scholarly journals The Impact of Hot Melt Extrusion and Spray Drying on Mechanical Properties and Tableting Indices of Materials Used in Pharmaceutical Development

2013 ◽  
Vol 102 (10) ◽  
pp. 3604-3613 ◽  
Author(s):  
Raman Iyer ◽  
Shridhar Hegde ◽  
Yu-E. Zhang ◽  
James Dinunzio ◽  
Dharmendra Singhal ◽  
...  
Pharmaceutics ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 379 ◽  
Author(s):  
Xiangyu Ma ◽  
Felix Müller ◽  
Siyuan Huang ◽  
Michael Lowinger ◽  
Xu Liu ◽  
...  

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.


2016 ◽  
Vol 43 (5) ◽  
pp. 797-811 ◽  
Author(s):  
Soraya Hengsawas Surasarang ◽  
Justin M. Keen ◽  
Siyuan Huang ◽  
Feng Zhang ◽  
James W. McGinity ◽  
...  

2016 ◽  
Vol 511 (2) ◽  
pp. 1142
Author(s):  
Alison Keating ◽  
Duncan Craig ◽  
Catherine Tuleu ◽  
Claire Forbes ◽  
Barry Aldous ◽  
...  

2016 ◽  
Vol 498 (1-2) ◽  
pp. 254-262 ◽  
Author(s):  
W. Grymonpré ◽  
W. De Jaeghere ◽  
E. Peeters ◽  
P. Adriaensens ◽  
J.P. Remon ◽  
...  

Pharmaceutics ◽  
2020 ◽  
Vol 12 (6) ◽  
pp. 511 ◽  
Author(s):  
Hanna Ponsar ◽  
Raphael Wiedey ◽  
Julian Quodbach

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.


2014 ◽  
Vol 35 (9) ◽  
pp. 1792-1797 ◽  
Author(s):  
Michael A. Gunning ◽  
Luke M. Geever ◽  
John A. Killion ◽  
John G. Lyons ◽  
Clement L. Higginbotham

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