Characterization of Micro and Nanoparticles for Biomedical Applications

Any generic or innovative pharmaceutical product requires to undergo an extensive characterization cycle (in-vitro, ex-vivo, cell lines based evaluation) before getting to preclinical and clinical stages and eventually to be eligible for marketing authorization. The expectation of high-quality data is essentially dependent on the analytical methodology applied for characterization. For routine products like tablets, capsules, and solutions, the regulatory guidelines, product-specific monographs, and pharmacopoeial annexures are set and are standard of operation. In addition, GMP/ISO guidelines support industries, academicians, and contract labs to evaluate, document, and validate the routine product to get qualified. However, for nano-micro pharmaceuticals, the regulatory guidelines are still evolving and are very much dependent on the literature data and latest draft reports from experts and regulatory body discussions. This book aims to provide one-stop resources on all the analytical techniques used in the field of micro and nanoparticles evaluation and characterization. The chapters will bring together knowledge on current analytical methodologies, limitations, and advances in the in vitro analysis field. Characterization of Micro and Nanoparticles for Biomedical Applications is a helping guide for industry researchers, academicians, regulatory experts, and material scientists working in this field of pharmaceuticals, cosmeceuticals, nutraceuticals, agriculture, food, fragrance, and chemical industry. The equipment industry can benefit from its innovations by understanding the needs of researchers and the challenges of current techniques. Covers the entire landscape of in vitro analytical techniques applied for characterization and analysis of micro-and nanoparticles in biomedicine Examines limitations and challenges of currently used methodologies Discusses new advances in the field of micro-nano characterization INDICE: 1. Particle size analysis 2. Zeta potential and surface characterization (eg, porosity, BET, hydrophilicity, etc.) 3. Microscopic analysis (AFM, SEM, TEM) etc. 4. XRD-EDS- crystallinity, compatibility 5. Isotonicity, osmolarity, osmolality, plasma/blood compatibility 6. In vitro release testing (including Franz diffusion cells) 7. Nanoparticle tracking analysis 8. Chemical analysis 9. Thermal analysis- DSC, TGA etc. 10. Chromatographic analyses (all) 11. Drug loading, entrapment assays of nano and micro particles: current practices 12. Nanoparticle dissolution 13. Sterility testing nanoparticles 14. Lyophilization characterization

• ISBN: 978-0-323-96138-7
• Editorial: Elsevier Science
• Encuadernacion: Rústica
• Páginas: 480
• Fecha Publicación: 01/08/2023
• Nº Volúmenes: 1
• Idioma: Inglés