Targets: labeled dose (e.g., 1–6 mg/strip) with content uniformity RSD ≤ 5%; disintegration 30–120 s; t80 as the primary dissolution milestone.
DoE/Response surface: factors include polymer/plasticizer, solids content, pH, coat weight, and drying temperature; optimize the combined score of thickness–strength–palatability–release curve.
Process linkage: web tension and release force, online thickness and edge-profile control, de-aeration and pinhole prevention; mitigate curl, flaking, blocking, and brittleness.
Test methods: pharmacopeial or custom oral models for disintegration; paddle/basket/flow-through cell for dissolution; water activity; tensile/tear strength and moisture control.
Risk management: dose-driven bitterness and brittleness, flavor–release interactions, and statistical monitoring of intra/inter-batch variability.