About Author:
Dr. Chandirlal Varyaldas Achhra, M.Pharm , PhD in Pharmacy; LL.M, PhD in Law; M.A, PhD in Lit.
He is currently working as Director (administration) at ‘Hyderabad (Sind) National Collegiate Board, Mumbai. He was former Principal of Principal K. M. Kundnani Pharmacy Polytechnic, Ulhasnagar and also former Director of Smt. CHM College Campus, Ulhasnagar. He has 39 years of teaching and 34 years of administrative experience. He has published many research and review articles in various national / international journals of repute. He has also presented various research papers in national / international conference, seminars, symposia and workshops.
Harshal Ashok Pawar, M. Pharm., PhD (Pharmacy), MD (AM)
He is currently working as an Assistant Professor with Dr. L. H. Hiranandani College of Pharmacy, Ulhasnagar, (Affiliated to University of Mumbai, India). He has 15 years of teaching and industry research experience. He also worked as a Head of Department of Quality Assurance for six years. He worked with various pharmaceutical industries like Medley, Charak and Alkem Research Centre, Mumbai. He has published more than 60 research and review articles in various national / international journals of repute. He has also presented various research papers in national / international conference, seminars, symposia and workshops. He has two Indian and two international patents to his credit. He has received research grants from University of Mumbai. He is on editorial board and reviewer of various National / International journals. He has guided 25 M. Pharmacy Research scholars in the subject of Quality Assurance. He is also recognized PhD guide of University of Mumbai. He has authored seven books in the field of Pharmaceutical sciences. He is a life member of Association of Pharmaceutical Teachers of India (APTI).
About Book:
This book attempts to over view the concepts of formulation technology of
phytopharmaceuticals beginning from herbal raw materials, their processing
technology based on conventional and modern methods as per WHO guidelines and
their standardization using modern techniques. Further, it highlights an
excipients used in herbal formulations with concepts of pre-formulation studies
to be carried out before designing phytopharmaceuticals / herbal formulations.
This book further enlightens about design, formulation development, evaluation,
quality assurance and quality control aspects of Ayurvedic formulations,
conventional dosage forms and new drug delivery systems to ensure quality,
safety, efficacy and effectiveness. In this book, comprehensive review of
concepts of pre-clinical toxicological studies and clinical trials is also
included in order to establish clinical safety and efficacy for
phytopharmaceuticals / herbal formulations with objective of undertaking
bioavailability and bio-equivalence studies. The attempt is also made to
enlighten reader about regulatory and patenting aspects of herbal drugs and
laws regulating herbal drug industry in India. The book briefly highlights the
various legal aspects of protection of Traditional Knowledge (TK) of India
under Indian intellectual property laws and further need of strengthening the
existing statutes. The procedural aspects of patent filing are also discussed in
this book. Generally herbal products are considered safe being of natural origin
but herbal drug interactions and herbal drugs- food and herbal drugs with
prescribed drugs interactions are also well known and are discussed in detail
in this book. Drug safety monitoring of phytopharmaceuticals are also discussed
with WHO research guidelines. Lastly clinical applications of herbal drugs
although not comprehensive are highlighted.
BOOK CONTENTS
Glossary of terms
Preface
Acknowledgments
1. Introduction to phytopharmaceuticals
1.1
Introduction and background
1.2
Definitions of terms as per WHO guideines
1.3
Different systems of medicines
1.4
Drug discovery and development of drugs
from botanicals
1.5
Advantages and limitations of herbal
medicines and phytopharmaceuticals.
1.6
Challenges in the development of
phytopharmaceuticals.
1.7
Global Trends, Economics and Regulatory
Aspects.
1.8
Regulatory requirements for herbals as
drugs.
1.9
Regulatory restrictions.
1.10 Quality
Assurance in Phytopharmaceuticals.
1.11 Summary
of steps to be followed for design of phytopharmaceutical formulations from
plant source.
1.12 Future
of herbal medicines.
1.13 Conclusion.
2. Herbal Raw Materials.
2.1
Introduction
2.1.1 Definitions.
2.2 Source of herbs
2.3 Selection, Identification and
Authentication of herbal materials
2.4 Processing of herbal raw materials
2.5 Purpose of processing
2.6 Processing of herbs into herbal
materials
2.7 Processing of herbal materials into
herbal preparations
2.8 Processing of herbal materials or
herbal preparations into herbal dosage forms
2.9 Important Primary Processing steps.
2.10 Important Secondary Processing steps
2.11 Important special processes adopted
for herbal preparations from processed herbal raw
Materials as per WHO guidelines
2.12
Conclusion
3. Standardization of herbal raw
materials
3.1 Introduction and Background
3.2 Concept and scope of standardization
3.3 Methods of standardization and quality
control
3.4 Factors affecting the quality control
of herbal drugs
3.5 Analytical methods adopted in
standardization of herbal drugs
3.6 Validation for standardization of
herbal products
3.7 Labelling of herbal products
3.8 Conclusion
4. Excipients used in herbal
preparations
4.1 Introduction and background
4.2 Categorization of excipients
4.3 Excipients as per source
4.4 Commonly used excipients in herbal
formulations
4.5 Herbal excipients used in Novel Drug
Delivery Systems
4.6 Safety, Quality and Regulatory issues
of excipients
4.7 Conclusion
5. Pre-formulation Studies in
formulation development
5.1 Introduction and objectives
5.2 Factors to be considered prior to
commencement of pre-formulation studies.
5.3 Information required for
pre-formulation evaluation studies
5.4 Pre-formulation drug characterization
in a structured program.
5.5 Basic steps for pre-formulation studies
5.6 Pre-formulation studies for
phytopharmaceuticals
5.7 Conclusion
6. Herbal formulation development
6.1 Introduction and background
6.2 Types of herbal / Ayurvedic
formulations
6.3 Conventional drug delivery systems
6.4 New drug delivery systems (NDDS) are
summarized as under
6.5 Design, development and evaluation of
phytopharmaceuticals and their formulations
6.6 WHO guidelines for evaluating the
safety and efficiency of herbal medicines
6.7 Quality Assurance in herbal
formulations
6.8 Important steps of the process of
formulation development / pharmaceutical dosage form
Design (Conventional dosage forms)
6.9 Conclusion
7. Evaluation / Quality Control of
herbal formulations
7.1 Introduction and background
7.2 Evaluation and quality control tests
of dosage forms / formulations
7.3 Conclusion
8. Concepts of Pre-Clinical studies
and Clinical trials
8.1 Introduction
8.2 Types of Pre-clinical studies /
research
8.3 Toxicological study of new drug on
animals and clinical trials in humans
8.4 Conduct of Pre-clinical toxicological
tests for new drugs or drug compounds
8.5 Draft OECD guidelines for the testing
of chemicals
8.6 Definitions
8.7 OECD guidelines for testing of
chemicals OECD /OCDE 423
8.8 Procedure to be followed for each of
the starting doses
8.9 Clinical Trials in Humans
8.10 Conclusion
9. Herbal drugs and Regulatory Issues
9.1 Introduction
9.1.1 Herbal drug industry in India
9.2 Commercial aspects of herbal drugs
9.2.1 Global trends, Economics
9.2.2 Plant based industries and
institutions in India
9.3 Regulatory issues for herbals in
India
9.3.1 Ayurvedic, Siddha and Unani
drugs (ASU drugs)
9.3.2 Regulations for manufacture
and sale of ASU drugs in India
9.3.3 Features of proposed
guidelines under schedule Z
9.4 Objections filed by Ayurvedic Drug
Manufacturers Association (ADMA)
9.5 Provisions in Indian Drugs and
Cosmetics Act related to ASU drugs.
9.6 Regulatory requirements for
setting herbal drug industry.
9.7 Traditional Knowledge Digital
Library (TKDL)
9.8 Steps to be taken towards
standardization of ASU drugs
9.9 Commercial aspects of
establishing herbal industry
9.10 Organizational set up for herbal industry
(State level)
9.11 Components of Ayurvedic
medicines
9.12 Concepts of purification and
detoxification (Shodhana) of herbal drugs to ensure safety
9.13 Standardization of Ayurvedic
drugs / herbal drugs
9.14 Regulatory issues in developed
and developing countries
9.15 Conclusion
10. Patenting and Intellectual
Property Rights of herbal products / phytopharmaceuticals
10.1 Introduction:
“Intellectual Property,
Intellectual Property Rights and Patents”
10.1.1 The purpose of the
patent system
10.2 Patent Laws
10.2.1 Patent infringement
10.2.2 Patent enforcement
10.3 Patenting of life forms
10.3.1 Sui generis system of
protection of intellectual property rights.
10.3.2 Farmers Rights and
Breeder’s Rights
10.3.3 Biodiversity and
Biopiracy
10.4 Patenting aspects of Traditional
Knowledge (TK) and natural products
10.4.1 What is
Traditional Knowledge?
10.4.2 Features of
Traditional Knowledge
10.4.3 Patenting
aspects
10.4.4 Protection of
Traditional Knowledge (TK)
10.5 Protection of rights of
Traditional Knowledge holders
10.6 Indian Patent Laws and
bills for the protection of TK / Herbal / Natural products
10.7 Protection of TK / Herbal /
Natural products under intellectual property laws
10.8 TK as trade secret
10.9 Protection of TK under
the protection of plant varieties and Farmer’s Rights Act,
2001.
10.10 Protection of TK /
Herbals / Natural products under non-intellectual property
Laws.
10.10.1 under
Indian Contract Act, 1872
10.10.2 under
Biological Diversity Act
10.10.3 under the Scheduled Tribes and
other Traditional Forest Dwellers
(Recognition of Forest Rights Act), 2006.
10.10.4 Under Traditional Knowledge Digital
Library (TKDL).
10.10.5 Protection
of TK under Indian Draft Bills.
10.10.5.1 Draft
Traditional Knowledge Management Bill, 2009.
10.10.5.2 Draft
Traditioal Knowledge (Protection and
Management) Bill,
2010.
10.11 International laws related to TK
/Herbal/ Natural products
10.11.1
The international instruments dealing with TK /Herbal / Natural
Products
10.11.2 International
organizations dealing with TK / Herbal / Natural
Products.
10.12 Provisions in
US and EU Patent Laws responsible for misappropriation
Of
traditional knowledge about herbal drugs.
10.13 Patenting of
herbal products / phytopharmaceuticals in India / filing of
Patent
applications.
10.13.1
Procedure for Indian Patent filing / patent registration process
10.13.2 Patent
Registration.
10.14 Rights and
obligations of patentee
10.15 Controller of patents
10.16 Overview of
patents of medicinal plants with case studies on Turmeric
and
Neem.
10.17 Conclusion
11. Herbal Drug Interactions
11.1 Introduction
11.2 Drug-Drug interactions
11.2.1 Classification of drug
interactions
11.2.2 Conditions potentiating
the drug interactions
11.3 Food-Drug interactions
11.4 Herbal drugs-Prescribed drug
interactions
11.5 Safety monitoring of
phytopharmaceuticals / Herbal drugs / Natural medicines
11.6 WHO research guidelines for
evaluating the safety and efficacy of herbal medicines.
11.7 Drug Safety
11.8
Applications of herbal drugs
11.9 Conclusion
12. Herbal Cosmetics and
Cosmeceuticals
12.1 Introduction
12.2 Definitions
12.3 History
12.4 Advantages of herbal cosmetics over
the synthetic
12.5 Disadvantages
12.6 Herbs used in cosmetics /
cosmeceuticals
12.7 Herbal hair preparations
12.8 Cosmeceuticals
12.9 Finished product forms
12.10 Cosmetic ingredients
12.11 Evaluation of the finished products
12.12 Storage of herbal raw materials /
extracts
12.13 Regulatory Status
12.14 Conclusion
References
Publishers
