A preliminary assessment of the impact of hot-melt extrusion on the physico-mechanical properties of a tablet

2013 ◽  
Vol 40 (10) ◽  
pp. 1386-1394 ◽  
Author(s):  
Nathan Boersen ◽  
Thomas Wai-Yip Lee ◽  
Xiaole (George) Shen ◽  
Ho-Wah Hui
Keyword(s):  
Mechanical Properties ◽  
Hot Melt Extrusion ◽  
Melt Extrusion ◽  
Preliminary Assessment ◽  
The Impact ◽  
Hot Melt

scholarly journals Influence of Carbamazepine Dihydrate on the Preparation of Amorphous Solid Dispersions by Hot Melt Extrusion

Pharmaceutics ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 379 ◽  
Author(s):  
Xiangyu Ma ◽  
Felix Müller ◽  
Siyuan Huang ◽  
Michael Lowinger ◽  
Xu Liu ◽  
...  
Keyword(s):  
Energy State ◽  
Solid Dispersions ◽  
Amorphous Solid ◽  
Hot Melt Extrusion ◽  
Water Soluble ◽  
Melt Extrusion ◽  
Amorphous Solid Dispersions ◽  
Water Soluble Drugs ◽  
The Impact ◽  
Hot Melt

Amorphous solid dispersions (ASDs) are commonly used in the pharmaceutical industry to improve the dissolution and bioavailability of poorly water-soluble drugs. Hot melt extrusion (HME) has been employed to prepare ASD based products. However, due to the narrow processing window of HME, ASDs are normally obtained with high processing temperatures and mechanical stress. Interestingly, one-third of pharmaceutical compounds reportedly exist in hydrate forms. In this study, we selected carbamazepine (CBZ) dihydrate to investigate its solid-state changes during the dehydration process and the impact of the dehydration on the preparation of CBZ ASDs using a Leistritz micro-18 extruder. Various characterization techniques were used to study the dehydration kinetics of CBZ dihydrate under different conditions. We designed the extrusion runs and demonstrated that: 1) the dehydration of CBZ dihydrate resulted in a disordered state of the drug molecule; 2) the resulted higher energy state CBZ facilitated the drug solubilization and mixing with the polymer matrix during the HME process, which significantly decreased the required extrusion temperature from 140 to 60 °C for CBZ ASDs manufacturing compared to directly processing anhydrous crystalline CBZ. This work illustrated that the proper utilization of drug hydrates can significantly improve the processability of HME for preparing ASDs.

scholarly journals The impact of hot-melt extrusion on the tableting behaviour of polyvinyl alcohol

2016 ◽  
Vol 498 (1-2) ◽  
pp. 254-262 ◽  
Author(s):  
W. Grymonpré ◽  
W. De Jaeghere ◽  
E. Peeters ◽  
P. Adriaensens ◽  
J.P. Remon ◽  
...  
Keyword(s):  
Polyvinyl Alcohol ◽  
Hot Melt Extrusion ◽  
Melt Extrusion ◽  
The Impact ◽  
Hot Melt

scholarly journals Hot-Melt Extrusion Process Fluctuations and Their Impact on Critical Quality Attributes of Filaments and 3D-Printed Dosage Forms

Pharmaceutics ◽  
2020 ◽  
Vol 12 (6) ◽  
pp. 511 ◽  
Author(s):  
Hanna Ponsar ◽  
Raphael Wiedey ◽  
Julian Quodbach
Keyword(s):  
Process Analysis ◽  
Hot Melt Extrusion ◽  
Quality Attributes ◽  
Dosage Forms ◽  
Melt Extrusion ◽  
Critical Quality Attributes ◽  
Filament Diameter ◽  
3D Printed ◽  
The Impact ◽  
Hot Melt

Fused deposition modeling (FDMTM) is a 3D-printing technology of rising interest for the manufacturing of customizable solid dosage forms. The coupling of hot-melt extrusion with FDMTM is favored to allow the production of pharma-grade filaments for the printing of medicines. Filament diameter consistency is a quality of great importance to ensure printability and content uniformity of 3D-printed drug delivery systems. A systematical process analysis referring to filament diameter variations has not been described in the literature. The presented study aimed at a process setup optimization and rational process analysis for filament fabrication related to influencing parameters on diameter inhomogeneity. In addition, the impact of diameter variation on the critical quality attributes of filaments (mechanical properties) and uniformity of mass of printed drug-free dosage forms was investigated. Process optimization by implementing a winder with a special haul-off unit was necessary to obtain reliable filament diameters. Subsequently, the optimized setup was used for conduction of rational extrusion analysis. The results revealed that an increased screw speed led to diameter fluctuations with a decisive influence on the mechanical resilience of filaments and mass uniformity of printed dosage forms. The specific feed load was identified as a key parameter for filament diameter consistency.

Improvement in mechanical properties of grafted polylactic acid composite fibers via hot melt extrusion

2014 ◽  
Vol 35 (9) ◽  
pp. 1792-1797 ◽  
Author(s):  
Michael A. Gunning ◽  
Luke M. Geever ◽  
John A. Killion ◽  
John G. Lyons ◽  
Clement L. Higginbotham
Keyword(s):  
Mechanical Properties ◽  
Polylactic Acid ◽  
Hot Melt Extrusion ◽  
Composite Fibers ◽  
Melt Extrusion ◽  
Hot Melt

Effect of Compatibilizer Content on the Mechanical Properties of Bioplastic Composites via Hot Melt Extrusion

2014 ◽  
Vol 53 (12) ◽  
pp. 1223-1235 ◽  
Author(s):  
Michael A. Gunning ◽  
Luke M. Geever ◽  
John A. Killion ◽  
John G. Lyons ◽  
Clement L. Higginbotham
Keyword(s):  
Mechanical Properties ◽  
Hot Melt Extrusion ◽  
Melt Extrusion ◽  
Hot Melt

scholarly journals Hot Melt Extrusion Processing Parameters Optimization

Processes ◽  
2020 ◽  
Vol 8 (11) ◽  
pp. 1516
Author(s):  
Abdullah Alshetaili ◽  
Saad M. Alshahrani ◽  
Bjad K. Almutairy ◽  
Michael A. Repka
Keyword(s):  
Factorial Design ◽  
Processing Parameters ◽  
Hot Melt Extrusion ◽  
Parameters Optimization ◽  
Extrusion Temperature ◽  
In Vitro Dissolution ◽  
Dissolution Profile ◽  
Melt Extrusion ◽  
The Impact ◽  
Hot Melt

The aim of this study was to demonstrate the impact of processing parameters of the hot-melt extrusion (HME) on the pharmaceutical formulation properties. Carbamazepine (CBZ) was selected as a model water-insoluble drug. It was incorporated into Soluplus®, which was used as the polymeric carrier, to produce a solid dispersion model system. The following HME-independent parameters were investigated at different levels: extrusion temperature, screw speed and screw configuration. Design of experiment (DOE) concept was applied to find the most significant factor with minimum numbers of experimental runs. A full two-level factorial design was applied to assess the main effects, parameter interactions and total error. The extrudates’ CBZ content and the in vitro dissolution rate were selected as response variables. Material properties, including melting point, glass transition, and thermal stability, and polymorphs changes were used to set the processing range. In addition, the extruder torque and pressure were used to find the simplest DOE model. Each change of the parameter showed a unique pattern of dissolution profile, indicating that processing parameters have an influence on formulation properties. A simple, novel and two-level factorial design was able to evaluate each parameter effect and find the optimized formulation. Screw configuration and extrusion temperature were the most affecting parameters in this study.

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