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Pharmaceutical Hot Melt Extrusion

From Materials Selection to Commercial Production

  • 1st Edition - November 1, 2026
  • Latest edition
  • Editor: Purnima D. Amin
  • Language: English

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… Read more

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Description

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.

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

Readership

Pharmaceutical formulation scientists and R&D professionals

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

Product details

  • Edition: 1
  • Latest edition
  • Published: October 31, 2028
  • Language: English

About the editor

PA

Purnima D. Amin

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.
Affiliations and expertise
Senior Professor of Pharmacy, Institute of Chemical Technology (formerly UDCT), Mumbai, India