WO2021214361A1 - Antiseptique à action prolongée pour le lavage hygiénique par friction et lavage pré-chirurgical des mains - Google Patents

Antiseptique à action prolongée pour le lavage hygiénique par friction et lavage pré-chirurgical des mains Download PDF

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Publication number
WO2021214361A1
WO2021214361A1 PCT/ES2021/070260 ES2021070260W WO2021214361A1 WO 2021214361 A1 WO2021214361 A1 WO 2021214361A1 ES 2021070260 W ES2021070260 W ES 2021070260W WO 2021214361 A1 WO2021214361 A1 WO 2021214361A1
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WO
WIPO (PCT)
Prior art keywords
antiseptic
biocidal
hygienic
washing
concentration
Prior art date
Application number
PCT/ES2021/070260
Other languages
English (en)
Spanish (es)
Inventor
Ricardo Becerro De Bengoa Y Vallejo
David SEVILLANO FERNÁNDEZ
Luis Alou Cervera
Natalia GONZÁLEZ HIDALGO
Marta Elena LOSA IGLESIAS
Original Assignee
Universidad Complutense De Madrid
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Universidad Complutense De Madrid filed Critical Universidad Complutense De Madrid
Publication of WO2021214361A1 publication Critical patent/WO2021214361A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/34—Alcohols
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/36—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/40—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing nitrogen
    • A61K8/43—Guanidines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/02—Local antiseptics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A61Q19/10—Washing or bathing preparations

Definitions

  • the present invention falls within the healthcare sector. More specifically, it refers to an antiseptic for hygienic washing for personal or medical use.
  • Antiseptics are biocidal agents of low toxicity (or, in any case, of lower toxicity than disinfectants) with indications of preferential use on intact, altered skin or human mucosa where they destroy or prevent the proliferation of pathogenic microorganisms.
  • the antiseptic agents used most frequently in our environment belong to the chemical group of alcohols (such as ethanol or ethyl alcohol, propanol-1 (propanol) and pronpanol-2 or isopropyl alcohol), to the chemical group of halogenated compounds (such as iodized ), the group of biguanides (such as chlorhexidine) and phenolic derivatives (such as bisphenols); Hexachlorophene (currently substituted by triclosan or halophenols) and chloroxylenol or PCMX are also widely used.
  • alcohols such as ethanol or ethyl alcohol, propanol-1 (propanol) and pronpanol-2 or isopropyl alcohol
  • halogenated compounds such as iodized
  • biguanides such as chlorhexidine
  • phenolic derivatives such as bisphenols
  • Hexachlorophene currently substituted by triclosan or halophenols
  • the chemical structure of antiseptics defines the mechanisms of action on sensitive microorganisms, the spectrum of activity and the immediate and prolonged antimicrobial action. This last parameter (prolonged action over time), is closely linked to the residual action of the biocide and, in general, is predetermined by the stability of the biocidal agent to the external environment (temperature, pH, among others), the presence of inactivating organic matter or simultaneous application with other chemical inhibitory agents.
  • the antisepsis of the hands of health personnel is one of the most spreads of antiseptics on intact skin and in the clinical setting. They are simple and strictly protocolized procedures that seek to sufficiently reduce the habitual resident burden and eliminate the transient pathogenic microbial flora from the skin of healthcare personnel.
  • the antisepsis of intact skin on the hands of healthcare personnel limits the proliferation of the microbial load and subsequent dissemination to the patient, thereby reducing the risk of infection during patient handling, especially at the surgical site.
  • Disinfection protocols rarely include the application of a single antiseptic.
  • the sequential application of different antiseptics under strictly defined contact times, is a common practice that guarantees immediate and prolonged skin disinfection.
  • the application of antiseptics by aggressive brushing is preferred because of the general belief that it leads to more effective antisepsis and, therefore, greater safety for the patient.
  • UNE-EN 14885 any proposal for a biocidal agent or combinations of biocidal agents with options for use as antiseptic agents in Spain must demonstrate the microbicidal properties implicitly included in the European standard UNE-EN 14885 and, specifically according to their possible applications, those included in the UNE-EN standards. 1499: 21033 (referring to hand washing), UNE-EN 1500: 2013 (referring to hygienic treatment of hands by friction) or UNE-EN 12791: 2016 + A1: 2018 (referring to pre-operative hand washing) .
  • biocidal agents marketed and involved in pre-operative antisepsis in the hands of healthcare personnel claim said regulation, as they exhibit an immediate and prolonged effect in time not less than that of the reference antiseptic (60% propanol-1).
  • the present invention describes a chemical composition that solves the progressive loss of antisepsis of biocidal agents for antiseptic use.
  • This composition is a unique combination of three biocidal substances with action and indication legally recognized in Spain, formulated with concentrations admitted by the competent authorities and, therefore, free of any adverse or harmful effect other than those implicitly included in the technical specifications of the combined agents.
  • the antiseptic of the present invention is a hydroalcoholic formulation that consists of the unique combination of three biocidal substances and water where one biocidal agent is an alcohol, another biocidal agent is a halogenated compound and a third substance is a food additive. antimicrobial.
  • Antiseptics intended for hand antisepsis are currently liquid or soapy products that include chemical biocidal active ingredients such as alcohol, povidone iodine, chlorhexidine glutonate or chloroxylenol.
  • biocides with antiseptic or disinfectant capacity there is a set of biocides that, due to their antimicrobial properties and low or no toxicity on the host, are used for technological purposes in the preparation, storage and preservation of food. They are known as food additives. At the international level, these biocides or additives are collected and regulated through Codex Alimentarius or joint food standard edited by FAO (Food and Agriculture Organization of the United Nations) and WHO (World Health Organization). Among these additives is potassium sorbate (E-202), a derivative of ascorbic acid with a food preservative function due to its properties to inhibit the growth of microorganisms for long periods of time.
  • E-202 potassium sorbate
  • the formulation presented in this invention is a hydroalcoholic formulation that includes two antiseptic biocidal agents commonly used in disinfection of intact skin (ethanol and chlorhexidine gluconate) and a food additive commonly used in food preservation (potassium sorbate).
  • the concentration of ethanol is in the range 60-70% (v / v)
  • the concentration of chlorhexidine gluconate is in the range 0.5 - 4%% (v / v)
  • the concentration of potassium sorbate is comprised between 0.3-0.6%% (v / v); the rest is deionized water.
  • Ethanol like other alcohols, has a rapid action mechanism based on the denaturation of proteins in the presence of water and without any residual activity. It exhibits a broad antimicrobial spectrum that includes gram-positive and gram-negative bacteria, fungi, and viruses in general.
  • Chlorhexidine has a spectrum of action very similar to alcohols, although in vitro it only shows activity on enveloped viruses (such as herpes simplex virus, HIV, cytomegalovirus, influenza and RSV, among others). Chlorhexidine is a cationic molecule that binds to negatively charged cell wall structures. At low concentrations, it affects the integrity of the cell wall, interfering with the natural process of osmosis. The immediate effect is slower than that of alcohols, although the residual activity is substantial.
  • enveloped viruses such as herpes simplex virus, HIV, cytomegalovirus, influenza and RSV, among others.
  • non-ionized potassium sorbate differs well through cell membranes. It is attributed a direct mechanism of action on the membrane, triggering effects similar to chlorhexidine but of less intensity. It has also been related to a certain inhibitory effect on cellular metabolism. It has a limited immediate activity, directed at bacteria and fungi, and a broad residual activity. The immediate antiseptic effectiveness and maintained over time of the described hydroalcoholic formulation is much higher compared to other commonly used antiseptics marketed.
  • Residual concentrations of chlorehexidine and potassium sorbate to preserve the skin from recolonization by the resident microbiota at least three hours after application of the formulation.
  • the formulation is applied by brushing or by direct friction with the skin with a contact time of at least 1 minute, without the need for aggressive brushing or rinsing.
  • the hydroalcoholic formulation of the present invention can be used in a domestic and sanitary environment for hygienic hand washing and pre-surgical hand washing. Its characteristics make it easy to adhere to the procedure, provide greater security for the management of infections, and confer a lower risk of infection of the surgical site in medium and long-term interventions.
  • It can also be used as a component in the manufacture of other hygienic products such as wipes, hand washing products or in the manufacture of products for cleaning clothes or surfaces, among others.
  • Figure 1 is attached as an integral part of the invention, where, by way of illustration and not limitation, the immediate and prolonged effect of 3 hours (reduction of the basal bacterial load) of the hydroalcoholic formulation of the present invention has been represented compared to the reference antiseptic propanol-1.
  • the hydroalcoholic formulation is composed of ethanol (70% v / v), chlorhexidine gluconate (3% v / v), potassium sorbate (0.3% v / v) and deionized water.
  • This formulation is called SORBECTOL (Trade name registered in OEPM N0414614).
  • This example describes the antiseptic properties of the hydroalcoholic formulation.
  • the antiseptic properties of the hydroalcoholic formulation were tested by clinical trial in healthy volunteers, following the design and evaluation criteria specified in the UNE-EN 12971: 2016 standard.
  • the trial approved by the Ethics Committee for Clinical Research of the Hospital Universitario San Carlos de Madrid with the internal code 18/237-R_X, involved 24 volunteers who were instructed in hand washing.
  • hydroalcoholic formulation described in example 1 (SORBITOL) was used. In each case, a volume of 3 ml was applied and spread by friction, maintaining a contact time of 1 minute.
  • SORBECTOL exhibits an immediate effect of 3.77 ⁇ 0.64 log CFU / ml and a prolonged effect at 3 hours of 3.12 ⁇ 0.82 log CFU / ml (expressed as the mean ⁇ standard deviation of the test ), complying with the effectiveness requirements demanded in the UNE-EN 12971: 2016 regulation.
  • Example 3
  • antiseptic properties of the hydroalcoholic formulation are compared with the reference antiseptic.
  • Propanol-1 at 60% v / v is used as a reference antiseptic and it was compared with the hydroalcoholic formulation of the previous examples (SORBECTOL).
  • the reference antiseptic was proceeded in the same way as with SORBECTOL as described in Example 2.
  • SORBECTOL unlike the reference antiseptic, does not show significant losses of antimicrobial activity after the maximum test time established by the European reference standard with respect to the effect achieved immediately after application on intact skin.
  • the activity of the components of the hydroalcoholic formulation is evaluated separately or in combination in pairs and in different ways of application: aggressive brushing or friction.
  • the loss of turgor of the membrane can stimulate the cell to passively accumulate solutes, favoring the passage of undissociated, hydrophobic and well-diffusing sorbate through the membrane, or actively favoring the intracellular accumulation of potassium and sorbic acid ions.
  • Potassium ions impair enzymatic metabolism as a result of increased ionic charge, and sorbic acid and sorbate ions disrupt metabolism and destabilize cell membranes, contributing to membrane destabilization by chlorhexidine.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Birds (AREA)
  • Emergency Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Chemical & Material Sciences (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Dermatology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)

Abstract

La présente invention concerne une composition chimique qui résout la perte progressive d'antisepsie des agents biocides à usage antiseptique. Cette composition est une combinaison unique de trois substances biocides à action et indication légalement reconnue et exmpte d'un quelconque effet indésirable ou nocif. La composition est constituée de la combinaison de trois substances biocides et d'eau, un agent biocide étant un alcool, un autre agent biocide étant un composé halogéné et une troisième substance étant un additif alimentaire antimicrobien. L'efficacité antiseptique immédiate et prolongée dans le temps de la formulation hydroalcoolique décrite est bien supérieure comparé à celle d'autres antiseptiques à usage habituel commercialisés. L'antiseptique peut être utilisé pour des usages domestiques ou sanitaires.
PCT/ES2021/070260 2020-04-24 2021-04-20 Antiseptique à action prolongée pour le lavage hygiénique par friction et lavage pré-chirurgical des mains WO2021214361A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ES202030346A ES2784275B2 (es) 2020-04-24 2020-04-24 Antiséptico de acción prolongada para el lavado higiénico por fricción y lavado pre-quirúrgico de manos
ESP202030346 2020-04-24

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WO2021214361A1 true WO2021214361A1 (fr) 2021-10-28

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6383997B1 (en) * 2001-07-02 2002-05-07 Dragoco Gerberding & Co. Ag High lathering antibacterial formulation
WO2004084973A2 (fr) * 2003-03-24 2004-10-07 Becton, Dickinson And Company Gant antimicrobien invisible et antiseptique pour les mains
CN105769635A (zh) * 2014-12-24 2016-07-20 阎珊珊 一种抗菌型洗手液的制备
CN108653121A (zh) * 2017-03-31 2018-10-16 景有超 一种含中草药成分的抑菌洗手消毒液

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6383997B1 (en) * 2001-07-02 2002-05-07 Dragoco Gerberding & Co. Ag High lathering antibacterial formulation
WO2004084973A2 (fr) * 2003-03-24 2004-10-07 Becton, Dickinson And Company Gant antimicrobien invisible et antiseptique pour les mains
CN105769635A (zh) * 2014-12-24 2016-07-20 阎珊珊 一种抗菌型洗手液的制备
CN108653121A (zh) * 2017-03-31 2018-10-16 景有超 一种含中草药成分的抑菌洗手消毒液

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ES2784275B2 (es) 2021-04-15
ES2784275A1 (es) 2020-09-23

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