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HERBALS IN
PHARMACEUTICAL
INDUSTRY
www.PharmInfopedia.com
 INRODUCTION
 Approaches to Herbal Formulation
Development
 Standardization of Herbs
 Marketing of Herbal Formulations...
INTRODUCTION
www.PharmInfopedia.com
Results of Patient Survey
Questionnaire
3106 patients were surveyed……..
 22% of presurgical patients reported the use of
...
Why Herbal Products In
Demand
 Placebo effect - Mind over Matter
 Placebos do what you think they will do
 Placebos wor...
Two Sides to Herbs
 Assumed herbs have only benefits
 Two sides to herbs
 Most herbs have mostly placebo effects
with m...
Herbs Are Safe
 Herbs are the source of some potent
pharmaceutical medications
 extremely useful, and potentially fatal
...
Not Well-Tested
 Because herbs are classified as a “dietary
supplements” not “food” or “drugs” they
do not have to have g...
Lack Quality Control
 Because herbs are classified as “dietary
supplements” they do not have the
quality control standard...
Potency Imprecise
 Potency of an herbal products can vary
 Plant variety
 Part of plant used
 Environmental conditions...
Interact With Medications
 Herbs contain active ingredients that act
like drugs
 Interact with other herbs or
pharmaceut...
Approches to Herbal Formulation
Development
As a formulator one has two major options
 The conventional or traditional do...
Conventional or traditional dosage form
 Ark - Obtained by distillation of water soaked
drugs in ark-yantra
 Asva/Arista...
Conventional or traditional dosage form…
 Churna - A form of powder
 Ghrita - Ghee is boiled with
decoctions(kasayas) or...
Conventional or traditional dosage form…
 Lepa - Paste for external applications
 Satva/Dravya - Drug is cut into small ...
 Low calorie high intensity natural sweeteners
 Sweet protein plants native to West Africa
 Thaumatin (T. danielli) – 3...
Modern concept of dosage form
 Tablet (Plain or sugar coated or film
coated)
 Lozenges,
 Capsule (hard or soft),
 Liqu...
Choice of Herbal Ingredients
After finalizing the dosage form one
intend to prepare, the herb or herb
part is selected
 B...
Choice of Herbal Ingredients
 Powders of the herb or herb part so
selected may be used as such, if they
are potent enough...
Factors affecting the choice of processing
method
 Shodhan
 Proper choice of solvent
 Choice of process
 How to admix ...
 Shodhan - which involves the
detoxifying/purifying the herb or herb part
with cow urine, to make the herb safe.
 Proper...
 Choice of process - manufacturing
process/equipments should keep in view
the thermostability of the active
constituent(s...
Number of Herbal Ingredients :
 This must be kept to the minimum subject to
the therapeutic efficacy in minimum
dosage, t...
Herbal Tablet
 The dried herb extract is admixed with
starch, tragacanth, gums, to act as
binders/ disintegrators and lub...
Herbal liquid orals
 Herb or herb part, coarsely or finely powdered is
extracted with water (by hot or cold process),
con...
Procurement of proper herb
 Names of the herbs mentioned in the scriptures
and ancient literature does not match the loca...
Anamolies in nomenclature of herbs
Local
Name
Botanical origin
Brahmi Bacopa monnieri or Centella asiatica
Babuna Matricar...
Identification of the herb
Macroscopy
Microscopy
www.PharmInfopedia.com
Identification of the herb
 Fluorescence studies :
 The fluorescence is unique under UV light
for certain herbs.
 Quali...
Checking the quality of the herb
The herb is subjected to the following
various parameters singly or in
combination to ens...
Checking the quality of the herb
 Foreign matter
 Any non-specified part of the plant or
matter should not exceed the
pr...
Checking the quality of the herb
 Instrumental Analysis :
 Microbial Contamination
www.PharmInfopedia.com
Toxicity studies
 The herbs mentioned in the scriptures and
ancient literature  should be first tested for
toxicity, if a...
Plant Name Reported Toxicity
Atropa belladonna Hallucinogenic
Aconitum spp. Irregularity of heart beat
Colchicum autumnale...
Points to ensure quality of herbs
 Herbs procured are collected only when their
active principles are maximum
 Unwanted ...
Parameters of the Finished
Product
 The finished product should be
standardized in terms of
 shelf life,
 colour,
 tas...
WHO Guidelines – Assessment for
modern herbal medicines
 Pharmaceutical assessment
 Crude plant material
 Plant prepara...
PACKAGING AND STORAGE
 It provides an image of the final product and
serves as an identity of certain medicines.
 Packag...
MARKETING
 The industry is largely informal and
undeveloped despite it size, economic
value and cultural importance.
 Th...
MARKETING
 Phytomedicines are marketed, but there is strict
control exercised. The information given must
be reliable, ac...
Patients Use Herbs but Doctors
are Reluctant to Prescribe
Them. Why?
 Knowledge deficit
 Tradition
 Real concerns about...
Guidelines For Using Herbs
 Purchase standardized herbal products
 specified amount of active ingredient
 reputable com...
Guidelines For Using Herbs
 Stop taking an herb if any side effect
develops such as allergy, stomach upset,
skin rash or ...
Echinacea St. John’s Wort Valerian Ephedra
Garlic Ginkgo Kava
Some Very Popular Herbs
www.PharmInfopedia.com
List of Reference
 UTMB— http://atc.utmb.edu/altmed —
Resources: HealthNotes Online
 NIH--- www.nccam.nih.gov
 American...
www.PharmInfopedia.com
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Herbals

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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.
  • Transcript of "Herbals"

    1. 1. HERBALS IN PHARMACEUTICAL INDUSTRY www.PharmInfopedia.com
    2. 2.  INRODUCTION  Approaches to Herbal Formulation Development  Standardization of Herbs  Marketing of Herbal Formulations  Guidelines for Using Herbs  List of References  Questions www.PharmInfopedia.com
    3. 3. INTRODUCTION www.PharmInfopedia.com
    4. 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 www.PharmInfopedia.com
    5. 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 www.PharmInfopedia.com
    6. 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 www.PharmInfopedia.com
    7. 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 www.PharmInfopedia.com
    8. 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 www.PharmInfopedia.com
    9. 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 www.PharmInfopedia.com
    10. 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 www.PharmInfopedia.com
    11. 11. Interact With Medications  Herbs contain active ingredients that act like drugs  Interact with other herbs or pharmaceutical medications www.PharmInfopedia.com
    12. 12. Approches to Herbal Formulation Development As a formulator one has two major options  The conventional or traditional dosage form,  Modern concept www.PharmInfopedia.com
    13. 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 www.PharmInfopedia.com
    14. 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. www.PharmInfopedia.com
    15. 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. www.PharmInfopedia.com
    16. 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 www.PharmInfopedia.com
    17. 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. www.PharmInfopedia.com
    18. 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 www.PharmInfopedia.com
    19. 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. 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 www.PharmInfopedia.com
    21. 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). www.PharmInfopedia.com
    22. 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. www.PharmInfopedia.com
    23. 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. www.PharmInfopedia.com
    24. 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. www.PharmInfopedia.com
    25. 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. . www.PharmInfopedia.com
    26. 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. 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 www.PharmInfopedia.com
    28. 28. Identification of the herb Macroscopy Microscopy www.PharmInfopedia.com
    29. 29. Identification of the herb  Fluorescence studies :  The fluorescence is unique under UV light for certain herbs.  Qualitative test using UV, TLC, HPTLC : www.PharmInfopedia.com
    30. 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 www.PharmInfopedia.com
    31. 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. . www.PharmInfopedia.com
    32. 32. Checking the quality of the herb  Instrumental Analysis :  Microbial Contamination www.PharmInfopedia.com
    33. 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 www.PharmInfopedia.com
    34. 34. Plant Name Reported Toxicity Atropa belladonna Hallucinogenic Aconitum spp. Irregularity of heart beat Colchicum autumnale Kidney damage Hyocyamus niger Hallucinogenic www.PharmInfopedia.com
    35. 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. 36. Parameters of the Finished Product  The finished product should be standardized in terms of  shelf life,  colour,  taste,  toxicity studies and  biological assay www.PharmInfopedia.com
    37. 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 www.PharmInfopedia.com
    38. 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. www.PharmInfopedia.com
    39. 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. 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. 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 www.PharmInfopedia.com
    42. 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 www.PharmInfopedia.com
    43. 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 www.PharmInfopedia.com
    44. 44. Echinacea St. John’s Wort Valerian Ephedra Garlic Ginkgo Kava Some Very Popular Herbs www.PharmInfopedia.com
    45. 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   www.PharmInfopedia.com
    46. 46. www.PharmInfopedia.com
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