The FDA outlined its current thinking on the information sponsors of transdermal and topical delivery systems (TDS) should include in their NDAs and ANDAs in draft guidance.
Transdermal and topical delivery systems “present similar manufacturing and quality control concerns and similar risks to patients,” the agency noted.
Sponsors should include a summary of the quality characteristics of the drug — known as the quality target product profile (QTPP) — and a list of critical quality attributes (CQAs) for the product. They should also flag important product quality components for the drug substance, excipients, container closure system, and manufacturing processes, the agency said.
The guidance offers a list of typical manufacturing steps and operations for TDS, including mixing, coating, drying and lamination, and describes their potential impacts on quality. For example, mixing can have an effect on attributes such as assay, drug substance and/or excipient stability, content uniformity, microscopic appearance, and physical properties of the adhesive.