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SABINSA Authors: Muhammed Majeed, Ph.D., Pritee Paliwal, Ph.D., Anurag Pande, Ph.D. TETRAPURE ® SKIN. HAIR. NAILS. NATURALLY. TETRAPURE ® HIGHLIGHTS: ! Anti-Fungal ! Anti-Oxidant ! Anti-Dandruff ! Skin Lightening Agent ! Use in: o Creams / Lotions / Spray / Powder TetraPure ® is standardized for a minimum of 99% of Tetrahydrocurcumin (1, 79Bis(49 hydroxy939methoxyphenyl)93,59 heptanedione). It is known to exhibit similar physiological and pharmacological actions as curcumin, in some cases even better. HO OH O O H CO 3 OCH 3

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  • SABINSAAuthors: Muhammed Majeed, Ph.D., Pritee Paliwal, Ph.D., Anurag Pande, Ph.D.

    TETRAPURESKIN. HAIR. NAILS. NATURALLY.

    TETRAPURE HIGHLIGHTS:! Anti-Fungal! Anti-Oxidant! Anti-Dandruff! Skin Lightening Agent! Use in:

    o Creams / Lotions / Spray / Powder

    TetraPure!is!standardized!for!a!minimum!of! 99%! of! Tetrahydrocurcumin! (1,! 79Bis(49h y d r o x y 9 3 9 m e t h o x y p h e n y l ) 9 3 , 5 9heptanedione).! It! is! known!to! exhibit! similar!physiological! and!pharmacological! actions!as!curcumin,!in!some!cases!even!better.!

    HO OH

    OOH CO3 OCH3

  • 2

    Sabinsas( patent( (US( 8119696)( emphasizes( the( role( of( TetraPure( ((1,[email protected]([email protected]@[email protected])@3,[email protected]))(in(the(management(of(superficial(and(cutaneous(mycosis.!

    A!mycosis !(plural !/!mycoses)!is !a !fungal !infec5on!affec5ng!both!humans !and!animals.!Approximately! 90%!of!fungal !skin! infec5ons !are!caused!by! 'dermatophytes',!which!are!parasi5c! fungi !affec5ng! the !skin,!hair! and!nails.! In!fact,! fungal !infec5on!of! nails !is !the!most! commonly! occurring!mycoses.!Skin!is !affected!by! fungus!because!it! feeds !on!kera5n.! In!hair,!fungal !invasion!oGen!occurs !on!the !hair! shaG.!It! is!manifested!as !itchy,!scaly!flakes!of!the!scalp!(dandruff)!or!inflammatory!abscess!that!may!result! in!permanent!hair! loss.!People!on!strong!an5bio5cs !are!also!at!risk!of!fungal !infec5ons,!as !an5bio5cs!kill !not!only!damaging!bacteria,!but!healthy!bacteria!as!well.!This!alters!the!balance!of!microorganisms!and!results!in!an!overgrowth!of!fungus.!

    TetraPure,!is !an!excellent!ingredient! for!cosme5c!formula5ons !with!proven!efficacy!against!a !wide!range!of!fungi.!It!can!also!be !used!as!a!poten5al !natural !an5/fungal !replacing!the!harmful!topical !steroids,!which!oGen!are!not!free !from!side!effects.!TetraPure!can!be !used!in!cream,!shampoo,!ointment,!lo5on,!spray,!or!powder!form!for!topical!applica5on!in!hair!care,!skin!care!and!nail!care!formula5ons.!

    Laboratory! studies!done !at!Sami !Labs !Ltd.!have!shown!that!TetraPure!can!be!used!for! the!management!of!superficial!and!cutaneous!mycoses !as!well !as !with!mul5func5onal !topical!benefits !such!as !an5oxidant!and!skin!lightening!proper5es.! !TetraPure,!has !been!proven!safe !for! topical !use!with!no!irritant!or!sensi5za5on!side!effects.!It!can!effec5vely! relive!the!skin!discomforts!caused!by! fungal !infec5ons!and!offer!a!soothing!solu5on!to!relieve!redness,!irrita5on,!scaling,!itching,!and!burning!associated!with!fungal!infec5ons.!

    Turmeric (Curcuma longa) A rhizomatous herbaceous perennial plant of the ginger family, Zingiberaceae. It is native to tropical South Asia and needs temperatures between 20 C and 30 C (68 F and 86 F) and a considerable amount of annual rainfall to thrive. Plants are gathered annually for their rhizomes, and propagated from some of those rhizomes in the following season.

    Source: en.wikipedia.org/wiki/Turmeric

  • 2012 Sabinsa Corporation 3

    1.(TetraPure:(Treatment(of(superficial(and(cutaneous(mycosis((fungal(infecXon)

    Human!mycoses!may!be!broadly!classified!based!on!the!loca5on!of!the!infec5on!within!the!body!(i)!Superficial,!cutaneous!and!subcutaneous;!and!(ii)!Systemic.

    Superficial !mycoses !include!cosme5c!fungal!infec5ons !of!the !skin!or!hair! shaG!with!no!involvement!of!living!5ssue! or! cellular! (immunological ! or! pathological)! responses! from! the! host.! Cutaneous!mycoses !are! also!superficial! fungal ! infec5on! of! the! skin,! hair! or! nails.! No! living! 5ssue! is ! invaded,! however! a ! variety! of!pathological !changes !occur! in! the!host! because !of! the!presence !of! the! infec5ous!agent! and! its !metabolic!products.! Therapeu5c! management! of! superficial!and! cutaneous!fungal!diseases !has !posed!a !tremendous!challenge !owing! to! the !fact! that! fungal !cells,! like! other! living! organisms,! may! become! resistant! to!drugs.!An5fungal !resistance!may!be!defined!as !a !stable,!inheritable !adjustment!by!fungal!cell !to!an!an5fungal!agent,!resul5ng!in!a!less!than!normal!sensi5vity!to!that!an5fungal!agent.

    Fungal ! infec5ons! are! responsible ! for! several ! disease! condi5ons ! in! human! and! plant! kingdom.! Some!pathogenic! fungi! such! as !Malassezia( furfur! give! rise !to!an!unhygienic! scaling! of! the !skull.! Other! systemic!infec5ons !produce!debilita5ng!health!condi5ons !such!as!fever!and!pain.!TetraPure(is(novel(inhibitor(of(fungi(growth.(It!can!be!used!in!cream,!shampoo,!ointment,!lo5on,!spray,!or!powder!form!to!relieve!skin!discomforts!that!arise!from!fungal!infec5ons.!

    AnXfungal(Efficacy((Agar(DiluXon(Method((Sabourauds(Dextrose(Agar,(SDA)

    TetraPure!inhibits!the!growth!of!dermatophytes!Trichophyton(rubrum,(Microsporum(gypseum(and(Epidermophyton(floccosum!at!all!tested!concentra5ons!viz!5%,!2.5%,!1.25%.!0.625%.!0.31%!&!0.15%!(Table!1).

  • 2012 Sabinsa Corporation 4

    Figure!1a!shows!the!an5/dermatophy5c!ac5vity!of!TetraPure.!TetraPure!at!concentra5ons!of:

    ! 0.15%

    ! 0.31%

    ! 0.625%

    ! 1.25%

    ! 2.5%

    ! 5.0%

    Completely! inhibi5ng! the! growth! of! Trichophyton( rubrum,( Microsporum( gypseum( and( Epidermophyton(floccosum!both!at!low!and!high!concentra5ons.!

  • 2012 Sabinsa Corporation 5

    Figure!1b!shows!no!effect!of!DMSO!used!to!dissolve!the!test!compound!(TetraPure)!on!the!growth!of!dermatophytes!Trichophyton(rubrum,(Microsporum(gypseum(and(Epidermophyton(floccosum.(

    AnXfungal(Efficacy((Agar(DiluXon(Method((Sabourauds(Dextrose(Agar,(SDA)

    TetraPure!at!0.15%,!reduces!the!colony!counts!of!Candida(albicans(NCIM3471!(Yeast)!to!less!than!100cfu/ml!with!an!overall!percentage!reduc5on!of!99.99%!over!a!test!interval!5me!of!28!days!(Table!2).

    Candida albicans

    NCIM 3471

    (yeast)

    50 14.6 x 10 ---57 72 x 10 50.6814 20 x 10 99.8221 75 x 10 99.9428

  • 2012 Sabinsa Corporation 6

    2.(TetraPure((AnXoxidant(PotenXal

    TetraPure! offers! effec5ve ! topical! an5oxidant! protec5on.! Its ! an5oxidant! ac5on! is! of! a ! comprehensive!bioprotectant!nature,!efficiently!preven5ng!the!forma5on!of!free !radicals,!while!quenching!pre/formed!ones!as !well.!This !dual!ac5on!protects!the!skin!cells !from!damage!by!UV!radia5on!and!the!resultant!inflamma5on!and! injury! with! far! reaching! beneficial !effects !on!overall !health! and!well! being.! In! vitro! data !reveal ! that!TetraPure!efficiently!scavenges !free!radicals !and!protects !the!skin!cells.!The !free!radical !scavenging!ac5vity!of!TetraPure!was !found!to!be!superior!to!that!of!the !Vitamin!C,!kojic!acid!and!arbu5n!(Table!3).!TetraPure!offer!protec5on!to!the!skin!and!could!be!included!in!as!func5onal!an5oxidants!in!topical!prepara5ons.!

    3.([email protected](acXvity((AcXvity(against(Malassezia(furfur((MF)((Agar(DiluXon(Method()

    TetraPure!inhibited!the!ac5vity!of!Malassezia(furfur(at!all!tested!concentra5on!(Table!4).!

    TetraPure 1.3 10,212Vitamin C 1.93 3,400Kojic Acid 500 NilArbutin 500 NilSource: Sami Labs Ltd.

    Table 3: Comparison of Antioxidant Potential

    Product ORAC Value (mol Trolox

    equivalents/g)

    DPPH Inhibition(IC g/ml)50

    Lower the IC value, greater is the Antioxidant Potential.50 Greater the ORAC value, better is the Antioxidant Potential.

    Malassezia

    furfur

    Trial 5% 2.5% 1.25% 0.625% 0.31% 0.15% MF1 N/G N/G N/G N/G N/G N/GMF2 N/G N/G N/G N/G N/G N/GMF3 N/G N/G N/G N/G N/G N/GSource: Sami Labs Ltd. (N/G= NO GROWTH)

    Table 4: Activity Against Malassezia furfurTest Organism

    TetraPure DMSO solvent with final concentration

  • 2012 Sabinsa Corporation 7

    4.(TetraPure((Skin(Lightening(PotenXal

    In(vitro(studies!indicate !that!TetraPure!efficiently!inhibits !tyrosinase,!the !rate!limi5ng!enzyme!in!the!synthesis!of!melanin.!Its!efficacy! is !superior! to!that!of!commonly!used!natural !skin!lightening!agents!such!as !kojic!acid,!and!of!related!compounds!(Table!5).

    5.(Safety(Studies(of(TetraPure

    TetraPure 1.8 3.2Vitamin C 9.33 25Kojic Acid 7 100Arbutin 193.6 100Source: Sami Labs Ltd.

    Table 5: Comparison of Skin Lightening Activities

    Product Melanin

    Inhibition(IC g/ml)50

    Tyrosinase Inhibition(IC g/ml)50

    Lower the IC value, greater is the Skin lightening activity.50

    Dermal Irritation Non-IrritantRepeated insult patch test Did not induce skin sensitization or any reactionPrimary Skin Irritation Did not cause any irritation

  • 2012 Sabinsa Corporation 8

    6.(Suggested(Use(Level

    In!An5/fungal/!An5/dandruff!formula5on!:!0.15%w/w

    In!Skin!lightening/an5/oxidant!formula5on:!0.1!/!0.5%w/w!

    References:

    Majeed&M,& (2012).&Treatment&of& superficial& and&cutaneous&mycoses&with& a&pure&form&of& 1,[email protected]([email protected]@[email protected])@3,[email protected]&US&8119696.

    Research&[email protected]&Labs&Ltd.&(2003).&Primary&skin&irritaOon&test,&Report&8954. Research&[email protected]&Labs&Ltd.&(2003).&Repeated&insult&patch&test,&Report&AACP/PP/163. Research&[email protected]&Sami&Labs&Ltd.&(2006).&Report&on&Dermal&IrritaOon,&Report&IR&161

    "TetraPure effectively relieves skin

    discomforts due to fungal infections and offers

    a balmy resolution to soothe redness,

    irritation, scaling, itching, and blazing

    compared with fungal infections, and can be

    used in all ranges of cosmetic products for

    progressing healthy skin, hair and nails