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provides a large surface area which improves absorption and solubility that increase cellular
uptake of bioactive by the gastrointestinal membrane. Similarly, nanoemulsion could be used
for transdermal and topical administration of herbal drugs as this route avoids the first-pass
metabolism of bioactive and is able to release active constituents in a targeted and controlled
manner resulting in the decreased side effect and less dose requirement. Various factors are
considered in the development of topical/transdermal nanoe mulsion systems such as hydra-
tion time, penetration enhancer, skin condition, age, site of application, and temperature.
Herbal bioactives like epicatechin, gallate, caffeine, curcumin, and herbal extracts have
been found very effective when delivered in the form of topical nanoemulsion [53,54].
5. Conclusion
Herbal drugs/extracts have regained attention worldwide, especially after the COVID-19
pandemic. Standardized herbal product with assured safety and pharmacokinetic profiling is
the need of the hour. Such value-added products are being developed with the help of nano-
technology and are termed phyto-nanomedicine. Nanoparticles-based herbal products offer
high stability and shelf life as well. However, there are no clear guid elines available for herbal
phytomedicine and their quality assurance. Future calls for viewing many of these products
are available for diverse medical applications.
FIGURE 8.3 Representation of various techniques for development of nanoemulsion, difference between oil-in-
water and water-in-oil emulsion and advantages of nanoemulsion.
8. Nanophytomedicine: nanotechnology for herbal product development and value addition208
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Safety considerations,
regulatory, and commercial
aspects
SECTION III
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9
Phytopharmaceuticals and herbal
drugs: prospects and safety issues in
the delivery of natural products
Gaurav Gopal Naik
1
, Alakh N. Sahu
1
, Vichitra Kaushik
2
,
Atul Kaushik
3
and Biresh Kumar Sarkar
4
1
Department of Pharmaceutical Engineering & Technology, IIT (BHU), Varanasi, Uttar
Pradesh, India;
2
Shanti Niketan College of Pharmacy, Mandi, Himachal Pradesh, India;
3
Asmara College of Health Sciences, Asmara, Eritrea;
4
Central Ayurveda Research Institute,
CCRAS, Ministry of Ayush, Kolkata, West Bengal, India
1. Introduction
Herbal drugs and their derivatives have been used for centuries in various therapeutic sys-
tems worldwide, including the Indian medicinal system, Chinese medicinal system, African
medicinal system, Sowa-Rigpa, and others. Natural products have long been an imperative
source of novel medications. It may also be supported by the fact that about 506 of the
1881 new approved medications between January 1, 1981, and September 30, 2019, are either
natural products, a natural product derived/derivatives, natural product botanicals, or nat-
ural product pharmacophores [1]. According to the United Nations Convention on Biological
Diversity (UNCBD), preservation of biological diversity and sustai nable utilization are signif-
icant for meeting the world population’s health, food, and other needs.
People’s confidence in superst itions, folklore, or scientific wisdom guides the traditional
use of various medicinal plants. Some herbal medicine treatments have been transferred
from generation to generation. Ancient physicians like Charaka and Sushruta received heav-
enly medicinal wisdom, opening up new paths to treat complicated ailments in current times.
Natives, particularly tribes, have a solid commitment to traditional herbal therapy since they
are obligated to maintain their traditions while also unable to acquire contemporary medi-
cines. Natural ingredients or their derivatives are used in a vast number of allopathic
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Phytopharmaceuticals and Herbal Drugs
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treatments. Quinine, an antimalarial medication, was discovered in cinchona bark, atropine
in nightshade, aspirin in Willow tree bark, digoxin in digitalis, and so on.
Herbal medicines differ from chemical treatments in two ways: they employ raw herbs
and are used for a lengthy period. A singl e herb can have many natural ingredients, and a
mixture of herbs can have even more. Because the ingredients in whole medicinal plants
and their extracts function in concert, long-term usage has been demonstrated to have sub-
stantial benefits. However, as the medicine approval process does not allow for unsorted
mixes of natural compounds, there is relatively little research on whole plants. It would
take a long time to extract each active constituent from each herb. Owing to their easy acces-
sibility, lesser-known adverse effects, traditional values, cost, and other factors, herbal med-
ications are among the most widely accepted and chosen therapy options for various
common disorders worldwide. Herbal medications are the first line of defense in the manage-
ment of unknown diseases and pandemics. People in villages, isolated locations, and lower
socioeconomic groups rely primarily on herbal treatments to meet their medical needs. The
Ministry of Health and Family Welfare (Department of Health and Family Welfare), Govern-
ment of India, New Delhi, has included phytopharmaceutical drugs in regulation 2 of the
Drugs and Cos metics Rules, 1945 clause. ASU drugs are all medicines intended for internal
or external use for the diagnosis, treatment, mitigation, or prevention of disease or disorder in
humans or animals, and manufactured exclusively according to the formulae described in the
authoritative books of Ayurveda, Siddha, and Unani Tibb systems of medicine. On the other
hand, Phytopharmaceutical medications are a subset of crude extract that has been refined
and standardized.
A purified and standardized fraction of a medicinal plant extract or its part, with a defined
minimum of four bioactive or phyt ochemical compounds (quantitatively and qualitatively
assessed) for internal or external use by humans or animals for diagnosis, treatment, mitiga-
tion, or prevention of any disease or disorder is referred to as a phytopharmaceutical drug [2]. A
minimum of four bioactive/phytochemical substances ought to be discovered. It is preferable
if they are all bioactive; therefore, the requirement of identifying at least four chemicals from
the fraction is unavoidable. Depending on the justification, the number of bioactive chemicals
may be examined on a case-by-case basis. It is governed by the Central Drugs Standard Con-
trol Organization’s separate regulations (CDSCO).
This gazette notification establishes regulatory requirements for phytopharmaceuticals
and submission requirements for scientific data on efficacy, safety, and quality to analyze
and market herbal drugs in the same way that synthetic chemical moieties are marketed.
A single plant is used to create a phytopharmaceutical medication. Phytopharmaceutical is
a balanced method that trusts everything while emphasizing the revalidation of plant mate-
rial specifications. As a result, it differs from the development of traditional Ayurvedic, Sid-
dha, and Unani (ASU) medications and mainstream NCE-based drugs.
Clinical studies f or phytopharmaceutical medications should follow the same criteria and
guidelines that apply to new drugs. Before conducting the trials, data from phase I (t o deter-
mine the maximum tolerated dose and associated toxicities) and the procedures must be
submitted for all phytopharmaceutical medicines. Before conducting the research, the
data from the dose-finding studies and the procedures must be provided. The studies
may be abridged, changed, or relaxed if the phytopharmaceutical medicine has been on
the market for more than five years or if there is sufficient published data regarding the
9. Phytopharmaceuticals and herbal drugs: prospects and safety issues in the delivery of natural products216
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safety of the phytopharmaceutical drug. Th e Schedule M of the D and C Rules specifies the
standards for manufacturing pharmaceuticals under Good Manufacturing Practices (GMP).
However, no speci fic GMP guideline for phytopharmaceutical medications has been final-
ized as of yet. The ingredients and stage of processing would determine the GMP require-
ments. A common GMP requirement across the chain-raw herb (cultivation/collection/
drying/minimal processing/storage and transportation) may be recognized: botanical pro-
cessing such as grinding, extraction, fractionation steps, other unit operations such as pack-
ing, and bulk storage, tray drying, spray drying, etc., formulation (compatibility with
excipients/dosage form used for product formulation/various procedures involved in the
production, etc.) needs to be employed. This sector is projected to develop further in the
future, and for the time being, we must implement methods and documentation that avoid
degradation and contamination, and maintain the integrity and quality of the final phyto-
pharmaceutical product. Phytoph armaceutical medications in parenteral dosage forms are
not eligible for market approval.
Many people began to favor herbal treatments over allopathic pharmaceuticals as side ef-
fects and toxicological consequences became more common, owing to the former’s safety
even at higher doses. Are these phytopharmaceuticals and natural products, on the other
hand, truly safe and free of serious adverse effects? Don’t they have an effect on organ
viability over time? We hope to highlight some of the safety factors considered while
designing phytopharmaceuticals to deliver natural products in this book chapter.
2. Safety issues
2.1 Preformulation issues
Preformulation is a field of pharmaceutical science that determines the physicochemical
qualities of medicinal plant material using biopharmaceutical principles. It is the study of a
natural product’s physicochemical properties, whether single or mixed, to generate a safe
and effective herbal medicinal product for usage. It is the initial step in the rational formula-
tion of natural products’ dosage forms. It is a study of the physicochemical properties of nat-
ural products on their own and in combination with additional substances called excipients.
Characterization of the therapeutic molecule is an essential step in the preformulation phase
of herbal product development. It also comprises accelerated stability (stress) investigations,
the development of stability-indicating analytical methods, and other physicochemical char-
acterization targeted to detect stability concerns and enable formulation improvement. Ad-
vances in the pharmaceutical industry have resulted in the evolution of a new class of
drugs known as phytopharmaceuticals. As per Indian phytopharmaceutical authority these
include purified and standardized fraction with defined minimum four bioactive or phyto-
chemical compounds (qualitatively and quantitatively assessed) of an extract of a medicinal
plant or its part, fo r internal or external use of human beings or animals for diagnosis, treat-
ment, mitigation, or prevention of any disease or disorder but does not include administra-
tion by parenteral route. This approach, on the other hand, conflicts with the treatment
concepts outlined in Ayurvedic writings. The industry should develop new formulations
while keeping in mind the fundamental principles of Bhaishajya Kalpana (Ayurvedic
2. Safety issues 217
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