Application of melt granulation technology to enhance stability of a moisture sensitive immediate-release drug product

Application of Melt Granulation Technology Using Twin-screw Extruder in Development of High-dose Modified-Release Tablet Formulation

“…Melt granulation is a process by which pharmaceutical powders are efficiently agglomerated by the use of a binder, which can be a molten liquid, a solid, or a solid that melts during the process. There are numerous reports of melt granulation performed by using high shear granulator employing low-melting waxy materials as binders [15][16][17][18][19] and, more recently, using ram extruder employing polyethylene glycol (PEG) 6000 and stearic acid 20 and melt extruder employing lowmelting waxes 21 and PEGs 22 as granulating agents.…”

Preparation of Controlled-Release Fine Particles Using a Dry Coating Method

“…While the DSC curve for HRSO was one sharp peak, the curve for HCO showed a broad peak. According to previous reports (17,18), the melting point of HCO was about 85°C. Therefore, it was considered that the peak on the high-temperature side of the HCO DSC curve was due to pure HCO, whereas the peak on the low-temperature side was due to HCO contaminants (polymorphism or analogous substances of HCO).…”

The use of Rheology Combined with Differential Scanning Calorimetry to Elucidate the Granulation Mechanism of an Immiscible Formulation During Continuous Twin-Screw Melt Granulation

“…The processing of the hyperspectral images consisted of the following consecutive steps. (1). The spectral range was narrowed to 1100-2200 nm.…”

“…However, some pharmaceutical actives are not suitable for wet processing and drying because of stability and degradation problems. Hot melt granulation (HMG) or thermoplastic granulation can be a valuable alternative to process moisture sensitive drugs as it uses a molten binder to agglomerate the pharmaceutical powder particles (1,2). As no liquids or solvents are used, no drying step is needed, reducing the process time and energy consumption.…”