Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Ester doai
Reexamination Certificate
1994-01-26
2003-10-28
Travers, Russell (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Ester doai
C514S552000, C514S946000
Reexamination Certificate
active
06638978
ABSTRACT:
TECHNICAL FIELD
The present invention relates generally to food grade materials as preservatives and, more particularly, to the addition of glyceryl fatty acid esters, in combination with at least one or more acids selected from the group consisting of C
6
-C
18
, preferably C
6
-C
12
, fatty acids to food compositions, cosmetics or pharmaceutical preparations or the like.
BACKGROUND OF THE INVENTION
The use of antimicrobial agents plays an important part in current food preservation techniques. However, the addition of these additives have several disadvantages. The addition of antimicrobials may dramatically effect the taste of the food composition. With certain additives, the amount of the additive which may be employed in a food composition may be limited by government regulations. And while many agents are useful in certain environments, certain additives may have a narrow spectrum of micro-organism activity and type of foods it may be employed with. Accordingly, there is a need for an antimicrobial that may be added to food compositions which is safe, effective and which overcomes these disadvantages. The present invention meets this need for food, cosmetic and drug preservation.
The prior art teaches several different carboxylic acids which are generally useful in suppressing the growth of fungi, bacteria, molds, and the like such as U.S. Pat. No. 2,154,449 issued to Hoffman et al. teaches the use of aliphatic C
3
-C
12
carboxylic acids and their salts as mold inhibitors in food compositions. U.S. Pat. No. 2,190,714 issued to Hoffman, et al. teaches the addition of a C
3
-C
12
carboxylic acid to inhibit growth food products other than margarine and sourdough bread. U.S. Pat. No. 3,404,987 to Kooistra, et al. teaches an antimicrobial containing edible mineral salt and edible acid preservative substances, particularly propionic acid. U.S. Pat. No. 2,466,663 issued to Russ, et al. teaches the use of a topical or intravenous caprylic acid solution to combat mycotic infections or growths. U.S. Pat. No. 2,729,586 issued to Peck teaches a therapeutic composition having at least one salt of a C
3
-C
11
monocarboxylic acid and water soluble chlorophyll. However, the majority of these are outside the food area. For example, U.S. Pat. No. 4,406,884 issued to Fawzi discloses a topical antimicrobial composition in the form of an aqueous gel or lotion. This composition contains C
5
-C
12
fatty acids having a pH no greater than about 5. U.S. Pat. No. 4,343,798 issued to Fawzi, teaches a topical antimicrobial anti-inflammatory composition having a pH no greater than about 5 and containing C
5
-C
12
fatty acids together with a corticosteroid component. U.S. Pat. No. 4,489,097 issued to Stone, teaches the addition of anti-fungal/antibacterial materials to sterile compositions. The antifungal/antibacterial material disclosed is a C
4
-C
9
carboxylate antimicrobial agent having a pH of about 6.0 or below. U.S. Pat. No. 4,410,442 issued to Lucas, et al. teaches solutions for use with hydrophilic soft contact lenses containing C
5
-C
12
fatty acids, especially octanoic acid. U.S. Pat. No. 4,392,848 issued to Lucas, et al. teaches a catheter having a liquid reservoir of an antimicrobial agent flowing through the lumen of the catheter. The antimicrobial agent disclosed is a straight-chain carboxylic acid or carboxylic acid salt having a C
4
-C
9
chain. U.S. Pat. No. 4,430,381 issued to Harvey, et al. teaches a process for imparting antimicrobial properties to a material. The antimicrobial being a C
3
-C
12
alkane, alkene or alkyne monocarboxylate. U.S. Pat. Nos. 4,343,788 and 4,479,795, both issued to Mustacich, et al. teach medical polymers that provide diffusion for certain carboxylate antimicrobial agents. U.S. Pat. No. 4,002,775 issued to Kabara teaches a food grade microbicidal composition having a monoester with a C
12
aliphatic fatty acid as its primary microbicide. U.S. Pat. No. 1,772,975 issued to Weiland teaches the use of lactic acid, acetic acid, or combinations thereof, as antiseptics at properly adjusted pH levels.
Other materials also disclose the use of fatty acids for the suppression of fungi, bacteria, mold and the like. Kabara, J.,
Medium
-
chain Fatty Acids and Esters as Antimicrobial Agents,
Cosmetic and Drug Preservation, Pgs. 275-304, 1984, teaches the use of C
6
-C
22
saturated and unsaturated fatty acids as antimicrobials. Kabara, J.,
Toxicological, Bactericidal and Fungicidal Properties of Fatty Acids and Some Derivatives,
The Journal of the American Oil Chemists' Society, Vol. 56, No. 11, Pages 760A-767A (1979) teaches the applying of fatty acids to animal skin and eyes. Some fatty acids were found to be skin and eye irritants. Kabara, J.,
Inhibition of Staphylococlus Aureus In a Model Agar
-
Meat System By Monolaurin: A Research Note,
Journal of Food Safety, Vol. 6, Pgs. 197-201 (1984), teaches the use of monolaurin as a food preservative to combat microorganisms. Kabara, J.,
Antimicrobial Agents Derives from Fatty Acids, JAOCS,
Vol. 61, No. 2, Pgs. 397-403 (1984) teaches the use of saturated and unsaturated fatty acids as antimicrobial agents. Kabara, J.,
GRAS Antimicrobia Agents for Cosmetic Products,
Journal of the Society of Cosmetic Chemists, Vol. 31, Pgs. 1-10 (1980), teaches the composition of monolaurin, a phenol, di-tert-butyl anisole, and a chelating agent such as ethylenediaminetetracetic acid to be useful in destroying gram positive and gram negative bacteria. Schemmel, R., Lynch, P., Krohn, K., and Kabara, J.,
Monolaurin as an Anticaries Agent,
teaches the use of glycerol-monolaurin in inhibiting development of smooth surface caries in rats innoculated with Streptococcus mutants. Kabara, Jr., Ohkawa M., Ikekawa, T., Katori, T., and Mishikawa, Y.,
Examination on Antitumor, Immunological and Plant
-
Growth Inhiditory Effects of Monoglycerides of Caprylic, Capric, and Lauric Acids and Related Compounds,
Pharacological Effects of Lipids, Volume II, Pgs. 263-272 (1985) teaches the use of the monoglycerides or caprylic, capric and lauric acids for regulating antitumor, immunological, and plant-growth activity. Li, C., and Kabara, J.,
Effects of Lauricidin on Fomes Annosus and Phellinus
Weirii, AOCS Monograph No. 5, Pgs. 45-47 (1978) teaches the use of monolaurin in combating root rot fungi in coniferous forest. Kenney, D.,
Cosmetic Formulas Preserved With Food
-
Grade Chemicals,
Cosmetics and Toiletries, Part 1, Vol. 97, Pgs. 71-76 (1982) and Kabara, J. and Wernette, C.,
Cosmetic Formulas Preserved with Food
-
Grade Chemicals,
Cosmetics and Toiletries, Part II, Vol. 97, Pgs. 77-84 (1982) teaches the use of monoglyceride emulsifier, food-grade phenols and a chelator in the preservation of cosmetics. Kabara, J.,
A New Preservative System For Food,
Journal of Food Safety, Volume 4, Pgs. 13-25 (1982) teaches the use of monolaurin, a food grade phenolic, and a chelator as an antimicrobial for the preservation of food. Branan, A. and Davison, P.
Antimicrobials in Foods,
Marcel Dekker, New York 1983, Pgs. 109-140 teaches the use of saturated, unsaturated and esters of fatty acids as antimicrobials and the use of these compounds for food preservation. Kabara, J.,
Fatty Acids and Derivatives as Antimicrobial Agents—A Review,
AOCS Monograph No. 5, Pgs. 1-14(1978) teaches the use of saturated, unsaturated and esters of fatty acids as antimicrobials and the use of these compounds for permeating microorganism cellular membranes for killing the microorganism.
The art also teaches many methods of ethoxalation.
Nonionic Surfactants,
Schick, M. J., Marcel Dekken, Inc., New York (1966) and Dillan, K.
Effects of the Ethylene Oxide Distribution on Nonionic Surfactant Properties,
JAOCS, Vol. 62, No. 7, Pgs. 1144-1151 (1985) teach the ethoxalation of primary alcohols to produce nonionic surfactants.
The above discussion clearly reflects the ambiguous state of the art with regard to the suitability and selection of fatty acid-based materials as food preservatives. The art disclosed materials vary widely in their preservative efficacy an
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