Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Biocides; animal or insect repellents or attractants
Reexamination Certificate
1999-05-19
2001-02-13
Jones, D. L. (Department: 1619)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Biocides; animal or insect repellents or attractants
C424S400000, C424S404000, C424S401000
Reexamination Certificate
active
06187327
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to sanitizing lotions having antimicrobial properties; and particularly to a highly persistent antimicrobial hand sanitizing lotion which displays unique barrier properties.
BACKGROUND OF THE INVENTION
Hand washing has long been recognized as a particularly effective method for reducing the transmission of communicable diseases. In hospitals, where patients are in a weakened condition, it is most important for health-care professionals to utilize an antimicrobial hand cleaning composition to prevent the spread of various pathogenic microorganisms. Furthermore, it is necessary to treat parts of the skin and mucous membranes antiseptically prior to any type of surgical procedure, injection, or puncture so as to prevent the transmission of infectious microorganisms. In such environments, compositions such as alcohols are effective antimicrobials. However, the defatting properties of alcohols cause chapping and cracking to occur to the skin of the user. The resultant damaged skin is then more prone to additional infectious contamination, since pathogenic microorganisms can enter and evade sanitizing materials by residing within the cracked epidermal layer. Additionally, the presence of alcohols inhibits the foaming action of various detergent compositions which are likely to be used in combination therewith. Various antimicrobials are known for use in such formulations, for example, iodophors, iodine formulations, phenolic compounds, e.g. hexachlorophene, and bisbiguanides, e.g. chlorhexidene gluconate. Such antimicrobial ingredients are also well-known additives for a variety of products, such as deodorant soap bars, underarm deodorants, liquid soaps and fabric treatments.
In order to form an efficacious antimicrobial product which is not injurious to the user's skin, various proposals have been made. Improvements in mildness and skin after-feel have called for the addition of such additives as glycerin, sorbitol, vitamin E, coco fatty acid derivatives and their salts, alkyl quaternary salts and sugar esters.
DESCRIPTION OF THE PRIOR ART
U.S. Pat. No. 5,173,216 discloses a composition for decontaminating and/or disinfecting the hands comprising an amphoteric-cationic surfactant, a cationic surfactant, a wetting agent which is compatible with the cationic surfactant, and a nonionic regressing agent. The composition exhibits both bacteriostatic and fungistatic effectiveness at varying concentrations.
U.S. Pat. No. 5,719,113 discloses an antimicrobial cleansing composition containing chlorhexidine, a nonionic surfactant which does not include polyoxypropylene/polyoxyethylene block copolymers, an amphoteric surfactant, and an alkyl polyglucoside. Additionally included are viscosifiers or thickeners, emollients, fragrances, perfumes, coloring agents, preservatives, foaming agents, vitamins and fungicides.
U.S. Pat. No. 5,259,984 discloses a cleansing composition containing a storage-stable volatile polymer gel solution and a cleaning agent including an alkali metal hydroxide. In a preferred embodiment, the polymer gel solution includes a hydroxypropylmethylcellulose polymer. The composition is formed by forming a pre-mixed cleaning agent and a pre-mixed volatile aqueous gel solution. These pre-mixed components are then intermixed to form the final cleaner composition.
U.S. Pat. No. 5,562,912 discloses a cleansing composition containing an EO/PO/EO tri-block nonionic copolymer surfactant in conjunction with a generic skin cleanser composition.
U.S. Pat. No. 5,629,006 discloses a cleansing composition containing an alcohol, a block copolymer, a foaming surfactant, an emulsifier, a cleaning agent, a polyalkylene glycol, an emollient and water. Stepwise addition of the components with continuous mixing to a point of homogeneity is utilized in the method of formulation.
U.S. Pat. No. 5,728,662 discloses a cleansing composition which consists essentially of a d-limonene, a solvent, a C
11
alcohol ethoxylate, polyoxyethylene (20) sorbitan monooleate, a water-soluble acrylic polymer, sodium hydroxide, mixed isothioazolinones, 2,6-di-tert--butyl-p-cresol and water.
U.S. Pat. No. 5,767,163 discloses a cleansing composition and method for its use as a hand antiseptic. The composition is an alcoholic solution containing cetyl alcohol, glycolic acid, benzalkonium chloride and isopropyl alcohol as its major constituent.
U.S. Pat. No. 5,750,579 is drawn to a cleansing composition which is useful for the hands and fingers. The composition is in the form of a solution which comprises a disinfecting medicament in an alcohol and a thickening agent consisting of a combination of a carboxyvinyl polymer and a water-soluble, high molecular weight cellulose compound. The process of manufacture requires that various of the ingredients are blended to a point of homogeneity, resulting in a final, homogeneous composition.
U.S. Pat. No. 5,591,442 is drawn to an antiseptic and disinfectant hand cleaning composition containing a synergistic mixture of an alkyl alcohol component and a glycerol monoalkyl ether.
U.S. Pat. No. 5,650,143 drawn to a deodorant cosmetic stick composition provides a deodorant cosmetic stick product which has a translucent or transparent light transmitting appearance. The cosmetic stick contains propylene glycol, sodium stearate, dimethicone copolyol, TRICLOSAN, PENTADOXYNOL-200, and water.
U.S. Pat. No. 5772640 drawn to TRICLOSAN-containing medical devices, discloses polymeric medical articles containing the antiinfective agents chlorhexidine and TRICLOSAN. The patent discloses a synergistic relationship between these compounds which permits the use of relatively low levels of both agents, while achieving effective antimicrobial activity when these compounds are contained in either hydrophilic or hydrophobic polymers.
The prior art formulations suffer from the fact that increased use of various surfactants and lipid-restoring compositions reduce the effectiveness of the antimicrobial active ingredient. Therefore, if a composition including skin barrier properties and persistent anti-microbial characteristics could be formulated in such a way that both enhanced skin-care and increased antimicrobial effectiveness resulted, a long-felt need in the art would be satisfied.
SUMMARY OF THE INVENTION
The present invention describes an antimicrobial hand sanitizing lotion in the form of a medicated polymer/emulsion based product and the method by which it is produced. The product is intended to be used as a topical antimicrobial lotion. 2,4,4′-trichloro-2′-hydroxydiphenyl ether, available under the tradename TRICLOSAN or IRGASAN DP 300 from the Ciba Geigy Corp., is the antimicrobial agent of choice in the present formulation. TRICLOSAN has demonstrated efficacy against the following gram-positive and gram-negative bacteria, plus fungi and yeasts:
GRAM-POSITIVE BACTERIA
Bacillus subtilis
Bacillus megatherium
Bacillus cereus
Bacillus cereus
var.
mycoides
Clostridium botulinum
Clostridium tetani
corynebacterium diphtheriae
Corynebacterium acnes
*
Diplococcus pneumonise
Lactobacillus arabinosus
Lactobacillus fermenti
Mycobacterium tuberculosis
Mycobacterium smegmatis
Mycobacterium phlei
Sarcina lutea
Sarcina ureae
staphylococcus aureas
Staphylococcus albus
streptococcus agalactiae
streptococcus haemolyticus
A
streptococcus faecalis
streptococcus pyogenes
*
Propionibacterium acnes
GRAM-NEGATIVE BACTERIA
Aerobacter aerogenes
Alraligenes; faecalis
Brucella intermedia
Brucella abortus
Brucella melitensis
Brucella suis
cloaca cloacae
Escherichia coli
Haemophilus Influenzae
Klebsiella edwardsii
Klebsiella aerogenes
Klebsiella pneumoniae
Loeffierella mallei
Loeffierella pseudomallei
Moraxells duplex
Moraxella glucidolytica
Moraxella lwoffi
Neisseria catarrhilis
Pasteurella septica
Pasteurella pseuclotuberculosis
Proteus vulgaris
proteus mirabills
Pseudomonas aeruginosa
Pseudomonas fluorescens
Salmonella enteritidis
Salmonella typhimurium
salmonella typhi
Salmonella paratyphi
A
salmonella paratyphi
B
Salmonella pullorum
Serratia marcescens
Sh
Jones D. L.
McHale & Slavin
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