ArticleDrug development and industrial pharmacy2016
Optimization of hot melt extrusion parameters for sphericity and hardness of polymeric face-cut pellets.
Article in Drug development and industrial pharmacy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Who cites it
5 citing papers in PubMed.
- Precision Drug Delivery of LY-11h for Acute Myeloid Leukemia Treatment Using Machine Learning-Assisted Hot Melt Extrusion and 3D-Printed Technologies.Pharmaceutics · 2026Article
- The Development and Optimization of Hot-Melt Extruded Amorphous Solid Dispersions Containing Rivaroxaban in Combination with Polymers.Pharmaceutics · 2021Article
- The Effect of Thermal-Treating on Drug Release from Sustained Release Alginate-Eudragit RS Matrices.Advanced pharmaceutical bulletin · 2021Article
- Article
- Twin-screw extrusion of sustained-release oral dosage forms and medical implants.Drug delivery and translational research · 2018Review
Corrections and comments
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Authors and funding
14 authors.
Funding
Abstract
The aim of this study was to formulate face-cut, melt-extruded pellets, and to optimize hot melt process parameters to obtain maximized sphericity and hardness by utilizing Soluplus(®) as a polymeric carrier and carbamazepine (CBZ) as a model drug. Thermal gravimetric analysis (TGA) was used to detect thermal stability of CBZ. The Box-Behnken design for response surface methodology was developed using three factors, processing temperature ( °C), feeding rate (%), and screw speed (rpm), which resulted in 17 experimental runs. The influence of these factors on pellet sphericity and mechanical characteristics was assessed and evaluated for each experimental run. Pellets with optimal sphericity and mechanical properties were chosen for further characterization. This included differential scanning calorimetry, drug release, hardness friability index (HFI), flowability, bulk density, tapped density, Carr's index, and fourier transform infrared radiation (FTIR) spectroscopy. TGA data showed no drug degradation upon heating to 190 °C. Hot melt extrusion processing conditions were found to have a significant effect on the pellet shape and hardness profile. Pellets with maximum sphericity and hardness exhibited no crystalline peak after extrusion. The rate of drug release was affected mainly by pellet size, where smaller pellets released the drug faster. All optimized formulations were found to be of superior hardness and not friable. The flow properties of optimized pellets were excellent with high bulk and tapped density.
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