Colonial Monolaurin

Colonial Monolaurin CTFA/INCI: Glyceryl Laurate CLEARANCES: NICNAS, EINECS # 205-526-6 C.A.S. Number: 142-18-7

DESCRIPTION Colonial Chemical is pleased to offer a distilled glyceryl monolaurate commercially identified as Colonial Monolaurin This unique, multifunctional compound can bring added elegance and utility to personal care and pharmaceutical products. When compared with standard “mono glycerides”, Colonial Monolaurin has many more positive characteristics which are not typically found in just a single product. Some of these features are: • • • •

Stability to oxidation Low odor & pure white color Potent emulsification Superior emolliency

• • • •

Virtually no skin irritation Transdermal penetrating properties No pH effects on the skin Antimicrobial activity

In formulating, effective use levels can range between 0.1% and 5.0%, depending upon the application. Colonial Monolaurin should be added to a formulation so that it does not receive severe heating for prolonged periods. Colonial Monolaurin can be dispersed in water and dissolved in oil. Colonial Monolaurin solubility in glycerin and PG is limited to less than 5%. It would be highly soluble in ETOH, probably 10%-20%. Depending upon which phase Colonial Monolaurin is added, it will have an effect on the final viscosity and texture properties. Traditional alkyl glycerides have a monoglyceride level in the 35-45% range. Recently developed technology has lead to the production of Monolaurin with a monglyceride content above 90%. It has always been known that higher the monoglyceride content, the better the emulsification properties. In addition, the fatty acid composition of this unique product has been peaked to give greater than 98% lauric acid, resulting in a very pure glyceryl monolaurate that is available nowhere else. Research over the last several years suggests that the features mentioned above lend themselves to some of the following suggested applications. In a healing type ointment, Colonial Monolaurin can contribute to the promotion of wound healing through the reduction of advantageous bacteria. Any ointment of this type aimed at burns, bites and cuts, will be enhanced.

225 Colonial Drive

South Pittsburg, TN 37380

Ph: 423-837-8800

Fax: 423-837-3888

Numerous papers suggest that Colonial Monolaurin can be very useful in toothpastes and mouth rinses to mitigate the formation of “caries,” thus reducing tooth decay. It also inhibits plaque build-up. Due to its transdermal properties, it is indicated that Colonial Monolaurin will improve the performance of the patch type delivery systems coming into vogue today. Further, Monolaurin should improve the penetration of lidocaine, capcaisin and similar actives used to relieve discomfort caused by teething, gum pain, cold sores and muscular aches. Numerous papers site the improved transdermal penetration of drugs using Colonial Monolaurin. The addition of 10% Colonial Monolaurin can give a five-fold improvement in the drug’s transdermal penetration. Another abstract of record suggests that Colonial Monolaurin demonstrates the effective promotion of topically applied drugs in the treatment of psoriasis by providing better topical adsorption with reduced loss of the relevant active. Colonial Monolaurin could make treatments less irritating, easier to apply, and more cost effective by extending product usage. The transesterification products of triglycerides and glycerin have a long history of use, particularly in the food industry as emulsifiers. Their safety and efficacy has been proven for years and they have achieved GRAS (Generally Recognized as Safe) status as designated by the U.S. Code of Federal Regulations. Some of the available data relevant to the antimicrobial activity of Monolaurin is given in the following two tables. In Table 1, Colonial Monolaurin is ranked against two common preservatives using gram-positive bacteria and yeast organisms. Table 1 Comparison of Antibacterial Activity for Colonial Monolaurin and Common Preservatives Minimum Inhibitory Concentration (µgm/ml)

COLONIAL MONOLAURIN

B. Subtillis B. Cereus S. Aureus S. Cerevisiae A. Niger C. Utilis --------------------------Gram+------------------------- ---------Yeast-----20 20 20 20 20 20

Butylhydroxybenxoate

400

200

200

200

400

200

Sorbic Acid

4000

4000

4000

4000

4000

4000

Notes: Data generated by the agar dilution method

225 Colonial Drive

South Pittsburg, TN 37380

Ph: 423-837-8800

Fax: 423-837-3888

Gram positive organisms are generally associated with the semi-dry conditions found on surfaces such as skin. The control of these types of organisms is important when considering how many finished products are used. Consumers using open jars of cremes or lotions will often dip their fingers or an applicator into the product causing repeated exposure of the emulsion to gram positive microbes. Without sufficient preservation, microbial growth is augmented particularly along the sides of the container and the underside of the cap. Although Colonial Monolaurin is less effective against gram-negative organisms as compared with other traditional preservatives, its action can be potentiated by the addition of chelants such as EDTA, lactic, citric acid, and polyphosphates. In Table 2, a simple oil-in-water emulsion is challenged by the addition of two gram-negative organisms where Colonial Monolaurin is the emulsifier and preservative. By itself, the emulsion is not preserved, but a small addition of EDTA effectively controls microbial growth. Note that additional methyl paraben is not effective; the synergistic action is due solely to the presence of EDTA. Table 2 Preservative Effect of Food-Grade Chemicals Against Gram-negative Organisms in a Colonial Monolaurin Lotion

Preservative

At 24 h At 48 h P. Aeruginosa E. Coli P. Aeruginosa

At 1 wk E.Coli P. Aeruginosa

E.Coli

EDTA 0.1% 0.2% 0.3%

+ -

+ +/+/-

+ -

+ +/+/-

-

-

Methylparaben 0.1% 0.2% 0.3%

+ + +

+ + +

+ + +

+ + +

+ + +

-

+/-

+ + +/-

-

-

EDTA + Methylparaben 0.1% + 0.1% + + 0.2% + 0.2% + 0.3% + 0.3% +/a+, growth; +/-, slight growth; -, no growth. Source: From Ref 57

Colonial Monolaurin is a very exciting product for formulators that can:

225 Colonial Drive

South Pittsburg, TN 37380

Ph: 423-837-8800

Fax: 423-837-3888

• • • •

Provide strong self-preservation activityPromote the penetration of actives through the skin Exhibit proven safety profiles Enhance the aesthetics of formulations Create superior stability in emulsions of all types.

TYPICAL PROPERTIES *Monoester content: Fatty acid composition:

Minimum 90% Capric: max. 2%, Lauric: min. 90%, Myristic: max. 8%

Iodine value: Saponification value: Free glycerol: Free fatty acid: Melting point: Appearance:

Maximum 1 200-210 Maximum 4%; Maximum 1.5% Approximately 59°C - 60°C White flake or white powder

Description: Colonial Monolaurin is a distilled monoglyceride made from fractionated fatty acids or trilaurin. Storage conditions: Colonial Monolaurin may be stored for 36 months when kept cool and dry *Should be used for quality control.

TYPICAL FORMULATION MONO LAURIN CLEAR GEL BASE – This formulation makes a great hand sanitizer and cleanser. The Colonial Monolaurin helps prevent the hands from becoming chapped and cracked. Product is a clear, peaking gel suitable as a carrier base for topically applied actives. COMPONENT

WT. %

CHEMICAL DESCRIPTION

A. Carbopol 980 Isopropanol 91% Water

0.40 50.60 43.00

Polyacrylic acid Isopropanol

B. Propylene glycol Glycerin Colonial Monolaurin TOTAL

2.00 2.00 2.00 100.00

Propylene glycol Glycerin Glyceryl monolaurate

Adjust to pH 6.0 with aminomethylpropanol (Angus, AMP-95).

COLONIAL MONOLAURIN LIQUID HAND SOAP – Colonial Monolaurin gives great feel and conditioning to the skin. 225 Colonial Drive

South Pittsburg, TN 37380

Ph: 423-837-8800

Fax: 423-837-3888

COMPONENT

WT. %

CHEMICAL DESCRIPTION

Water Colonial ALES-60 Hamposyl L-30 Cola®Mid AL Colonial Monolaurin Versene 100 Glycerin Phenoxyethanol TOTAL

73.80 10.00 10.00 3.00 2.00 0.50 0.20 0.50 100.00

Ammonium lauryl ether sulfate Sodium lauryl sarcosinate Lauramide DEA Glyceryl monolaurate Tetrasodium EDTA Glycerin Fragrance fixative

Adjust to pH 6.5 with 88% lactic acid, add ~ 1.0% to increase viscosity to 2500 cps. Product is a very light yellow clear liquid that is high foaming and exceptionally mild. CLEAR EAR WITH MONOLAURIN – Designed for pets as an ear wash, Colonial Monolaurin helps soothe the ear and provides mildness to the formulation. COMPONENT Propylene glycol Glycerin Colonial Monolaurin Benzyl alcohol Phenoxyethanol TOTAL

WT. % 60.00 37.50 0.50 1.00 1.00 100.00

CHEMICAL DESCRIPTION Propylene glycol Glycerin Glyceryl monolaurate Benzyl alcohol Phenoxyethanol

Product is a lightly viscous fluid with a very slight haze. Use as a miticide for animal ears. COLONIAL MONOLAURIN LIGHT MOISTURIZING HAND CREAM WITH PCMX Phase 1 Deionized water Glycerin EDTA (Na2) Berberine Phase 2 Dimethicone Varisoft TA-100 Cetyl Alcohol Colonial Monolaurin Cola®Mulse PCMX Phase 3 Lemon Oil Vitamin E TOTAL

225 Colonial Drive

WT.% 82.44 5.00 0.10 0.01

4.00 2.50 2.00 3.00 0.50

0.25 0.20 100.00

South Pittsburg, TN 37380

Ph: 423-837-8800

Fax: 423-837-3888

Procedure Blend ingredients in Phase 1 as given with stirring and heat to 60oC – 70oC. Blend ingredients in Phase 2 with stirring and heat sufficiently to melt all waxes. Add Phase 2 to Phase 1 with sufficient agitation to create a homogenous blend. Stir-cool to 40oC and then add Phase 3 ingredients. LAST UPDATED 06/20/2008

WARRANTY Colonial Chemical guarantees that its products meet published specifications. No other warranties or guarantees are expressed or implied because the use of this material is beyond the control of Colonial Chemical.

Colonial Chemical, Inc. www.colonialchem.com 225 Colonial Drive South Pittsburg, TN 37380

225 Colonial Drive

South Pittsburg, TN 37380

Ph: 423-837-8800 Fax: 423-837-3888

Ph: 423-837-8800

Fax: 423-837-3888