A detailed view on preservatives in pharmaceuticals and food industry with Ayurvedic perspective

1. PRESERVATIVES IN
PHARMACEUTICS & FOOD
INDUSTRY
Dr. Sandhya Ramesh MD (Ayu)

2. CONTENTS
•Definition
•History
•Ideal preservative
•Classification
•E number
•Mechanism of action
•Action of antimicrobial preservatives

3. •Food presrvatives
•Methods of food preservation
•Preservatives in ayurvedic pharmaceutics
•Ayurvedic view
•Present scenario
•Conclusion
Contd....

4. DEFINITION
A preservative is a substance or a chemical that is added to
products such as food, beverages, pharmaceutical drugs,
paints, biological samples, cosmetics, wood and many other
products to prevent decomposition by microbial growth or
by undesirable chemical changes.

5. • Are used to prolong the shelf life of the products.
• Add especially to those that have higher water content
• For avoiding alteration & degradation by microbes
• Are put in foods to inhibit disease causing microbial
growth
•To slow down the spoiling process

6. HISTORY
• Used since pre historic period
• Earliest preservative used were vinegar sugar and salt which
produce food environment of high pressure

7. IDEAL PRESERVATIVE
1. Should not be irritant.
2. Should not be toxic.
3. Should be physically & chemically stable.
4. Should be compatible with other ingredients.
5. Should act as a good antimicrobial agent.

8. 5. Should exert a wide spectrum activity.
6. Should act as a preservative in small
concentration.
7. Should contain activity through out product
manufacturing, shelf life & storage.

9. CLASSIFICATION
MECHANISM OF
ACTION
SOURCE
CHEMICAL NATURE

10. 1. Based on source
a. Class I (natural)
b. Class II (artificial)
2. Based on mechanism of action
a. Anti oxidants
b. Antimicrobial
c. Chelating agents

11. 3. Based on chemical nature
a. Acids
b. Esters
c. Alcohols
d. Phenols
e. Mercurial preparations
f. Quaternary ammonium compounds

12. Class I Preservatives
• These are obtained from natural sources such as plants,
minerals, animals...etc
Eg: Neem oil
Salt
Lemon
Honey
Sugar ....etc

13. Class II Preservatives
• Man made
• Active against various micro organisms in small amount
Eg: Benzoic acids
Sodium benzoate
Nitrites

14. Anti Oxidants
• The agent that prevent oxidation of active pharmaceutical
ingredient which otherwise undergo degradation due to oxidation as
they are sensitive to oxygen
Eg: Vit E
Vit C
Butyl dehydroxy anisol (BHA)
Butyl dehydroxy toluene (BHT)

15. Anti Microbial Agents
•The agent which active against gram –ve & gram +ve organism
•Which are active in small inclusion level
Eg: Benzoate
Sodium benzoate
Sorbates

16. Chelating Agents
•The agents which form a complex with pharmacuetical ingrediants
Eg: EDTA
Poly phosphates
Citric acid

17. Chemical Nature
Acids Benzoic acid, sorbic acid, boric acid...
Esters Methyl paraben, ethyl paraben, propyl
paraben, sodium benzoate, sodium
propionate, potassium sorbate...
Alcohols Chlorobutanol, benzyl alcohol, phenyl ethyl
alcohol...
Phenols Phenol, cholesterol, α phenyl phenol...
Mercurial compounds Tiomersol, nitro mersol, phenyl mercuric
nitrites, phenyl mercuric acetate...
Quaternary ammonium
compounds
Benzalkonium chloride, cetyl pyridinium
chloride...

18. Mechanism of action
Antimicrobial agents
 Which acting by cell wall inhibition, protein
synthesis, DNA & RNA synthesis
Anti oxidants
They are self reducing agents and pevent
oxidation of oxygen sensitive ingredients

19. ACTION OF ANTIMICROBIAL
PRESERVATIVE
On Cell wall
 Aryl and alkyl acids
 Phenols
 Organo mercurial
compounds
 EDTA
 Chlorohexidine
Glutaraldehyde
 Anionic surfectants

20. On Cytoplasmic membrane
 2 phenoxy ethanol
 Parabens
 Organo mercurial compounds
 EDTA
 Chloro hexidine
 Formaldehyde donaters
 Benzalconium chloride

21. Cytoplasm
 2-phenoxy ethanol
 Aryl and alkyl acids
 Chlorohexidine
 Formaldehyde donators
 Halogenated preservatives

23. Preservation process includes
 Heating to kill/denature micro organisms
 Oxidation
 Toxic inhibition
 Dehydration
 Osmotic inhibition
 Low temperature inactivation
 Ultra high water pressure

24. Methods
• Drying
• Freezing
• Vacuum packing
• Salt
• Sugar
• Pickling
• Lye
• Canning & bottling
• Jellying
• Potting
• Jugging
• Irradiation
• Modified atmosphere
• Burial in the ground
• Controlled use of micro
organism
• High pressure preservative

25. E number
 Codes for substances that are permitted
to be used as food additives with in the
European union
 E stands for Europe/ European union
 The numbering scheme follows that of
INS as determined by the codex
alimentarious committee

32. HARMFUL EFFECTS
Preservative Effects
Sulfied (fruits) Head ache, palpitation,
allergies, adven cancer
Nitrites & nitrates (meat
products)
Stomach cancer
Benzoates (antimicrobial) Allergies, asthma, skin rashes
Sorbates/sorbic acid
(antimicrobial)
Urticaria, contact dermatitis

33. Preservatives in Ayurvedic
Pharmaceutics

34. Preservatives used are
• Parabens
 Butyl paraben
 Ethyl paraben
 Methyl paraben
• Benzoic acid
• Sodium benzoate

35. PARABENS
•Widely used preservatives in pharmaceutics and cosmetics
•Chemically a series of para hydroxy benzoates
•As bactericide or fungicide

36. Butyl paraben (C11H14O3)
•Highly successful antimicrobial preservative
•Act as both bactericide and fungicide
•Especially against mold and yeast
Ethyl paraben (C9H10O3)
•Anti fungal
•E no: E214
•Excess use can cause skin irritation , contact dermatitis
•On the skin it react with UV rays leading to skin aging and DNA
damage

37. Methyl praben (C8H8O3)
•Methyl ester of para-hydroxy benzoic acid
•Antifungal agent
•Safe for food and cosmetic antibacterial preservation
•Hydrolysed to para-hydroxy benzoic acid and rapidly
excreted in urine without accumulating in the body

38. Benzoic acid(C6H6COOH)
•Colourless crystalline solid and a simple aromatic
carboxylic acid
•E no: E210
•Maximum permitted level: 0.1%
•Inhibit growth of mold, yeast and some bacterial species

39. Sodium Benzoate (C6H5COONa / C7H5NaO2)
Sodium salt of benzoic acid
E no: E211
Maximum permitted level 0.1%
1g is soluable in 2ml of water
Safe for consumption with in the range 647-825mg/Kg body
wt/day
ph< 4.5

40. METABOLISM
 Average excretion : 0.7g/dL
Sodium benzoate Liver
Combines with Coenzyme A
Mitochondria
Benzyl Coenzyme A
Combines with glycene Hippuric acid
Excreted through urine

41. Side Effects
+ artificial colours Hyper active behaviour
+ ascorbic acid Benzene which is a carcinogen
 In some persons nausea and vomiting
 Exacerbation of peptic ulcer, mild hyperventilation &
respiratory alkalosis
 Hyper-natremia in patients with diminished renal
function

42. AYURVEDIC VIEW

43. • गुणहीनं भवेद्वर्षादू र्ध्वं तद्रूपमौर्धम् ।
• मषसद्वयषत्थष चूणं हीनत्वं आप्नुयषत् ॥
• हीनत्वं गुडिकषलेहौ लभते वत्सरषत् परम् ।
• हीनष: स्युर्घाततैलषद्यषश्चमषासषकषस्तथष ॥
• ओर्ध्यो लर्ुपषकष: स्युडनावीयो वत्सरषत्परम् ।
• पुरषणष: स्युगुाणैयुाक्तष आसवो धतवो रसष: ॥
Sa.Sam Pu 1/51-53

44. • The main aim of converting primary kalpanas into
secondary types is maintaining the health of the
patient.
• Preservative action is an added benefit

45. Present scenario
 The type and concentration of preservatives used by major
pharmacies lack uniformity, especialy in ayurvedic
pharmaceutics
 In almost all ayurvedic pharmaceutics, a mixture of 2-3
class 2 preservatives are used and is restricted by prevention
of food adultration act 1954

46.  Even in asavas and aristas contain preservatives which is not
at all needed
 From different studies it was found that the level of
preservatives added was 8-10 times higher than the level
permitted
 So more researches must be done to keep the preparation
more stable with lesser amount of preservatives

47. 1. In our classics shelf life of each preparation is mentioned in
detail
2. In aristasavas there is no need of preservatives at all since the
self generated alcohol itself act as a preservative

48. 3. If we look for proper paka and siddha lakshana of avaleha,
ghrita, taila..etc, these can be stored up to the mentioned
shelf life
4. Chemicals which are used as preservatives have side effects
5. It is better to use the preservative free food