Developing HME-Based Drug Products Using Emerging Science: a Fast-Track Roadmap from Concept to Clinical Batch
| Autor: | Kinga Biedrzycka, Johannes Khinast, Josip Matić, Amrit Paudel, Hannes Bauer, Raymar Andreína Lara García |
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| Rok vydání: | 2020 |
| Předmět: |
Hot Temperature
Process development Process (engineering) Computer science Chemistry Pharmaceutical Drug Compounding process and product modeling Pharmacology toxicology Plastics extrusion Pharmaceutical Science Review Article 02 engineering and technology Aquatic Science Thermal load 030226 pharmacology & pharmacy hot melt extrusion 03 medical and health sciences 0302 clinical medicine rational formulation development Drug Discovery Integrated product and process development Process engineering Ecology Evolution Behavior and Systematics Ecology business.industry General Medicine 021001 nanoscience & nanotechnology Workflow Pilot plant Models Chemical Solubility amorphous solid dispersions 0210 nano-technology business Agronomy and Crop Science |
| Zdroj: | AAPS PharmSciTech |
| ISSN: | 1530-9932 |
| DOI: | 10.1208/s12249-020-01713-0 |
| Popis: | This paper presents a rational workflow for developing enabling formulations, such as amorphous solid dispersions, via hot-melt extrusion in less than a year. First, our approach to an integrated product and process development framework is described, including state-of-the-art theoretical concepts, modeling, and experimental characterization described in the literature and developed by us. Next, lab-scale extruder setups are designed (processing conditions and screw design) based on a rational, model-based framework that takes into account the thermal load required, the mixing capabilities, and the thermo-mechanical degradation. The predicted optimal process setup can be validated quickly in the pilot plant. Lastly, a transfer of the process to any GMP-certified manufacturing site can be performed in silico for any extruder based on our validated computational framework. In summary, the proposed workflow massively reduces the risk in product and process development and shortens the drug-to-market time for enabling formulations. |
| Databáze: | OpenAIRE |
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