title: Influence of degassing on hot-melt extrusion process.
abstract: The present study aimed to evaluate the effect of degassing on an extrusion process, with respect to extrudate quality and drug release properties. Processed formulations were extruded with and without a degassing vent port at various locations along the barrel. All the experiments were performed under constant processing temperature, feeding rate, and screw speed. During the extrusion process, torque and pressure were monitored and recorded. The degassing process was beneficial when used over a conveying section after a mixing section. This is attributed to the large surface area available on the conveying elements, which minimizes the internal volume of the processed material, thereby facilitating the escape of entrapped gases. Degassing enhanced the homogeneity, physical appearance, and drug release properties of all the formulations. Furthermore, the degassing process also enhanced the cross-sectional uniformity of the extruded material, which is beneficial for visual monitoring during processing. Degassing considerably reduced the post-extrusion moisture content of Formula D3, which contains the highly hygroscopic polymer Kollidon® 17 PF, suggesting that the greatest influence of this process is on hygroscopic materials. The reduction in post-extrusion moisture content resulting from the inclusion of a degassing vent port, reduced fluctuations in the values of in-line monitoring parameters such as pressure and torque. Employing a degassing unit during hot-melt extrusion processing could help increase process efficacy and product quality.
authors: Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, United States.
authors: Saad M
authors: SM
authors: Alshahrani
authors: Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, United States.
authors: Joseph T
authors: JT
authors: Morott
authors: Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, United States.
authors: Abdullah S
authors: AS
authors: Alshetaili
authors: Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, United States.
authors: Roshan V
authors: RV
authors: Tiwari
authors: Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, United States.
authors: Soumyajit
authors: S
authors: Majumdar
authors: Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, United States; Pii Center for Pharmaceutical Technology, The University of Mississippi, University, MS 38677, United States. Electronic address: marepka@olemiss.edu.
authors: Michael A
authors: MA
authors: Repka
mesh_terms: D002626:Chemistry, Pharmaceutical; D004355:Drug Stability; D005615:Freezing; D005740:Gases; D006358:Hot Temperature; D017550:Spectroscopy, Fourier Transform Infrared; D013678:Technology, Pharmaceutical / Q000379:methods*
chemical_list: D005740:Gases
keywords: Carbamazepine; Chemical imaging; Degassing; Hot-melt extrusion (HME)