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 Chlorphenesin Bronopol

carbamate

Chlorhexidine
Organic Acids

Sorbic acid

Benzoic acid Dehydroacetic acid

Quaternary Ammonium Salts

Benzethonium chloride Cetyl pyridinium chloride

Benzalkonium chloride Quaternium 15

Miscellaneous

Phenoxy ethanol Ethyl hexyl glycerol

Benzyl alcohol 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): 74087416.
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
2-phenoxy ethanol

CAS No 122-99-6
Occurs in nature (Green Tea)
Used as antiseptic in olden time
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-Capryloyl glycine

CAS No 14246-53-8
N-octanoyl glycine

Non-preservative substances to inhibit

microbial growth in cosmetics,
C & T,17(3), 11-13, 16-19, (1996)
Derma-protector; restores the skin's acid layer
Active against the normal resident skin flora
Reduces scalp irritation and inhibits 5 -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
N-undecylenoyl glycine

CAS No 54301-26-7
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)
Products containing lipidated
glycines

LJH 5-Alpha Control Cleansing Gel Melvita Roll-on Deodorant

Products containing lipidated
glycines

John Master Organics-Morroccan Les Soin Bio Plante

Clay Purifying Mask 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

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 Pseudomonas aeruginosa Staphylococcus aureus Propionibacterium acnes

4000 ppm 4000 ppm 6000 ppm 7000 ppm

Candida albicans Aspergillus niger Malassezia furfur

5000 ppm 6000 ppm 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
THANK YOU