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© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
Kumar Organic Products Limited
Ingredients For Us
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
Dandruff - Cause & Consequences
Dandruff, the shedding of dead skin cells from the
scalp at an excessive rate, is the result of metabolic
by products of skin micro-organisms (fungus
Malassezia furfur previously known as
Pityrosporum Ovale.
Malassezia metabolizes triglycerides present in
sebum by the expression of lipase, resulting in a
lipid byproduct Oleic Acid (OA). Penetration by OA
of the top layer of the epidermis, the results in
cleavage of the stratum corneum cells, As a result
dead skin cells are shed in large oily clumps which
appears as white or grayish patches on the scalp,
skin and clothes
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net IProduct Code: K006.2
Metabolizes
Triglyceride
present in sebum
Lipid by Product
Oleic Acid
Penetrates top
layer of
epidermis
Stratum
Corneum
Dandruff
Inflammatory
Response
Malassezia
Erratic cleavage
of Stratum
Corneum cell
Dandruff - Cause & Consequences
Dandruff cause is linked with presence of higher than normal count of
lipophilic yeast –Pityrosporum Ovale ( Malassezia furfur)
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
Zinc Pyrithione - Mechanism of Action
The Antifungal effect of ZINC PYRITHIONE is proposed to derive from its ability to
disrupt membrane transport by blocking the proton pump that energizes the
transport mechanism.
A. ZINC PYRITHIONE yields a soluble portion of Zinc Pyrithione molecules, which
penetrate the fungal cell membrane (green).
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
Zinc Pyrithione - Mechanism of Action
B. ZINC PYRITHIONE undergoes
dissociative equilibrium which reduces
portion of the material present in the
bio-active complexed form
C. The addition of an exogenous
source of zinc ions (red) shifts the
equilibrium in the favor of the
complexed Zinc Pyrithione form,
thereby increasing delivery to the
fungal cells (red)
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
Zinc Pyrithione - Clinical Study
1. Efficacy and safety study of Zinc Pyrithione shampoo against dandruff
In the clinical evaluation of 20 subjects, for a period of 4 weeks of usage of anti-dandruff
shampoo With zinc Pyrithione, none of them complained of any adverse effects like pruritis
(itching), erythema, increase in dandruff, local discomfort etc, After 4 weeks of usage of
anti-dandruff shampoo with Zinc Pyrithione, it was not possible to isolate Malassezia furfur
in culture from all volunteers. Further there was definite reduction in dandruff in all the
volunteers
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
Zinc Pyrithione - Clinical Study
2. Testing of susceptibility of Malssezzia furfur to anti-dandruff shampoo with Zinc
Pyrithione
The minimum inhibitory concentration of anti-dandruff shampoo with Zinc Pyrithione
required for the total inhibition of Malassezia furfur (1X 106 cells / ml) is found to be
700 µ/ml.
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
Kopthione 50% – Product Specification
Trade Name KOPTHIONE 50 % fine particle
suspension
INCI Name Zinc Pyrithione
Molecular Formula C10H8N2O2S2Zn
CAS No 13463-41-7
EINECS 236 – 671 – 3
Appearance White to off-white suspension
Assay 48 -50 %
pH 6.5 – 9.0 %
Zinc content 9.3 to 11.3 %
Solubility Water – Practically Insoluble
Caustic Soda – Soluble
Acids - Soluble
Storage Keep away from sunlight and heat
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
Safety Data & Regulatory Status
Safety Data:
The acute as well as the sub-chronic toxicity was moderate to low, for both Zinc
Pyrithione alone, or incorporated in market formulations, In chronic toxicity
experiments it was shown that an oral application of 500 µg/kg/day can be regarded as
a dose that does not cause any adverse effects (NOAEL). No evidence of a
carcinogenic response was seen when Zinc Pyrithione was applied topically upto 100
mg/kg/day or given orally up to 5 mg/kg/day in lifetime studies.
Regulatory Status
USA : Approved for OTC topical use
Europe: Approved for OTC topical use
Japan : Approved for OTC topical use
Rest of the world: Approved for use in many Asian, African and South American
countries
*Consult your regulatory authority for use level and restrictions.
R.E.A.C.H: Pre-registration reference number : 05-2114092713-46-0000
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
Zinc pyrithione is best known for its use in treating dandruff and seborrhoeic
dermatitis. It also has antibacterial properties and is effective against many
pathogens from the Streptococcus and Staphylococcus genera. Its other
medical applications include treatments of psoriasis, eczema, ringworm,
fungus, athletes foot, dry skin, atopic dermatitis, tinea, and vitiligo.
Packaging Sizes :
For Dispersion : 25 Kg drums
Shelf Life : Minimum 3 years from the date of manufacturing in original
sealed containers
Storage Conditions : Keep away from sunlight and heat
Dosage & Application
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
Literature References:
[1] G Lorette, and V Ermosilla, Clinical efficacy of a new ciclopiroxolamine/zinc pyrithione shampoo in scalp
seborrheic dermatitis treatment, Eur J Dermatol, 16(5):558-564, 2006.
[2] E Guthery, LA Seal, and EL Anderson, Zinc Pyrithione in alcohol-based products for skin antisepsis:
Persistence of antimicrobial effects, Am J Infect Control, 33(1):15-22, 2005.
[3] KS Grunnet, and I Dahllof, Environmental fate of the antifouling compound zinc pyrithione in seawater,
Environ Toxicol Chem, 24(12):3001-3006, 2005.
[4] P Bailey, C Arrowsmith, K Darling, J Dexter, J Eklund, A Lane, C Little, B Murray, A Scott, A Williams, and
D Wilson, A double-blind randomized vehicle-controlled clinical trial investigating the effect of ZnPTO dose
on the scalp vs. antidandruff efficacy and antimycotic activity. Int J Cosmet Sci, 25(4):183-188, 2003.
[5] RS Berger, JL Fu JL, KA Smiles, CB Turner, BM Schnell, KM Werchowski, KM Lammers, The effects of
minoxidil, 1% pyrithione zinc and a combination of both on hair density: a randomized controlled trial, Br J
Dermatol, 149(2):354-362, 2003.
Disclaimer:
The information given and the recommendations made herein are based on literature search and are believed
to be accurate but no guarantee of their accuracy is made. Information is supplied upon the condition that the
receivers will make their own determination as to its suitability for their purposes prior to use. In no event will
KUMAR ORGANIC PRODUCTS LTD be responsible for the damage of any nature whatsoever resulting from the
use of or upon reliance of the information
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
KUMAR ORGANIC PRODUCTS LIMITED
819/C, 13th Cross, 7th Block, Near JSS College Circle,
Jayanagar, Bangalore-560041. Karnataka, India.
Ph: 91 - 80 - 41425832/41525960 Ext- 153
Email : kop@kumarorganic.net

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Zinc Pyrithione (Kopthione Zn 50% fps) - Anti-Dandruff Agent

  • 1. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Kumar Organic Products Limited Ingredients For Us
  • 2. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Dandruff - Cause & Consequences Dandruff, the shedding of dead skin cells from the scalp at an excessive rate, is the result of metabolic by products of skin micro-organisms (fungus Malassezia furfur previously known as Pityrosporum Ovale. Malassezia metabolizes triglycerides present in sebum by the expression of lipase, resulting in a lipid byproduct Oleic Acid (OA). Penetration by OA of the top layer of the epidermis, the results in cleavage of the stratum corneum cells, As a result dead skin cells are shed in large oily clumps which appears as white or grayish patches on the scalp, skin and clothes
  • 3. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net IProduct Code: K006.2 Metabolizes Triglyceride present in sebum Lipid by Product Oleic Acid Penetrates top layer of epidermis Stratum Corneum Dandruff Inflammatory Response Malassezia Erratic cleavage of Stratum Corneum cell Dandruff - Cause & Consequences Dandruff cause is linked with presence of higher than normal count of lipophilic yeast –Pityrosporum Ovale ( Malassezia furfur)
  • 4. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Zinc Pyrithione - Mechanism of Action The Antifungal effect of ZINC PYRITHIONE is proposed to derive from its ability to disrupt membrane transport by blocking the proton pump that energizes the transport mechanism. A. ZINC PYRITHIONE yields a soluble portion of Zinc Pyrithione molecules, which penetrate the fungal cell membrane (green).
  • 5. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Zinc Pyrithione - Mechanism of Action B. ZINC PYRITHIONE undergoes dissociative equilibrium which reduces portion of the material present in the bio-active complexed form C. The addition of an exogenous source of zinc ions (red) shifts the equilibrium in the favor of the complexed Zinc Pyrithione form, thereby increasing delivery to the fungal cells (red)
  • 6. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Zinc Pyrithione - Clinical Study 1. Efficacy and safety study of Zinc Pyrithione shampoo against dandruff In the clinical evaluation of 20 subjects, for a period of 4 weeks of usage of anti-dandruff shampoo With zinc Pyrithione, none of them complained of any adverse effects like pruritis (itching), erythema, increase in dandruff, local discomfort etc, After 4 weeks of usage of anti-dandruff shampoo with Zinc Pyrithione, it was not possible to isolate Malassezia furfur in culture from all volunteers. Further there was definite reduction in dandruff in all the volunteers
  • 7. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Zinc Pyrithione - Clinical Study 2. Testing of susceptibility of Malssezzia furfur to anti-dandruff shampoo with Zinc Pyrithione The minimum inhibitory concentration of anti-dandruff shampoo with Zinc Pyrithione required for the total inhibition of Malassezia furfur (1X 106 cells / ml) is found to be 700 µ/ml.
  • 8. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Kopthione 50% – Product Specification Trade Name KOPTHIONE 50 % fine particle suspension INCI Name Zinc Pyrithione Molecular Formula C10H8N2O2S2Zn CAS No 13463-41-7 EINECS 236 – 671 – 3 Appearance White to off-white suspension Assay 48 -50 % pH 6.5 – 9.0 % Zinc content 9.3 to 11.3 % Solubility Water – Practically Insoluble Caustic Soda – Soluble Acids - Soluble Storage Keep away from sunlight and heat
  • 9. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Safety Data & Regulatory Status Safety Data: The acute as well as the sub-chronic toxicity was moderate to low, for both Zinc Pyrithione alone, or incorporated in market formulations, In chronic toxicity experiments it was shown that an oral application of 500 µg/kg/day can be regarded as a dose that does not cause any adverse effects (NOAEL). No evidence of a carcinogenic response was seen when Zinc Pyrithione was applied topically upto 100 mg/kg/day or given orally up to 5 mg/kg/day in lifetime studies. Regulatory Status USA : Approved for OTC topical use Europe: Approved for OTC topical use Japan : Approved for OTC topical use Rest of the world: Approved for use in many Asian, African and South American countries *Consult your regulatory authority for use level and restrictions. R.E.A.C.H: Pre-registration reference number : 05-2114092713-46-0000
  • 10. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Zinc pyrithione is best known for its use in treating dandruff and seborrhoeic dermatitis. It also has antibacterial properties and is effective against many pathogens from the Streptococcus and Staphylococcus genera. Its other medical applications include treatments of psoriasis, eczema, ringworm, fungus, athletes foot, dry skin, atopic dermatitis, tinea, and vitiligo. Packaging Sizes : For Dispersion : 25 Kg drums Shelf Life : Minimum 3 years from the date of manufacturing in original sealed containers Storage Conditions : Keep away from sunlight and heat Dosage & Application
  • 11. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Literature References: [1] G Lorette, and V Ermosilla, Clinical efficacy of a new ciclopiroxolamine/zinc pyrithione shampoo in scalp seborrheic dermatitis treatment, Eur J Dermatol, 16(5):558-564, 2006. [2] E Guthery, LA Seal, and EL Anderson, Zinc Pyrithione in alcohol-based products for skin antisepsis: Persistence of antimicrobial effects, Am J Infect Control, 33(1):15-22, 2005. [3] KS Grunnet, and I Dahllof, Environmental fate of the antifouling compound zinc pyrithione in seawater, Environ Toxicol Chem, 24(12):3001-3006, 2005. [4] P Bailey, C Arrowsmith, K Darling, J Dexter, J Eklund, A Lane, C Little, B Murray, A Scott, A Williams, and D Wilson, A double-blind randomized vehicle-controlled clinical trial investigating the effect of ZnPTO dose on the scalp vs. antidandruff efficacy and antimycotic activity. Int J Cosmet Sci, 25(4):183-188, 2003. [5] RS Berger, JL Fu JL, KA Smiles, CB Turner, BM Schnell, KM Werchowski, KM Lammers, The effects of minoxidil, 1% pyrithione zinc and a combination of both on hair density: a randomized controlled trial, Br J Dermatol, 149(2):354-362, 2003. Disclaimer: The information given and the recommendations made herein are based on literature search and are believed to be accurate but no guarantee of their accuracy is made. Information is supplied upon the condition that the receivers will make their own determination as to its suitability for their purposes prior to use. In no event will KUMAR ORGANIC PRODUCTS LTD be responsible for the damage of any nature whatsoever resulting from the use of or upon reliance of the information
  • 12. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I KUMAR ORGANIC PRODUCTS LIMITED 819/C, 13th Cross, 7th Block, Near JSS College Circle, Jayanagar, Bangalore-560041. Karnataka, India. Ph: 91 - 80 - 41425832/41525960 Ext- 153 Email : kop@kumarorganic.net