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FDA: low drug load and blend segregation create product uniformity risks in DPIs
Summary
CDER said capsule and blister DPIs — the main generic submissions since 2015 — pose product‑uniformity risks because of low drug load and small fill volumes; the agency recommended justified sampling sizes, BU/CU plans and stratified in‑process testing.
Vikkiha noted that capsule and blister dry‑powder inhalers (DPIs) have been the main generic submissions to FDA since 2015 and that their manufacturing risks stem from very low drug‑load and tiny fill volumes. "For example, high product uniformity risk, due to the low drop loading and potential blend segregation," she said.
She recommended that sponsors provide detailed blend‑uniformity (BU) sampling locations, sample sizes and acceptance criteria — and justify when larger sampling than the typical 1×–3× unit‑dose weight is required — because sampling error can be significant when extracting very small amounts from a blender. She also advised that stratified in‑process CU test data with a statistical plan be included to show product uniformity throughout the run.
