Pharmaceutical Hot Melt Extrusion
From Materials Selection to Commercial Production
- 1st Edition - November 27, 2026
- Latest edition
- Editor: Purnima D. Amin
- Language: English
The Practical/User Manual for Making Pharmaceutical Products with Hot Melt Extrusion (HME) is a comprehensive resource addressing the evolving landscape of HME technology. This… Read more
Description
Description
The Practical/User Manual for Making Pharmaceutical Products with Hot Melt Extrusion (HME) is a comprehensive 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.
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.
Key features
Key features
• Provides an up-to-date, comprehensive guide on HME technology and applications
• Highlights formulation design, process optimization, and scalability strategies
• Explores advances in materials, equipment, and innovative drug delivery systems
• Includes case studies, industry trends, and patentability insights
• Emphasizes environmentally friendly, solvent-free manufacturing approaches
• Highlights formulation design, process optimization, and scalability strategies
• Explores advances in materials, equipment, and innovative drug delivery systems
• Includes case studies, industry trends, and patentability insights
• Emphasizes environmentally friendly, solvent-free manufacturing approaches
Readership
Readership
Pharmaceutical formulation scientists and R&D professionals
Table of contents
Table of contents
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
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
Product details
Product details
- Edition: 1
- Latest edition
- Published: November 27, 2028
- Language: English
About the editor
About the editor
PA
Purnima D. Amin
Prof. Purnima D. Amin is a Senior Professor of Pharmacy at the Institute of Chemical Technology (formerly UDCT), with more than three decades of distinguished academic and research experience in pharmaceutics. Her research is primarily centered on the application of Hot Melt Extrusion (HME) technology for the development of advanced
drug delivery systems intended for oral, topical, and parenteral administration. Her work includes the use of HME in melt granulation, solubility enhancement of poorly water-soluble drugs, and the formulation of orally disintegrating films, implants, topical dosage forms such as creams and emulgels, and in situ gelling systems.
Prof. Amin’s research group has published more than 40 scientific papers in the field of HME and has secured several patents. She has collaborated extensively with leading pharmaceutical industries to facilitate the translation of research into industrial applications and has mentored several PhD and Master’s students. Prof. Amin is also recognized for her contributions through editorial activities, peer review, and international scientific engagements.
Affiliations and expertise
Senior Professor of Pharmacy, Institute of Chemical Technology (formerly UDCT), Mumbai, India