Paediatrics database have been used for national and international pediatric drug development. The drawbacks of both international databases were the lack of information on excipients commonly used in Japan and the historically used maximum dose for each excipient. Future improvements in database information and clarification and standardization of the excipient regulatory process will be required.