Development of Maltodextrin-Based Immediate-Release Tablets Using an Integrated Twin-Screw Hot-Melt Extrusion and Injection-Molding Continuous Manufacturing Process
| Autor: | Jung-Hoon Chun, Dave Brancazio, Allan S. Myerson, Keith D. Jensen, Vibha Puri, Bernhardt L. Trout, Parind M. Desai |
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| Rok vydání: | 2017 |
| Předmět: |
Antifungal Agents
Materials science Chemistry Pharmaceutical Drug Compounding Plastics extrusion Pharmaceutical Science 02 engineering and technology Molding (process) 030226 pharmacology & pharmacy Griseofulvin Excipients Matrix (chemical analysis) 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Polysaccharides Freezing Polymer chemistry medicine Composite material Xylitol Polyvinylpyrrolidone 021001 nanoscience & nanotechnology Maltodextrin Isomalt Microcrystalline cellulose Drug Liberation Solubility chemistry Extrusion Crystallization 0210 nano-technology Tablets medicine.drug |
| Zdroj: | Journal of Pharmaceutical Sciences. 106:3328-3336 |
| ISSN: | 0022-3549 |
| DOI: | 10.1016/j.xphs.2017.06.020 |
| Popis: | The combination of hot-melt extrusion and injection molding (HME-IM) is a promising process technology for continuous manufacturing of tablets. However, there has been limited research on its application to formulate crystalline drug–containing immediate-release tablets. Furthermore, studies that have applied the HME-IM process to molded tablets have used a noncontinuous 2-step approach. The present study develops maltodextrin (MDX)-based extrusion-molded immediate-release tablets for a crystalline drug (griseofulvin) using an integrated twin-screw HME-IM continuous process. At 10% w/w drug loading, MDX was selected as the tablet matrix former based on a preliminary screen. Furthermore, liquid and solid polyols were evaluated for melt processing of MDX and for impact on tablet performance. Smooth-surfaced tablets, comprising crystalline griseofulvin solid suspension in the amorphous MDX-xylitol matrix, were produced by a continuous process on a twin-screw extruder coupled to a horizontally opening IM machine. Real-time HME process profiles were used to develop automated HME-IM cycles. Formulation adjustments overcame process challenges and improved tablet strength. The developed MDX tablets exhibited adequate strength and a fast-dissolving matrix (85% drug release in 20 min), and maintained performance on accelerated stability conditions. |
| Databáze: | OpenAIRE |
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