2. INRODUCTION
Approaches to Herbal Formulation
Development
Standardization of Herbs
Marketing of Herbal Formulations
Guidelines for Using Herbs
List of References
Questions
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4. Results of Patient Survey
Questionnaire
3106 patients were surveyed……..
22% of presurgical patients reported the use of
herbal remedies
51% used vitamins
Women and patients 40-60 more likely to use
herbal medicines
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5. Why Herbal Products In
Demand
Placebo effect - Mind over Matter
Placebos do what you think they will do
Placebos work about one-third of the time
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6. Two Sides to Herbs
Assumed herbs have only benefits
Two sides to herbs
Most herbs have mostly placebo effects
with minimal good and bad effects
Some herbs are more beneficial than
harmful, while others are more harmful than
beneficial
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7. Herbs Are Safe
Herbs are the source of some potent
pharmaceutical medications
extremely useful, and potentially fatal
herbal products are safe because they
are natural
can be harmful if consumed improperly or
in excessive amounts
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8. Not Well-Tested
Because herbs are classified as a “dietary
supplements” not “food” or “drugs” they
do not have to have go through the pre-
market testing that drugs and food
additives do
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9. Lack Quality Control
Because herbs are classified as “dietary
supplements” they do not have the
quality control standards “drugs” do
There have been problems with
Identification
Quality
Contamination
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10. Potency Imprecise
Potency of an herbal products can vary
Plant variety
Part of plant used
Environmental conditions grown
How processed
Some standardized herbal products with
known concentrations of active
ingredients
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11. Interact With Medications
Herbs contain active ingredients that act
like drugs
Interact with other herbs or
pharmaceutical medications
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12. Approches to Herbal Formulation
Development
As a formulator one has two major options
The conventional or traditional dosage form,
Modern concept
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13. Conventional or traditional dosage form
Ark - Obtained by distillation of water soaked
drugs in ark-yantra
Asva/Arista - Drug is soaked in solution of
jaggery and allowed to ferment.
Avaleha/Pak - Decoctions(kasayas) or
infusions (kalkas) of drug is repeatedly boiled
and condensed with jaggery
Bhasma - Prepared by heating (oxidation) of
drug
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14. Conventional or traditional dosage form…
Churna - A form of powder
Ghrita - Ghee is boiled with
decoctions(kasayas) or infusions (kalkas) of
drug.
Gutika/Bati/Pill - Pulverized drug admixed with
honey and made up into Gutika or Bati or Pill.
Kwatha - Coarse powder of drugs or in
combination for kasayas.
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15. Conventional or traditional dosage form…
Lepa - Paste for external applications
Satva/Dravya - Drug is cut into small pieces and
macerated in water overnight, strained through
cloth. process is repeated and the supernatant
liquid (Satva) is dried and powdered.
Taila - Taila is boiled with decoctions (kasayas)
or infusions (kalkas) of drug.
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16. Low calorie high intensity natural sweeteners
Sweet protein plants native to West Africa
Thaumatin (T. danielli) – 3000 X sweeter than sugar
Brazzein (P. brazzeana) - heat stable protein; j’oublie
Miraculin (R. dulcifica)
- alter sour taste to sweet
Sweet Proteins
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17. Modern concept of dosage form
Tablet (Plain or sugar coated or film
coated)
Lozenges,
Capsule (hard or soft),
Liquid orals (suspension or emulsion or
syrup),
External application (cream or
ointment) or
Sterile preparations (injectables or eye
or ear drops), etc.
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18. Choice of Herbal Ingredients
After finalizing the dosage form one
intend to prepare, the herb or herb
part is selected
Based on traditional literature
available
By phytochemical investigations of the
herb or herb part
Clinical trials/bioactivity studies of herb
or herb part
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19. Choice of Herbal Ingredients
Powders of the herb or herb part so
selected may be used as such, if they
are potent enough.
Usually, processing of herb or herb part
is desired to obtain a herbal drug of
suitable/sufficient potency. like
Extraction,
Distillation,
Fermentation, etc. : www.PharmInfopedia.com
20. Factors affecting the choice of processing
method
Shodhan
Proper choice of solvent
Choice of process
How to admix Herb Extract into the
Formulation
Number of Herbal Ingredients
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21. Shodhan - which involves the
detoxifying/purifying the herb or herb part
with cow urine, to make the herb safe.
Proper choice of solvent - keeping in view
the solubility, cost, toxicity, taxes and Law
(Drug Law and others).
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22. Choice of process - manufacturing
process/equipments should keep in view
the thermostability of the active
constituent(s) present in the herb or herb
part since the activity of the herb is
generally attributed to the complete
extract of the herb or herb part.
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23. Number of Herbal Ingredients :
This must be kept to the minimum subject to
the therapeutic efficacy in minimum
dosage, toxicity and safety of the
formulation.
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24. Herbal Tablet
The dried herb extract is admixed with
starch, tragacanth, gums, to act as
binders/ disintegrators and lubricants, as
in the case of allopathic formulations.
The tablet may then be sugar coated or
film coated or marketed plain, as such.
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25. Herbal liquid orals
Herb or herb part, coarsely or finely powdered is
extracted with water (by hot or cold process),
consistent agitation and filtration.
Extract has to be treated carefully with respect
to its pH, which must allow chemical and
physical stability of the product uniformly.
.
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26. Procurement of proper herb
Names of the herbs mentioned in the scriptures
and ancient literature does not match the local
or vernacular names at places, which at times
does not allow proper identification.
The nomenclature may change from region to
region of the same drug.
Example ‘Haritaki’ (fruit of Terminalia chebula)
of which seven varieties originating from
different parts of the country, are attributed
with different therapeutic properties.www.PharmInfopedia.com
27. Anamolies in nomenclature of herbs
Local
Name
Botanical origin
Brahmi Bacopa monnieri or Centella asiatica
Babuna Matricaria chamomilla or Corchorus
depressus
Rasna Vanda roxburghii or Pluchea lanceolata
Vadarikhand Pueraria tuberosa or Ipomea digitata
Varahikand Dioscora bulbifera or Tacca aspera
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29. Identification of the herb
Fluorescence studies :
The fluorescence is unique under UV light
for certain herbs.
Qualitative test using UV, TLC, HPTLC :
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30. Checking the quality of the herb
The herb is subjected to the following
various parameters singly or in
combination to ensure the quality of
the herb
Extractive values
Alcohol and water soluble extractives
do give an idea of the quality of the
herb.
Ash value
The Total ash, acid insoluble ash and
water soluble ash are helpful tools in
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31. Checking the quality of the herb
Foreign matter
Any non-specified part of the plant or
matter should not exceed the
prescribed limit set to ensure quality
herb.
Chemical Assay
Specific assays for active principles viz.
total alkaloids, glycosides, resins,
tannins, saponins, volatile oil contents,
etc. are carried out by chemical
means. .
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32. Checking the quality of the herb
Instrumental Analysis :
Microbial Contamination
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33. Toxicity studies
The herbs mentioned in the scriptures and
ancient literature should be first tested for
toxicity, if any, and not just be taken,
since scientific data may not be available
for them
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35. Points to ensure quality of herbs
Herbs procured are collected only when their
active principles are maximum
Unwanted foreign material free herb is made
available
Herbs procured should be graded according to
quality
Drying of herb should be under controlled
conditions, with moisture usually below 9-10%
(excess would encourage fungal growth)www.PharmInfopedia.com
36. Parameters of the Finished
Product
The finished product should be
standardized in terms of
shelf life,
colour,
taste,
toxicity studies and
biological assay
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37. WHO Guidelines – Assessment for
modern herbal medicines
Pharmaceutical assessment
Crude plant material
Plant preparations
Finished product
Stability
Activity
Evidence required to support
indication
Combination products
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38. PACKAGING AND STORAGE
It provides an image of the final product and
serves as an identity of certain medicines.
Packaging and storage is dictated by GPP
guidelines for modern medicines.
Material used for the packaging of medicines
differ for both disciplines.
Storage practices for both discipline differ, with
modern medicine being more controlled with
the methods used.
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39. MARKETING
The industry is largely informal and
undeveloped despite it size, economic
value and cultural importance.
There is no law regulating the market
due to lack of corporation between
traditional healers and health
professionals.
Healers market themselves mainly
through their patients. www.PharmInfopedia.com
40. MARKETING
Phytomedicines are marketed, but there is strict
control exercised. The information given must
be reliable, accurate, truthful, informative and
capable of substantiation.
Promotional material shall not be designed to
disguise the general public of the true nature of
the medication.
Marketing strategies must contain information
such as the active ingredients, indications,
dosing, warnings and precautions. www.PharmInfopedia.com
41. Patients Use Herbs but Doctors
are Reluctant to Prescribe
Them. Why?
Knowledge deficit
Tradition
Real concerns about product safety, drug-
herb interactions
Unnecessarily high concerns about liability
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42. Guidelines For Using Herbs
Purchase standardized herbal products
specified amount of active ingredient
reputable company
provide the herb’s botanical scientific
name
provide warnings about potential side
effects
provide possible interactions with
pharmaceutical medications
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43. Guidelines For Using Herbs
Stop taking an herb if any side effect
develops such as allergy, stomach upset,
skin rash or headache
Herbal products are not recommended
for:
pregnant or lactating women
infants or children under six years of age
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44. Echinacea St. John’s Wort Valerian Ephedra
Garlic Ginkgo Kava
Some Very Popular Herbs
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45. List of Reference
UTMB— http://atc.utmb.edu/altmed —
Resources: HealthNotes Online
NIH--- www.nccam.nih.gov
American Botanical Council —
www.herbalgram.org
Herb Research Foundation— www.herbs.org
Duke’s Phytochemical and Ethnobotanical
Database http://www.ars-grin.gov/duke
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Why Are Herbal Products In Demand
Why then are herbal products used so much and in such demand? The answer lies to some extent in the “placebo effect.” The placebo effect is a physiological improvement brought about by a psychological mechanism or “Mind over Matter.” Basically, a placebo does what you think it will do. Many scientific studies have shown that placebos work about one-third of the time. Placebos seem to work even better when the goal is a change in behavior, a sensation, or a response controlled by the endocrine gland or by the autonomic nervous system.
Two Sides to Herbs
Consumers often assume that herbs and herbal remedies have only benefits and no side effects. However, there are two sides to herbal products. For centuries herbs have been used to treat or cure or a variety of health problems. In fact some herbs are the original source of important pharmaceutical medicines. The majority of herbs have mostly placebo effects, with minimal good and bad effects. Some herbs are more beneficial than harmful, while others are more harmful than beneficial.
In this century, pharmaceutical medications have largely replaced herbs. However, the use of herbal products has reappeared in recent years. While some herbal products seem to be safe and effective, the use of herbals has created several problems.
Belief That Herbal Products Are Safe
Some of the most potent pharmaceutical medications are from herbs, digitalis from foxglove, morphine and strong painkillers from poppy seed. Although both morphine and digitalis are extremely useful, they are also both potentially fatal. The fact that a compound is found in a plant says nothing about its potential for being safe. Deaths from eating wild mushrooms are an example.
Unfortunately, some promotional literature recommends harmful or even deadly poisonous herbs. Some claims are often based on outdated or misunderstood literature, hearsay, folklore or tradition. There seems to be a false sense of security that herbal products are safe because they are natural. In fact almost the opposite is true. Most compounds have the potential to be harmful, if consumed improperly or in excessive amounts.
Herbal Products Are Not Well-Tested
Herbal products do not undergo the safety and efficacy testing required of pharmaceutical products. Unlike pharmaceutical products, information is lacking about the safety or effectiveness of most herbal remedies. It is not unrealistic to expect that of the 13,000 plants that have been used for medicinal purposes throughout the world, that may have not been tested. While herbs are diluted drugs, the effect of the active agents is often a matter of observation and tradition, rather than from extensive clinical testing.
Herbal Products Lack Quality Control
Unlike pharmaceutical medications, FDA does not enforce any standards of quality for herbal products. Since it is almost impossible for the lay person to determine the quality or even to identify an herb by visual inspection, this means that the consumer is totally dependent upon the reputation of the seller for product quality.
Many herbal products are susceptible to fraud or adulteration. One study of 54 ginseng products showed that 60 % were worthless and 25 % contained no ginseng at all. Another study of 10 St John's Wort products found that three brands had approximately half the potency listed on the label and four brands had less than 90 percent of the potency listed.
Potency of Herbal Products Is Imprecise
The potency of an herb can vary considerably depending on several factors. Herbs can contain many related active ingredients that have different speeds of action, or duration of effect. Different plant varieties vary in the amount of active ingredients they contain. What part of the plant is used can effect the potency. In addition, the environmental conditions under which an herb is grown (soil, growing season, temperature, moisture, and the maturity at harvest) can effect the potency. How an herb is processed can also effect the potency. Some active ingredients are heat sensitive and are destroyed if they are dried a high temperatures, others are destroyed by enzymatic action if they are dried at too low of a temperature.
This can lead to a dangerous situation when the consumer uses an herbal product that may have a low potency and feels all right, but the next time they use the product the potency is different. Consumers are not warned that herbs contain active ingredients that have powerful or even toxic effects if consumed in large amounts. In response to this issue some manufactures are now introducing standardized herbal products with known concentrations of active ingredients.
Herbal Products Can Interact With Pharmaceutical Medications
Because herbs contain active ingredients that act like drugs, they can interact with other herbs or pharmaceutical medications an individual in taking causing dangerous results. Information on how pharmaceutical medications interact with foods or other medications is available, but this type of information is not available for most herbs.
General Guidelines In The Use of Herbal Products
For safety, consumers are recommended to purchase standardized herbal products that contain a specified amount of an active ingredient marketed by a reputable company. Another indicator of quality is the label should contain the botanical scientific name of the herb, the name and address of the actual manufacture, and the expiration date. The label should also contain warnings about any potential side effects of the herb, and possible interactions between the herb and prescription medications.
General Guidelines In The Use of Herbal Products
Another safety recommendation is that consumers should stop taking an herb immediately if any adverse effects develop such as allergy, stomach upset, skin rash, headache
In general, herbal products are not recommended for pregnant women, lactating mothers, infants, or children under the age of six. In addition, the elderly should also be particularly cautious in using herbal products.