Pharmaceutical Drug Product Development and Process Optimization
Effective Use of Quality by Design

Editors: Sarwar Beg, PhD
Mahfoozur Rahman, PhD
Syed Sarim Imam, PhD
Nabil K. Alruwaili, PhD
Majed Al Robaian, PhD
Sunil K. Panda, PhD

Pharmaceutical Drug Product Development and Process Optimization

Published. Available now.
Pub Date: April 2020
Hardback Price: see ordering info
Hard ISBN: 9781771888721
Paperback Price: see ordering info
Paperback ISBN: 978-1-77463-496-7
E-Book Price:  see ordering info
E-Book ISBN: 9780367821678
Pages: 382pp w/index
Binding Type: hardback / paperback / ebook
Notes: 24 color and 30 b/w illustrations

Now Available in Paperback


Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume, Pharmaceutical Drug Product Development and Process Optimization: Effective Use of Quality by Design, addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding.

This volume presents and discusses the vital precepts underlying the efficient, effective, and cost-effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development, which is imperative in achieving continuous improvement in end-product quality and also leads to reducing cost, time, and effort, while meeting regulatory requirements.

The volume covers the important new advances in the development of solid oral dosage forms, modified release oral dosage forms, parenteral dosage forms, semisolid dosage forms, transdermal drug, delivery systems, inhalational dosage forms, ocular drug delivery systems, nanopharmaceutical products, and nanoparticles for oral delivery.

Providing an abundance of knowledge, this volume will be valuable for those who are engaged in pharmaceutical product development, including new drugs and generic drug products.

Key features
  • Reviews a vast collection of literature on applicability of systematic product development tools
  • Discusses various dosage forms where challenges are very high
  • Provides regulatory guidance related to specific dosage form development
  • Covers the major types of drug products, including enteral, parenteral, and other (including transdermal, inhalation, etc.)

CONTENTS:
Preface

1. Introduction to Pharmaceutical Product Development
Rahul Shukla, Mayank Handa, and Vishwas P. Pardhi

2. Systematic Product and Process Development Tools in Life Cycle Management
Mohamad Taleuzzaman, Sanjay Chuhan, Sadaf Jamal Gilani, and Syed Sarim Imam

3. Recent Advances in the Development of Solid Oral Dosage Forms
Mohammed Tahir Ansari, Farheen Mohd Sami, Mohammad Saquib Hasnain, Shahnaz Majeed, and Sadat Ali

4. Recent Advances in the Development of Modified Release Oral Dosage Forms
Goutam Kumar Jena, Ch Niranjan Patra, and Sarwar Beg

5. Recent Advances in the Development of Parenteral Dosage Forms
Abdul Muheem, Sobiya Zafar, Mohammed Asadullah Jahangir, Musarrat Husain Warsi, Syed Sarim Imam, Gaurav Kumar Jain, and Farhan Jalees Ahmad

6. Recent Advances in the Development of Semisolid Dosage Forms
Rabinarayan Parhi

7. Recent Advancements in Transdermal Drug Delivery Systems
Mohammed Asadullah Jahangir, Abdul Muheem, and Syed Sarim Imam

8. Recent Advances in the Formulation Development of Inhalational Dosage Forms
A. A. Sallam

9. QBD-Based Novel Ocular Drug Delivery Systems
Mohammed Jafar, Syed Sarim Imamb, and Syed Azizullah Ghori

10. Recent Advances in the Development of Nanopharmaceutical Products
Rahul Shukla, Ajit Singh, Nidhi Singh, and Dheeraj Kumar

11. Recent Advances in the Development of Nanoparticles for Oral Delivery
Md. Rizwanullah, Mohd. Moshahid Alam Rizvi, and Saima Amin

Index


About the Authors / Editors:
Editors: Sarwar Beg, PhD
Assistant Professor, Pharmaceutics &Biopharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard University, New Delhi, India

Sarwar Beg, PhD, is currently serving as Assistant Professor of Pharmaceutics & Biopharmaceutics at Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard University, New Delhi, India (Rank #1 in pharmacy as per the government of India). Prior to that, Dr. Beg has worked with Jubilant Generics Limited, Noida, India, as Research Scientist, where he was solely responsible for implementation of Quality by Design (QbD) in formulation development and analytical development of generic products. He has nearly a decade of experience in systematic development and characterization of novel and nanostructured drug delivery systems using QbD paradigms including Design of Experiments (DoE), Quality Risk Management (QRM), Multivariate Chemometric Approaches, and Advanced Biopharmaceutics and Pharmacokinetic. To date, Dr. Beg has authored over 150 publications including research and review papers in high-impact peer-reviewed journals, eight journal special issues, 12 books, 45 book chapters, and three Indian patent applications. He is a Regional Editor (Asia) of the journal Current Nanomedicine and is an editorial board member of several other journals. Dr. Beg has also participated and presented his research work and delivered lectures at several conferences held at India, China, Bangladesh, Canada and USA, receiving several best paper awards. His other awards include an Innovative Pharma Researcher Award 2016 by SIPRA Lab (Hyderabad), the Eudragit® Award 2014 in South-Asia by M/s Evonik (Germany), Budding QbD Scientist Award 2014 and Budding ADME Scientist Award 2013 by M/s Select Biosciences (UK), and the Novartis Biocamp Award 2012 (Hyderabad). In 2017, Dr. Sarwar was recognized by the Honorable Union Health Minister of India and Managing Director of Sun Pharmaceutical Industries with prestigious Sun Pharma Science Foundation Award.

Mahfoozur Rahman, PhD
Assistant Professor, Department of Pharmaceutical Sciences, Faculty of Health Science, Sam Higginbottom University of Agriculture, Technology & Sciences (SHUATS), Allahabad, India

Mahfoozur Rahman, PhD, is an Assistant Professor at the Department of Pharmaceutical Sciences, Faculty of Health Science, Sam Higginbottom University of Agriculture, Technology & Sciences (SHUATS), Allahabad, India. To date he has published over 90 publications in peer-reviewed journals (such as Seminar in Cancer Biology, Drug Discovery Today, Nanomedicine, Expert Opinion on Drug Delivery), as well as 17 book chapters, four international books, and three articles in international magazines. Dr. Rahman has received several travel grants for various international congresses, such as IAPRD, MDS, Nano Today Conference, etc. He is also serving as the Guest Editor of several journals, such as Seminar Cancer Biology, Recent Patents on Anti-Infective Drug Discovery, and Current Nanomedicine, and is an editorial member for many prestigious journals. His major areas of research interest include development and characterization of nanosized drug delivery systems for inflammatory disorders including psoriasis, arthritis, neurodegenerative disorders, cancer, etc. In addition, he is also working on amalgamation of herbal medicinal plants with modern therapeutics in order to deliver a scientifically acceptable therapy for various diseases management.

Syed Sarim Imam, PhD
Associate Professor, College of Pharmacy, King Saud University, Saudi Arabia

Syed Sarim Imam, PhD, is an Associate Professor at the College of Pharmacy, King Saud University, Saudi Arabia. He has more than 10 years of teaching and research experience. Dr. Imam has a list of more than 60 research/review manuscripts published in journals of international repute. He has also participated and presented his research work at several conferences held in India and abroad. He has contributed about 20 book chapters in books published by Elsevier, CRC, and Springer. Dr. Imam is reviewer to a large number of international and national journals of repute and is a member/fife member of many Indian scientific organizations. His research interests include drug delivery, brain targeting, formulation optimization, and lipid-based delivery systems. Dr. Imam earned his PhD from the faculty of Pharmacy, Jamia Hamdard, New Delhi, India. He received a research fellowship from the Indian Council of Medical Research, New Delhi, during his doctorate tenure.

Nabil K. Alruwaili, PhD
Pharmaceutics Department, School of Pharmacy, Jouf University, Sakaka, Saudi Arabia

Nabil K. Alruwaili, PhD, is an Assistant Professor in the Pharmaceutics Department, School of Pharmacy, Jouf University, Sakaka, Saudi Arabia. He is the chairman of the Pharmaceutics Department. He obtained both his BSc (Pharmaceutical Sciences, 2008) and MSc (Quality Control of Pharmaceutics, 2011) from the College of Pharmacy at King Saud University (KSU), Riyadh, Saudi Arabia. He was awarded his PhD (Pharmaceutics, 2017) from Massachusetts College of Pharmacy and Health Sciences University, Boston, Massachusetts, USA. Previously, Dr. Alruwaili worked at the Saudi Food & Drug Authority in product evaluation and standards-setting administration Riyadh, Saudi Arabia, for three years. He has significant experience in assessment and registration dossiers submitted by companies for a variety of pharmaceutical products. There are many aspects to be assessed in such files, including Drug Master File (DMF), which involves drug design and manufacturing. Dr. Alruwaili is effective in building successful projects through open channels of communication and synergistic relationships across research disciplines in order to motivate others on all levels in the achievement of individual and organizational goals. He has published several articles and has presented papers at international and national scientific conferences.

Majed Al Robaian, PhD
Faculty of Pharmacy, Taif University, Saudi Arabia

Majed AlRobaian, PhD, is the Dean of the Faculty of Pharmacy at Taif University, Saudi Arabia. He obtained his BSc from King Saud University in Riyadh Saudi Arabia and his MSc in Pharmaceutical Sciences from Strathclyde University in the United Kingdom in 2010 and his PhD from the same university in 2014. His research interests focus on drug delivery and in particular the delivery of therapeutic genes for the treatment of cancer. Before obtaining his PhD, he worked as Director of Pharmacy in King Abdulaziz Hospital, Saudi Arabia. Currently, he has been appointed as the Science Faculty Ambassador for Strathclyde University, UK. He is also a member of a number of committees in the Saudi Commission for Health Specialties.

Sunil K. Panda, PhD
Director of Research & Development, Menovo Pharmaceuticals, People’s Republic of China

Sunil Kumar Panda, PhD, serves as Director of Research and Development at Menovo Pharmaceuticals (Shanghai stock exchange listed company) in the People’s Republic of China. He has rich research work experience with top Indian pharmaceutical companies, such as Zydus Cadila, Dr. Reddy’s Laboratories, Jubilant, and Unichem. He is an academic consultant to the Government College of Engineering and Technology, Bhubaneswar, India. With 14 years of research experience in India and abroad, he has received many international grants for pursuing his research. He is listed as a foreign research expert in the People




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