Pharmaceutical QbD with Design of Experiments

Statistical Tools and Applications in Drug Delivery Systems

Khushwant Yadav, Piyush Verma (Herausgeber)

Buch | Hardcover

875 Seiten

2025
Academic Press Inc (Verlag)
978-0-443-29208-8 (ISBN)

Infos

Pharmaceutical QbD with Design of Experiments: Statistical Tools and Applications in Drug Delivery Systems offers comprehensive coverage of the best practices in pharmaceutical manufacturing. With a focus on design of experiments, examples, and case studies, this book is ideal for manufacturing researchers and industry professionals. The contents of the book cover all drug delivery systems and is structured in five parts. The first discusses the principles and basics of Quality by Design (QbD). Part two covers the foundational statistical principles and tools for the Design of Experiments (DoE). Section three is dedicated to the applications of QbD for conventional formulations. The next section provide ample coverage of applications to Novel Drug Delivery Systems (NDDS), including micro and nano-particles. The final section discusses extensively the application of QbD for optimization of pharmaceutical processes and equipment used in the formulation of NDDSs. Researchers in pharmaceutical manufacturing will benefit from the thorough statistical review in part two, while students in this field will gain practical insights the experienced chapter authors provide in case studies. Industry professionals can find solutions to their particular problems within the insights and strategies shared in this book.

Autor

Dr. Khushwant Yadav has an experience of more than 19 years in both Industry and Academics. He has been a Research Scientist in Claris Lifesciences, Ahmedabad and Alembic Ltd., Vadodara. Dr. Yadav has completing AICTE-RPS project as Principal Investigator with a grant of Rupees 18 Lakhs. He has done collaborative research with National Institute for Research in Reproductive Health (NIRRH), ICMR Lab, Mumbai; Institute of Nuclear Medicine & Allied Sciences (INMAS), DRDO Lab, Delhi. His publications have been listed in 25 Hottest Articles by Elsevier, Most-Read Article by Parenteral Drug Association, USA, Most Viewed Article (Top 10) by AAPS, USA. He is recipient of Fellow of Institute of Chemists (India). Mr. Piyush Verma is a seasoned professional, holding a Masters in Pharmacy specialized in Industrial Pharmacy from SPPSPTM, NMIMS, India, complemented by a master's degree in business administration. His research delves into Quality by Design, Design of Experiments, Novel Drug Delivery Systems, and topical drug delivery. Notably, Piyush is the driving force behind Velite Healthcare, a pioneering dermatology company in India, where he serves as the founding member and chief consultant. His work amalgamates scientific innovation with strategic leadership, making a significant impact in pharmaceuticals and healthcare.

Inhalt

Section-I Basics on QbD
1. Quality by Design (QbD) Concept
2. Benefits and Importance of QbD in Pharmaceutical Dosage Forms
3. QbD Approach for Pharmaceutical Dosage Forms
4. Case Studies on QbD Implementation in Pharmaceutical Dosage Forms
5. Challenges and Limitations of QbD Implementation
6. Future Perspectives and Emerging Trends in QbD for Dosage Forms
7. Pharmaceutical Formulation by Design

Section-II Basic Statistics for Design of Experiment
8. Basic definitions & concepts in statistics useful in DoE
9. Response surface methodology: Basics
10. Basics of Factorial Designing and DoE
11. Response Surface Modelling

Section-III Application of QbD for Development of Dosage Form Design of Conventional Formulations
12.. Solid Dosage Forms:
13. Liquid Dosage Forms:
14. Semisolid Dosage Forms:
15. Parenteral Dosage Forms:
16. Inhalation Dosage Forms:
17. Nasal Dosage Forms:
18. Topical and Transdermal Dosage Forms:
19. Ophthalmic Dosage Forms:
20. Rectal and Vaginal Dosage Forms:

Section-IV Application of QbD for Development of Dosage Form Design of Novel Drug Delivery Systems including Nano and Micro drug delivery systems
21. Nano vesicular systems
22. Polymeric micro and nano particles
23. Dendrimers
24. Carbon based novel drug delivery systems
25. Microemulsions and Nanoemulsions
26. Microneedles
27. Bioengineered and bio mimicking drug delivery systems
28. Nanofibers
29. Gel-based Formulations

Section-V Application of QbD for optimization of pharmaceutical processes and equipment used in the formulation of Novel drug delivery systems
30. Freeze Drying
31. Spray Drying
32. High pressure homogenization
33. 3-D Printing
34. Electrospinning

Produkt-Details

• Erscheint lt. Verlag: 1.6.2025
• Verlagsort: San Diego
• Sprache: englisch
• Maße: 210 x 297 mm
• Themenwelt: Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
• Themenwelt: Medizin / Pharmazie ► Pharmazie
• Themenwelt: Technik
• ISBN-10: 0-443-29208-6 / 0443292086
• ISBN-13: 978-0-443-29208-8 / 9780443292088
• Zustand: Neuware