"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.)"--
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.
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| Contributors |
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xiii | |
| Abbreviations |
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xvii | |
| Preface |
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xxv | |
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1 Introduction to Pharmaceutical Product Development |
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1 | (32) |
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2 Systematic Product and Process Development Tools in Life Cycle Management |
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33 | (20) |
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3 Recent Advances in the Development of Solid Oral Dosage Forms |
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53 | (26) |
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4 Recent Advances in the Development of Modified Release Oral Dosage Forms |
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79 | (18) |
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5 Recent Advances in the Development of Parenteral Dosage Forms |
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97 | (28) |
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Mohammed Asadullah Jahangir |
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6 Recent Advances in the Development of Semisolid Dosage Forms |
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125 | (66) |
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7 Recent Advancements in Transdermal Drug Delivery Systems |
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191 | (26) |
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Mohammed Asadullah Jahangir |
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8 Recent Advances in the Formulation Development of Inhalational Dosage Forms |
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217 | (34) |
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9 Recent Advances in the Development of Novel Ocular Drug Delivery Systems |
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251 | (22) |
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10 Recent Advances in the Development of Nanopharmaceutical Products |
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273 | (36) |
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11 Recent Advances in the Development of Nanoparticles for Oral Delivery |
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309 | (24) |
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Mohd. Moshahid Alam Rizvi |
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| Index |
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333 | |
Sarwar Beg, PhD, is Assistant Professor of Pharmaceutics & Biopharmaceutics at Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard University, New Delhi, India. A prolific author, Dr. Beg has authored over 150 publications in his field.
Mahfoozur Rahman, PhD, is Assistant Professor at the Department of Pharmaceutical Sciences, Faculty of Health Science, Sam Higginbottom University of Agriculture, Technology & Sciences, Allahabad, India. He has published many articles in peer-reviewed journals as well as book chapters, books, and articles in international magazines.
Syed Sarim Imam, PhD, is Associate Professor at the College of Pharmacy, King Saud University, Saudi Arabia. He is also a reviewer for several professional journals.
Nabil K. Alruwaili, PhD, is Assistant Professor and Chairman in the Pharmaceutics Department, School of Pharmacy, Jouf University, Sakaka, Saudi Arabia. He has significant experience in assessment and registration dossiers submitted by companies for a variety of pharmaceutical products.
Majed Al Robaian, PhD, is Dean of the Faculty of Pharmacy at Taif University, Saudi Arabia. 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 Kumar Panda, PhD, is the Director of Research and Development at Menovo Pharmaceuticals (Shanghai stock exchange listed company) in the Peoples Republic of China. He is an academic consultant to the Government College of Engineering and Technology, Bhubaneswar, India.
