Application of Quality by Design (QbD) Approach to Ultrasonic Atomization Spray Coating of Drug-Eluting Stents
| Autor: | Sharmista Chatterjee, Minerva Hughes, Martin K. McDermott, Dinesh V. Patwardhan, Tina Zhang, Anastasiya Belyaeva, Celia N. Cruz, Joanne Leadbetter, Nancy Tang, David M. Saylor, Ariel Ash-Shakoor, Conrad W. Merkle, Xiaoli Hu, Reginald K. Avery, Taylor Moot, Sepideh Parvinian |
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| Rok vydání: | 2015 |
| Předmět: |
Materials science
Surface Properties Kinetics Pharmaceutical Science Surface finish Aquatic Science engineering.material Microscopy Atomic Force Quality by Design Coating Drug Discovery Ultrasonics Everolimus Composite material Polyglactin 910 Chromatography High Pressure Liquid Ecology Evolution Behavior and Systematics Ecology Elution Design of experiments Drug-Eluting Stents General Medicine Biodegradable polymer Microscopy Electron Scanning engineering Ultrasonic sensor Agronomy and Crop Science Research Article |
| Zdroj: | AAPS PharmSciTech. 16:811-823 |
| ISSN: | 1530-9932 |
| Popis: | The drug coating process for coated drug-eluting stents (DES) has been identified as a key source of inter- and intra-batch variability in drug elution rates. Quality-by-design (QbD) principles were applied to gain an understanding of the ultrasonic spray coating process of DES. Statistically based design of experiments (DOE) were used to understand the relationship between ultrasonic atomization spray coating parameters and dependent variables such as coating mass ratio, roughness, drug solid state composite microstructure, and elution kinetics. Defect-free DES coatings composed of 70% 85:15 poly(DL-lactide-co-glycolide) and 30% everolimus were fabricated with a constant coating mass. The drug elution profile was characterized by a mathematical model describing biphasic release kinetics. Model coefficients were analyzed as a DOE response. Changes in ultrasonic coating processing conditions resulted in substantial changes in roughness and elution kinetics. Based on the outcome from the DOE study, a design space was defined in terms of the critical coating process parameters resulting in optimum coating roughness and drug elution. This QbD methodology can be useful to enhance the quality of coated DES. |
| Databáze: | OpenAIRE |
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