2. CONTENTS
• INTRODUCTION
• OBJECTIVE
• QUALITIES OF AUSHADHI
• CLASSIFICATION OF AYURVEDIC DRUGS
• DRUGS AND COSMETICS ACT
• CONCEPT OF VIRYA
• DRUG STABILITY
• LABELLING
• PACKAGING
• STORAGE CONDITION
• CONCLUSION
3. INTRODUCTION
• Ayurveda is a natural gift to humanity for its
Goodness.
• The origin of the eternal health science, every thing
in the nature can be beneficial but cannot be used in
raw form .
• These different aspect of dosage forms of a drug
were developed under the Rasa Shastra and
Bhaishajya kalpana.
• Stability and Storage condition is an essential factor
of quality in traditional medicines and health
supplements .
4. OBJECTIVES
• To determine maximum Expiation date /Shelf Life
• To Provide better Storage condition.
• To determine the Packaging components.
• Prevention , Promotion , & Maintence of Health.
5. QUALITIES OF AUSHADHI
• Bahut (high availability of Drugs)
• Yogya (Applicability)
• Anekavidha Kalpana (Utility in various forms)
• Sampat (Wholesome)
7. DRUGS AND COSMETICS ACT, 1940
• The Rule 161 (B) of Drugs and Cosmetics Act, 1940 and
rules their under has made it.
• Mandatory to print the manufacture and expiry date of all
Ayurvedic, Siddha and Unani Medicine .
• Drugs from April 1, 2010 onwards, "Under no
circumstances, consumers should buy these drugs after
their expiry date.”
8. DEFINITION OF EXPIRY DATE
• The time from the date of manufacturing of the medicine
to the time till which the medicine has sufficient potency
to bring about the desired therapeutic action can be
termed as shelf life or expiration date.
9. FACTORS RESPONSIBLE FOR THE
EXPIRY DATE OF MEDICINE
• The dosage form of the Ayurvedic medicine i.e.
(Powder, Vati , Ghruta , Avleha , Kwath , Taila etc)
• Usage of particular herbs that usually Contribute to the
anti oxidant / natural Preservative property to the
Ayurvedic Medicine.
10. SAVIRYATAAVADHI
• In Ayurvedic Texts, Saviryata Avadhi term is mentioned
in context of the time period during which the Virya
(potency/Strength) of any drug remain unaffected due to
environmental / microbial deterioration.
11. SHELF LIFE
Saviryta Avadhi of different Ayurvedic dosage forms as per classics
Dosage Form
Saviryta Avadhi
According to Sharangdhar
According
to Yogaratnakar
Kwatha (decoction) ---- 03 hours
Kalka (paste) ---- 03 hours
Swarasa (expressed juice) ---- 03 hours
Anjana (collyrium) ---- 03 months
Churna (Powder) 02 months 03 months
Vati (pills) 12 months ----
Guda/Avaleha (electuary) 12 months 06 months
Ghrita & Taila (Oil & Fat based preparation) 16 months 12 months
Asava (Alcoholic preparation) Long term stability -----
Dhatu (Metallic preparation) Long term stability -----
Rasa (Mercurial preparation) Long term stability -----
12. DRUG STABILITY
Factors Affecting Drug Stability
• Temperature – High temperature accelerate oxidation ,
Reduction & Hydrolysis reaction which leads to drugs
degradation .
• PH – Acidic and Alkaline PH influence the rate of
decomposition of most drugs . Many drugs are Stable in
between 4 -8.
• Moisture – Water catalyses chemical reactions as
oxidation, Hydrolysis and reduction reaction . Water
Promotes microbial growth.
• Light – Affects Drugs Stability through its energy or
thermal effect which leads to oxidation.
13. LONGER STABILITY OF AYURVEDIC
DRUGS
• Quality of raw material.
• Packaging.
• Quality control and Quality assurance.
• Storage conditions.
14. LABELLING
• Drugs and cosmetics Act 1940 and Rules 1945, Rule 161
• Name of drug.
• Net contents.
• Name and address of manufacturer.
• Licence no.
• Batch no.
• Mfg. date.
• Expiry date.
• Ayurvedic medicine
• If for external use then Write “EXTERNAL USE
ONLY’’
• “Not to be sold’’/ “Physician sample’’/ “ Govt, Supply’’
15. PACKAGING
• ACCORDING TO AYURVEDIC CLASSICS -
• Packing material should not interfere with physical,
chemical or biological property of the drug being packed
inside.
• Beside this some of indications are found for the air tight
Packaging of Churna , Taila etc.
• So it has a great role in Obtaining a product of suitable
Purity and Potency.
• Because unsatisfactory packaging permits or fasten the
Degradation in the product.
16. CONTI……
• Any Package must possesses Sufficient quality so that
environmental hazard like Temperature, Moisture,
infestation, contamination and Exposure to air can be
avoided.
• Certain Photosensitive drugs must be protected from
light there are numerous types of transparent, opaque and
coloured containers available for packaging.
17. STORAGE CONDITIONS
• The Most important Point in the evaluation of the
stability study of a product is its storage conditions.
• Storage conditions are derived from real climatic
situation.
• Because most of the chemical reaction follow
logarithmic and not linear functions.
• Nowadays, the Ayurvedic industries are also utilizing
these technology for the packaging and storage of their
formulations.
18. CONCLUSION
• According to Ayurveda, Acharyas explained the
storage and stability of drug very minutely, from
Desha, land, kala etc.
• Today some criteria's like specific season, directions
and nakshatras etc is to follow to Preserve Ayurvedic
Medicine.