Modeling and Simulation of Process Technology for Nanoparticulate Drug Formulations—A Particle Technology Perspective
| العنوان: | Modeling and Simulation of Process Technology for Nanoparticulate Drug Formulations—A Particle Technology Perspective |
|---|---|
| المؤلفون: | Tobias Schikarski, Jens Uhlemann, Holger Diedam, Wolfgang Peukert, Werner Hoheisel |
| المصدر: | Pharmaceutics, Vol 13, Iss 22, p 22 (2021) Pharmaceutics |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | comminution, Process (engineering), Population, product design, lcsh:RS1-441, Pharmaceutical Science, Process design, Review, 02 engineering and technology, precipitation, Pharmaceutical formulation, 030226 pharmacology & pharmacy, nanocrystal, lcsh:Pharmacy and materia medica, Modeling and simulation, 03 medical and health sciences, 0302 clinical medicine, modeling and simulation, education, pharmaceutical material science, education.field_of_study, Product design, 021001 nanoscience & nanotechnology, Multiscale modeling, Biopharmaceutical, oral bioavailability, poorly soluble drug, Biochemical engineering, ddc:620, 0210 nano-technology |
| الوصف: | Crystalline organic nanoparticles and their amorphous equivalents (ONP) have the potential to become a next-generation formulation technology for dissolution-rate limited biopharmaceutical classification system (BCS) class IIa molecules if the following requisites are met: (i) a quantitative understanding of the bioavailability enhancement benefit versus established formulation technologies and a reliable track record of successful case studies are available; (ii) efficient experimentation workflows with a minimum amount of active ingredient and a high degree of digitalization via, e.g., automation and computer-based experimentation planning are implemented; (iii) the scalability of the nanoparticle-based oral delivery formulation technology from the lab to manufacturing is ensured. Modeling and simulation approaches informed by the pharmaceutical material science paradigm can help to meet these requisites, especially if the entire value chain from formulation to oral delivery is covered. Any comprehensive digitalization of drug formulation requires combining pharmaceutical materials science with the adequate formulation and process technologies on the one hand and quantitative pharmacokinetics and drug administration dynamics in the human body on the other hand. Models for the technical realization of the drug production and the distribution of the pharmaceutical compound in the human body are coupled via the central objective, namely bioavailability. The underlying challenges can only be addressed by hierarchical approaches for property and process design. The tools for multiscale modeling of the here-considered particle processes (e.g., by coupled computational fluid dynamics, population balance models, Noyes–Whitney dissolution kinetics) and physiologically based absorption modeling are available. Significant advances are being made in enhancing the bioavailability of hydrophobic compounds by applying innovative solutions. As examples, the predictive modeling of anti-solvent precipitation is presented, and options for the model development of comminution processes are discussed. |
| وصف الملف: | application/pdf |
| اللغة: | English |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e56024487c9843ca7f166a42667e7033 https://opus4.kobv.de/opus4-fau/files/15516/pharmaceutics-13-00022-v2.pdf |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....e56024487c9843ca7f166a42667e7033 |
| قاعدة البيانات: | OpenAIRE |
| الوصف غير متاح. |