Pharmaceutical Hot Melt Extrusion

From Materials Selection to Commercial Production
Erscheinungsjahr 2026
ISBN: 978-0-443-51606-1
Verlag: Elsevier Science

Buch, Englisch, 500 Seiten, Format (B × H): 191 mm x 235 mm

The Practical/User Manual for Making Pharmaceutical Products with Hot Melt Extrusion (HME) is an authoritative resource addressing the evolving landscape of HME technology. This reference explores the core principles of formulation development, equipment design, process scaling, and regulatory considerations, providing essential knowledge for researchers and industry professionals. It emphasizes innovative, green manufacturing practices, solvent-free processes, and patient-centric delivery systems, making it a vital guide for advancing pharmaceutical and nutraceutical formulations. This reference enhances understanding of cutting-edge HME applications, supporting environmentally sustainable practices and innovative product development for both academia and industry. It equips formulation scientists, R&D professionals, and students with the knowledge to accelerate research, improve efficiency, and translate laboratory innovations into market-ready solutions.

Autoren/Hrsg.

Amin, Purnima D.

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie

Inhaltsverzeichnis

Section I: Instrumentation & Equipment
1. Introduction to Hot-Melt Extrusion Equipment

Section II: Material Selection & Material Processing – Prediction/Preformulation
2. Materials, Material Selection & Material Processing

Section III: Drug Delivery Systems & Solubilization Techniques
3. Granulation
4. Pellets
5. Taste-Masking
6. Topical Dosage Forms
7. Films – Oral, Topical & Transdermal
8. Sterile Dosage Forms in Continuous Manufacturing by Hot-Melt Extrusion Technology
9. Co-Crystallization
10. Solubility & Bioavailability Enhancement
11. Abuse Deterrent/Tamper-Resistant Formulation
12. HME vs. Spray Drying

Section IV: Advances in HME
13. Advanced Polymers & Excipients
14. Vertical HME (Innovation in Instrumentation/Equipment)
15. 3D Printing/Patient-Centric Formulation – Customization
16. Recent Innovations in HME

Section V: Patentability, Quality Control, Quality Assurance, QbD-Predictive Models & Regulatory Compliance
17. Patentability of HME Products
18. Quality-Assured Development & Scale-Up
19. Regulatory Compliance – FDA and Other Regulatory Bodies

Über Autor(innen)

Amin, Purnima D.
Prof. Purnima D. Amin is Senior Professor of Pharmacy at the Institute of Chemical Technology (formerly UDCT), Mumbai, with over three decades of academic and research leadership in pharmaceutics. She earned her B.Pharm (1982), M.Pharm (1984), and Ph.D. (Tech) in Pharmaceutics (1988) from UDCT, Mumbai, where her doctoral work focused on polymeric drug delivery systems.

A pioneer in the field of pharmaceutical technology, Prof. Amin’s research centers on the development of innovative drug delivery systems through Hot Melt Extrusion (HME). Her group has produced more than 60 publications in HME and holds multiple patents in the field. Her contributions span solubility enhancement of poorly soluble drugs, fixed-dose combinations for tuberculosis and malaria, orally disintegrating films, topical formulations, probiotic inserts, nanostructured lipid carriers, and sustained-release implants for both human and veterinary applications.
In addition to her extensive academic work, Prof. Amin has collaborated with leading pharmaceutical companies, including Merck, BASF, Evonik, and Hindustan Unilever, ensuring translation of her laboratory innovations into industrially scalable dosage forms. She has supervised over 30 Ph.D. and 75 Master’s students, and her expertise is widely recognized through awards at international forums, editorial roles (including Remington: The Science and Practice of Pharmacy), and service as a reviewer for leading journals.