Overview

A practical and up-to-date discussion of the formulation and design of dosage forms and delivery systems containing herbal ingredients In Formulating Pharma-, Nutra-, and Cosmeceutical Products from Herbal Substances: Dosage Forms and Delivery Systems, a team of distinguished researchers delivers a step-by-step approach to preparing and manufacturing dosage forms and delivery systems. Intuitively organized with comprehensive coverage of the fundamentals, functional materials, manufacturing, and marketing of pharmaceutical, nutraceutical, and cosmeceutical products, the book also examines regulatory issues of quality, safety, and efficacy. The authors discuss essential formulation development and delivery information for novel and controlled delivery systems of herbal ingredients. Readers will also find: A thorough introduction to the basic principles of developing modern pharma-, nutra-, and cosmeceutical products from herbal substances Comprehensive explorations of conventional formulations, including issues of stability Practical discussions of advanced formulations, including chronotherapeutic delivery systems, liposome-based delivery of phytoconstituents, and nanoparticle mediated delivery of herbal actives Complete treatments of regulatory challenges, including nonclinical characterization and documentation for marketing authorizations of herbal formulations Perfect for professionals working in the herbal drug, natural product, and dietary supplement industries, Formulating Pharma-, Nutra-, and Cosmeceutical Products from Herbal Substances will also benefit academic researchers and graduate students studying herbal research, cosmetics, and pharmaceutical sciences.

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Author:   Anupama Singh (Sardar Bhagwan Singh University, India) ,  Hitesh Kulhari (Central University of Gujarat, India) ,  Vikas Anand Saharan (National Institute of Pharmaceutical Education and Research Guwahati (NIPER-G), India)
Publisher:   John Wiley & Sons Inc
Imprint:   John Wiley & Sons Inc
Weight:   2.282kg
ISBN:  

9781119769477

ISBN 10:   1119769477
Pages:   816
Publication Date:   25 September 2025
Audience:   Professional and scholarly ,  College/higher education ,  Professional & Vocational ,  Postgraduate, Research & Scholarly
Format:   Hardback
Publisher's Status:   Active
Availability:   Out of stock  
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Table of Contents

List of Contributors xxxi Foreword by Prof. J.M.S. Rana xxxix Foreword by Prof. Anil Bhandari xli About the Editors xliii Preface xlv Section I Introduction and Basic Principles 1 1 From Traditional to Modern Medicine: The Role of Herbs and Phytoconstituents in Pharmaceuticals, Nutraceuticals, and Cosmetics 3 Pooja Shah, Surojit Banerjee, Anupama Singh, Hitesh Kulhari, and Vikas Anand Saharan 1.1 Introduction 3 1.2 Traditional Uses of Herbs in Pharmaceuticals, Nutraceuticals, and Cosmeceuticals 5 1.3 Herbs as a Source of Modern Medicine 17 1.4 Herbs as a Source of Nutraceuticals/Dietary Supplements 18 1.5 Herbs as a Source of Cosmeceuticals 18 1.6 Advantages of Herbal Formulations 24 1.7 Challenges of Herbal Formulations 33 1.8 Regulatory Scenario for Herbal Products in Modern Medicine 45 1.9 Approved Herbal Products 47 1.10 Conclusion 48 2 Preparation of Extracts and Their Standardization 75 Neeraj K. Sethiya, Garima Agarwal, Samir Bhargava, Vijay S. Rana, Bhavna Kumar, Manmohan Singhal, Dheeraj Bisht, and Umesh K. Patil 2.1 Introduction 75 2.2 Major Parameters 76 2.3 Minor Parameters 76 2.4 Important Terminology Used for the Preparation of Extracts and Standardization 76 2.5 Preparation of Extracts 77 2.6 Extraction of Plant Material 77 2.7 Extraction Methods 77 2.8 Types of Extractions 82 2.9 Methods of Fractionation and Separation of Phytoconstituents 83 2.10 Factors Affecting Selection of Extraction Method 83 2.11 Standardization 83 2.12 Conclusion 85 3 Isolation and Purification of Phytoconstituents 91 Shreya Sen Sarma, Biswajit Singh, Sushil K. Chaudhary, and Deepak Kumar 3.1 Introduction 91 3.2 Isolation and Purification 92 3.3 Hyphenated Techniques and Metabolomics 104 3.4 Chemical Fingerprinting 107 3.5 Bio-Assay-Guided Isolation 107 3.6 Conclusion 108 4 Natural Polysaccharides for Designing Herbal Formulations 119 Saumyadeep Bora, Shuchi Patel, Shreyansh Sharma, Deep Pooja, and Hitesh Kulhari 4.1 Introduction 119 4.2 Classification of Natural Polysaccharides 120 4.3 General Properties and Applications of Important Natural Polysaccharides 122 4.4 Conclusion and Future Perspectives 127 5 Principles of Sustained, Controlled, and Targeted Delivery of Herbal Actives 139 Aseem Setia, Abhishesh K. Mehata, Chandrashekar Singh, Paresh Badgujar, and Madaswamy S. Muthu 5.1 Introduction 139 5.2 Need for a Drug Delivery System 140 5.3 Solubility and Dissolution-Enhanced Drug Delivery Systems 140 5.4 Modified-Release Drug Delivery System 141 5.5 Types of Modified Drug Delivery Systems 141 5.6 Plant Actives and Extracts as a NDDS 148 5.7 Drug Delivery Systems of Herbal Actives 150 5.8 Targeted Drug Delivery Systems 154 5.9 Clinical Trials of Herbal Actives 155 5.10 Commercially Available Herbal Actives Drug Delivery System 156 5.11 Conclusion and Future Perspective 156 6 Formulation and Delivery Issues for Active Ingredients of Herbal Medicines, Nutraceuticals, and Cosmetics: Comparisons to Small-Molecule Drugs 163 Monika Ola, Rajveer Bhaskar, Pradeep S. Patil, Sangita V. Badgujar, and Nitin G. Haswani 6.1 Introduction 163 6.2 Incompatibility Within Formulation 164 6.3 Challenges Associated with Herbal Formulations 167 6.4 Stability Issues 169 6.5 Solubility Issues 170 6.6 Permeability Issues 172 6.7 Bioavailability and Pharmacokinetics 172 6.8 Factors Affecting Bioavailability of Natural Actives 173 6.9 Factors Affecting the Pharmacokinetics of Herbal Formulation 174 6.10 Modification of Herbal Actives Half-Life 175 6.11 Strategies for Modifying the Half-Life of Herbal Actives 176 6.12 Enhancement of Bioavailability of Herbal Actives 177 6.13 Small Molecules (Synthetic Drugs) Versus Herbal Actives 180 6.14 Conclusion 182 Section II Conventional Formulations 193 7 Stability of Herbal Formulations: Emerging Trends and Techniques 195 Dimple S. Lalchandani, Laltanpuii Chenkual, and Pawan K. Porwal 7.1 Introduction 195 7.2 Importance of Analytical Methods in the Stability Study of Herbal Formulations 196 7.3 Challenges Encountered in the Stability Study of Herbal Formulations 196 7.4 Analytical Techniques for Estimating the Stability of Herbal Formulations 197 7.5 Emerging Trends in Analytical Methods of Herbal Medicine 207 7.6 Quality Control and Assurance of Herbal Products 212 7.7 Challenges in Quality Assurance of Herbal Medicine 212 7.8 Regulatory Basis of Herbal Drug and Stability Testing 213 7.9 Conclusion 214 8 Fast-Dissolving/-Disintegrating Herbal Dosage Forms 219 Debadri Banerjee, Vikas Anand Saharan, and Anupama Singh 8.1 Introduction 219 8.2 Principles of Disintegration 220 8.3 Natural and Synthetic Disintegrants 221 8.4 Orally Disintegrating Tablets (ODTs) 221 8.5 Orally Disintegrating Films (ODFs) 229 8.6 Fast-Disintegrating Pellets 232 8.7 Fast-Dissolving/-Disintegrating Dosage Forms of Phytoconstituents 233 8.8 Challenges 234 8.9 Clinical Trials 235 8.10 Marketed Formulation 236 8.11 Conclusion 236 9 Herbal Formulations for Transmucosal Drug Delivery 243 Debadri Banerjee, Vikas Anand Saharan, and Anupama Singh 9.1 Introduction 243 9.2 Mucoadhesion 243 9.3 Transcellular and Paracellular Permeation 246 9.4 Various Transmucosal Routes: Drug Delivery Aspects 247 9.5 Phytochemical Delivery Through Transmucosal Route 257 9.6 Challenges 258 9.7 Clinical Trials 261 9.8 Marketed Herbal Mucoadhesive Products 261 9.9 Conclusion 261 10 Solid Dispersions 271 Kirti Shirsath, Indrani Maji, Srushti Mahajan, Mayur Aalhate, Ujala Gupta, and Pankaj K. Singh 10.1 Introduction 271 10.2 Components for Solid Dispersion-Based Formulations 273 10.3 Physiological Principle Behind Drug Absorption 276 10.4 Methods of Preparation 277 10.5 Characterization of Solid Dispersion 281 10.6 Drug Delivery Applications 283 10.7 Challenges in the Extraction of Phytoconstituent 286 10.8 Conclusion 287 11 Formulating Pharma-, Nutra-, and Cosmeceutical Products from Herbal Substances 299 Pooja Khairnar, Tejaswini Kolipaka, Giriraj Pandey, Vivek Phatale, Aachal Hedaoo, and Saurabh Srivastava 11.1 Introduction 299 11.2 Challenges for the Delivery of Herbal Actives 300 11.3 Rationale for Pelletization 300 11.4 Ideal Characteristics and Advantages of Pelletization of Herbal Actives 301 11.5 Phenomenon of Pelletization 302 11.6 Pelletization Techniques 303 11.7 Characterization of Pellets 306 11.8 Delivery Aspects of Pellets for Herbal Actives 309 11.9 Regulatory Considerations Toward Clinical Translation 314 11.10 Marketed Products 316 11.11 Conclusion and Future Perspective 316 12 Hydrogels as Delivery Systems in Herbal Medicine 323 Khushi Rode, Nandkishor Rajankar, Mayur Aalhate, Srushti Mahajan, Indrani Maji, Ujala Gupta, and Pankaj K. Singh 12.1 Introduction 323 12.2 Application of Hydrogels 324 12.3 Benefits of Hydrogels in Delivering Herbal Medicine 326 12.4 Hydrogels as an Effective Delivery of Nanocarrier System 330 12.5 Modification in Hydrogel Properties to Effectively Deliver Herbal Medicine 335 12.6 Formulation of Hydrogels to Precisely Deliver Herbal Medicine 342 12.7 Challenges Associated with the Delivery of Hydrogels 343 12.8 Conclusion and Future Prospects 344 13 Emulsions and Self-Emulsifying Delivery Systems for Herbal Actives 355 Puja Tripathy, Raju Barman, Rinku Baishya, and Deepak Kumar 13.1 Introduction 355 13.2 Emulsions 356 13.3 Composition of Emulsion 357 13.4 Thermodynamics of EMs 358 13.5 Preparation Methods 359 13.6 Characterization of Emulsions 362 13.7 Optimization of Emulsions 363 13.8 Herbal-Active Loaded Emulsions 364 13.9 Clinical Studies 364 13.10 Conclusion and Future Perspectives 371 Section III Advanced Formulations 379 14 Chronotherapeutic Delivery Systems 381 Akanksha Chaturvedi, Priyanka Arora, and Rahul Shukla 14.1 Introduction 381 14.2 Principles of Biological Clock 382 14.3 Need for a Chronotherapeutic Drug Delivery System 383 14.4 Mechanisms of Chronotherapeutic Drug Delivery Systems 384 14.5 Development of Chronotherapeutic Delivery Systems 384 14.6 Technological Advancement in Chronotherapeutic Drug Delivery Systems 386 14.7 Phytomedicine-Loaded Chronotherapeutic Drug Delivery Systems in Therapeutic Intervention 388 14.8 Chinese Herbal Medicines-Incorporated Chronotherapeutic Drug Delivery Systems 391 14.9 Herbal Excipients Modulating Chronotherapeutic Drug Delivery Systems 391 14.10 Clinical Translation and Patented Chronotherapeutic Drug Delivery Systems-Based Formulations 392 14.11 Challenges/Hurdles in Chonopharmaceutical Drug Research and Development 393 14.12 Conclusion and Future Perspectives 395 15 Liposomes-Based Delivery of Phytoconstituents 399 Shuchi Patel, Mahima Jadav, Deepali Sammal, Hitesh Kulhari, and Deep Pooja 15.1 Introduction 399 15.2 Types of Liposomes 399 15.3 Preparation of Liposomes by Different Methods 401 15.4 Delivery of Phytoconstituents Using Liposomes 403 15.5 Conclusion 412 16 Nanoparticles-Mediated Delivery of Herbal Actives 419 Priyanka Dubey, Shivangi Bharadwaj, Shruti Richa, Kajal Kumari, Payal Khesarwani, and Swapnil Sharma 16.1 Introduction 419 16.2 General Principles of Nanoparticle-Mediated Herbal Actives 420 16.3 Types of Herbal Nanoformulations 422 16.4 Methods of Preparation for Herbal Active Nanoformulations 432 16.5 NPs Mediated Delivery of Herbal Actives to Treat Different Diseases 435 16.6 New Approaches, Challenges, and Limitations of Herbal-Mediated Nanoformulation 439 16.7 Clinical Trials and US Food and Drug Administration-Approved Herbal Active Nanoformulations 442 16.8 Conclusion and Future Prospective 442 17 Herbal Extracts and Phytoconstituents-Loaded Transferosomes, Ethosomes, and Transdermal Patches in Drug Delivery 453 Nirmal Morya, Keshav Hirave, Debadri Banerjee, Anupama Singh, and Vikas Anand Saharan 17.1 Introduction 453 17.2 Delivery Aspects 454 17.3 Transferosomes 456 17.4 Ethosomes 466 17.5 Transdermal Patches 476 17.6 Challenges in Herbal Active Delivery 486 17.7 Conclusion 486 18 Dendrimers as Nanocarriers for Phytoceuticals 495 Surojit Banerjee, Keshav Hirave, Deep Pooja, Hitesh Kulhari, Anupama Singh, and Vikas Anand Saharan 18.1 Introduction 495 18.2 Principles of Dendrimers 496 18.3 Types of Dendrimers 499 18.4 Dendrimer Formulations 504 18.5 Preparation Process 508 18.6 Toxicity of Dendrimers 511 18.7 Challenges for Herbal Actives 514 18.8 Examples of Dendrimer-Based Delivery of Phytoconstituents 517 18.9 Preclinical Studies 517 18.10 Conclusion 523 19 Applications of Carbon-Based Nanomaterials for the Delivery of Herbal Molecules 533 Saumyadeep Bora, Deep Pooja, Brahmaji R. Mutyala, and Hitesh Kulhari 19.1 Introduction 533 19.2 Properties of Herbal Molecules 534 19.3 Challenges Associated with the Delivery of Herbal Molecules 535 19.4 Role of Nanocarriers in Herbal Molecule Delivery 536 19.5 Characteristics of Carbon-Based Nanomaterials for Herbal Molecule Delivery 537 19.6 Classification of Carbon-Based Nanomaterials 537 19.7 Applications of Carbon-Based Nanomaterials in Herbal Molecule Delivery 539 19.8 Conclusion and Future Perspectives 542 20 Phytoconstituents and Plant Extract-Based Formulations for Wound Healing 549 Keshav Hirave, Nirmal Morya, Surojit Banerjee, Anupama Singh, and Vikas Anand Saharan 20.1 Introduction 549 20.2 Mechanism of Wound Healing 550 20.3 Wound Classification 553 20.4 Factors Affecting Wound Healing 554 20.5 Nanocarrier in Wound Dressing 556 20.6 Medicinal Plants in Wound Healing/Plant Extracts, Extract Fractions and Phytoconstituent and Plant Extract Used in Wound Healing 556 20.7 Plant-Derived Phytoconstituent and Extract-Based Formulation for Wound Healing 567 20.8 Clinical Trials 573 20.9 Role of Different Plants in Wound Healing 573 20.10 Marketed Formulations/Commercial Products 584 20.11 Some Patented Innovations in Wound Healing 585 20.12 Future Directions and Challenges 585 20.13 Conclusion 589 21 Chemo-Herbal Combination Drug Delivery for Cancer Management 599 Shivangi Bharadwaj, Priyanka Dubey, Shruti Richa, Kajal Kumari, Payal Kesarwani, Kanika Verma, and Swapnil Sharma 21.1 Introduction 599 21.2 Challenges in Targeting Chemo-Herbal Drugs: Overcoming Physicochemical, Biological, and Physiological Barriers for Effective Drug Delivery 601 21.3 Optimizing Drug Delivery Strategies for Chemo-herbal Drugs: Overcoming Barriers and Enhancing Therapeutic Efficacy with Effective Targeting 602 21.4 Delivery Aspects of Chemo-Herbal Formulation in Cancer Therapy 614 21.5 Clinical Trials of Chemo-Herbal Formulations 621 21.6 Conclusion and Future Perspective 624 22 Protein Nanocarriers for the Delivery of Phytoconstituents 633 Ngangom Bidyarani, Kulandaivelu Velmourougane, Umesh Kumar, and Radha Prasanna 22.1 Introduction 633 22.2 Protein Nanocarriers 633 22.3 Methods of Preparation of Protein-Based Nanocarriers 634 22.4 Protein Nanocarriers for Phytoconstituents Delivery 635 22.5 Prospects of Nanotechnology for Delivery Purposes 637 22.6 Current Scenario and the Path Ahead 638 22.7 Conclusions 638 Section IV Regulatory Challenges 643 23 Nonclinical Characterization and Documentation for Marketing Authorizations of Herbal Formulations 645 Swati Dobhal, Nitish S. Jangwan, Shradha Bisht, Vikas Anand Saharan, and Mamta F. Singh 23.1 Introduction 645 23.2 Nonclinical Characterization of Herbal Formulations: Pharmacodynamics, Toxicology and Pharmacokinetic Studies 646 23.3 Regulatory Approvals for Marketing Herbal Formulations: A Global Overview of Documentation Requirements 652 23.4 Challenges 668 23.5 Conclusion 669 24 Quality Challenge in Regulatory Approval of Medicinal Products Containing Combinations of Herbal Substances 677 Siddheshwar Kisan Chauthe, Soham Rajyaguru, Aditi Puranik, Nishi Yadao, and Kajal Rathod 24.1 Introduction to Phytomedicines 677 24.2 Classification of Herbal Medicines Based on Regulatory Frameworks and Standards 678 24.3 Quality Challenges Related to Herbal Medicines 679 24.4 Global Regulatory Landscape of Herbal Medicines 684 24.5 WHO Regulatory Guidelines on GMP, GACP and Quality Control of Herbal Medicines 690 24.6 Development and Standardization of Herbal Medicines 695 24.7 Challenges in the Development of Herbal Medicines 696 24.8 Conclusion 697 25 Evidence-Based Clinical Assessment of Herbal Formulations: Traditional and Modern Insights 703 Debadri Banerjee, Surojit Banerjee, Pooja Shah, Anupama Singh, and Vikas Anand Saharan 25.1 Introduction 703 25.2 Indian Traditional Medicine 704 25.3 Modern Herbal Medicine 706 25.4 Regulatory Guidelines 708 25.5 Validation Approaches and Clinical Assessments 713 25.6 Obstacles to Clinical Assessment of Herbal Formulations 716 25.7 Conclusion 732 References 733 26 Patient Safety Issues with Herbal Substances and Formulations 743 Deepali Sammal, Saumyadeep Bora, Hitesh Kulhari, and Deep Pooja Objectives 743 26.1 Introduction 743 26.2 World Health Organization Regulatory Guidelines for Safety of Herbal Medicines 744 26.3 European Guidelines for the Herbal Medicines 745 26.4 Indian Regulations for Herbal Medicines 746 26.5 USFDA Guidelines for Herbal Medicines 746 26.6 Safety of Herbal Medicinal Products 747 26.7 Hepatotoxicity Caused by Herbal Medicines 748 26.8 Nephrotoxicity Induced by Herbal Drug Medicines 749 26.9 Genotoxicity Induced by Herbal Drug Medicines 749 26.10 Other Toxicities Induced by Herbal Drug Medicines 750 26.11 Conclusion 750 Acknowledgment 750 References 750 Index 753

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Anupama Singh, PhD, is Professor and Head of the Department of Pharmacognosy at Sardar Bhagwan Singh University. Hitesh Kulhari, PhD, is an Assistant Professor in the School of Nano Sciences at the Central University of Gujarat. Vikas Anand Saharan, PhD, is Associate Professor and In-charge of the Department of Pharmaceutical Technology (Formulations) at National Institute of Pharmaceutical Education and Research Guwahati (NIPER-G).

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