Formulating Pharma-, Nutra-, and Cosmeceutical Products from Herbal Substances E-Book

• Herausgeber: John Wiley & Sons
• Kategorie: Fachliteratur
• Sprache: Englisch

Seitenzahl: 2233

Veröffentlichungsjahr: 2025

Beschreibung

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.

Leseprobe

Table of Contents

Cover

Table of Contents

Title Page

Copyright

Dedication

List of Contributors

Foreword by Prof. J.M.S. Rana

Foreword by Prof. Anil Bhandari

About the Editors

Preface

Section I: Introduction and Basic Principles

1 From Traditional to Modern Medicine: The Role of Herbs and Phytoconstituents in Pharmaceuticals, Nutraceuticals, and Cosmetics

General Objectives

1.1 Introduction

1.2 Traditional Uses of Herbs in Pharmaceuticals, Nutraceuticals, and Cosmeceuticals

1.3 Herbs as a Source of Modern Medicine

1.4 Herbs as a Source of Nutraceuticals/Dietary Supplements

1.5 Herbs as a Source of Cosmeceuticals

1.6 Advantages of Herbal Formulations

1.7 Challenges of Herbal Formulations

1.8 Regulatory Scenario for Herbal Products in Modern Medicine

1.9 Approved Herbal Products

1.10 Conclusion

References

2 Preparation of Extracts and Their Standardization

Objectives

2.1 Introduction

2.2 Major Parameters

2.3 Minor Parameters

2.4 Important Terminology Used for the Preparation of Extracts and Standardization

2.5 Preparation of Extracts

2.6 Extraction of Plant Material

2.7 Extraction Methods

2.8 Types of Extractions

2.9 Methods of Fractionation and Separation of Phytoconstituents

2.10 Factors Affecting Selection of Extraction Method

2.11 Standardization

2.12 Conclusion

References

3 Isolation and Purification of Phytoconstituents

3.1 Introduction

3.2 Isolation and Purification

3.3 Hyphenated Techniques and Metabolomics

3.4 Chemical Fingerprinting

3.5 Bio‐Assay‐Guided Isolation

3.6 Conclusion

References

4 Natural Polysaccharides for Designing Herbal Formulations

Objectives

4.1 Introduction

4.2 Classification of Natural Polysaccharides

4.3 General Properties and Applications of Important Natural Polysaccharides

4.4 Conclusion and Future Perspectives

Acknowledgments

References

5 Principles of Sustained, Controlled, and Targeted Delivery of Herbal Actives

Objectives

5.1 Introduction

5.2 Need for a Drug Delivery System

5.3 Solubility and Dissolution‐Enhanced Drug Delivery Systems

5.4 Modified‐Release Drug Delivery System

5.5 Types of Modified Drug Delivery Systems

5.6 Plant Actives and Extracts as a NDDS

5.7 Drug Delivery Systems of Herbal Actives

5.8 Targeted Drug Delivery Systems

5.9 Clinical Trials of Herbal Actives

5.10 Commercially Available Herbal Actives Drug Delivery System

5.11 Conclusion and Future Perspective

References

6 Formulation and Delivery Issues for Active Ingredients of Herbal Medicines, Nutraceuticals, and Cosmetics: Comparisons to Small‐Molecule Drugs

6.1 Introduction

6.2 Incompatibility Within Formulation

6.3 Challenges Associated with Herbal Formulations

6.4 Stability Issues

6.5 Solubility Issues

6.6 Permeability Issues

6.7 Bioavailability and Pharmacokinetics

6.8 Factors Affecting Bioavailability of Natural Actives

6.9 Factors Affecting the Pharmacokinetics of Herbal Formulation

6.10 Modification of Herbal Actives Half‐Life

6.11 Strategies for Modifying the Half‐Life of Herbal Actives

6.12 Enhancement of Bioavailability of Herbal Actives

6.13 Small Molecules (Synthetic Drugs) Versus Herbal Actives

6.14 Conclusion

References

Section II: Conventional Formulations

7 Stability of Herbal Formulations: Emerging Trends and Techniques

Objectives

7.1 Introduction

7.2 Importance of Analytical Methods in the Stability Study of Herbal Formulations

7.3 Challenges Encountered in the Stability Study of Herbal Formulations

7.4 Analytical Techniques for Estimating the Stability of Herbal Formulations

7.5 Emerging Trends in Analytical Methods of Herbal Medicine

7.6 Quality Control and Assurance of Herbal Products

7.7 Challenges in Quality Assurance of Herbal Medicine

7.8 Regulatory Basis of Herbal Drug and Stability Testing

7.9 Conclusion

References

8 Fast‐Dissolving/‐Disintegrating Herbal Dosage Forms

Objectives

8.1 Introduction

8.2 Principles of Disintegration

8.3 Natural and Synthetic Disintegrants

8.4 Orally Disintegrating Tablets (ODTs)

8.5 Orally Disintegrating Films (ODFs)

8.6 Fast‐Disintegrating Pellets

8.7 Fast‐Dissolving/‐Disintegrating Dosage Forms of Phytoconstituents

8.8 Challenges

8.9 Clinical Trials

8.10 Marketed Formulation

8.11 Conclusion

References

9 Herbal Formulations for Transmucosal Drug Delivery

Objectives

9.1 Introduction

9.2 Mucoadhesion

9.3 Transcellular and Paracellular Permeation

9.4 Various Transmucosal Routes: Drug Delivery Aspects

9.5 Phytochemical Delivery Through Transmucosal Route

9.6 Challenges

9.7 Clinical Trials

9.8 Marketed Herbal Mucoadhesive Products

9.9 Conclusion

References

10 Solid Dispersions

Objectives

10.1 Introduction

10.2 Components for Solid Dispersion‐Based Formulations

10.3 Physiological Principle Behind Drug Absorption

10.4 Methods of Preparation

10.5 Characterization of Solid Dispersion

10.6 Drug Delivery Applications

10.7 Challenges in the Extraction of Phytoconstituent

10.8 Conclusion

References

11 Formulating Pharma‐, Nutra‐, and Cosmeceutical Products from Herbal Substances

11.1 Introduction

11.2 Challenges for the Delivery of Herbal Actives

11.3 Rationale for Pelletization

11.4 Ideal Characteristics and Advantages of Pelletization of Herbal Actives

11.5 Phenomenon of Pelletization

11.6 Pelletization Techniques

11.7 Characterization of Pellets

11.8 Delivery Aspects of Pellets for Herbal Actives

11.9 Regulatory Considerations Toward Clinical Translation

11.10 Marketed Products

11.11 Conclusion and Future Perspective

Acknowledgments

Conflict of Interest

References

12 Hydrogels as Delivery Systems in Herbal Medicine

Objectives

12.1 Introduction

12.2 Application of Hydrogels

12.3 Benefits of Hydrogels in Delivering Herbal Medicine

12.4 Hydrogels as an Effective Delivery of Nanocarrier System

12.5 Modification in Hydrogel Properties to Effectively Deliver Herbal Medicine

12.6 Formulation of Hydrogels to Precisely Deliver Herbal Medicine

12.7 Challenges Associated with the Delivery of Hydrogels

12.8 Conclusion and Future Prospects

References

13 Emulsions and Self‐Emulsifying Delivery Systems for Herbal Actives

Objectives

13.1 Introduction

13.2 Emulsions

13.3 Composition of Emulsion

13.4 Thermodynamics of EMs

13.5 Preparation Methods

13.6 Characterization of Emulsions

13.7 Optimization of Emulsions

13.8 Herbal‐Active Loaded Emulsions

13.9 Clinical Studies

13.10 Conclusion and Future Perspectives

References

Section III: Advanced Formulations

14 Chronotherapeutic Delivery Systems

Objectives

14.1 Introduction

14.2 Principles of Biological Clock

14.3 Need for a Chronotherapeutic Drug Delivery System

14.4 Mechanisms of Chronotherapeutic Drug Delivery Systems

14.5 Development of Chronotherapeutic Delivery Systems

14.6 Technological Advancement in Chronotherapeutic Drug Delivery Systems

14.7 Phytomedicine‐Loaded Chronotherapeutic Drug Delivery Systems in Therapeutic Intervention

14.8 Chinese Herbal Medicines‐Incorporated Chronotherapeutic Drug Delivery Systems

14.9 Herbal Excipients Modulating Chronotherapeutic Drug Delivery Systems

14.10 Clinical Translation and Patented Chronotherapeutic Drug Delivery Systems‐Based Formulations

14.11 Challenges/Hurdles in Chonopharmaceutical Drug Research and Development

14.12 Conclusion and Future Perspectives

References

15 Liposomes‐Based Delivery of Phytoconstituents

15.1 Introduction

15.2 Types of Liposomes

15.3 Preparation of Liposomes by Different Methods

15.4 Delivery of Phytoconstituents Using Liposomes

15.5 Conclusion

Acknowledgments

References

16 Nanoparticles‐Mediated Delivery of Herbal Actives

16.1 Introduction

16.2 General Principles of Nanoparticle‐Mediated Herbal Actives

16.3 Types of Herbal Nanoformulations

16.4 Methods of Preparation for Herbal Active Nanoformulations

16.5 NPs Mediated Delivery of Herbal Actives to Treat Different Diseases

16.6 New Approaches, Challenges, and Limitations of Herbal‐Mediated Nanoformulation

16.7 Clinical Trials and US Food and Drug Administration‐Approved Herbal Active Nanoformulations

16.8 Conclusion and Future Prospective

References

17 Herbal Extracts and Phytoconstituents‐Loaded Transferosomes, Ethosomes, and Transdermal Patches in Drug Delivery

Objectives

17.1 Introduction

17.2 Delivery Aspects

17.3 Transferosomes

17.4 Ethosomes

17.5 Transdermal Patches

17.6 Challenges in Herbal Active Delivery

17.7 Conclusion

References

18 Dendrimers as Nanocarriers for Phytoceuticals

18.1 Introduction

18.2 Principles of Dendrimers

18.3 Types of Dendrimers

18.4 Dendrimer Formulations

18.5 Preparation Process

18.6 Toxicity of Dendrimers

18.7 Challenges for Herbal Actives

18.8 Examples of Dendrimer‐Based Delivery of Phytoconstituents

18.9 Preclinical Studies

18.10 Conclusion

References

19 Applications of Carbon‐Based Nanomaterials for the Delivery of Herbal Molecules

19.1 Introduction

19.2 Properties of Herbal Molecules

19.3 Challenges Associated with the Delivery of Herbal Molecules

19.4 Role of Nanocarriers in Herbal Molecule Delivery

19.5 Characteristics of Carbon‐Based Nanomaterials for Herbal Molecule Delivery

19.6 Classification of Carbon‐Based Nanomaterials

19.7 Applications of Carbon‐Based Nanomaterials in Herbal Molecule Delivery

19.8 Conclusion and Future Perspectives

Acknowledgments

References

20 Phytoconstituents and Plant Extract‐Based Formulations for Wound Healing

20.1 Introduction

20.2 Mechanism of Wound Healing

20.3 Wound Classification

20.4 Factors Affecting Wound Healing

20.5 Nanocarrier in Wound Dressing

20.6 Medicinal Plants in Wound Healing/Plant Extracts, Extract Fractions and Phytoconstituent and Plant Extract Used in Wound Healing

20.7 Plant‐Derived Phytoconstituent and Extract‐Based Formulation for Wound Healing

20.8 Clinical Trials

20.9 Role of Different Plants in Wound Healing

20.10 Marketed Formulations/Commercial Products

20.11 Some Patented Innovations in Wound Healing

20.12 Future Directions and Challenges

20.13 Conclusion

References

21 Chemo‐Herbal Combination Drug Delivery for Cancer Management

21.1 Introduction

21.2 Challenges in Targeting Chemo‐Herbal Drugs: Overcoming Physicochemical, Biological, and Physiological Barriers for Effective Drug Delivery

21.3 Optimizing Drug Delivery Strategies for Chemo‐herbal Drugs: Overcoming Barriers and Enhancing Therapeutic Efficacy with Effective Targeting

21.4 Delivery Aspects of Chemo‐Herbal Formulation in Cancer Therapy

21.5 Clinical Trials of Chemo‐Herbal Formulations

21.6 Conclusion and Future Perspective

References

22 Protein Nanocarriers for the Delivery of Phytoconstituents

22.1 Introduction

22.2 Protein Nanocarriers

22.3 Methods of Preparation of Protein‐Based Nanocarriers

22.4 Protein Nanocarriers for Phytoconstituents Delivery

22.5 Prospects of Nanotechnology for Delivery Purposes

22.6 Current Scenario and the Path Ahead

22.7 Conclusions

References

Section IV: Regulatory Challenges

23 Nonclinical Characterization and Documentation for Marketing Authorizations of Herbal Formulations

23.1 Introduction

23.2 Nonclinical Characterization of Herbal Formulations: Pharmacodynamics, Toxicology and Pharmacokinetic Studies

23.3 Regulatory Approvals for Marketing Herbal Formulations: A Global Overview of Documentation Requirements

23.4 Challenges

23.5 Conclusion

References

24 Quality Challenge in Regulatory Approval of Medicinal Products Containing Combinations of Herbal Substances

24.1 Introduction to Phytomedicines

24.2 Classification of Herbal Medicines Based on Regulatory Frameworks and Standards

24.3 Quality Challenges Related to Herbal Medicines

24.4 Global Regulatory Landscape of Herbal Medicines

24.5 WHO Regulatory Guidelines on GMP, GACP and Quality Control of Herbal Medicines

24.6 Development and Standardization of Herbal Medicines

24.7 Challenges in the Development of Herbal Medicines

24.8 Conclusion

References

25 Evidence‐Based Clinical Assessment of Herbal Formulations: Traditional and Modern Insights

25.1 Introduction

25.2 Indian Traditional Medicine

25.3 Modern Herbal Medicine

25.4 Regulatory Guidelines

25.5 Validation Approaches and Clinical Assessments

25.6 Obstacles to Clinical Assessment of Herbal Formulations

25.7 Conclusion

References

26 Patient Safety Issues with Herbal Substances and Formulations

26.1 Introduction

26.2 World Health Organization Regulatory Guidelines for Safety of Herbal Medicines

26.3 European Guidelines for the Herbal Medicines

26.4 Indian Regulations for Herbal Medicines

26.5 USFDA Guidelines for Herbal Medicines

26.6 Safety of Herbal Medicinal Products

26.7 Hepatotoxicity Caused by Herbal Medicines

26.8 Nephrotoxicity Induced by Herbal Drug Medicines

26.9 Genotoxicity Induced by Herbal Drug Medicines

26.10 Other Toxicities Induced by Herbal Drug Medicines

26.11 Conclusion

Acknowledgment

References

Index

End User License Agreement

List of Tables

Chapter 1

Table 1.1 Some phytoconstituents derived from natural plants and re...

Table 1.2 Some phytoconstituent‐based modern medicinal products app...

Table 1.3 Some nutraceutical/dietary supplement products approved b...

Table 1.4 Raw materials generally used in herbal cosmetics/cosmeceu...

Table 1.5 Some cosmeceutical products approved by FDA/EMA or other ...

Chapter 2

Table 2.1 Relative polarity index of various solvents majorly used ...

Chapter 3

Table 3.1 Selected examples of droplet countercurrent chromatograph...

Table 3.2 Selected examples of high‐speed countercurrent chromatogr...

Table 3.3 Selected examples of centrifugal partition chromatography...

Table 3.4 Application of gas chromatography/gas chromatography‐mass...

Table 3.5 Examples depicting the application of planar chromatograp...

Table 3.6 Comparative summary of HPLC techniques.

Table 3.7 Selected examples of the different column chromatographic...

Table 3.8 Examples of metabolomics and chemical fingerprinting.

Table 3.9 Examples of bio‐assay‐guided isolation.

Chapter 4

Table 4.1 Examples of natural polysaccharides, structure, and sourc...

Table 4.2 Summary of natural polysaccharides‐based herbal formulati...

Chapter 5

Table 5.1 Illustration of herbal moiety‐based drug delivery system....

Table 5.2 List of several herbal bioactive formulations.

Table 5.3 Several clinical trials of herbal actives.

Table 5.4 List of marketed herbal actives drug delivery system.

Chapter 6

Table 6.1 Natural small molecules found in herbal drugs, nutraceuti...

Table 6.2 Nutraceuticals, their uses, and some branded products.

Table 6.3 Small natural molecules used in herbal cosmetics.

Table 6.4 Herbal drug and allopathic drug interaction.

Table 6.5 Bioavailability of some herbal phytochemicals.

Table 6.6 Enzymes involved in the metabolism of natural products....

Table 6.7 Factors affecting bioavailability of herbal actives.

Table 6.8 Nano herbal formulations in drug, cosmetic, and nutraceut...

Table 6.9 Phytochemical alterations in herbal drugs, nutraceuticals...

Table 6.10 Bioenhancers used in herbal drugs, cosmetics, and nutra...

Table 6.11 Phytochemical synergism in herbal drugs, nutraceuticals...

Table 6.12 Biological approaches to enhance bioavailability in her...

Table 6.13 Co‐administration of herbal formulations, their uses, a...

Table 6.14 Comparison of herbal active with small molecules (synth...

Chapter 7

Table 7.1 HPLC methods for assessing the stability of herbal formul...

Table 7.2 HPTLC methods for assessing the stability of herbal formu...

Table 7.3 Gas chromatography methods for assessing the stability of...

Chapter 8

Table 8.1 Synthetic superdisintegrants.

Table 8.2 Natural disintegrants used in manufacturing FDDFs.

Table 8.3 Some studies on ODTs comprising herbal active ingredients...

Table 8.4 Some studies on ODFs comprising herbal active ingredients...

Table 8.5 Natural film‐forming polymers.

Table 8.6 Clinical trials of herbal FDDFs.

Table 8.7 Marketed formulation of herbal FDDFs.

Chapter 9

Table 9.1 Factors affecting the process of mucoadhesion.

Table 9.2 Similarities and dissimilarities of different transmucosa...

Table 9.3 Some non‐exhaustive list of studies on intranasal transmu...

Table 9.4 Oromucosal herbal formulations comprising herbal active i...

Table 9.5 Rectal transmucosal herbal formulations.

Table 9.6 Vaginal transmucosal herbal formulations.

Table 9.7 Transmucosal delivery of phytoconstituents.

Table 9.8 Clinical trials on transmucosal herbal formulations.

Table 9.9 Some marketed formulations of herbal transmucosal product...

Chapter 10

Table 10.1 Classification of SD based on molecular arrangement and...

Table 10.2 Different types of hydrophilic carriers used in SD form...

Table 10.3 Classes of commonly used carriers and excipients in the...

Table 10.4 Characterization techniques for SD‐based products.

Table 10.5 Drug delivery applications of SD from a pharmacokinetic...

Table 10.6 Drug delivery applications of SD from a pharmacodynamic...

Chapter 11

Table 11.1 Scale of flow property.

Table 11.2 Summarization of case studies of herbal pellets.

Table 11.3 Marketed herbal pellet formulations.

Chapter 12

Table 12.1 Applications of herbal medicine‐loaded hydrogels.

Table 12.2 Phytoconstituent‐based hydrogel formulations.

Table 12.3 Herbal extract‐based hydrogel formulations.

Table 12.4 Natural polymers employed for the formulation of hydrog...

Table 12.5 Specifications indicating the design of hydrogels.

Table 12.6 Challenges and solutions on herbal‐based hydrogel formu...

Table 12.7 Herbal extract‐based hydrogel commercial medications an...

Chapter 13

Table 13.1 Surfactants used in the formulation of EMs and SEDDSs....

Table 13.2 Reported studies describing the formulation of emulsion...

Table 13.3 Selected clinical studies conducted on the herbal activ...

Chapter 14

Table 14.1 Herbal medications loaded chronotherapeutic drug delive...

Chapter 15

Table 15.1 Types of liposomes on the basis of size and number of l...

Table 15.2 Types of liposomal vesicles produced through different ...

Table 15.3 Classification of liposomes based on their composition....

Table 15.4 Types of liposomes based on stimuli.

Table 15.5 Summary of the benefits and drawbacks of the many stand...

Table 15.6 Different liposomal delivery with phytoconstituents in ...

Table 15.7 Liposomal‐based marketed anticancer liposomal formulati...

Table 15.8 Delivery of phytoconstituents by different routes of ad...

Table 15.9 Delivery of phytoconstituents using liposomes for the t...

Chapter 16

Table 16.1 A brief overview of lipid‐based herbal nanoformulations...

Table 16.2 Polymer‐based herbal nanoformulations.

Table 16.3 A summary of inorganic nanocarriers also utilized in he...

Table 16.4 Clinical trials and FDA‐approved herbal nanoformulation...

Chapter 17

Table 17.1 Plant extract‐loaded transferosome formulation.

Table 17.2 Phytoconstituents loaded transferosome formulations.

Table 17.3 Plant extract‐loaded ethosome formulation.

Table 17.4 Some phytoconstituents‐loaded ethosome formulations.

Table 17.5 Plant extract or phytoconstituents loaded marketed form...

Table 17.6 Plant extract‐loaded transdermal patch formulations.

Table 17.7 Phytoconstituent‐loaded transdermal patch formulations....

Table 17.8 Plant extract or phytoconstituents loaded marketed tran...

Table 17.9 Transdermal patch formulations investigated for clinica...

Chapter 18

Table 18.1 Glimpses of studies based on phytoconstituent‐loaded de...

Table 18.2 Preclinical studies on phytoconstituent–dendrimer conju...

Chapter 19

Table 19.1 The applications of various carbon‐based nanomaterials ...

Chapter 20

Table 20.1 Plant‐derived phytoconstituent‐based formulations inves...

Table 20.2 Plant‐derived extract‐based formulations for wound heal...

Table 20.3 Plant‐derived phytoconstituent‐based formulations inves...

Table 20.4 Some clinical trials performed on plant‐based formulati...

Table 20.5 Commercially available herbal wound healing formulation...

Table 20.6 Patents on phytoconstituents or extracts for wound heal...

Chapter 21

Table 21.1 Representing challenges associated with monochemotherap...

Table 21.2 Depiction of various methods of preparation of drug del...

Table 21.3 Summary of delivery systems encapsulated with herbal me...

Table 21.4 Summary of delivery systems encapsulated with herbal an...

Table 21.5 Summary of delivery systems encapsulated with herbal an...

Table 21.6 Summary of delivery systems encapsulated with herbal an...

Table 21.7 Summarizing some of chemo‐herbal drugs reached at clini...

Chapter 22

Table 22.1 Examples of phytoconstituents encapsulated in nanocarri...

Table 22.2 Potential of nanotechnology with its advantages and dis...

Chapter 23

Table 23.1 Recommended non – clinical pharmacokinetic assays (ADME...

Table 23.2 An overview of various regulatory landscapes and docume...

Table 23.3 An overview of various regulatory landscapes and docume...

Table 23.4 An overview of regulatory landscapes and documentation ...

Table 23.5 An overview of regulatory landscapes and documentation ...

Table 23.6 An overview of various regulatory landscapes and docume...

Chapter 24

Table 24.1 Various pharmacopoeias and their count for number of si...

Table 24.2 Schedules related to herbal medicines in D&C Act, 1940 ...

Table 24.3 Regulatory landscape of herbal medicines in rest of the...

Chapter 25

Table 25.1 Plant species with carcinogenic and hepatotoxic effects...

Table 25.2 WHO guidelines and resources on clinical trials.

Table 25.3 EMA guidelines and resources about clinical trials.

Table 25.4 FDA guidelines and resources on clinical trials.

Table 25.5 Indian guidelines on clinical trials for herbal drug pr...

Table 25.6 Details of a few herbs and their reported side effects ...

Chapter 26

Table 26.1 Classification of herbal medicines.

Table 26.2 Common contaminants and residues present in herbal prod...

Table 26.3 Adverse effects caused or induced by phytoconstituents....

List of Illustrations

Chapter 1

Figure 1.1 Challenges for the Ayurvedic system of medicine.

Figure 1.2 Validation of Ayurvedic medicines.

Chapter 2

Figure 2.1 Protocol in brief for standardization of medicinal plan...

Figure 2.2 Different types of extraction methods.

Figure 2.3 Factors affecting the selection of extraction method.

Figure 2.4 Phytochemical test for standardization of medicinal pla...

Figure 2.5 Standardization of medicinal plant extracts for identif...

Chapter 3

Figure 3.1 Graphical representation of the techniques employed in ...

Figure 3.2 Non‐chromatographic separation techniques.

Figure 3.3 Chemical structures of lycorine‐type alkaloids isolated...

Figure 3.4 Phytoconstituents of

Cannabis sativa

essential oil.

Figure 3.5 Chromatographic separation techniques.

Figure 3.6 Metabolomics flowchart.

Chapter 4

Figure 4.1 Applications of natural polysaccharides in the pharmace...

Chapter 5

Figure 5.1 (a) Controlled medication delivery systems for dissolut...

Figure 5.2 (a) Penetration of MDA‐MB‐231 tumor spheres by Cou‐6‐la...

Chapter 6

Figure 6.1 Classification of herbal medicines.

Figure 6.2 Classification of nutraceuticals.

Figure 6.3 Stability issues with herbal formulations.

Figure 6.4 Factors affecting bioavailability of herbal active.

Figure 6.5 Factors affecting the pharmacokinetics of herbal formul...

Chapter 7

Figure 7.1 Representative chromatogram of 6‐gingerol (RT 13.78 min...

Figure 7.2 Representative chromatograms illustrating fingerprintin...

Figure 7.3 Representative HPTLC chromatogram depicting degradation...

Figure 7.4 DSC thermograms of NIPRIMAL

®

under (a) room temper...

Figure 7.5 Steps involved in LCMS‐based fingerprinting analysis of...

Figure 7.6 GC‐MS‐based fingerprint analysis of

Houttuynia cordata

...

Figure 7.7 Steps involved chemometric‐based assessment of quality ...

Figure 7.8 A TQM approach representing 6M principle to maintain qu...

Figure 7.9 World map representing the different herbal regulations...

Chapter 8

Figure 8.1 Various mechanistic theories of disintegration: (a) swe...

Chapter 9

Figure 9.1 Different stages in the process of mucoadhesion.

Figure 9.2 Transcellular and paracellular permeation.

Figure 9.3 Nasal mucosa.

Figure 9.4 Trigeminal and olfactory epithelium pathways enable dir...

Figure 9.5 Structure of oral mucosa.

Figure 9.6 Rectal veins assist in absorption.

Figure 9.7 Vaginal mucosa.

Chapter 10

Figure 10.1 Benefits of developing solid dispersions (SDs) for he...

Figure 10.2 Schematic representation of spray drying process.

Figure 10.3 Schematic illustration of the hot melt extrusion (HME...

Figure 10.4 Schematic representation of the freeze‐drying process...

Chapter 11

Figure 11.1 Pellets for the delivery of herbal actives for the ma...

Figure 11.2 Possible interactions in phytoconstituents.

Figure 11.3 Various phenomena of pelletization.

Figure 11.4 Pelletization techniques.

Figure 11.5 Extrusion–spheronization process.

Figure 11.6 Diameter measurement of particles: Martin diameter, f...

Figure 11.7 Schematic illustration of the generation of personali...

Chapter 12

Figure 12.1 Classification of hydrogels depending on various prop...

Figure 12.2 Various phases of contact dermatitis therapy with a h...

Figure 12.3 An

in vitro

assessment of cytotoxicity and cell migra...

Figure 12.4 The viability of MG‐63 cells was evaluated for O.S hy...

Figure 12.5 Administration of the

S. trifasciata

leaf extract hyd...

Figure 12.6 The

S. trifasciata

hydrogel extract exhibits a notabl...

Figure 12.7 Wound closure percentage at various time points: (a) ...

Figure 12.8 Figure depicting different administration routes of h...

Figure 12.9 ((a–d) showing % of wound contraction) Topical applic...

Figure 12.10 Figure showing the combination of HC along with CMC...

Figure 12.11 Formation of

in situ

gelling, hydrazone‐cross‐linke...

Figure 12.12 Schematic diagram illustrating the formulation of a...

Figure 12.13 The impact of various ratios of

Calendulae flos

lyo...

Figure 12.14 The influence of various ratios of the

Calendulae f

...

Figure 12.15 A schematic illustration of hydrogel synthesis, dep...

Chapter 13

Figure 13.1 Structures of selected saturated lipid phases.

Figure 13.2 Schematic representation of the preparation of o/w (a...

Figure 13.3 Pictorial representation of the pseudo‐ternary phase....

Figure 13.4 Schematic representation of the fate of emulsions in ...

Chapter 14

Figure 14.1 Role of chronotherapeutics purporting time‐regulated ...

Figure 14.2 Concise description of the physiological functions of...

Chapter 15

Figure 15.1 General structural representation of liposomes.

Figure 15.2 Different routes for the delivery of liposomes.

Chapter 16

Figure 16.1 Strategies for the development and integration of tra...

Figure 16.2 Aschematic depiction of the general nanocarriers for ...

Figure 16.3 The (A) bottom‐up and (B) top‐down approaches for the...

Figure 16.4 General method of preparation for HPH.

Figure 16.5 Challenges and approach for the successful delivery o...

Chapter 17

Figure 17.1 Pathways of nose‐to‐brain delivery.

Figure 17.2 (a) Structure and layers of skin; (b) routes of perme...

Figure 17.3 Paracellular permeation of transferosomes.

Figure 17.4 Structure of transferosome.

Figure 17.5 Structure of ethosome.

Figure 17.6 Structure of transdermal patch.

Chapter 18

Figure 18.1 Structure of dendrimer with generations 1, 2, and 3....

Figure 18.2 Enhancement of oral absorption of CPT by PAMAM dendri...

Chapter 19

Figure 19.1 Chemical structures of different phytochemicals.

Figure 19.2 Schematic representation of various carbon‐based nano...

Chapter 20

Figure 20.1 Schematic diagram of methods and various studies on p...

Figure 20.2 Mechanism of wound healing.

Figure 20.3 Classification of wounds.

Figure 20.4 Role of nanocarriers in wound dressing.

Figure 20.5 Overview of cellular signaling pathways impacted by v...

Chapter 21

Figure 21.1 Significance of nanoparticles in delivery of chemo‐he...

Figure 21.2 Diagrammatic representation of beneficial aspects of ...

Figure 21.3 (a) Passive targeting and (b) active targeting approa...

Chapter 22

Figure 22.1 Some commonly used animal‐ and plant‐based protein st...

Chapter 23

Figure 23.1 Various steps in non‐clinical drug development.

Chapter 24

Figure 24.1 Morphine, one of the first isolated alkaloids.

Figure 24.2 Pacific yew tree (

Taxus brevifolia

).

Figure 24.3 Tu Youyou, Chinese scientist, Nobel Prize in Physiolo...

Figure 24.4 Various chemical constituents from plants.

Figure 24.5 Interactions of Tannins.

Figure 24.6 Representation of three different regulatory pathways...

Figure 24.7 Process of Herbal Drug Development.

Guide

Cover

Table of Contents

Title Page

Copyright

Dedication

List of Contributors

Foreword by Prof. J.M.S. Rana

Foreword by Prof. Anil Bhandari

Preface

Begin Reading

Index

End User License Agreement

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Formulating Pharma‐, Nutra‐, and Cosmeceutical Products from Herbal Substances

Dosage Forms and Delivery Systems

Edited by

Anupama SinghSchool of Pharmaceutical Sciences and TechnologySardar Bhagwan Singh UniversityDehradun, UttarakhandIndia

Hitesh KulhariSchool of Nano SciencesCentral University of GujaratGandhinagar, GujaratIndia

Vikas Anand SaharanDepartment of Pharmaceutical Technology (Formulations)National Institute of Pharmaceutical Education and Research Guwahati (NIPER‐G)Changsari, AssamIndia

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Dr. Anupama Singh and Dr. Vikas Anand Saharan would like to dedicate this book to their sons Inesh and Krit whose smiles and tantrums have added color and vibrancy to their writing experience.

List of Contributors

Mayur Aalhate

Department of PharmaceuticsNational Institute of Pharmaceutical Education and Research (NIPER), HyderabadHyderabad, TelanganaIndia

Garima Agarwal

Faculty of PharmacySchool of Pharmaceutical and Populations Health InformaticsDIT UniversityDehradun, UttarakhandIndia

Priyanka Arora

Department of PharmaceuticsNational Institute of Pharmaceutical Education and Research (NIPER)‐RaebareliLucknow, Uttar PradeshIndia

Paresh Badgujar

Department of Pharmaceutical Engineering and TechnologyIndian Institute of Technology (BHU)Varanasi, Uttar PradeshIndia

Sangita V. Badgujar

Department of PharmacognosyR. C. Patel Institute of PharmacyShirpur, MaharashtraIndia

Rinku Baishya

Chemical Science & Technology DivisionCSIR‐North East Institute of Science and TechnologyJorhat, AssamIndia

Debadri Banerjee

School of Pharmaceutical Sciences and TechnologySardar Bhagwan Singh UniversityDehradun, UttarakhandIndia

Surojit Banerjee

School of Pharmaceutical Sciences and TechnologySardar Bhagwan Singh UniversityDehradun, UttarakhandIndia

Raju Barman

Organic and Medicinal Chemistry DivisionCSIR‐Indian Institute of Chemical BiologyKolkata, West BengalIndia

and

Academy of Scientific and Innovative Research (AcSIR)Ghaziabad, Uttar PradeshIndia

Shivangi Bharadwaj

Department of PharmacyBanasthali Vidyapith UniversityBanasthali, RajasthanIndia

Samir Bhargava

Faculty of PharmacySchool of Pharmaceutical and Populations Health InformaticsDIT UniversityDehradun, UttarakhandIndia

Rajveer Bhaskar

Department of Industrial Pharmacy and Quality AssuranceR. C. Patel Institute of Pharmaceutical Education and ResearchShirpur, MaharashtraIndia

Ngangom Bidyarani

Department of Environmental SciencesFaculty of ScienceThe Maharaja Sayajirao University of BarodaVadodara, GujaratIndia

Dheeraj Bisht

Devsthali Vidyapeeth College of Pharmacy (Veer Madho Singh Bhandari Uttarakhand Technical University, Dehradun)Rudrapur, UttarakhandIndia

Shradha Bisht

Uttaranchal Institute of Pharmaceutical SciencesUttaranchal UniversityDehradun, UttarakhandIndia

Saumyadeep Bora

School of Nano SciencesCentral University of GujaratGandhinagar, GujaratIndia

Akanksha Chaturvedi

Department of PharmaceuticsNational Institute of Pharmaceutical Education and Research (NIPER)‐RaebareliLucknow, Uttar PradeshIndia

Sushil K. Chaudhary

Institute of Bioresources and Sustainable Development (IBSD)Imphal, ManipurIndia

Siddheshwar Kisan Chauthe

Department of Natural Products National Institute of Pharmaceutical Education and Research‐Ahmedabad (NIPER‐A)Gandhinagar, GujaratIndia

Laltanpuii Chenkual

Department of Pharmaceutical AnalysisNational Institute of Pharmaceutical Education and Research‐Guwahati (NIPER‐G)Changsari, AssamIndia

Swati Dobhal

School of Pharmaceutical Sciences and TechnologySardar Bhagwan Singh UniversityDehradun, UttarakhandIndia

Priyanka Dubey

Department of PharmacyBanasthali Vidyapith UniversityBanasthali, RajasthanIndia

Ujala Gupta

Department of PharmaceuticsNational Institute of Pharmaceutical Education and Research (NIPER), HyderabadHyderabad, TelanganaIndia

Nitin G. Haswani

Department of Pharmaceutical ChemistryR. C. Patel Institute of PharmacyShirpur, MaharashtraIndia

Aachal Hedaoo

Pharmaceutical Innovation and Translational Research Lab (PITRL)Department of PharmaceuticsNational Institute of Pharmaceutical Education and Research (NIPER), HyderabadHyderabad, TelanganaIndia

Keshav Hirave

Department of Pharmaceutical Technology (Formulations)National Institute of Pharmaceutical Education and Research-Guwahati (NIPER-G)Changsari, AssamIndia

Mahima Jadav

School of Nano SciencesCentral University of GujaratGandhinagar, GujaratIndia

Nitish S. Jangwan

Department of Pharmacognosy and PhytochemistrySchool of Pharmaceutical SciencesDelhi Pharmaceutical Sciences and Research UniversityNew Delhi, New DelhiIndia

Payal Kesarwani

Department of PharmacyRameesh Institute of Vocational and Technical EducationGreater Noida, Uttar PradeshIndia

Pooja Khairnar

Pharmaceutical Innovation and Translational Research Lab (PITRL)Department of PharmaceuticsNational Institute of Pharmaceutical Education and Research (NIPER), HyderabadHyderabad, TelanganaIndia

Payal Khesarwani

Department of PharmacyRameesh Institute of Vocational and Technical EducationKnowledge Park IGreater NoidaUttar PradeshIndia

Tejaswini Kolipaka

Pharmaceutical Innovation and Translational Research Lab (PITRL)Department of PharmaceuticsNational Institute of Pharmaceutical Education and Research (NIPER), HyderabadHyderabad, TelanganaIndia

Hitesh Kulhari

School of Nano SciencesCentral University of GujaratGandhinagar, GujaratIndia

Bhavna Kumar

Faculty of PharmacySchool of Pharmaceutical and Populations Health InformaticsDIT UniversityDehradun, UttarakhandIndia

Deepak Kumar

Organic and Medicinal Chemistry DivisionCSIR‐Indian Institute of Chemical Biology (IICB)Kolkata, West BengalIndia

and

Academy of Scientific and Innovative Research (AcSIR)Ghaziabad, Uttar PradeshIndia

Umesh Kumar

Nutrition Biology DepartmentSchool of Interdisciplinary and Applied SciencesCentral University of HaryanaMahendragarh, HaryanaIndia

Kajal Kumari

Department of PharmacyBanasthali Vidyapith UniversityBanasthali, RajasthanIndia

Dimple S. Lalchandani

Department of Pharmaceutical AnalysisNational Institute of Pharmaceutical Education and Research‐Guwahati (NIPER‐G)Changsari, AssamIndia

Srushti Mahajan

Department of PharmaceuticsNational Institute of Pharmaceutical Education and Research (NIPER), HyderabadHyderabad, TelanganaIndia

Indrani Maji

Department of PharmaceuticsNational Institute of Pharmaceutical Education and Research (NIPER), HyderabadHyderabad, TelanganaIndia

Abhishesh K. Mehata

Department of Pharmaceutical Engineering and TechnologyIndian Institute of Technology (BHU)Varanasi, Uttar PradeshIndia

Nirmal Morya

Department of Pharmaceutical Technology (Formulations)National Institute of Pharmaceutical Education and Research-Guwahati (NIPER-G)Changsari, AssamIndia

Madaswamy S. Muthu

Department of Pharmaceutical Engineering and TechnologyIndian Institute of Technology (BHU)Varanasi, Uttar PradeshIndia

Brahmaji R. Mutyala

Department of Pharmaceutical AnalysisA. U. College of Pharmaceutical SciencesAndhra UniversityVisakhapatnam, Andhra PradeshIndia

Monika Ola

Department of PharmaceuticsR. C. Patel Institute of PharmacyShirpur, MaharashtraIndia

Giriraj Pandey

Pharmaceutical Innovation and Translational Research Lab (PITRL)Department of PharmaceuticsNational Institute of Pharmaceutical Education and Research (NIPER), HyderabadHyderabad, TelanganaIndia

Shuchi Patel

School of PharmacyNational Forensic Sciences UniversityGandhinagar, GujaratIndia

Pradeep S. Patil

Department of PharmaceuticsR. C. Patel Institute of PharmacyShirpur, MaharashtraIndia

Umesh K. Patil

Department of Pharmaceutical SciencesDr. Harisingh Gour Vishwavidyalaya (A Central University)Sagar, Madhya PradeshIndia

Vivek Phatale

Pharmaceutical Innovation and Translational Research Lab (PITRL)Department of PharmaceuticsNational Institute of Pharmaceutical Education and Research (NIPER), HyderabadHyderabad, TelanganaIndia

Deep Pooja

Parul Institute of Pharmacy & ResearchParul UniversityVadodara, GujaratIndia

Pawan K. Porwal

Department of Pharmaceutical AnalysisNational Institute of Pharmaceutical Education and Research‐Guwahati (NIPER‐G)Changsari, AssamIndia

Radha Prasanna

Division of MicrobiologyIndian Agricultural Research InstituteNew Delhi, New DelhiIndia

Aditi Puranik

Department of Natural ProductsNational Institute of Pharmaceutical Education and Research‐Ahmedabad (NIPER‐A)Gandhinagar, GujaratIndia

Nandkishor Rajankar

Department of PharmaceuticsNational Institute of Pharmaceutical Education and Research (NIPER), HyderabadHyderabad, TelanganaIndia

Soham Rajyaguru

Department of Natural ProductsNational Institute of Pharmaceutical Education and Research‐Ahmedabad (NIPER‐A)Gandhinagar, GujaratIndia

Vijay S. Rana

Faculty of PharmacySchool of Pharmaceutical and Populations Health InformaticsDIT UniversityDehradun, UttarakhandIndia

Kajal Rathod

Department of Natural ProductsNational Institute of Pharmaceutical Education and Research‐Ahmedabad (NIPER‐A)Gandhinagar, GujaratIndia

Shruti Richa

Department of PharmacyBanasthali Vidyapith UniversityBanasthali, RajasthanIndia

Khushi Rode

Department of PharmaceuticsNational Institute of Pharmaceutical Education and Research (NIPER), HyderabadHyderabad, TelanganaIndia

Vikas Anand Saharan

Department of Pharmaceutical Technology (Formulations)National Institute of Pharmaceutical Education and Research-Guwahati (NIPER-G)Changsari, AssamIndia

Deepali Sammal

School of PharmacyNational Forensic Sciences UniversityGandhinagar, GujaratIndia

Shreya Sen Sarma

Organic and Medicinal Chemistry DivisionCSIR‐Indian Institute of Chemical Biology (IICB)Kolkata, West BengalIndia

and

Academy of Scientific and Innovative Research (AcSIR) Ghaziabad, Uttar Pradesh India

Neeraj K. Sethiya

Faculty of PharmacySchool of Pharmaceutical and Populations Health InformaticsDIT UniversityDehradun, UttarakhandIndia

Aseem Setia

Department of Pharmaceutical Engineering and TechnologyIndian Institute of Technology (BHU)Varanasi, Uttar PradeshIndia

Pooja Shah

School of Pharmaceutical Sciences and TechnologySardar Bhagwan Singh UniversityDehradun, UttarakhandIndia

Shreyansh Sharma

School of PharmacyNational Forensic Sciences UniversityGandhinagar, GujaratIndia

Swapnil Sharma

Department of PharmacyBanasthali Vidyapith UniversityBanasthali, RajasthanIndia

Kirti Shirsath

Department of PharmaceuticsNational Institute of Pharmaceutical Education and Research (NIPER), HyderabadHyderabad, TelanganaIndia

Rahul Shukla

Department of PharmaceuticsNational Institute of Pharmaceutical Education and Research (NIPER)‐RaebareliLucknow, Uttar PradeshIndia

Anupama Singh

School of Pharmaceutical Sciences and TechnologySardar Bhagwan Singh UniversityDehradun, UttarakhandIndia

Biswajit Singh

Organic and Medicinal Chemistry DivisionCSIR‐Indian Institute of Chemical Biology (IICB)Kolkata, West BengalIndia

Chandrashekar Singh

Department of Pharmaceutical Engineering and TechnologyIndian Institute of Technology (BHU)Varanasi, Uttar PradeshIndia

Mamta F. Singh

College of PharmacyCOER UniversityRoorkee, UttarakhandIndia

Pankaj K. Singh

Department of PharmaceuticsNational Institute of Pharmaceutical Education and Research (NIPER), HyderabadHyderabad, TelanganaIndia

Manmohan Singhal

Faculty of PharmacySchool of Pharmaceutical and Populations Health InformaticsDIT UniversityDehradun, UttarakhandIndia

Saurabh Srivastava

Pharmaceutical Innovation and Translational Research Lab (PITRL)Department of PharmaceuticsNational Institute of Pharmaceutical Education and Research (NIPER), HyderabadHyderabad, TelanganaIndia

Puja Tripathy

Organic and Medicinal Chemistry DivisionCSIR‐Indian Institute of Chemical Biology (IICB)Kolkata, West BengalIndia

Kulandaivelu Velmourougane

Agricultural MicrobiologyICAR‐Central Institute for Cotton ResearchNagpurIndia

Kanika Verma

Department of PharmacyBanasthali Vidyapith UniversityJaipurRajasthanIndia

Nishi Yadao

Department of Natural ProductsNational Institute of Pharmaceutical Education and Research‐Ahmedabad (NIPER‐A)Gandhinagar, GujaratIndia

Foreword by Prof. J.M.S. Rana

The dynamic intersection of pharmaceutical, nutraceutical, and cosmeceutical sciences with traditional herbal medicine presents an exciting frontier in modern healthcare. Driven by the growing demand for safer, more sustainable, and holistic approaches to wellness, a global resurgence of interest in natural remedies has potentially emerged. This trend has significantly been propelled by advancements in biotechnology, analytical techniques, and drug delivery systems, enabling the development of sophisticated dosage forms derived from herbal substances. Therefore, in an era where the convergence of traditional herbal wisdom and modern scientific innovation is more crucial than ever before, the book, Formulating Pharma‐, Nutra‐, and Cosmeceutical Products from Herbal Substances: Dosage Forms and Delivery Systems, stands as a beacon of knowledge and expertise. Authors have meticulously compiled a comprehensive guide that bridges the gap between ancient herbal practices and contemporary formulation science, encompassing theoretical concepts and practical applications. This book delves into the intricate processes of developing pharmaceutical, nutraceutical, and cosmeceutical products from herbal substances. It provides a detailed exploration of extraction, isolation, characterization, various novel dosage forms, and delivery systems, ensuring a dividend to readers in terms of a profound understanding of the complexities involved in creating effective and safe products.

Herbal substances, long been used in traditional medicinal systems, offer a vast reservoir of bioactive compounds with potential therapeutic benefits. However, harnessing the full potential of these substances requires a careful understanding of their pharmacological properties, stability, bioavailability, and interactions within the human body. The formulations of pharmaceuticals, nutraceuticals, and cosmeceuticals from herbal sources encounter unique challenges, especially in terms of standardization, optimization of dosage forms, and effective delivery to target sites. This book addresses these challenges through a multidisciplinary lens, integrating principles from pharmacognosy, pharmaceutics, biotechnology, and cosmetic sciences. It serves as a comprehensive guide for researchers, formulators, and industry professionals seeking to bridge the gap between traditional herbal remedies and modern therapeutic practices.

The resurgence of interest in herbal medicine has brought traditional formulations to the forefront of modern healthcare. Different sections of this book delve into the key aspects of herbal formulations, right from the selection of raw materials to the design of cutting‐edge delivery systems. These sections also offer insights into current trends, regulatory considerations, and scientific rigor required to bring herbal‐based products to the global market.

The sections “Introduction and Basic Principles” “Conventional Formulations” demonstrates the enduring relevance of conventional methods in today's herbal medicine landscape. It also serves as a vital resource for understanding the foundational techniques and methods, in practice for centuries, to harness the therapeutic potential of herbs. Authors have explored various extraction methods employed to obtain active ingredients from herbal sources, providing a solid foundation for anyone looking to delve into herbal extraction. The section covers a wide range of dosage forms ensuring that the readers gain a thorough understanding of how to create effective and reliable herbal products. As stability and preservation are crucial aspects of herbal formulations, this section offers valuable insights into maintaining the efficacy of herbal products under natural preservatives to optimal storage conditions. The guidelines provided here are essential for ensuring the longevity and potency of herbal remedies.

Due to innovative techniques and advanced formulations, the field of herbal medicine is undergoing a remarkable transformation. As the field of herbal medicine continues to evolve, the development of advanced formulations has become increasingly important. The section, “Advanced Formulations” delves into the cutting‐edge techniques and innovative approaches that are shaping the future of herbal product development. The latest advancements in extraction technologies from supercritical fluid extraction to ultrasonic‐assisted extraction emphasize enhanced efficiency and precision in obtaining bioactive compounds from herbal sources paving the way for more potent and effective products. The exploration of novel dosage forms is another highlight of this section. Advanced delivery systems such as nanoparticles, liposomes, carbon nanotubes, and transdermal patches have been discussed in detail. Displaying their potential to improve the bioavailability and therapeutic efficacy of herbal substances represents a significant leap forward in herbal medicine. Encapsulation techniques are another focal point, with detailed insights into microencapsulation and nanoencapsulation. These methods protect sensitive herbal ingredients and control their release, ensuring stability and effectiveness in the final product. These real‐world applications demonstrate the transformative potential of advanced techniques in herbal medicine. It is a testament to the ongoing innovation in herbal medicine and the exciting possibilities that lie ahead.

The journey of bringing herbal formulations to market is fraught with regulatory complexities and challenges. The section, “Regulatory Challenges” offers a comprehensive overview of the hurdles and considerations involved in navigating the regulatory landscape for herbal products. In this section, readers will gain detailed insights into the intricacies of regulatory frameworks that govern herbal formulations, across various regions, which are essential for ensuring compliance and facilitating the approval process. The section also addresses the documentation and evidence requirements necessary for regulatory approval, right from clinical trials to quality control measures. This section guides readers through the essential steps to meet these stringent requirements. As safety and efficacy are of paramount importance in the approval process, this section delves into the methods and standards used to evaluate these critical aspects of herbal formulations. Understanding these evaluation criteria is crucial for developing products that meet regulatory standards and gain market approval. The section also explores the challenges of standardization in herbal formulations. Given the natural variability of herbal substances, achieving consistent quality and potency is a significant challenge. This section provides essential knowledge and guidance in understanding and addressing regulatory challenges to bring safe and effective herbal products to the market.

Thus, the book sets up a high standard for quality and efficacy in the industry and offers invaluable insights and practical guidance for well‐formulated herbal products. It is a testament to the authors' dedication in advancing the science of herbal formulations and their commitment to improving public health through natural and holistic alternatives. I am confident that this book will serve not only as an essential technical resource for researchers, formulators, practitioners, and industry professionals but also as an inspiration for future advancements in this field while blending tradition with innovation and excellence to unlock the full potential of herbal substances in human health and wellness.

I heartfully congratulate Dr. Anupama Singh, Dr. Hitesh Kulkari, and Dr. Vikas Anand Saharan for their tireless efforts in compiling this book and commend all of them for their contributions to advancing this important area of research and development.

Professor (Dr.) J.M.S. RanaFormer DirectorUttarakhand State Biotechnology DepartmentGovernment of UttarakhandFormer Member and ChairmanUttarakhand Public Service Commission20 October 2024

Foreword by Prof. Anil Bhandari

It gives me immense pleasure to introduce the book Formulating Pharma‐, Nutra‐, and Cosmeceutical Products from Herbal Substances: Dosage Forms and Delivery Systems published by Wiley and edited by Dr. Anupama Singh, Dr. Hitesh Kulhari, and Dr. Vikas Anand Saharan. The editors have done a herculean task by dedicating their endless time and efforts to bring out this comprehensive resource.

The book is aptly organized into four main sections:

Introduction and Basic Principles (

Chapters 1

–

6

):

This section lays the groundwork for understanding the properties, extraction, and characterization of herbal substances, as well as the principles of drug delivery and formulation design.

Conventional Formulations (

Chapters 7

–

13

):

This section explores traditional dosage forms, such as tablets, capsules, and liquids, and discusses the challenges and strategies associated with formulating herbal substances into these formats.

Advanced Formulations (

Chapters 14

–

22

):

This section into cutting‐edge technologies and delivery systems, including nanoparticles, liposomes, and transdermal patches, that offer enhanced efficacy, bioavailability, and targeted delivery of herbal actives.

Regulatory Challenges (

Chapters 23

–

26

):

This section provides an overview of the regulatory landscape governing herbal products, addressing issues such as quality control, safety assessment, and clinical trials.

Ancient systems of medicine, like Ayurveda, Traditional Chinese Medicine, Homeopathy, and many others, have a rich history of using plants and natural substances for healing, and they often lack scientific rigor and technological advancements. Modern sciences, such as chemistry and pharmacology, can help identify and isolate the active compounds in traditional medicinal plants. Herbal actives can then be studied in greater detail to understand their mechanisms of action and potential therapeutic applications. Additionally, modern analytical techniques can be used to assess the quality and purity of herbal preparations. Furthermore, advancements in formulation technology can enable the development of more effective and efficient formulations and delivery systems for herbal medicines, such as targeted drug delivery or controlled‐release formulations. This can help to maximize the therapeutic benefits of herbal actives while minimizing potential side effects.

Beyond the technical aspects, the book provides valuable insights into the preclinical and clinical assessment of herbal products and subsequently the regulatory scenarios across the globe which is vital in translating the product from research to the patient. This book covers a wide range of applications, including wound healing and cancer treatment.

I believe this book will serve as a valuable reference for students, researchers, and industry professionals in the fields of pharmacy, cosmetics, herbal medicines, and nutraceuticals.

Dr. Anil BhandariProfessor, PharmacyJai Narain Vyas UniversityJodhpur20 October 2024

About the Editors

Dr. Anupama Singh received her masters degree from BR Nahata College of Pharmacy, and her PhD from Jodhpur National University. She has 17 years of teaching and research experience. She has supervised 16 MPharm students and is currently guiding 3 PhD scholars. Her work has resulted in the publication of 1 book, 18 book chapters, 30 research/review papers in national and international journals, and 72 presentations/abstracts at scientific meetings, conferences, and workshops. Currently, she serves as the professor and head of the Department of Pharmacognosy at the School of Pharmaceutical Sciences and Technology, Sardar Bhagwan Singh University. Her research interests include pharmacognosy, extraction, isolation, and herbal formulations.

Dr. Hitesh Kulhari is an assistant professor at the School of Nano Sciences, Central University of Gujarat, Gandhinagar. He has also worked as an associate professor and in‐charge of Department of Pharmaceutical Technology (Formulations) at National Institute of Pharmaceutical Education and Research (NIPER), Guwahati, Assam. Dr. Kulhari has received his PhD degree from RMIT University, Melbourne, Australia. He has about 13 years of teaching and research experience. His research focus is on designing of targeted drug delivery systems and pharmaceutical nanotechnology. He has published 91 journal publications in peer‐reviewed international journals, 21 book chapters, and edited 04 books.

Dr. Vikas Anand Saharan is an associate professor in the Department of Pharmaceutical Technology (Formulations) at NIPER Guwahati. He holds degrees from SBSPGI, NIPER Mohali, and Mohanlal Sukhadia University, with additional qualifications in IPR, patent laws, and regulatory affairs. With 23 years of teaching and research experience, he has guided 58 MPharm and 2 PhD students and currently supervises 7 Ph.D. scholars. His research focuses on formulation development, taste masking, particle engineering (microparticles/nanoparticles/solid‐state), and oral drug delivery. He has authored 66 articles in journals, 32 book chapters, and 5 edited books, and serves as an editorial board member of several journals. Dr. Anand received the AICTE MODROBS grant and DoP CoE grant and multiple honors, including the Teacher of the Year Award (2022), Prof. M.L. Schroff Pharma Recognition Award, and an Honour Award from Seth GL Bihani Shiksha Trust. Notably, he was listed among the world's top 2% scientists (2024) by Elsevier.

Preface

Herbs have been an essential part of the human healthcare system for centuries in various traditional medicinal systems like Ayurveda, Traditional Chinese Medicine, Siddha, Unani, Homeopathy, and many more. With the advancement of science, many phytoconstituents, like paclitaxel, vincristine, digoxin, resveratrol, etc., have been isolated and assessed for their therapeutic, cosmetic, or nutritional benefits. Developments in formulation technologies helped in addressing various formulation concerns of both phytoconstituents and extracts to overcome their challenges in developing robust herbal drug products.

This book titled Formulating Pharma‐, Nutra‐, and Cosmeceutical Products from Herbal Substances: Dosage Forms and Delivery Systems