FDA and the excipient industry are giving more thought to how the inactive ingredient database (IID) can be improved to better support the development of emerging dosage forms, including drug delivery devices such as transdermal patches, metered dose inhalers, nasal sprays, and implants.
A session was held at the 2016 IPEC-Americas/ExcipientFest Conference, held in late April in Baltimore, Maryland, to explore the regulatory issues encountered in formulating emerging dosage forms and how the IID can be restructured to make it a more useful resource for both industry and regulators.
At the session, FDA Office of Pharmaceutical Quality (OPQ) IID Working Group leader Susan Zuk provided an update on her office’s ongoing effort to make the IID as useful as possible to industry. She concluded with a review of some of the challenges for emerging dosage forms, in particular. [See IPQ July 31, 2016, for a broad review of the issues involved in improving the IID.]
Lubrizol Life Sciences Global Regulatory Affairs Manager Meera Raghuram, who chairs IPEC-Americas Regulatory Affairs Committee, followed with an industry view of the need for more regulatory guidance and further clarity in the IID regarding excipients in drug delivery devices.
Raghuram maintained that careful consideration is needed as to how excipients are evaluated, what data is captured, and how the precedence of use is established. More transparency is essential, she stressed, to improve the utility of the data in the IID for excipients with a long history of use in medical devices such as discs, rods and patches.