Processing Stability and the Significance of Variation in Extrusion Speeds and Temperatures on SSB® 55 Pharma Grade Shellac for Oral Drug Delivery

Abstract

Abstract:The melt-extrusion process is utilized in the pharmaceutical arena for the manufacturing of a variety of dosage forms and formulations, including solid dispersions. This technology is considered an efficient and continuous dosage form manufacturing method. However, there are potential challenges mainly because, during hot-melt extrusion, polymers are subject to mechanical and thermal degradation. Mechanical degradation may be induced by the shear effects imposed by the rotating screw. Thermal degradation results from high temperatures and includes random scission, scission from the ends of the polymer and unzipping of substitute groups. This paper endeavors to understand the impact of thermal and/or mechanical components of the melt-extrusion process on the stability of a pH sensitive polymer, namely Shellac. Correlation between the screw speeds and processing temperature profile was examined in the context of the overall degradation profile of the polymer. The results suggest that the processing stability of Shellac was reliant on optimization of screw speed (rpm) and process temperature.

Advances in Designing Essential Oil Nanoformulations: An Integrative Approach to Mathematical Modeling with Potential Application in Food Preservation

“…Bioactives can be injected at different time intervals throughout the extrusion process; their residence time is brief and can be tracked online. Hot-melt extrusion is used to stabilize bioactive chemicals, which improves controlled release, flavor mask ink, and particle size uniformity (500-1000 nm) [105].…”

The use of extrusion technology for encapsulation of bioactive components for their improved stability and bioavailability

“…In contrast to spray drying, its operating costs are expected to be nearly double and the temperature for HME is 85°C-150°C and 120°C-200°C for spray drying. Therefore, the extruded component has to be able to withstand high temperatures (Gately and Kennedy, 2017). The high size of extrudates formed by HME (500-1000 mm) restricts their utilization in food applications owing to a detrimental influence on mouthfeel (Lakkis, 2016), which might also necessitate other steps such as grinding before use.…”

Effect of static mixer on fiber orientation of injection molded fiber‐reinforced composites

“…[6][7][8] However, these screw elements contribute to an increase in shear rate, shear stress, and melt temperature, which can cause degradation to the polymer material and damage to fillers, such as fibers, glass spheres, and biomolecules. [9][10][11][12][13] Further, in multi-cavity molds complex runner systems can allow for fiber orientation and nonhomogeneous material properties to develop prior to the filling of the part cavities. A method of alleviating these issues is to introduce a static mixer that is closer to the molded part into the process.…”