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1. Herbal Medicine
Development
There has been an alarming increase in the number of
diseases and disorders caused by synthetic drugs
prompting a switch over to traditional natural medicine.
Herbal medicines are being used by nearly about 80%
of the world population, primarily in developing
countries for primary health care

2. Plants, as a whole or their parts or exudates,
are subjected to certain treatments such as
extraction, distillation, purification,
concentration or fermentation to obtain
herbal preparations
Herbal Medicine
Development

3. Stability is defined as the capacity of a drug substance
or drug product to remain within established
specifications to maintain its identity, strength, quality,
and purity throughout the retest or expiration dating
periods.
Currently, the usage of standardized extract in natural
medicines has become common and popular
Herbal Medicine
Development

4. Declaration of herbal
substances and herbal
preparations in herbal
medicinal products/traditional
herbal medicinal products -
Scientific guideline
https://www.ema.europa.eu/en/human-regulatory/research-
development/scientific-guidelines/multidisciplinary/herbal-
medicinal-products-scientific-guidelines

5. Herbal Medicine
Development
Definitions
Traditional herbal medicinal products: are
medicinal products for human use that fulfil the
conditions laid down in article 16a (1) of Directive
2001/83/EC, as amended.

6. Herbal Medicine
Development
Herbal substances: all mainly whole, fragmented or
cut plants, plant parts, algae, fungi, lichen in an
unprocessed, usually dried form but sometimes fresh.
Certain exudates that have not been subjected
to a specific treatment are also considered to be
herbal substances.
Herbal substances are precisely defined by the plant
part used and the botanical name according to the
binomial system (genus, species, variety and author).

7. Herbal Medicine
Development
Definitions
Herbal preparations: are obtained by subjecting herbal
substances to treatments such as extraction,
distillation, expression, fractionation, purification,
concentration or fermentation. These include
comminuted or powdered herbal substances,
tinctures, extracts, essential oils, expressed juices
and processed exudates.

8. Herbal Medicine
Development
Definitions
Herbal medicinal products: any medicinal product,
exclusively containing as active substances one
or more herbal substances or one or more herbal
preparations, or one or more such herbal
substances in combination with one or more such
herbal preparations.

9. Herbal Medicine
Development
Herbal teas: consist exclusively of one or more herbal
substance(s) intended for oral aqueous preparations
by means of decoction, infusion or maceration.
The preparation is prepared immediately before use.
Herbal teas are usually supplied in bulk form or in
sachets
Definitions

10. Herbal Medicine
Development
Markers: are chemically defined constituents or groups
of constituents of a herbal substance, a herbal
preparation or a herbal medicinal product which are of
interest for control purposes independent of whether
they have any therapeutic activity
Markers serve to calculate the quantity of herbal
substance(s) or herbal preparation(s) in the herbal
medicinal product if the marker has been
quantitatively determined in the herbal substance or
herbal preparation

11. Herbal Medicine
Development
Active markers are constituents or groups of
constituents which are generally accepted to
contribute to the therapeutic activity.
Analytical markers are constituents or groups of
constituents that serve for analytical purposes.

12. Herbal Medicine
Development
Quantification: means adjusting the herbal substance
or herbal preparation to a defined range of
constituents (active markers) exclusively achieved
by blending different batches of herbal substances
and/or herbal preparations

13. Herbal Medicine
Development
Standardisation: means adjusting the herbal
substance/preparation to a defined content of a
constituent or a group of constituents with known
therapeutic activity respectively either by adding
excipients or by blending batches of the herbal
substance and/or herbal preparation (e.g.
standardised
extracts).

14. Herbal Medicine
Development
Declaration of herbal substances in the SmPC
1. Name of the herbal substance.
2. Quantity of the genuine herbal substance.
3. Name and quantity of the constituent(s) with
known therapeutic activity (standardised herbal
substances), if applicable.
4. Name and quantity (given as a range) of the
active markers (quantified herbal substances), if
applicable.

15. Herbal Medicine
Development
Herbal Drug Standardization and Evaluation
Standardization of herbal drugs is not an easy task
as numerous factors influence the bioefficacy and
reproducible therapeutic effect.

16. Herbal Medicine
Development
Herbal Drug Standardization and Evaluation
In order to obtain quality oriented herbal products, care
should be taken right from the
• proper identification of plants,
• season and area of collection
• their extraction and
• purification process
• rationalizing the combination in the case of polyherbal
drugs

17. Herbal Medicine
Development
The Standardization of crude drug materials
includes the following steps
1- Authentication:
a) Stage of collection.
b) Parts of the collected plant.
c) Regional status.
d) Botanical identity like phytomorphology, microscopical
and histological analysis (characteristic of cell walls, cell
contents, starch grains, calcium oxalate crystals,
trichomes, fibers, vessels etc.)

18. Herbal Medicine
Development
The Standardization of crude drug materials
includes the following steps
2- histological parameter:
a) Leaf constant
b) Trichomes
c) Stomata
d) Quantitative microscopy
e) Taxonomical identity
f) Organoleptic evaluation
g) Ash values and extractive values
h) Moisture content determination
i) Chromatographic and spectroscopic evaluation
j) Heavy metal, Pesticide residue, Microbial contamination

19. Herbal Medicine
Development
The stability parameters for the herbal formulations
Physical parameters:color, odor, appearance, clarity, viscosity,
moisture content, pH, disintegration time, friability, hardness,
flowability, flocculation, sedimentation, settling rate and ash values.
Chemical parameters:limit tests, chemical tests, chemical assays
Chromatographic analysis of herbals can be done using TLC, HPLC,
HPTLC, GC, UV, GC-MS and fluorimetry .
Microbiological parameters include total viable content, total mold
count, total enterobacterial and their count.

20. Herbal Medicine
Development
PROBLEMS RELATED TO THE HERBAL PRODUCT
STABILITY
Physical instability
• The presence of impurities and reaction
• Growth of the microorganisms
• Chemical composition of plants.
• Volatile active components

21. Herbal Medicine
Development
PROBLEMS RELATED TO THE HERBAL PRODUCT
STABILITY
Environmental conditions
Rainfall , altitude, temperature, soil, storage conditions
Different harvesting procedures, time and method of
collection,
Manufacturing processes: drying, purifying, extracting
Genetic variability: variability in the product quality,
stability and in the concentration of plant chemicals
within different products

22. Herbal Medicine
Development
PROBLEMS RELATED TO THE HERBAL PRODUCT
STABILITY
Chemical instability
degradation during storage by oxidation, hydrolysis,
crystallization, emulsion breakdown, enzymatic deterioration
and chemical reactions with the additives and excipients
Temperature and moisture are the two major factors that
affect quality and stability of a herbal product.

23. Herbal Medicine
Development
PROBLEMS RELATED TO THE HERBAL PRODUCT
STABILITY
Complex mixtures, variability and inconsistency
Herbal formulations are complex mixtures of different
components obtained during extraction process.
Each component has variable shelf-life, activity,
concentration and consistency

24. Herbal Medicine
Development
PROBLEMS RELATED TO THE HERBAL PRODUCT
STABILITY
Drug interactions, deterioration, decomposition and
Storage
• Moisture content above the critical value and mold growth
in natural products can cause the interaction of the active
components with the packaging material
• Interactions of active component with the other
ingredients
• Herbal formulations have many active constituents and
each component is having different stability conditions

25. Herbal Medicine
Development
Different techniques to deal with instability
related to natural medicines
Nanoparticle coating
Semisolid preparations based on supercritical carbon dioxide
Antioxidants and liquid formulations
Chelating agents
Tablet formulation
Use of colloidal silicon dioxide in the enhancement of the
drying of herbal preparations

26. Technologies for processing
essential oils
Schematic of steam distillation process.
• Aromatic plants account for only ~10% of
counted plant species globally (rare) e.g.
lavender/peppermint
• These synthesise a unique essence
compound which often have health
benefits due to their properties
(antibacterial/antimicrobial)
• Essential oils are extracted via steam
distillation or mechanically through cold
pressing
• Can be combined to produce natural
products such as face creams, medicines
and aromatherapy/herbal remedies

27. New technologies for processing herbs
Drying of
Herb
Grinding of
herb to powder
Evaporation
Further
processing

28. Herbal Cosmetics Bioproducts
Algae Face Mask Peppermint Foot Scrub
Soothing and Healing Benefits
• 100%
brown
algae
extract
(Alginate
)
• Algal
blooms
removals
as
possible
source
material
• Peppermint
essential oil
and volcanic
rock
granules
• Smooth hard
skin while
providing
cooling
effect

29. Essential Oils in Pharmaceuticals
Products
Tisserand Lavender Essential
Oil
Biolat ‘Silbiola’ Cream
Soothing / calming properties
• Essential
oils from
confier trees
eg pine,
spruce
• Cream for
allergy-
prone /
inflamed
skin due to
cooling and
healing
properties
• £12.95 for
just 20ml
• Organic,
pure
lavender oil
calms
anxiety,
helps
promote a
good
night’s
sleep
• Sooth
minor cuts
and grazes