AU2006235798B2 - Topical composition - Google Patents
Topical composition Download PDFInfo
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- AU2006235798B2 AU2006235798B2 AU2006235798A AU2006235798A AU2006235798B2 AU 2006235798 B2 AU2006235798 B2 AU 2006235798B2 AU 2006235798 A AU2006235798 A AU 2006235798A AU 2006235798 A AU2006235798 A AU 2006235798A AU 2006235798 B2 AU2006235798 B2 AU 2006235798B2
- Authority
- AU
- Australia
- Prior art keywords
- topical composition
- chlorhexidine
- topical
- microorganism
- salts
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired
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- 239000000203 mixture Substances 0.000 title claims description 85
- 230000000699 topical effect Effects 0.000 title claims description 83
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims description 22
- GHXZTYHSJHQHIJ-UHFFFAOYSA-N Chlorhexidine Chemical compound C=1C=C(Cl)C=CC=1NC(N)=NC(N)=NCCCCCCN=C(N)N=C(N)NC1=CC=C(Cl)C=C1 GHXZTYHSJHQHIJ-UHFFFAOYSA-N 0.000 claims description 21
- 229960003260 chlorhexidine Drugs 0.000 claims description 21
- 239000006210 lotion Substances 0.000 claims description 21
- 238000000034 method Methods 0.000 claims description 21
- 239000000645 desinfectant Substances 0.000 claims description 17
- 244000005700 microbiome Species 0.000 claims description 15
- 150000003839 salts Chemical class 0.000 claims description 15
- 239000002202 Polyethylene glycol Substances 0.000 claims description 11
- 229920001223 polyethylene glycol Polymers 0.000 claims description 11
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 9
- 230000002421 anti-septic effect Effects 0.000 claims description 8
- 230000005540 biological transmission Effects 0.000 claims description 7
- 229960003333 chlorhexidine gluconate Drugs 0.000 claims description 7
- YZIYKJHYYHPJIB-UUPCJSQJSA-N chlorhexidine gluconate Chemical group OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(O)=O.OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(O)=O.C1=CC(Cl)=CC=C1NC(=N)NC(=N)NCCCCCCNC(=N)NC(=N)NC1=CC=C(Cl)C=C1 YZIYKJHYYHPJIB-UUPCJSQJSA-N 0.000 claims description 7
- -1 emolument Substances 0.000 claims description 7
- 241000191967 Staphylococcus aureus Species 0.000 claims description 6
- 210000004400 mucous membrane Anatomy 0.000 claims description 6
- 239000002674 ointment Substances 0.000 claims description 6
- 241000894007 species Species 0.000 claims description 6
- 239000003755 preservative agent Substances 0.000 claims description 5
- 239000000865 liniment Substances 0.000 claims description 4
- 239000004094 surface-active agent Substances 0.000 claims description 4
- 239000000499 gel Substances 0.000 claims description 3
- 238000000265 homogenisation Methods 0.000 claims description 3
- 238000004519 manufacturing process Methods 0.000 claims description 3
- 238000002156 mixing Methods 0.000 claims description 3
- 239000003921 oil Substances 0.000 claims description 3
- 238000003756 stirring Methods 0.000 claims description 3
- 239000002562 thickening agent Substances 0.000 claims description 3
- WJLVQTJZDCGNJN-UHFFFAOYSA-N Chlorhexidine hydrochloride Chemical compound Cl.Cl.C=1C=C(Cl)C=CC=1NC(N)=NC(N)=NCCCCCCN=C(N)N=C(N)NC1=CC=C(Cl)C=C1 WJLVQTJZDCGNJN-UHFFFAOYSA-N 0.000 claims description 2
- 235000010654 Melissa officinalis Nutrition 0.000 claims description 2
- 239000000654 additive Substances 0.000 claims description 2
- 239000000443 aerosol Substances 0.000 claims description 2
- 239000003963 antioxidant agent Substances 0.000 claims description 2
- 235000006708 antioxidants Nutrition 0.000 claims description 2
- 229960002152 chlorhexidine acetate Drugs 0.000 claims description 2
- 229960004504 chlorhexidine hydrochloride Drugs 0.000 claims description 2
- 239000003086 colorant Substances 0.000 claims description 2
- 239000002537 cosmetic Substances 0.000 claims description 2
- 239000006071 cream Substances 0.000 claims description 2
- 239000003995 emulsifying agent Substances 0.000 claims description 2
- 239000006260 foam Substances 0.000 claims description 2
- 239000003205 fragrance Substances 0.000 claims description 2
- 229940040145 liniment Drugs 0.000 claims description 2
- 239000002304 perfume Substances 0.000 claims description 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 2
- 239000003380 propellant Substances 0.000 claims description 2
- MCSINKKTEDDPNK-UHFFFAOYSA-N propyl propionate Chemical compound CCCOC(=O)CC MCSINKKTEDDPNK-UHFFFAOYSA-N 0.000 claims description 2
- 239000000243 solution Substances 0.000 claims description 2
- 239000007921 spray Substances 0.000 claims description 2
- 239000003381 stabilizer Substances 0.000 claims description 2
- 239000000725 suspension Substances 0.000 claims description 2
- 241000021559 Dicerandra Species 0.000 claims 1
- 239000003974 emollient agent Substances 0.000 description 16
- 230000000845 anti-microbial effect Effects 0.000 description 14
- 239000004599 antimicrobial Substances 0.000 description 11
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 10
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 10
- 125000000217 alkyl group Chemical group 0.000 description 9
- 230000000694 effects Effects 0.000 description 9
- 239000003906 humectant Substances 0.000 description 7
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 6
- 208000015181 infectious disease Diseases 0.000 description 6
- 150000001298 alcohols Chemical class 0.000 description 5
- 210000003491 skin Anatomy 0.000 description 5
- 239000000344 soap Substances 0.000 description 5
- JCYZMTMYPZHVBF-UHFFFAOYSA-N Melarsoprol Chemical compound NC1=NC(N)=NC(NC=2C=CC(=CC=2)[As]2SC(CO)CS2)=N1 JCYZMTMYPZHVBF-UHFFFAOYSA-N 0.000 description 4
- 235000011187 glycerol Nutrition 0.000 description 4
- 239000004615 ingredient Substances 0.000 description 4
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 3
- 230000002159 abnormal effect Effects 0.000 description 3
- 150000007860 aryl ester derivatives Chemical class 0.000 description 3
- 230000001580 bacterial effect Effects 0.000 description 3
- PRAKJMSDJKAYCZ-UHFFFAOYSA-N dodecahydrosqualene Natural products CC(C)CCCC(C)CCCC(C)CCCCC(C)CCCC(C)CCCC(C)C PRAKJMSDJKAYCZ-UHFFFAOYSA-N 0.000 description 3
- 229920001451 polypropylene glycol Polymers 0.000 description 3
- 230000002035 prolonged effect Effects 0.000 description 3
- 238000004659 sterilization and disinfection Methods 0.000 description 3
- 210000000434 stratum corneum Anatomy 0.000 description 3
- 241000894006 Bacteria Species 0.000 description 2
- 208000035473 Communicable disease Diseases 0.000 description 2
- 206010020751 Hypersensitivity Diseases 0.000 description 2
- 239000004166 Lanolin Chemical class 0.000 description 2
- 239000002253 acid Substances 0.000 description 2
- 150000007513 acids Chemical class 0.000 description 2
- 230000002411 adverse Effects 0.000 description 2
- 230000000844 anti-bacterial effect Effects 0.000 description 2
- 230000004888 barrier function Effects 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 235000013870 dimethyl polysiloxane Nutrition 0.000 description 2
- 150000002009 diols Chemical class 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- 150000002148 esters Chemical class 0.000 description 2
- 150000002170 ethers Chemical class 0.000 description 2
- 238000001704 evaporation Methods 0.000 description 2
- 230000008020 evaporation Effects 0.000 description 2
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 description 2
- 235000019388 lanolin Nutrition 0.000 description 2
- 229940039717 lanolin Drugs 0.000 description 2
- 230000000813 microbial effect Effects 0.000 description 2
- 229920000435 poly(dimethylsiloxane) Polymers 0.000 description 2
- 229920001296 polysiloxane Polymers 0.000 description 2
- YYGNTYWPHWGJRM-UHFFFAOYSA-N (6E,10E,14E,18E)-2,6,10,15,19,23-hexamethyltetracosa-2,6,10,14,18,22-hexaene Chemical compound CC(C)=CCCC(C)=CCCC(C)=CCCC=C(C)CCC=C(C)CCC=C(C)C YYGNTYWPHWGJRM-UHFFFAOYSA-N 0.000 description 1
- CPKVUHPKYQGHMW-UHFFFAOYSA-N 1-ethenylpyrrolidin-2-one;molecular iodine Chemical compound II.C=CN1CCCC1=O CPKVUHPKYQGHMW-UHFFFAOYSA-N 0.000 description 1
- VRACDWUCKIDHCO-UHFFFAOYSA-N 16-methylheptadecyl 10-[5,6-dihexyl-2-[8-(16-methylheptadecoxy)-8-oxooctyl]cyclohex-3-en-1-yl]dec-9-enoate Chemical class CCCCCCC1C=CC(CCCCCCCC(=O)OCCCCCCCCCCCCCCCC(C)C)C(C=CCCCCCCCC(=O)OCCCCCCCCCCCCCCCC(C)C)C1CCCCCC VRACDWUCKIDHCO-UHFFFAOYSA-N 0.000 description 1
- 208000035143 Bacterial infection Diseases 0.000 description 1
- 206010011409 Cross infection Diseases 0.000 description 1
- 241000195493 Cryptophyta Species 0.000 description 1
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 1
- RGHNJXZEOKUKBD-SQOUGZDYSA-N D-gluconic acid Chemical class OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(O)=O RGHNJXZEOKUKBD-SQOUGZDYSA-N 0.000 description 1
- SNPLKNRPJHDVJA-ZETCQYMHSA-N D-panthenol Chemical compound OCC(C)(C)[C@@H](O)C(=O)NCCCO SNPLKNRPJHDVJA-ZETCQYMHSA-N 0.000 description 1
- VGGSQFUCUMXWEO-UHFFFAOYSA-N Ethene Chemical compound C=C VGGSQFUCUMXWEO-UHFFFAOYSA-N 0.000 description 1
- 239000005977 Ethylene Substances 0.000 description 1
- 241000233866 Fungi Species 0.000 description 1
- 244000062730 Melissa officinalis Species 0.000 description 1
- 206010029803 Nosocomial infection Diseases 0.000 description 1
- 241000282320 Panthera leo Species 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 239000004721 Polyphenylene oxide Substances 0.000 description 1
- 229920000153 Povidone-iodine Polymers 0.000 description 1
- 206010040880 Skin irritation Diseases 0.000 description 1
- 206010070835 Skin sensitisation Diseases 0.000 description 1
- 206010041925 Staphylococcal infections Diseases 0.000 description 1
- BHEOSNUKNHRBNM-UHFFFAOYSA-N Tetramethylsqualene Natural products CC(=C)C(C)CCC(=C)C(C)CCC(C)=CCCC=C(C)CCC(C)C(=C)CCC(C)C(C)=C BHEOSNUKNHRBNM-UHFFFAOYSA-N 0.000 description 1
- 208000036142 Viral infection Diseases 0.000 description 1
- 241000700605 Viruses Species 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 150000001335 aliphatic alkanes Chemical class 0.000 description 1
- 150000001336 alkenes Chemical class 0.000 description 1
- 125000003342 alkenyl group Chemical group 0.000 description 1
- 125000005907 alkyl ester group Chemical group 0.000 description 1
- 125000005376 alkyl siloxane group Chemical group 0.000 description 1
- 230000000172 allergic effect Effects 0.000 description 1
- 208000030961 allergic reaction Diseases 0.000 description 1
- 125000003118 aryl group Chemical group 0.000 description 1
- 208000010668 atopic eczema Diseases 0.000 description 1
- 208000022362 bacterial infectious disease Diseases 0.000 description 1
- 235000013871 bee wax Nutrition 0.000 description 1
- 239000012166 beeswax Substances 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 125000004122 cyclic group Chemical group 0.000 description 1
- SZXQTJUDPRGNJN-UHFFFAOYSA-N dipropylene glycol Chemical compound OCCCOCCCO SZXQTJUDPRGNJN-UHFFFAOYSA-N 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 230000002458 infectious effect Effects 0.000 description 1
- 230000007794 irritation Effects 0.000 description 1
- 229940119170 jojoba wax Drugs 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 244000144972 livestock Species 0.000 description 1
- 231100000053 low toxicity Toxicity 0.000 description 1
- 208000015688 methicillin-resistant staphylococcus aureus infectious disease Diseases 0.000 description 1
- 239000002480 mineral oil Substances 0.000 description 1
- 235000010446 mineral oil Nutrition 0.000 description 1
- 229940042472 mineral oil Drugs 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- JXTPJDDICSTXJX-UHFFFAOYSA-N n-Triacontane Natural products CCCCCCCCCCCCCCCCCCCCCCCCCCCCCC JXTPJDDICSTXJX-UHFFFAOYSA-N 0.000 description 1
- CXQXSVUQTKDNFP-UHFFFAOYSA-N octamethyltrisiloxane Chemical class C[Si](C)(C)O[Si](C)(C)O[Si](C)(C)C CXQXSVUQTKDNFP-UHFFFAOYSA-N 0.000 description 1
- 239000011619 pantothenol Substances 0.000 description 1
- 235000020957 pantothenol Nutrition 0.000 description 1
- 230000008506 pathogenesis Effects 0.000 description 1
- WXZMFSXDPGVJKK-UHFFFAOYSA-N pentaerythritol Chemical compound OCC(CO)(CO)CO WXZMFSXDPGVJKK-UHFFFAOYSA-N 0.000 description 1
- 229920001281 polyalkylene Polymers 0.000 description 1
- 229920000570 polyether Polymers 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 229960001621 povidone-iodine Drugs 0.000 description 1
- BDERNNFJNOPAEC-UHFFFAOYSA-N propan-1-ol Chemical compound CCCO BDERNNFJNOPAEC-UHFFFAOYSA-N 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 230000036556 skin irritation Effects 0.000 description 1
- 231100000475 skin irritation Toxicity 0.000 description 1
- 231100000370 skin sensitisation Toxicity 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 235000010356 sorbitol Nutrition 0.000 description 1
- 229940032094 squalane Drugs 0.000 description 1
- 229940031439 squalene Drugs 0.000 description 1
- TUHBEKDERLKLEC-UHFFFAOYSA-N squalene Natural products CC(=CCCC(=CCCC(=CCCC=C(/C)CCC=C(/C)CC=C(C)C)C)C)C TUHBEKDERLKLEC-UHFFFAOYSA-N 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 230000003655 tactile properties Effects 0.000 description 1
- 229940100613 topical solution Drugs 0.000 description 1
- 230000003612 virological effect Effects 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
- 239000001993 wax Substances 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Cosmetics (AREA)
Description
AUSTRALIA
Patents Act 1990 COMPLETE SPECIFICATION STANDARD PATENT Applicant: Invention Title: AUSTIN HEALTH TOPICAL COMPOSITION The following statement is a full description of this invention, including the best method of performing it known to us: 00 2 The entire disclosure in the complete specification of our Australian Patent Application O No. 2003203452 is by this cross-reference incorporated oo into the present specification.
TECHNICAL FIELD 00 tt3 The present invention relates to topical CA compositions, which may be used as an antiseptic and/or
\O
disinfectant.
BACKGROUND
Control of nosocomial infection and exposure to infectious disease is of paramount concern to doctors, nurses, and clinicians that work in hospitals, clinics and surgical and medical centres. One of the most effective methods for controlling infection is regimented hand disinfection before and after each patient contact and before invasive procedures.
Hand disinfection is generally accomplished using anti-microbial soaps with water. These soaps are usually formulated to include either povidone-iodine or chlorhexidine gluconate as the active anti-microbial agent. In addition, these formulated soaps may contain surfactants and possibly low levels of humectants such as glycerin.
Hand disinfection is also accomplished using hand wash replacements. These are used instead of the soap and water scrub. Hand wash replacements ideally achieve bacterial kill equal to or better than a traditional soap N \Melborn\ca~es\Patenr\49000-49999\P49134. \Specia\P49134 .AU.1 *pecification 2008.1112.do 16/11/0 3 00 3 and water scrub and in a shorter period of time.
Additionally, they maintain or improve the skin's natural O barrier to microbial and chemical contamination while 00 providing acceptable tactile properties. Examples of hand wash replacements include hydroalcoholic gels, which generally include high levels of either ethanol or 00 C isopropanol as the disinfecting agent and also include a V) thickener and/or surfactant and optionally include a C humectant glycerin).
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C< SUMMARY The present invention provides a topical composition for application to any part of the body excluding mucous membranes, the topical composition comprising: isopropanol in an amount from about 65% v/v to about 70% v/v of the total concentration of the topical composition; chlorhexidine, one or more salts of chlorhexidine, or both chlorhexidine and one or more salts of chlorhexidine, in an amount of from about 4 g/L to about 7g/L of the topical composition; and polyethylene glycol in an amount of from about to about 1.8% of the total the concentration of the topical composition.
The present invention also provides a method of reducing and/or preventing the transmission of a microorganism by applying an effective amount of a topical composition as defined above to any part of the body excluding mucous membranes.
The topical composition as defined above may N:\eboue\Cas$e\Pactnt\490O-49999\P4S4 .4AU. 1\Specig\P49134 AU.1 opecificaLion 2008-i-12.doc 18/11/00 4 00 o therefore be used to reduce and/or prevent the transmission of a microorganism.
O
The topical composition may also be used in the 00 manufacture of a disinfectant and/or antiseptic to reduce and/or prevent the transmission of a microorganism.
00 The microorganism is preferably a multi- Ci resistant organism such as, for example, methicillian- S 10 resistant staphylococcus aureus.
The topical composition may be applied before and after routine or specialised health-care delivery or preparatory to invasive procedures.
An effective amount of the topical composition is preferably about 1 ml to about 3 ml.
The present invention further provides a method of preparing a topical composition as defined above comprising the step of mixing isopropanol, chlorhexidine, one or more salts of chlorhexidine, or both chlorhexidine and one or more salts of chlorhexidine, and polyethylene glycol, with stirring, until complete homogenisation is achieved.
DETAILED DESCRIPTION The present invention relates to topical compositions comprising an alcohol, an anti-microbial, and an emollient.
N:\MoIbo-ne\Case\Paen\49O0-4999\P4914.AU.\Specia\P49134.AU.1 epecMc8Lton 2DOB-11-12.d6c 1$/11/08 5 00 Alcohols O Alcohol is an effective vehicle for a disinfectant. It provides a broad spectrum bactericidal 00 effect and is fast drying.
00 Alcohols may include straight or branched chain i alcohols. Suitable C 1 to C 4 alkanols include ethanol, n- Ci propanol and isopropanol.
IND
CA While topical compositions may comprise only one alcohol, a combination of alcohols may be used.
Isopropanol is a good disinfectant with a pleasant odour and, compared to other alcohols, it has a less cutaneous drying effect of the skin. Therefore, isopropanol is the alcohol used in the topical composition of the present invention.
The alcohol concentration of the topical composition should provide the greatest possible bacterial kill effect. Therefore, the alcohol concentration is preferably about 65% v/v to about 75% v/v, more preferably about 70% v/v, of the total concentration of the topical composition.
Anti-microbials The term "anti-microbials" is used herein in its broadest sense and refers to any agent that can treat any infection caused by a microorganism and includes viral and bacterial infections. Examples of such infectious microorganisms may be found in a number of well known N:\Melbourn\Ca~e.\Patenr\49DOO-49999\P49134.AU. 1\Speci\P49134.AU specification 2008-1-12.doc 11/11/08 6 00 6 texts such as 'Medical Microbiology' (Greenwood, D., Slack, Peutherer, Churchill Livingstone Press, O 2002); 'Mims' Pathogenesis of Infectious Disease' (Mims, Nash, Stephen, Academic Press, 2000); 00 '"Fields" Virology. (Fields, Knipe, Howley, Lippincott Williams and Wilkins, 2001).
00 SChlorhexidine and its salts are is an anti- CA microbial effective against a wide-range of Gram-positive
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and Gram-negative bacteria.
While chlorhexidine may be used as an antimicrobial in the topical composition of the present invention, a salt of chlorhexidine is preferred due to its solubility properties. Preferred salts of chlorhexidine include chlorhexidine gluconate, chlorhexidine acetate and chlorhexidine hydrochloride. The most preferred antimicrobial for the topical composition of the present invention is chlorhexidine gluconate because it has excellent instantaneous bacterial effect that persists after use.
The amount of anti-microbial present in the topical composition should provide a balance between the desired antibacterial effect and unwanted adverse effects.
The anti-microbial is preferably present in an amount of about 4 g/L to about 7 g/L, more preferably about 5 g/L of the topical composition.
While a single anti-microbial may be used in the topical composition of the present invention, additional anti-microbials may be added to enhance the anti-microbial N;\Meoboeurn\ Ca.. \Patnt\49OO- -4999\P4934AU.1\SpPcli\P49134.AU.1 specification 200811-12.dc 1/11/0 7 00 9 action of the topical composition. This may be particularly desirable in critical uses such as 00 O preparatory to invasive procedures.
Emollients 00 h Emollients are typically added to topical V) compositions because they act to increase the moisture Cl content of the stratum corneum.
CI Emollients are generally separated into two broad classes based on their function. The first class of emollients function by forming an occlusive barrier to prevent water evaporation from the stratum corneum. The second class of emollients penetrate into the stratum corneum and physically bind water to prevent evaporation.
The first class of emollients is subdivided into compounds that are waxes at room temperature and compounds that are liquid oils. The second class of emollients includes those that are water-soluble and are often referred to as humectants.
Emollients may be selected from the following non-limiting list of general emollients, occlusive emollients and humectants.
Examples of general emollients include short chain alkyl or aryl esters (C 1
-C
6 of long straight or branched chain alkyl or alkenyl alcohols or acids (C 8
-C
32 and their polyethoxylated derivatives; short chain alkyl or aryl esters (CI-C 6 or C 4
-C
12 diacids or diols optionally substituted in available positions by -OH; alkyl or aryl
C
1 -Cio esters of glycerol, pentaerythritol, ethylene N:\Mlbourne\Cames\Patent\49000-49999\P49134.AU.I\SpCi.\P49134 AU I specification 200-11.12.doc 18/11/08 8 00 glycol, propylene glycol, as well as polyethoxylated derivatives of these and polyethylene glycol; C 12
-C
22 alkyl O esters or ethers of polypropylene glycol; C 12
-C
22 alkyl esters or ethers of polypropylene glycol/polyethylene 00 glycol copolymer; and polyether polysiloxane copolymers.
00 h Examples of occulsive emollients include cyclic n3 and linear dimethicones, polydialkysiloxanes, Ci polyaryl/alkylsiloxanes, long chain (C 8
-C
36 alkyl and C 10 alkenyl esters of long straight or branched chain alkyl or CI alkenyl alcohols or acids; long chain (C 8
-C
36 alkyl and alkenyl amides of long straight or branched chain alkanes and alkenes such as squalene, squalane and mineral oil; jojoba oil polysiloxane polyalkylene copolymers, dialkoxy dimethyl polysiloxanes, short chain alkyl or aryl esters
(CI-C
6 of C 12
-C
22 diacids or diols optionally substituted in available positions by -OH, such as diisostearyl dimer dilinoleate; lanolin and lanolin derivatives, and beeswax and its derivatives.
Examples of humectant type emollients include glycerol, propylene glycol, dipropylene glycol, polypropylene glycol, polyethylene glycol, sorbitol, pantothenol, gluconic acid salts and the like.
A humectant type emollient is preferred for the topical composition of the present invention. The most preferred humectant is polyethylene glycol. Polyethylene glycol is pleasant to use, readily available and economical.
The concentration of the emollient in the topical composition is preferably about 1.5% to about N. \MeI bourn\Ca Patent\4900-4999 9\P4914 AU. 1\Specia\F49134 AU. I specificatio 2000-11-12 .do 18/11108 00 more preferably about
(N
O The inventors have determined that having a oo concentration of polyethylene glycol in the topical composition of the present invention provides adequate moisturising while not causing irritation and/or allergic 00 h reactions. There are also no unwanted abnormal feelings V after application such as sliminess or stickiness.
cN S 10 Additional ingredients
(N
The topical composition may optionally comprise ingredients such as water, oils, salts, fragrances, perfumes, colorants, stabilisers, emulsifiers, propellants, additives, preservatives or preserving agents, anti-oxidants, surfactants, thickeners and other excipients normally used in topical compositions. If additional ingredients are included in the topical composition, ingredients that are known to cause skin irritation and/or sensitisation reactions should be avoided.
Formulations The topical composition may be formulated into the form of an aerosol, balm, cream, emolument, foam, gel, liniment, lotion, ointment, salve, solution, spray, suspension, unguent or the like.
Application The present invention is a topical composition, which is useful as a broad-spectrum antiseptic and/or N;\Wlbourne\Caoes\Patent\49000-49999NP4913 .*U.1\Spaciig\P4913 .AU.1opecific.Lion 2008-11-132Oo 1/11/08 10 00 Sdisinfectant for use in many environments including hospitals and clinics, veterinarian, industrial, food 0 industry, livestock and home environments. The topical O0 composition may be used, for example, as a skin disinfectant.
00 C The topical compositions of the present invention V) are highly efficacious in preventing the transmission of Cl microorganisms within hospitals.
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CI The term "microorganism" includes any microscopic organism or taxonomically related macroscopic organism within the categories algae, bacteria, fungi, protozoa, viruses and subviral agents or the like. The microorganism is preferably a multi-resistant organism such as, for example, methicillian-resistant staphylococcus aureus.
In addition, preferred topical compositions of this invention maintain moisture after both single and multiple applications without allergic reaction or unwanted side effects such as abnormal feelings of sliminess or stickiness.
Topical compositions of the present invention are suitable for frequent and repeated usage during routine and specialised health-care delivery in environments such as hospital or clinic. In hospitals and clinics, these topical compositions may be used before and after each patient contact or preparatory to invasive procedures.
If topical compositions of the present invention N:\Mlbourne\Cages\Patent\49000-49999\P4914AU.1\Specia\P49134 AU.1 ,peCification 2008.11-12.do 10/111/0 11 00 are formulated into a hand lotion, only a small amount, about 1 ml to about 3 ml, of the hand lotion would be O needed to be effective disinfectant and/or antiseptic.
z 00 Topical compositions of the present invention have advantages over known topical compositions in that 00 they may be applied frequently with minimal adverse Seffects, dry rapidly, provide both instantaneous and Ci prolonged anti-microbial activity, and have a low toxicity
\O
profile.
The term "topical composition" as used herein generally refers to a composition that is applied externally to any part of the body excluding mucous membranes such as the eyes, mouth, and so on. The topical composition may, therefore, be applied directly to any part of the body excluding mucous membranes such as the eyes, mouth, and so on. However, topical compositions of the present invention may also be incorporated into sponges, swabs, pads and/or wipes, which are then used to apply the topical solution to any part of the body excluding mucous membranes such as the eyes, mouth, and so on. The topical compositions may also be incorporated into cosmetic products.
Stability The topical composition of the invention conserves its activity for, at least, two years from its production. However, it is preferable to use it at least within 12 months of being prepared. Even so, incorporating appropriate preserving agents can extend the period to sustain activity.
N lbourne\Ca~\Pat 9000-9999 AU.\SpCi\P49134AU I specifiction 008-11-12.doc 18/11/08 12 00 In this specification, except where the context 0 requires otherwise, the words "comprise", "comprises", and OO "comprising" mean "include", "includes", and "including", respectively, i.e. when the invention is described or defined as comprising specified features, various 00 C embodiments of the same invention may also include V additional features.
cN 0 10 EXAMPLES The invention will now be further described with reference to the following Examples. These Examples are not intended to limit the invention in any way.
The topical composition of the present invention may be prepared by a variety of techniques.
One method of preparing the topical composition of the present invention involves mixing the components of the topical composition, in suitable quantities, with stirring, until complete homogenisation is achieved.
The following examples are topical compositions of the present invention that were prepared according to the above method.
Example 1 isopropyl alcohol 70% v/v chlorhexidine gluconate 5 g/L polyethylene glycol 1.5% concen.
water balance bvlourne\C~aoae$\l'ent\4900.49999\P49134AU.1\Speci.\P49134.AU.1 Spoci-icion 2008-11-12.doc 18/11/08 13 00 The topical composition of Example 1 was 0 formulated into the form of a lotion, in particular a hand lotion.
The hand lotion was shown to be an effective 00 C disinfectant and/or antiseptic. It was also gentle on the V) skin, dried rapidly and provided both instantaneous and C prolonged anti-microbial activity. The hand lotion showed
\O
0 10 no unwanted side effects such as abnormal feelings of CI sliminess or stickiness.
The hand lotion of Example 1 was also trialed as a disinfectant hand lotion in an intervention/study ward of the Austin Repatriation Medical Centre, Victoria, Australia.
The trial was conducted over a period of ten or so months.
The staff of the intervention/study ward were instructed to use about 1 ml to about 3 ml of the disinfectant hand lotion before and after each patient contact.
The results of the trial showed that there was an approximately 21% to 25% reduction in clinical infections with methicillian-resistant staphylococcus aureus ("MRSA").
Since the disinfectant hand lotion was easy to use, there was also a 25% to 100% improvement in hand hygiene compliance. Hand hygiene compliance refers to the N:\M lbourne\Cases\Patent\49000-49999\P49134.AU. \Speci\P49134AU.1 specifIcation 2008-11-12.dc 18/ /1108 00 14 00 p rates of hand washing, which in the present case would refer to the rates of use of the topical composition as a 0 disinfectant hand lotion.
00 Furthermore, there were no allergic reactions identified through repeated use of the hand lotion during 00 C the trial.
Ni, CA Accordingly, this trial showed that the topical composition of the present invention would be very C( effective as a disinfectant hand lotion in hospitals, clinics, surgical and medical centres and the like.
Example 2 isopropyl alcohol 70% v/v chlorhexidine gluconate 5 g/L polyethylene glycol 2.0% concen.
water balance The topical composition of Example 2 was formulated into the form of a lotion, in particular a hand lotion.
The hand lotion was shown to be an effective disinfectant and/or antiseptic. It was also gentle on the skin, dried rapidly and provided both instantaneous and prolonged anti-microbial activity.
The hand lotion was found, however, to have a slight unwanted after effect. Specifically, after repeated use of the hand lotion, there was a feeling of stickiness.
N ourne\C a\Pten 49999\P4 I\SpoCi.\P49134AU.1 opecifioaon 2008-11-12.d IA/11/08 00 15 00 It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be O made to the invention as shown in the specific embodiments without departing from the spirit or scope of the 00 invention as broadly described. The present embodiments are, therefore, to be considered in all respects as 00 0 illustrative and not restrictive.
IO
0q N:\Mlbou\C.e.\Pp.eet\49OO-49999\P49134 .AU.1\Speci\P49134 .AU.1 specification 2008-11-12.doc 18/11/08
Claims (20)
- 2. A topical composition according to claim 1, wherein isopropanol is present in an amount of about v/v of the total concentration of the topical composition.
- 3. A topical composition according to claim 1 or claim 2, wherein the salt of chlorhexidine is selected from chlorhexidine gluconate, chlorhexidine acetate, and chlorhexidine hydrochloride.
- 4. A topical composition according to claim 3, wherein the salt of chlorhexidine is chlorhexidine gluconate.
- 5. A topical composition according to any one of claims 1 to 4, wherein chlorhexidine, one or more salts of chlorhexidine, or both chlorhexidine and one or more salts of chlorhexidine is present in an amount of about 5 g/L of N \eltbom\Case.\Patent490OO.49999\P49134AU. I\Speci9\P49134.AU.1 Bpecificatio 2008-11-12.doc 18/11/08 17 00 the total the concentration of the topical composition. O 6. A topical composition according to any one of z claims 1 to 5, wherein the polyethylene glycol is present 00 in an amount of about 1.5% of the total the concentration of the topical composition. 00 S7. A topical composition according to any one of Cl claims 1 to 6 further comprising water, oils, salts, S 10 fragrances, perfumes, colorants, stabilisers, emulsifiers, CI propellants, additives, preservatives or preserving agents, anti-oxidants, surfactants, thickeners, and/or other excipients normally used in topical compositions.
- 8. A topical composition according to any one of claims 1 to 7, wherein the topical composition is formulated into the form of an aerosol, balm, cream, emolument, foam, gel, liniment, lotion, ointment, salve, solution, spray, suspension, unguent, or the like.
- 9. A topical composition according to any one of claims 1 to 8, wherein the topical composition is incorporated into sponges, swabs, pads, and/or wipes.
- 10. A topical composition according to any one of claims 1 to 9, wherein the topical composition is incorporated into cosmetic products.
- 11. A method of reducing and/or preventing the transmission of a microorganism by applying an effective amount of a topical composition as defined in any one of claims 1 to 10 to any part of the body excluding mucous membranes. N.\MelboAe\CU\Paen49000-U9999\P.I apscification 2008-11.12 .doc 1111/08 18 00
- 12. The method according to claim 11, wherein the O microorganism is a multi-resistant organism. 00
- 13. The method according to claim 12, wherein the multi-resistant organism is methicillian-resistant 00 0 0 staphylococcus aureus. t-- CI 14. The method according to any one of claims 11 to 0 10 13, wherein the topical composition is applied before and C after routine or specialised health-care delivery or preparatory to invasive procedures. The method according to any one of claims 11 to 14, wherein an effective amount is about 1 ml to about 3 ml.
- 16. Use of a topical composition as defined in any one of claims 1 to 10 to reduce and/or prevent the transmission of a microorganism.
- 17. The use according to claim 16, wherein the microorganism is a multi-resistant organism.
- 18. The use according to claim 17, wherein the multi-resistant organism is methicillian-resistant staphylococcus aureus.
- 19. The use according to any one of claims 16 to 18, wherein the topical composition is used before and after routine or specialised health-care delivery or preparatory to invasive procedures. N:\M1elburn\Cas.\Ptent\4900-49999\P49134.AU. \SpeCi.\P49134AU.1 specification 2008-1-12.1dc 1811/08 19 00
- 20. The use according to any one of claims 16 to 19, wherein about 1 ml to about 3 ml of the topical 0 composition is used. 00
- 21. Use of a topical composition as defined in any one of claims 1 to 10 in the manufacture of a disinfectant 00 0 and/or antiseptic to reduce and/or prevent the ln transmission of a microorganism. cN
- 22. The use according to claim 21, wherein the Cl microorganism is a multi-resistant organism.
- 23. The use according to claim 22, wherein the multi-resistant organism is methicillian-resistant staphylococcus aureus.
- 24. A disinfectant and/or antiseptic comprising a topical composition as defined in any one of claims 1 to A method of preparing a topical composition as defined in any one of claims 1 to 10 comprising the step of mixing isopropanol, chlorhexidine, one or more salts of chlorhexidine, or both chlorhexidine and one or more salts of chlorhexidine, and polyethylene glycol, with stirring, until complete homogenisation is achieved.
- 26. A topical composition, a method of preparing the topical composition, methods and uses involving the topical composition, or a disinfectant hand lotion comprising the topical composition, substantially as herein described with reference to Example 1. N \Mebourn\Case,\Patent\49O-4999\P4914 .AU. \Speci.\P49134 AU.1 specificaion 2008-11-12.doe 18/11/08
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU2006235798A AU2006235798B2 (en) | 2003-03-28 | 2006-11-01 | Topical composition |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU2003203452 | 2003-03-28 | ||
| AU2003203452A AU2003203452A1 (en) | 2003-03-28 | 2003-03-28 | Topical composition |
| AU2006235798A AU2006235798B2 (en) | 2003-03-28 | 2006-11-01 | Topical composition |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2003203452A Division AU2003203452A1 (en) | 2003-03-28 | 2003-03-28 | Topical composition |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| AU2006235798A1 AU2006235798A1 (en) | 2006-11-23 |
| AU2006235798B2 true AU2006235798B2 (en) | 2008-12-18 |
Family
ID=34318251
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2003203452A Abandoned AU2003203452A1 (en) | 2003-03-28 | 2003-03-28 | Topical composition |
| AU2006235798A Expired AU2006235798B2 (en) | 2003-03-28 | 2006-11-01 | Topical composition |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2003203452A Abandoned AU2003203452A1 (en) | 2003-03-28 | 2003-03-28 | Topical composition |
Country Status (1)
| Country | Link |
|---|---|
| AU (2) | AU2003203452A1 (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE102004062775A1 (en) | 2004-12-21 | 2006-06-29 | Stockhausen Gmbh | Alcoholic pump foam |
| CN105147829B (en) * | 2015-08-28 | 2019-05-10 | 爱品尚客(北京)电子商务有限公司 | A kind of maca externally applied spray |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5951993A (en) * | 1995-06-22 | 1999-09-14 | Minnesota Mining And Manufacturing Company | Stable hydroalcoholic compositions |
| US6090395A (en) * | 1995-06-22 | 2000-07-18 | Minnesota Mining And Manufacturing Company | Stable hydroalcoholic compositions |
| WO2001041556A1 (en) * | 1999-12-06 | 2001-06-14 | Københavns Universitet | Method of using mapk4 and orthologues thereof to control plant disease resistance and plant growth |
-
2003
- 2003-03-28 AU AU2003203452A patent/AU2003203452A1/en not_active Abandoned
-
2006
- 2006-11-01 AU AU2006235798A patent/AU2006235798B2/en not_active Expired
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5951993A (en) * | 1995-06-22 | 1999-09-14 | Minnesota Mining And Manufacturing Company | Stable hydroalcoholic compositions |
| US6090395A (en) * | 1995-06-22 | 2000-07-18 | Minnesota Mining And Manufacturing Company | Stable hydroalcoholic compositions |
| WO2001041556A1 (en) * | 1999-12-06 | 2001-06-14 | Københavns Universitet | Method of using mapk4 and orthologues thereof to control plant disease resistance and plant growth |
Also Published As
| Publication number | Publication date |
|---|---|
| AU2006235798A1 (en) | 2006-11-23 |
| AU2003203452A8 (en) | 2010-04-29 |
| AU2003203452A1 (en) | 2004-10-14 |
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