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CONTENTS
• Current Antimicrobials and their limitations
• Galguard Trident: The Composition
• Galguard Trident: Preservation Efficacy
• Summary
Challenges in Preservation
• Significant amount of water in all formulation types
• Manufacturing processes
• Multi-use nature of products
• All work-horse antimicrobials are under cloud:
Toxicity issues and bad press
Types of Preservatives
• Parabens
• Formaldehyde releasers
• Isothiazolinones
• Halogenated synthetic molecules
• Quaternary ammonium
• Miscellaneous (alcohols, ether alcohols, organic acids)
Phenolic Antimicrobials
Trichlosan
Parabens
Chlorxylenol
Formaldehyde Releasers
Imidazolidinyl urea
DMDM Hydantoin
Diazolidinyl urea
Isothiazolinones
Methyl isothiazolinone
Chloromethyl isothiazolinone
Halogenated Antimicrobials
Iodopropynyl butyl
carbamate
Chlorphenesin
Chlorhexidine
Bronopol
Organic Acids
Sorbic acid
Benzoic acid
Dehydroacetic acid
Quaternary Ammonium Salts
Benzethonium chloride
Benzalkonium chloride
Cetyl pyridinium chloride
Quaternium 15
Miscellaneous
Phenoxy ethanol
Benzyl alcohol
Ethyl hexyl glycerol
Phenethyl alcohol
Work-horse preservatives for
personal care
• Parabens
• DMDM Hydantoin and Urea derivatives
• Methyl and chloromethyl isothiazolinones
• IPBC
• Trichlosan
• Phenoxy ethanol
Parabens & Formaldehyde
Releasers
• Parabens are implicated in disrupting endocrine
system, ultimately linked to breast cancer [(Pharmacology
& Toxicology (Vol. 86(3), pp 110-13, March 2000, Toxicology
and Applied Pharmacology (Vol. 153(1), pp. 12-19 (Nov. 1998),
Journal of Veterinary Medical Science (Vol. 64(3), pp227-35
(March 2002, Journal of Applied Toxicology, 24 (3): 167-176, (2004)]
• DMDM Hydantoin and other formaldehyde releasers:
Formaldehyde is classified as Category 3 CMR (carcinogenic,
mutagenic and reproductive toxic) and hence all formaldehyde
releasers are being phase out. DMDM Hydantoin is an allergen
too.
IPBC & Isothiazolinones
• Iodopropynyl butyl carbamate: Contact allergen, presence iodine gets it
implicated in Goiter and malfunctioning thyroid gland (American Journal of
Contact Dermatitis 13(2),77-79 (2002)
• Isothiazolinones: Found to be neurotoxic in animals. Skin sensitizer and
irritant. All major manufacturers of personal care products are dropping it
from ‘leave-on’ formulations. (Journal of Neuroscience 22 (17): 7408–7416.
The Lancet, Volume 333, Issue 8633, Pages 314-316 (1989)
Trichlosan
• Trichlosan is reported to be an endocrine disruptor (thyroid
function) and is reported to impair cardiac and skeletal muscles. There
seems to be a special concern for children who are at higher risk of
allergies and the immune systems (Toxicological Sciences, 2009, 107
(1): 56-64, Reproductive Toxicology, Apr 2009, 27(2):177-185)
• Trichlosan is a phenolic and halogenated molecule and has been
implicated in ecotoxicity (algae, dolphins)
The Goal
• To develop broad spectrum composition from safe antimicrobials
that are not implicated in any controversy over toxicity to humans or
the ecosystem.
• To create a „stable‟ and „easy-to-use‟ composition of personal care
ingredients that coincidentally exhibit antimicrobial activity.
• To develop an „energy-efficient‟ and „eco-friendly‟ manufacturing
process of creating the above composition.
Galguard Trident
• A „three-component‟ system is free from parabens, isothiazolinones,
formaldehyde releasers including Hydantoin derivatives, Urea
derivatives and Quaternium-15
• It is free from halogenated or phenolic molecules
• The preservation technology is based on phenoxy ethanol and lipidated
glycines, namely, N-capryloyl glycine and N-undecylenoyl glycine
Galguard Trident: The constituents
2-Phenoxy ethanol
• Occurs in nature (Green Tea)
• Used as antiseptic in olden time
CAS No 122-99-6
2-phenoxy ethanol
• Preferred antimicrobial for preserving vaccines
• Broad spectrum activity, more active against Gram -ve bacteria
• Non-controversial, most widely used (produced), safe, popular with leave-on
Cosmetic and Drug Preservation, Principles and Practice, Vol I, Ed Jon Kabara,
Marcel Dekker
N-octanoyl glycine
• Non-preservative substances to inhibit
microbial growth in cosmetics,
C & T,17(3), 11-13, 16-19, (1996)
CAS No 14246-53-8
N-Capryloyl glycine
• Derma-protector; restores the skin's “acid layer”
• Active against the normal resident skin flora
• Reduces scalp irritation and inhibits 5 α-reductase action and hence the sebum
production
• Limits proliferation of the germs responsible for dandruff
• Protective agent for cosmetic formulas; reduces the quantity of preservative,
ideal for sensitive skin
N-undecylenoyl glycine
• Undecylenoyl amino acids for the
treatment of skin disorders
JP 49093521 (1974)
• Cosmetic compositions comprising
N-undecylenoyl glycine and N- capryloyl glycine. WO 9927902 (1992)
• Compositions containing undecylenoyl glycine and capryloyl glycine
for preserving personal care products US 20040096528 (2004)
CAS No 54301-26-7
N-Undecylenoyl glycine
Products containing lipidated
glycines
LJH 5-Alpha Control Cleansing Gel
Melvita Roll-on Deodorant
Products containing lipidated
glycines
John Master Organics-Morroccan
Clay Purifying Mask
Les Soin Bio Plante –
Softness Deodorant
Products containing lipidated
glycines
ATACHE Scientific Cosmetic Balancing cream
Undecylenoyl glycine & Capryloyl
glycine in Baby Care
Neways Baby & Child Care
Dr Luigi Rigano, Cosmetics & Toiletries, 128, 458-461(2013)
Undecylenoyl glycine & Capryloyl
glycine in Baby Care
California Baby Super Sensitive
Galguard Trident: Microemulsion
Galguard Trident: Microemulsion
Galguard Trident: Microemulsion
• Microemulsion of water, phenoxy ethanol and lipo-glycines
•
Optically isotropic , W/O type microemulsion
• Thermodynamically stable
• It is 65 % active and the ratio of lipo-glycines to phenoxy ethanol is 1 : 4
Particle Sizing by Dynamic Light
Scattering
Zetasizer Ver 6.01 Malvern Instruments Ltd
Dz =Z average = 10 nm
Chemical Incompatibility
pka 3.28
Benzoic acid pka 4.2, Acetic acid pKa 4.76 Sorbic acid pka 4.76
Galguard Trident: The Microemulsion
• Thermodynamically stable
• Chemical instability addressed
• Delivery of other antimicrobials into microbes body
• Microemulsion : nano-structure and easy fusion with the lipids of cell membrane
and delivering the surfactants to disrupt the membrane
• Peptide type surfactants (lipidated glycines) are good at breaching the cell
membrane
James Baker and team , Microbiol. Res. 2001, 156, 1 (Univ of Michigan)
Kyle Vanderelick, Langmuir, 2003, 19, 591(Princeton Univ)
HPLC analysis of Galguard Trident
N-Undecylenoyl glycine: NMR
Antimicrobial Efficacy
of
Galguard Trident
Galguard Trident MICs
Escherichia coli
4000 ppm
Pseudomonas aeruginosa
4000 ppm
Candida albicans
5000 ppm
Staphylococcus aureus
6000 ppm
Aspergillus niger
6000 ppm
Propionibacterium acnes
7000 ppm
Malassezia furfur
6000 ppm
Galguard Trident: Germ Count
Reduction Test ( 1%)
Efficacy in Body Wash: 1.0 %
Galguard Trident
Efficacy in Cream: 1.0 %
Galguard Trident
Galguard Trident: Summary
•
Benefits: Preservation without any controversy
• Preservation with well-accepted ingredients
• Broad spectrum antimicrobial activity
• Colorless, odorless, easy-to-use
• Compatible with other ingredients
•
Applications: Skin-care, hair-care, baby-care, sun-care formulations
• Nail-care, wet wipes
• Both leave-on and rinse-off formulations
• Recommended use level: 0.5 to 1.2 % on active basis
• Best Efficacy: pH range of the formulation, 4 to 7.0
Galguard Trident
Preservation without any controversy
• Paraben -free and Formaldehyde-donors-free
• Isothiazolinones-free (Methyl and chloromethyl analogs)
• No halogen (bromo, chloro, iodo) containing antimicrobials
• Free from phenolic molecules and quaternary ammonium
compounds
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