PRESENTED BY

DILLIP KUMAR JENA

Dept .of pharmaceutics and pharmaceutical Technology

L.M.College of pharmacy

INRODUCTION Approaches to Herbal Formulation

Development Standardization of Herbs Marketing of Herbal Formulations Guidelines for Using Herbs List of References Questions

INTRODUCTION

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

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

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

Herbs Are Safe

Herbs are the source of some potent pharmaceutical medicationsextremely useful, and potentially fatal

herbal products are safe because they are naturalcan be harmful if consumed

improperly or in excessive amounts

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

Lack Quality Control

Because herbs are classified as “dietary supplements” they do not have the quality control standards “drugs” do

There have been problems withIdentificationQualityContamination

Potency Imprecise

Potency of an herbal products can varyPlant varietyPart of plant usedEnvironmental conditions grownHow processed

Some standardized herbal products with known concentrations of active ingredients

Interact With Medications

Herbs contain active ingredients that act like drugs

Interact with other herbs or pharmaceutical medications

Approches to Herbal Formulation Development

As a formulator one has two major options

The conventional or traditional dosage form,

Modern concept

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

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.

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.

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

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.

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

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. :

Choice of Herbal Ingredients

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

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).

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.

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.

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.

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.

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

Identification of the herb

Macroscopy

Microscopy

Identification of the herb

Fluorescence studies : The fluorescence is unique under UV

light for certain herbs.

Qualitative test using UV, TLC, HPTLC :

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 ensuring quality herb

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. .

Checking the quality of the herb

Instrumental Analysis :

Microbial Contamination

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

Plant Name Reported Toxicity

Atropa belladonna Hallucinogenic

Aconitum spp. Irregularity of heart beat

Colchicum autumnale Kidney damage

Hyocyamus niger Hallucinogenic

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)

Parameters of the Finished Product

The finished product should be standardized in terms of shelf life, colour, taste, toxicity studies and biological assay

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

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.

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.

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.

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

Guidelines For Using Herbs

Purchase standardized herbal productsspecified amount of active ingredientreputable companyprovide the herb’s botanical scientific

name provide warnings about potential side

effectsprovide possible interactions with

pharmaceutical medications

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 womeninfants or children under six years of

age

Echinacea St. John’s Wort Valerian Ephedra

Garlic Ginkgo Kava

Some Very Popular Herbs

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