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SAVIRYATAAVADHI
DR ANJANA .P
2ND YEAR PG SCHOLAR
R& B DEPARTMENT
GOVT.AYURVEDA COLLEGE
TRIPUNITHURA, KERALA
SAVIRYATAAVADHI :-
Time period during which the virya or
potency of any drug remains unaffected due to
environmental or microbial deterioration.
 The period of potency is labelled as expiry date.
SHELF LIFE :-
Used to indicate the time period
during which an API ( Active pharmaceutical
ingradient ) or FPP ( Finished pharmaceutical
product ) is expected to remain within the approved
stability specification provided that it is stored
under the conditions defined on the container label.
 According to Susruta , a drug whether it is fresh or old
can be utilized for therapeutic purpose up to which
qualities ( appearance, taste, smell etc. ) remain intact.
 This reference directs that shelf life of any drug can be
considered up to that period until which it attains the
sub potent level and not up to its deterioration.
 Shelf life is to be understood in 2 dimensions
Raw drugs Formulations
 Factors affecting shelf life of raw drugs :-
 Natural factors -
1. Time
2. Environmental factors
3. Infections
 Unnatural factors –
1. Drug adulteration
2. Drug substitutions
 Shelf life of formulations –
1. Method of preparation
2. Packing
3. Storage
 There is no clear idea about shelf life of different
Ayurvedic dosage forms in the classical texts before
11th century A.D .
 After 12th century only descriptions about the specific
shelf life or stability period of different preparations.
 Acharya Sarangadhara ( 13th A.D) is the first one to
mention the shelf life of formulations .
 As per Sarangadhara , prathama khanda ,1/ 51-52
1. Choorna – 2months
2. Taila & Ghrita -- 16 months
3. Gutika & Lehya -- 12 months
4. Laghu paka aushadies – 12 months
5. Asava
Arista
Rasa preparations - indefinite / long term
 As per Yoga ratnakara ,
Kwatha – 3hours
Kalka – 3hours
Swarasa – 3 hours
Anjana – 3months
Choorna – 3months
Avaleha – 6 months
Guda - 6 months
Sneha - 12 months
 As per Vangasena,
Guda / Avaleha - 12 months
Ghrita / taila - 6 months
 As per G.S.P ( Good Storage Practises ) of the
National Medicinal Plant Board of Central
government
 CHOORNA KALPANA :-
 2months
 If airtight containers are used - up to 6 months
 More exposed surface area chances of oxidation &
hydrolysis.
 Exception – Lavana bhaskara choorna
 If the raw drugs are measured according to the recipe we
get a large quantity of Lavana bhaskara choorna .
 Main precaution to be taken is in proper storing.
 GUTIKA , VATI KALPANA –
 Complete removal of water content
 If protected from adverse atmospheric factors maintain
quality for longer periods .
 LEHA KALPANA –
 Presence of sweetening agent
 Little water content .
 Preservative methods are adopted nowadays to prolong
the shelf life.
 OUSHADI , TRICHUR ,
 Most commonly added preservatives in Lehya
preparations like Manibhadra gulam, Panchajeeraka
gudam, Koosmanda rasayana, Dasamoola rasayana ,
etc are - Methyl parabensodium & Propyl
parabensodium.
 SNEHA KALPANA :-
 Slow growth of microbes in fat medium
 Processed in rainy season is liable to lose its potency
quickly due to increased moisture content.
 Medicated Ghrita retains its potency for 4 months only
 Therefore up to one year quality decreases gradually
and beyond one year it is not useful.
 Taila kalpana keeps its potency for a longer period.
 Proper packaging and storage must be provided.
vaidyaparibhasa pradeep
 SHELF LIFE OF ASAVAAND ARISTA :-
 Resistant to deterioration
1. removal of starch material by fermentation.
2. presence of self generated alcohol .
 Adequate temperature maintainance ( 30-35 *c).
 Adding kwatha or Hima of of Dhataki puspha to prevent fungal
growth to maximum extent.
 Rainy season – chances of frequent fungal growth.
 According to classics – Vasantha , Sarad
 Between March – May and September – November.
PRESERVATIVES
 Preservatives are substances added to various pharmaceutical dosage
forms and cosmetic preparations to prevent or inhibit microbial
growth.
 An ideal preservative would be effective at low concentrations
against all possible microorganisms.
 They must be non toxic and compatible with other constituent of the
preparation and be stable for the shelf life of the preparation.
CLASSIFICATION
1. ACIDS – e.g. : Benzoic acids
Sorbic acid
Boric acids
2. ESTERS – e.g. :- Sodium benzovate , Methyl paraben
Ethyl paraben , propyl paraben ,
Butyl paraben , Potassium sorbate etc.
 ALCOHOLS – Benzyl alcohol , Phenyl alcohol , Chlorobutanol.
 PHENOLS - Phenol , Chlorocresol
 MERCURIAL COMPOUNDS - Phenyl mercuric nitrate
Phenyl mercuric acetate
Thiomersal
Nitromersol compounds.
 QUARTERNARY AMMONIUM COMPOUNDS - Benzyl alkonium chloride
Cetyl pyrinidium chloride
 BENZOIC ACID :-
 Food preservative
 Inhibit growth of moulds, yeast , and some bacteria.
 Externally – Antiseptic
 BORIC ACID :-
 Weak acid
 Also known as Orthoboric acid
 Colourless crystal, soluble in water
 Antiseptic , insecticide and flame retardant.
 METHYL PARABEN :-
 White crystalline powder , freely soluble in water & alcohol.
 Antiseptic
 Used in cosmetic preparations containing vegetable and animal fats
& oils that are susceptible to decomposition.
 ETHYL PARABEN :-
 White crystalline powder slightly soluble in water.
 Soluble in water and in most of organic solvents.
 pharmaceutical preservative & food additives.
 SODIUM BENZOVATE :-
 Extensively used as food & pharmaceutical preservatives.
 It is not a bactericidal, only a bacteriostatic agent.
 Fungistatic activity.
 ALCOHOL :-
 Bacteriostatic agent.
eg Benzyl alcohol.
• PHENYL MERCURIC NITRATE :-
• Topical antiseptic
• Bacteriosidal preservative in pharmaceutical preparations.
PRESERVATIVES IN LIQUID PHARMACEUTICAL
PREPARATIONS
 Liquids preparations are susceptible to microbial growth because of
the nature of their ingredients.
 Such preparations are protected by the addition of preservatives that
prevent the alteration and degradation of the formulation.
 Most commonly added preservatives are Sodium benzovate ,
Potassium sorbate , Methyl hydroxy benzovate or Methyl paraben etc.
 Typical allowed concentration range of these preservatives are
Sodium benzovate – 0.1 to 0.2 %
Potassium sorbate - 0.1 to 0.2 %
Methyl paraben - 0.1 to 0.25 %
• More than the allowable range ,
• Topically induce rashes, urticarial, or contact dermatitis.
• On ingestion - may induce allergic potential , oestrogenic potential
of parabens , genotoxicity activity potential of sodium benzovate.
 ESTIMATION OF SODIUM BENZOVATE IN KASHAYA
PREPARATION :-
 Most commonly used preservative .
 No standard procedure was known for the estimation.
 Titrimetric estimation – of Benzoic acid using NaOH , can be
used as a standard method for its estimation.
 Concentration of Sodium benzovate in Amritottaram ksh – 0.10 to 0.12
%.
 Concentration in Nayopayam ksh – 0.10 to 0.12 %.
 Daily intake of < 0.5gm is tolerable to humans.
 No accumulation of Benzoic acid occurs in body < up to 4g/ day.
 Metabolized , excreted through urine as Hippuric acid or glucuronic
acid .
 The maximum allowed concentration as per FDA is o.1 %
study conducted at department of
chemistry P.R.N.S.S College Mattanur – published in Asian journal of
chemistry.
 PRESERVATION OF FORMULATIONS:
 Protection against physical factors –
 Minimize moisture content
 strict and careful processing
 wet preparation converted to unhydrous products
e.g. : swarasa – dry extract ; kalka – choorna, leha,
tablets etc.
 Finished products should be kept in airtight containers
to avoid contact with moisture and oxygen
 During dispensing care should be taken to avoid
moisture contact
 Containers , measuring equipments, spoon etc should
be dried
 Time of the containers kept opened should be
minimized.
 Small packing and dosage packing will help
considerably in this regard
 Eg : blister packing of tablets
 sachet packing for powders
 Light may bring about decomposition of ingradients
such as glycosides, vitamins etc .
 So the products should be stored in dark or opaque or
amber glass containers.
 Enzymatic activity will be more rapid in slightly
increased temperature and may cause changes in the
products.
 Protection from temperature is attained by storing the
container in a cool place.
 Packing in air tight container helps to prevent oxidation
of products like oil, Ghrita, Asava, Arista etc.
 The container should be completely filled to avoid air
space.
 Dehydrating agents like silica gel can be placed in the
container as small packets to avoid deterioration by
moisture
 Selection of containers for storage
 must be inert to the medicine
 Glass vessels are considered to be safe
 Protection against infections –
 Living organisms like bacteria, fungus, and moulds may
cause deterioration of the formulation
 Every step of processing ie from raw drug to the packing
should be conducted under strictly sterilized conditions.
 By using antimicrobial preservatives eg Benzoic acid
 PACKAGING :-
 Packaging can be described as a coordinated system
of preparing goods for transport , warehousing,
storage and end use.
 It is a science , art and technology of enclosing or
protecting products.
 NEEDS OF PACKAGING –
 Physical protection
 Barrier protection
 Agglomeration
 Security
 Convenience
 Dose control
 Desirable characteristics of a packaging material
 Non reactive with the product
 Not impart taste or odour to the product
 Non toxic
 Adoptable to commonly employed high speed
packaging equipments.
 Meet applicable Tamper Resistance Requirements
 TYPES OF PACKAGING –
 Primary packaging – the material that first envelops the
product and holds it.
 Secondary packaging – outside the primary packaging ,
used to group primary packages together .
 Tertiary packaging – used for bulk handling . The most
common form is a palletized unit load that packs
tightly in to containers.
 Strip packaging
 Bottle packaging
 Blister packaging – type of pre formed plastic
packaging used for small consumer goods
 2 components – cavity and lidding
 Cavity contains the product , lidding – seals the
product
 4 basic components
 Forming film – receives the product in deep drawn
pockets
 Monolayer PVC films, PVC/PVDC duplex etc
commonly used.
 Aluminium blister foil etc
 Lidding material – provides base or main structural
component up on which the final blister package is
built.
 Paper aluminium, paper /PET/ aluminium
 Bottle packaging
 Glass – type 3 solids
 Plastic – LDPE, HDPE, PP, COC etc
Current status –
 Till date no specific guidelines are available regarding
the stability life estimation of pure Ayurvedic
formulations from any Government organization
 Except a Gazette notification issued by Government of
India on 20th October 2009 with slight modification in
the earlier draft notification issued on 26th November
2005.
 In this notification the department of AYUSH ,
Ministry of health & Family welfare has implemented
the rule namely 161B to display the date of expiry of
the ASU drugs and propose shelf life of the Ayurvedic
formulations.
CONCLUSION
In the present scenario saviryata avadhi can be
consider as an indicative of best before use .
This is the time limit after which one or more
properties of the formulations would have shown
considerable changes or degradation which can
be perceived by patients and lead to doubts about
the quality and efficacy of the product.
 Though Ayurveda has judiciously explained the
subjective criteria for assessment of virya of a drug but
those are not sufficient to assess the potency.
 Those parameters described by them in that period were
really admirable , scientific and show their keen
observation
 But in todays era such parameters are not sufficient and
hence new objective parameters for measuring these
properties are to be search out.
 In the ancient period when there was no
industrialization and the Vaidyas themselves used to
prepare the drug in smaller scale
 Their main objective was to achieve the desire action
rather than shelf life and palatability.
 Today in the era of globalization and large scale
production there is need to re determine the revised
stability period of these kinds of preparations by
following a suitable guidelines.
THANK U

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SAVEERYATA AVADHI ( SHELF LIFE PERIOD)

  • 1. SAVIRYATAAVADHI DR ANJANA .P 2ND YEAR PG SCHOLAR R& B DEPARTMENT GOVT.AYURVEDA COLLEGE TRIPUNITHURA, KERALA
  • 2. SAVIRYATAAVADHI :- Time period during which the virya or potency of any drug remains unaffected due to environmental or microbial deterioration.  The period of potency is labelled as expiry date.
  • 3. SHELF LIFE :- Used to indicate the time period during which an API ( Active pharmaceutical ingradient ) or FPP ( Finished pharmaceutical product ) is expected to remain within the approved stability specification provided that it is stored under the conditions defined on the container label.
  • 4.  According to Susruta , a drug whether it is fresh or old can be utilized for therapeutic purpose up to which qualities ( appearance, taste, smell etc. ) remain intact.  This reference directs that shelf life of any drug can be considered up to that period until which it attains the sub potent level and not up to its deterioration.
  • 5.  Shelf life is to be understood in 2 dimensions Raw drugs Formulations
  • 6.  Factors affecting shelf life of raw drugs :-  Natural factors - 1. Time 2. Environmental factors 3. Infections  Unnatural factors – 1. Drug adulteration 2. Drug substitutions
  • 7.  Shelf life of formulations – 1. Method of preparation 2. Packing 3. Storage
  • 8.  There is no clear idea about shelf life of different Ayurvedic dosage forms in the classical texts before 11th century A.D .  After 12th century only descriptions about the specific shelf life or stability period of different preparations.  Acharya Sarangadhara ( 13th A.D) is the first one to mention the shelf life of formulations .
  • 9.  As per Sarangadhara , prathama khanda ,1/ 51-52 1. Choorna – 2months 2. Taila & Ghrita -- 16 months 3. Gutika & Lehya -- 12 months 4. Laghu paka aushadies – 12 months 5. Asava Arista Rasa preparations - indefinite / long term
  • 10.  As per Yoga ratnakara , Kwatha – 3hours Kalka – 3hours Swarasa – 3 hours Anjana – 3months Choorna – 3months Avaleha – 6 months Guda - 6 months Sneha - 12 months
  • 11.  As per Vangasena, Guda / Avaleha - 12 months Ghrita / taila - 6 months  As per G.S.P ( Good Storage Practises ) of the National Medicinal Plant Board of Central government
  • 12.
  • 13.  CHOORNA KALPANA :-  2months  If airtight containers are used - up to 6 months  More exposed surface area chances of oxidation & hydrolysis.  Exception – Lavana bhaskara choorna
  • 14.  If the raw drugs are measured according to the recipe we get a large quantity of Lavana bhaskara choorna .  Main precaution to be taken is in proper storing.
  • 15.  GUTIKA , VATI KALPANA –  Complete removal of water content  If protected from adverse atmospheric factors maintain quality for longer periods .
  • 16.  LEHA KALPANA –  Presence of sweetening agent  Little water content .  Preservative methods are adopted nowadays to prolong the shelf life.
  • 17.  OUSHADI , TRICHUR ,  Most commonly added preservatives in Lehya preparations like Manibhadra gulam, Panchajeeraka gudam, Koosmanda rasayana, Dasamoola rasayana , etc are - Methyl parabensodium & Propyl parabensodium.
  • 18.  SNEHA KALPANA :-  Slow growth of microbes in fat medium  Processed in rainy season is liable to lose its potency quickly due to increased moisture content.  Medicated Ghrita retains its potency for 4 months only
  • 19.  Therefore up to one year quality decreases gradually and beyond one year it is not useful.  Taila kalpana keeps its potency for a longer period.  Proper packaging and storage must be provided. vaidyaparibhasa pradeep
  • 20.  SHELF LIFE OF ASAVAAND ARISTA :-  Resistant to deterioration 1. removal of starch material by fermentation. 2. presence of self generated alcohol .  Adequate temperature maintainance ( 30-35 *c).  Adding kwatha or Hima of of Dhataki puspha to prevent fungal growth to maximum extent.
  • 21.  Rainy season – chances of frequent fungal growth.  According to classics – Vasantha , Sarad  Between March – May and September – November.
  • 22. PRESERVATIVES  Preservatives are substances added to various pharmaceutical dosage forms and cosmetic preparations to prevent or inhibit microbial growth.  An ideal preservative would be effective at low concentrations against all possible microorganisms.  They must be non toxic and compatible with other constituent of the preparation and be stable for the shelf life of the preparation.
  • 23. CLASSIFICATION 1. ACIDS – e.g. : Benzoic acids Sorbic acid Boric acids 2. ESTERS – e.g. :- Sodium benzovate , Methyl paraben Ethyl paraben , propyl paraben , Butyl paraben , Potassium sorbate etc.
  • 24.  ALCOHOLS – Benzyl alcohol , Phenyl alcohol , Chlorobutanol.  PHENOLS - Phenol , Chlorocresol  MERCURIAL COMPOUNDS - Phenyl mercuric nitrate Phenyl mercuric acetate Thiomersal Nitromersol compounds.
  • 25.  QUARTERNARY AMMONIUM COMPOUNDS - Benzyl alkonium chloride Cetyl pyrinidium chloride
  • 26.  BENZOIC ACID :-  Food preservative  Inhibit growth of moulds, yeast , and some bacteria.  Externally – Antiseptic
  • 27.  BORIC ACID :-  Weak acid  Also known as Orthoboric acid  Colourless crystal, soluble in water  Antiseptic , insecticide and flame retardant.
  • 28.  METHYL PARABEN :-  White crystalline powder , freely soluble in water & alcohol.  Antiseptic  Used in cosmetic preparations containing vegetable and animal fats & oils that are susceptible to decomposition.
  • 29.  ETHYL PARABEN :-  White crystalline powder slightly soluble in water.  Soluble in water and in most of organic solvents.  pharmaceutical preservative & food additives.
  • 30.  SODIUM BENZOVATE :-  Extensively used as food & pharmaceutical preservatives.  It is not a bactericidal, only a bacteriostatic agent.  Fungistatic activity.
  • 31.  ALCOHOL :-  Bacteriostatic agent. eg Benzyl alcohol. • PHENYL MERCURIC NITRATE :- • Topical antiseptic • Bacteriosidal preservative in pharmaceutical preparations.
  • 32. PRESERVATIVES IN LIQUID PHARMACEUTICAL PREPARATIONS  Liquids preparations are susceptible to microbial growth because of the nature of their ingredients.  Such preparations are protected by the addition of preservatives that prevent the alteration and degradation of the formulation.  Most commonly added preservatives are Sodium benzovate , Potassium sorbate , Methyl hydroxy benzovate or Methyl paraben etc.
  • 33.  Typical allowed concentration range of these preservatives are Sodium benzovate – 0.1 to 0.2 % Potassium sorbate - 0.1 to 0.2 % Methyl paraben - 0.1 to 0.25 % • More than the allowable range , • Topically induce rashes, urticarial, or contact dermatitis. • On ingestion - may induce allergic potential , oestrogenic potential of parabens , genotoxicity activity potential of sodium benzovate.
  • 34.  ESTIMATION OF SODIUM BENZOVATE IN KASHAYA PREPARATION :-  Most commonly used preservative .  No standard procedure was known for the estimation.  Titrimetric estimation – of Benzoic acid using NaOH , can be used as a standard method for its estimation.
  • 35.  Concentration of Sodium benzovate in Amritottaram ksh – 0.10 to 0.12 %.  Concentration in Nayopayam ksh – 0.10 to 0.12 %.  Daily intake of < 0.5gm is tolerable to humans.  No accumulation of Benzoic acid occurs in body < up to 4g/ day.  Metabolized , excreted through urine as Hippuric acid or glucuronic acid .
  • 36.  The maximum allowed concentration as per FDA is o.1 % study conducted at department of chemistry P.R.N.S.S College Mattanur – published in Asian journal of chemistry.
  • 37.
  • 38.  PRESERVATION OF FORMULATIONS:  Protection against physical factors –  Minimize moisture content  strict and careful processing  wet preparation converted to unhydrous products e.g. : swarasa – dry extract ; kalka – choorna, leha, tablets etc.
  • 39.  Finished products should be kept in airtight containers to avoid contact with moisture and oxygen  During dispensing care should be taken to avoid moisture contact  Containers , measuring equipments, spoon etc should be dried  Time of the containers kept opened should be minimized.
  • 40.  Small packing and dosage packing will help considerably in this regard  Eg : blister packing of tablets  sachet packing for powders  Light may bring about decomposition of ingradients such as glycosides, vitamins etc .  So the products should be stored in dark or opaque or amber glass containers.
  • 41.  Enzymatic activity will be more rapid in slightly increased temperature and may cause changes in the products.  Protection from temperature is attained by storing the container in a cool place.  Packing in air tight container helps to prevent oxidation of products like oil, Ghrita, Asava, Arista etc.  The container should be completely filled to avoid air space.
  • 42.  Dehydrating agents like silica gel can be placed in the container as small packets to avoid deterioration by moisture  Selection of containers for storage  must be inert to the medicine  Glass vessels are considered to be safe
  • 43.  Protection against infections –  Living organisms like bacteria, fungus, and moulds may cause deterioration of the formulation  Every step of processing ie from raw drug to the packing should be conducted under strictly sterilized conditions.  By using antimicrobial preservatives eg Benzoic acid
  • 44.  PACKAGING :-  Packaging can be described as a coordinated system of preparing goods for transport , warehousing, storage and end use.  It is a science , art and technology of enclosing or protecting products.
  • 45.  NEEDS OF PACKAGING –  Physical protection  Barrier protection  Agglomeration  Security  Convenience  Dose control
  • 46.  Desirable characteristics of a packaging material  Non reactive with the product  Not impart taste or odour to the product  Non toxic  Adoptable to commonly employed high speed packaging equipments.  Meet applicable Tamper Resistance Requirements
  • 47.  TYPES OF PACKAGING –  Primary packaging – the material that first envelops the product and holds it.  Secondary packaging – outside the primary packaging , used to group primary packages together .  Tertiary packaging – used for bulk handling . The most common form is a palletized unit load that packs tightly in to containers.
  • 48.  Strip packaging  Bottle packaging  Blister packaging – type of pre formed plastic packaging used for small consumer goods  2 components – cavity and lidding  Cavity contains the product , lidding – seals the product
  • 49.  4 basic components  Forming film – receives the product in deep drawn pockets  Monolayer PVC films, PVC/PVDC duplex etc commonly used.  Aluminium blister foil etc
  • 50.  Lidding material – provides base or main structural component up on which the final blister package is built.  Paper aluminium, paper /PET/ aluminium
  • 51.  Bottle packaging  Glass – type 3 solids  Plastic – LDPE, HDPE, PP, COC etc
  • 52. Current status –  Till date no specific guidelines are available regarding the stability life estimation of pure Ayurvedic formulations from any Government organization  Except a Gazette notification issued by Government of India on 20th October 2009 with slight modification in the earlier draft notification issued on 26th November 2005.
  • 53.  In this notification the department of AYUSH , Ministry of health & Family welfare has implemented the rule namely 161B to display the date of expiry of the ASU drugs and propose shelf life of the Ayurvedic formulations.
  • 54. CONCLUSION In the present scenario saviryata avadhi can be consider as an indicative of best before use . This is the time limit after which one or more properties of the formulations would have shown considerable changes or degradation which can be perceived by patients and lead to doubts about the quality and efficacy of the product.
  • 55.  Though Ayurveda has judiciously explained the subjective criteria for assessment of virya of a drug but those are not sufficient to assess the potency.  Those parameters described by them in that period were really admirable , scientific and show their keen observation  But in todays era such parameters are not sufficient and hence new objective parameters for measuring these properties are to be search out.
  • 56.  In the ancient period when there was no industrialization and the Vaidyas themselves used to prepare the drug in smaller scale  Their main objective was to achieve the desire action rather than shelf life and palatability.  Today in the era of globalization and large scale production there is need to re determine the revised stability period of these kinds of preparations by following a suitable guidelines.