herbals
DESCRIPTION
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HERBALS IN PHARMACEUTICAL INDUSTRY
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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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INTRODUCTION
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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 www.PharmInfopedia.com
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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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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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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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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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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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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Interact With Medications Herbs contain active ingredients that
act like drugs
Interact with other herbs or pharmaceutical medications
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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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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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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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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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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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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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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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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. :
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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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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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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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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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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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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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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.
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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 asperawww.PharmInfopedia.com
Identification of the herb
Macroscopy
Microscopy
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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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Checking the quality of the herbThe 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 ensuring quality herb
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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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Checking the quality of the herb
Instrumental Analysis :
Microbial Contamination
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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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Plant Name Reported Toxicity
Atropa belladonna Hallucinogenic
Aconitum spp. Irregularity of heart beat
Colchicum autumnale Kidney damage
Hyocyamus niger Hallucinogenic
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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)
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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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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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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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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.
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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.
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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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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 medicationswww.PharmInfopedia.com
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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Echinacea St. John’s Wort Valerian Ephedra
Garlic Ginkgo Kava
Some Very Popular Herbs
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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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