Impact of super-disintegrants and film thickness on disintegration time of strip films loaded with poorly water-soluble drug microparticles
Although strip films are a promising platform for delivery of poorly water-soluble drug particles via slurry casting, the effect of critical materials attributes (CMAs), e.g., super-disintegrants on critical quality attributes (CQAs), including film disintegration time (DT), remains under-explored. A two-level factorial design is considered to examine the impact of the super-disintegrant (SDI) type (sodium starch glycolate and croscarmellose sodium), their amount, and film thickness. SDIs were used with hydroxypropyl methylcellulose (HPMC-E15LV) and glycerin solutions along with viscosity matching. Fenofibrate, a model poorly water-soluble drug, was micronized and surface modified (MC-FNB) via fluid energy milling. Significant decreases in film DT, measured using three different methods, were observed due to the addition of SDIs. Percentage reduction in DT was a strong function of SDI amount, and thinner films disintegrated faster. Films with either higher SDI concentrations (>9%) or films under 80 μm, exhibited fast DT (<180s, Ph. Eur.). All thin films (50−60 μm) exhibited immediate release (>80% in 10 min). All films achieved good content uniformity, except for those with the lowest amount of SDI, attributed to insufficient viscosity and thickness non-uniformity due to the SDI. Finally, all films achieved adequate mechanical properties, notwithstanding minor negative impact of SDIs.