Advanced stable lipid-based formulations for a patient-centric product design

Improving the granule strength of roller-compacted ibuprofen sodium for hot-melt coating processing

“…While N-acetylcysteine crystals could be taste masked with coating amounts of up to 40%w/w (Becker 2016), this study shows that larger coating amounts (44-48%w/w) are required for ibuprofen sodium granules. This is due to the more densely packed structure of N-acetylcysteine crystals compared with ibuprofen sodium granules, which is more resistant to abrasion during hot-melt coating.…”

“…To mask the unpleasent taste of ibuprofen sodium, a coating formulation comprising tripalmitin and polysorbate 65 was applied during hot-melt coating. The taste-masking efficacy of this coating formulation was previously confirmed in in vivo studies with N-acetylcysteine (Becker et al, 2016). In the current work, organoleptic measurements were avoided and a dissolution criterion (≤10% API dissolved in 5 minutes) that largely depends on the taste intensity of the drug was selected for an in vitro evaluation of the taste-masking properties (Siewert et al, 2003).…”

“…The effect of 10%w/w polysorbate 65 on the polymorphism of tripalmitin and on the stability of the coating has been discussed in detail elsewhere (Becker et al, 2016).…”

“…Recently, our group presented a novel and cost-efficient approach to manufacturing a taste-masked multiparticulate system with a stable immediate release profile by applying lipid-based excipients in a solvent-free hot-melt coating process (Becker et al, 2013;Becker et al, 2016). This technique uses fluid bed technology to apply molten coating material into fluidized particles (Jozwiakowski et al, 1990, Jannin & Cuppok 2013, Lopes et al, 2015.…”

Engineering Size and Structure of Particles in Novel Modified-Release Delivery Systems

“…Moreover, the addition of polysorbate 65 maintained the immediate release profile of the water-soluble drug as well. Both in vivo and in vitro results showed that the coating amount, emulsifier content, and spray pressure were the main critical parameters (68,69).…”