Herbal formulations

1. HERBAL FORMULATIONS

2. Herbal formulation
Herbal formulation shall mean a dosage form consisting of one or more herbs
or processed herb(s) in specified quantities to provide specific nutritional,
cosmetic benefits, and/or other benefits meant for use to diagnose treat,
mitigate diseases of human beings or animals and/or to alter the structure or
physiology of human beings or animals.
• 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.

3. 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
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.

4. Markers
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 purpose 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 markers has been
quantitatively determined in the herbal substance or herbal preparations.

5. Challenges in Herbal formulation
• A key challenge is to objectively assess conflicting toxicological, epidemiological,
and other data and the verification of herbal materials used.
• Management within ranges of risk
• Communication of uncertainty
• Pharmacological, toxicological, and clinical documentation
• Pharmacovigilance
• Understanding why addition of harmful additives works evaluating “drug”
interactions
• Constraints with clinical trials and people available
• Standardization
•Safety, and efficacy assessment

6. Factors affecting safety and Quality
• Quality of starting materials
• Complexity of nomenclature of herbal ingredients
• Chemical contamination by Heavy metals
• Choice of chemical markers
• Adulteration with synthetic chemical drugs
• Indiscriminate harvesting and poor post-harvest treatment practices.
• Lack of research on the development of high- yielding varieties, domestication etc.
• Poor agriculture and propagation methods.
• Inefficient processing techniques leading to low yields and poor quality products.
• Poor quality control procedures.

7. Constrains of herbal formulation
• Lack of current good manufacturing practices.
• Lack of R & D on product and process development.
• Difficulties in marketing.
• Lack of trained personnel and equipment.
• Lack of facilities to fabricate equipment locally.
• Lack of access to latest technological and market information
• Drug adulteration
• Faulty collection
• Imperfect preparation
• Incorrect storage
• Gross substitution with plant material
• Substitution with exhausted drugs

8. Ayurvedic formulations
• Ayurvedic medicine originated in the early evolution of India about 3,000-5,000 years
ago.
• These formulations are taken from the ancient Vedic text or Vedas (books of
Ayurveda), the ancient religious and philosophical texts that are the oldest surviving
literature in the world, which makes Ayurvedic medicine the oldest surviving healing
system.
Type of Ayurvedic formulations
1. CLASSICAL AYURVEDIC MEDICINES
• These medicines are present in traditional Ayurvedic text books such as Charaka
Samhita, Sushruta Samhita etc. The manufacturing company follows the same formula
and prepares medicines. For e.g bhasmas, asavas, arishtas, taila etc.

9. Type of Ayurvedic formulations
2. PROPRIETARY MEDICINES
• These are also known as patent medicines or modern Ayurvedic medicines.
Their formula, dosage form are decided by the manufacturing company and
ingredients used in these preparation are not found in traditional Ayurvedic text
books. Every company has its own formula and conducts clinical trial, research on
the medicine about its efficacy. For e.g. capsules, syrups etc.
Types and Forms of Ayuvedic formulations
• Solid dosage forms:
• Gutika & Chruna
• Semi solid forms:
• Avaleha & Ghrita
• Liquid dosage forms:
• Asava , Arista & Taila

10. Asava & Arishta Natural fermented liquid medicines
• Medicinal preparations processed by soaking drugs in the powdered forms
or in the form of their decoction (known as kasaya in Ayurveda), in a solution
of sugar or jiggery (gur), for a specified period of time.
• During soaking, it undergoes fermentation generating alcohol and in
process facilitating extraction of active constituents contained in the drugs.
Asava & Arishta
• Alcohol so generated also serves as preservative in the product.
• Absolute cleanliness is maintained during the preparation of arishta and
asava.
• The wooden pots (vessels) are fumigated with pippali (long pepper) churna
and also smeared with ghee before the fermentation liquids are poured into
them.
• They can be kept indefinitely, should be stored in well stoppered bottles or
jars.

11. Dhoopana Why fumigation?
• The fermentation vessels are subjected to dhoopana, a process of fumigation to
prevent the growth of naturally occurring microorganisms that may contaminate or
hamper the process of fermentation. Molasses or powders of crude drugs like Indian
valerian, agaru (Aquilaria agallocha), chandan (Santalum album), marich (Piper
negrum, Black pepper) and such are sprinkled on hot embers and burnt to fumigate.
• These crude drugs may contain volatile oils that have antibacterial, antiseptic action
thereby providing a specific eco- system similar to present day sterilization
procedures.

12. Asava (Definition by Sushruta)
• The medication which is prepared by mixing together different kinds of medicinal
juices, decoction, jaggery (molasses) and flowers in an earthen vessel buried deep into
a heap of grains for flavoring and to initiate fermentation.
Asava (Fermented infusion)
• Required quantity of water and jiggery or sugar is taken, boiled, cooled and
transferred to fermentation vessel or barrel.
• Finely powdered crude drugs and other ingredients as mentioned in the formula are
then added to it
• The container is covered with the lid and edges are sealed with clay smeared cloth,
wrapped in seven consecutive layers. Normally the vessels used for processing of asava
are placed in cellar(basement) of a specific period in order to facilitate sadhana
(fermentation) process.

13. • The contents are examined for completion of sadhana process and asava is filtered and
bottled.
• Filtered asava should be clear and without any froth (foam) at the top.
• It should not become sour on standing.
• It has characteristic, aromatic and alcoholic odour.
• Examples: Kumariasava, Punarnavasava, Chandanasava, Arvindasava, Kanakasava,
Madhukasava
Arishta
• The formulations which are prepared earlier prepared (cooked) medications like herbal
infusions or decoctions

14. Arishta (Fermented decoction)
• The crude drugs mentioned in the formula are coarsely powdered and decoction (Kashaya)
is prepared, filtered and transferred to wooden vessels .
• Sugar, honey or jiggery is added to it, dissolved and boiled.
• Dravyas, other finely powdered ingredients were added
• The container is covered with the lid and edges are sealed with clay smeared cloth,
wrapped in seven consecutive layers. Normally the vessels used for processing of arishta are
placed in cellar(basement) of a specific period in order to facilitate sadhana (fermentation)
process.
• The contents are examined for completion of sadhana process and arishta is filtered and
bottled. Filtered arishta should be clear and without any froth (foam) at the top.
• It should not become sour on standing.
• It has characteristic, aromatic and alcoholic odour.
• Examples: Ashokarishta, Vidangarista, Arjunarishta, Ashwagandharishta

15. Lepana –
• Ghee, honey or cow‟s urine are used as base with herbs like Pippali (long pepper)
Chavya (Piper retrofractum), made into the form of paste that is smeared evenly to
provide a coat on the inner surface of the fermentation vessel.
• Such a coat forms protective layer to prevent any unwarranted interaction between the
fermentation material and outside air. Most ingredients used for smear have pungent or
sharp attributes.

16. Avaleha (Jam/Paste like products)
• Avaleha or leha is a semi solid preparation of drugs prepared by addition of sugar,
jiggery(gur) or sugar candy and boiled with prescribed drug juice or decoction.
• Jaggery- or sugar candy is dissolved in liquid, boiled and strained.
• The powdered drugs in small quantities are added and stirred continuously to form
homogenous mass.
Ghee or oil is added when preparation is hot.
• Examples: • Chyawanprash,

17. Ghrita (Medicated clarified butters)
• The preparation in which ghee is boiled with the prescribed quantity of the decoction
(kasaya) and fine paste (kalka) of the drug as specified in the formula.
• The process of preparation of ghrita ensures the absorption of the therapeutically
active constituents of the drugs used in the preparation.
• Ghrita solidfies when cooled. It has colour, odour and taste of the ingredients used in
the preparation. Ghrita (Medicated clarified butters)
• Ghrita are preparation for internal consumption and are stable for about 16 months.
• Normally they are taken along with warm vehicle (water or milk).
• Examples: Asokaghrita, Nirgundi ghrita, Brahmi ghrita,
• It can be preserved in glass, polythene or aluminium containers.

18. Churna (Powders)
• Fine powder of drug or drugs is known as churna.
• Drugs mentioned in standard, are cleaned properly, dried thoroughly, pulverised and
then sieved.
• The churna is free flowing and retains potency for one year, if preserved in air-tight
containers.
• Examples: Triphala churna, Sudarshan churna,

19. Taila (Medicated Oils)
• They are called sneha kalpa/paka and prepared by cooking oil with the juice or the decoction
and paste of drugs.
• Unless otherwise specified, paste of drug should be 1/4th part of the oil and the liquid (drava)
should be 4 times of oil.
• If no liquid is specified in recipe, water should be used.
• For preparing medicated oil, the fine paste of drug, liquid and oil together, cooked, stirred
constantly to the paste at the bottom and prevented from getting charred.
• When medicated taila gets properly cooked, large amount of foam appears at the surface of
the oil.
• Therefore the formulation should be strained prior to packing.
• If salt or any alkali preparation is added to the recipe, it should be after the oil is strained and
mixed thoroughly.
• Tailas can be used internally and topically.
• They retain potency for about 16 months.
• They are taken internally with warm water or warm milk.
• Examples: Bhrinraj taila, Mahanarayan Taila, Anu taila, Jyotismati taila

20. Gutika (Pills)
• It is in the form of pills. They are made by using single or combinations of vegetable,
mineral or animal drugs.
• These preparations can be used up to 2 years. Pills with minerals can be used
indefinitely.
• These formulations should not loose their original colour, odour, taste and form on
standing.
They should be kept away from moisture, if they contain salt, ksara or sugar.
• Examples: Lasunadi gutika, Pranda gutika, Khadiradi gutika

21. Detoxification of Formulation
• Ayurveda involves the use of drugs obtained from plants, animals, and mineral origin.
• All the three sources of drugs can be divided under poisonous and nonpoisonous
category..
• There are various crude drugs, which generally possess unwanted impurities and toxic
substances, which can lead to harmful health problems.
• These poisonous/toxic plants are categorized as viṣa (poison) and upaviṣa (toxic but
not lethal for human health) in Ayurvedic texts and also listed in the schedule-E of Drugs
and Cosmetics Act 1940.
The detoxification or purification process of any toxic material used for medicinal
purposes is termed as “Śodhana”. • Śodhana (detoxification/purification) involves the
conversion of any poisonous drug into beneficial, nonpoisonous/nontoxic ones. • It is
cited in the treatises of Ayurveda that by proper processing, viṣa can be converted into
amṛta (nectar) and on other hand on adoption of inappropriate methods, nontoxic
materials become a toxic.