Develop a scalable IR ODF for a potent small molecule with 10–30 s disintegration, high 5-min release, pleasant taste, and compatibility with high-barrier unit-dose packs.
Approach
Matrix: HPMC/PVA blend; plasticizers glycerol/PEG-400 (15–25% of dry polymer).
Masking: HP-β-CD + small portion of ion-exchange resinate; sweet–acid balance and citrus/mint flavor at 0.8% w/w.
Process: 15–20% solids; wet-coat 250–350 µm; staged drying 60–70 °C; re-humidify to 4–6% moisture.
Pack: PET/Al/PE or PA/Al/PE, unit-dose nitrogen flushed.
Methods: Simulated saliva pH 6.8 at 37 °C; USP paddle 50 rpm, 300 mL medium; film clamped to fix wetted area. Mechanics on UTM at 23 °C/50%RH. Accelerated stability 40 °C/75%RH.
Disintegration: Median 18 s (n = 20), RSD 8%.
Dissolution: 2 min 65% ± 6%; 5 min 88% ± 5%; 10 min 96% ± 3%.
Mechanics: Thickness 75 µm; tensile strength 18 MPa; elongation at break 65%; Young’s modulus 280 MPa; curl ≤ 2 mm/10 cm.
Stability (6 mo accelerated): Assay 98–102%; 5-min dissolution shift ≤ ±6%; no significant drift in sensory or disintegration; no packaging-related off-odors.
Outcome & Value
Meets IR expectations with clean aftertaste (≤30 s) and strong batch consistency; defined design space and release specs de-risk tech transfer and seasonal variability.