Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
  • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
  • A61K8/0216—Solid or semisolid forms
• • 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
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
  • A61K2800/10—General cosmetic use
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
  • A61K2800/20—Chemical, physico-chemical or functional or structural properties of the composition as a whole
  • A61K2800/30—Characterized by the absence of a particular group of ingredients
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
  • A61K2800/80—Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
  • A61K2800/805—Corresponding aspects not provided for by any of codes A61K2800/81 - A61K2800/95
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
  • A61K2800/80—Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
  • A61K2800/87—Application Devices; Containers; Packaging

Definitions

• the present invention relates to a process for the treatment of cosmetic products by high hydrostatic pressure, in particular to irreversibly inactivate pathogenic microorganisms that can contaminate them while preserving their properties.
• the invention also relates to the products obtained and a container adapted for the treatment of cosmetic products and their preservation after treatment.
• Cosmetic products are sensitive products that can be contaminated by certain microorganisms. In order to avoid any health problem, especially in contact with the skin in the case of cutaneous use, it is necessary to decontaminate these products.
• Various techniques have been described for this purpose: thermal techniques such as pasteurization and possibly sterilization, ionizing radiation treatment techniques, and more recently other physical techniques such as ultrasound or microwaves.
• thermal techniques such as pasteurization and possibly sterilization, ionizing radiation treatment techniques, and more recently other physical techniques such as ultrasound or microwaves.
• all these processes especially through the developed energy, can lead to an alteration of the intimate structure of the processed cosmetic products (destabilization of emulsions, free radical formation, etc.) and therefore of their intrinsic properties.
• preservatives agents known as "preservatives” having either a bactericidal effect or effects limiting microbial growth.
• various regulations limit the use of some of these preservative additives.
• these chemical preservatives change the image of neutrality associated with these products.
• HHP high hydrostatic pressure
• HHP processes are known for the treatment of certain media.
• the application of HHP on food products can lead to reduce the microbial load (yeasts, molds, bacteria %) and thus allow an increase in their shelf life (E. RENDUELES et al., "Microbiological Food Safety Assessment of High Hydrostatic Pressure Processing: A Review," LWT-Food Science and Technology (2011), 44, pp. 1251-1260).
• the inactivation conditions of these microorganisms depend both on the nature of the microorganism (for example the nature of the strain) and the composition of the medium.
• carbohydrates, proteins, lipids and other constituents can have a protective effect for microorganisms vis-à-vis the effects of high pressure (JC CHEFTEL “Review: High Pressure, Microbial Inactivation and Food Preservation," Food Science and Technology International (1995), 1 (2-3) at 75-90, C. GARCIA-GRAELLS et al., "Inactivation of E. coli in milk. by high hydrostatic pressure treatment in combination with antimicrobial peptides, J. Food Prot (1999), 62, pp. 1248-1254).
• microbial inactivation by a HPP method in various cosmetic media often rich in lipids (for example emulsions of an oily phase in an aqueous phase or an aqueous phase in an oily phase) or containing polysaccharides , appeared until today hardly accessible.
• lipids for example emulsions of an oily phase in an aqueous phase or an aqueous phase in an oily phase
• polysaccharides appeared until today hardly accessible.
• the invention consists of a HHP treatment process for cosmetic products which makes it possible to sterilize them and irreversibly inactivate the pathogenic microorganisms that to contaminate them without using any preservative-type additive and while retaining their characteristic properties.
• the invention relates to a method for treating a cosmetic product by high hydrostatic pressure, consisting in applying a pressure P to the cosmetic product, with a continuous or cyclic mode of application MA, characterized by a speed VA of application of the pressure P for the compression between 0.5 and 50 MPa.s -1 , and at least one of the following parameters, preferably all:
• an initial temperature of the cosmetic product to be treated between -10 ° C. and 40 ° C.
• such a method makes it possible to decontaminate the cosmetic products treated by irreversibly inactivating pathogenic microorganisms that can contaminate them, while retaining their intrinsic properties.
• the invention also relates to the uses of this process, in particular for sterilizing cosmetic products, and the cosmetic products obtained.
• the invention also provides a device adapted to contain products to be treated and treated by high pressure, in particular cosmetic products.
• Figure 1 Schematic sectional view of a flexible envelope operculum.
• Figure 2 Schematic sectional view of an over-container for receiving the flexible envelope.
• Figure 3 Schematic view of a dispenser cap.
• Figure 4 Schematic view of the elements of Figures 1-3, assembled.
• the invention therefore relates to a method for treating a cosmetic product by high hydrostatic pressure, comprising applying to the cosmetic product a pressure P, with a continuous or cyclic MA application mode.
• the mode of application is cyclic.
• cosmetic products within the meaning of the invention is meant both:
• compositions in particular the active cosmetic ingredients and the additives or excipients, for example plant extracts or floral waters.
• Cosmetic products may be in any form suitable for treatment with HHP, that is to say in any form likely to lead the pressure, in particular creams, ointments, serums, lotions, water-based products floral, emulsions and certain powders having a surface treatment and grain size suitable and known to those skilled in the art to reduce the effects of compaction.
• the method of high hydrostatic pressure according to the invention is characterized by a number of parameters, in particular:
• the mode of application of the MA pressure which represents the way it is applied during the treatment: either continuously with the same value of the pressure throughout the duration of the treatment once the desired value is reached, or cyclic way,
• the pressure P of the process according to the invention is between 200 MPa and 600 MPa.
• the speed VA of application of the pressure P for the compression is between 0.5 and 50 MPa.s -1 , and preferably the speed VAn of decompression is between 0.5 and 50 MPa.s -1 .
• the process has a total duration t of application of the pressure P of between 2 and 60 minutes.
• the initial temperature Ti of the cosmetic product to be treated is preferably between -10 ° C. and 40 ° C.
• the invention relates to a process for treating a cosmetic product by high hydrostatic pressure, consisting in applying a pressure P to the cosmetic product, with a continuous or cyclic, preferentially cyclic, mode of application MA, characterized by at least all of the following parameters:
• an initial temperature Ti of the cosmetic product to be treated between 10 ° C. and 40 ° C.
• a cycle is described by a rise in pressure with the speed VA, a maintenance of the pressure at the value P for a duration then a descent in pressure with a speed
• the duration of application of the pressure P of each cycle is preferably between 2 and 20 minutes, preferably between 3 and 15 minutes. Either all the cycles have an identical duration, or at least two cycles have a duration different.
• the pressure P may be identical for all the cycles or for at least two of the cycles the applied pressure P is different.
• the compression speed VA and / or decompression can be identical for
• each cycle has a profile of compression and decompression.
• the compression or decompression profile corresponds to the general appearance of the application of the pressure during ascent or descent.
• the compression and decompression can be monotonous (at constant speed or with variable speeds) or with one or more pressure levels.
• Each bearing is made by applying an intermediate constant pressure of a value between the lowest pressure of the cycle and the highest pressure of the cycle. The achievement of this or these bearing (s) can be done at constant speed or at variable speeds. Before and after each step, the speed of application may be the same or different.
• the compression speed VA and / or the decompression speed varies until the pressure P is reached.
• cycles have the same profile of compression and / or decompression or at least two cycles have a different compression profile and / or decompression.
• the compression profile and the decompression profile may be identical or different, that is to say that for the same cycle the speeds VA and may be identical or different.
• Latency can be applied before the first cycle and / or between certain cycles
• This latency time is between 2 and 20 minutes. According to an embodiment
• the method comprises at least three cycles, and at least one latency
• these latency times may be the same or
• the total duration of application of the pressure P for the process is between 2 and 60 minutes. It is dependent in the case of a cyclic MA application, the number of cycles and the duration of each cycle at the treatment pressure P, the duration of the time of
• the number of cycles depends on the barosensitivity of the microorganisms to be inactivated and the treated cosmetic medium thus induces the total duration of maintenance t under high pressures. This number of cycles can not exceed 15 cycles.
• the initial temperature Ti of the medium is -10 ° C to 40 ° C.
• This temperature can be the ambient temperature (20 to 25 ° C) or a lower temperature or a negative temperature or a higher temperature.
• Low temperatures (below 10 ° C) and negative temperatures are well suited to very fragile cosmetic products (such as those containing thermolabile active ingredients) because they make it possible to preserve the Specific characteristics and the higher temperatures of between 30 and 40 ° C make it possible to ensure very good inactivation of the spores when the cosmetic product contains them.
• the compression speed that is to say the rate of rise of the pressure, is between 0.5 and 50M Pa.s -1 , in particular between 1 and 50 MPa.s -1 . Preferably it is between 1 and 10 M Pa.s -1 , even more preferably between 1 and 6.6 MPa.s -1 . This speed can be constant or variable until the desired pressure is reached. Similarly, for two different cycles, the compression speed may be the same or different.
• the decompression rate that is to say the rate of descent of the pressure, is between 0.5 and 50 MPa.s -1, in particular between 1 and 50 MPa.s -1, preferably between 1 and 50 MPa.s -1 . and 10 MPa.s -1 , even more preferably between 1 and 6.6 MPa.s.sup.- 1, This speed can be constant or variable until the desired pressure is reached.Also, for two different cycles, the decompression rate can be identical or different.
• the compression and decompression speeds may be identical or different.
• the method is implemented using "high pressure" devices adapted to the conditions of the invention.
• the cosmetic product to be treated must be preconditioned in its final packaging or part of its final packaging. This packaging must:
• the packaging- tank may be a packaging made of rigid material such as glass, plastic or any other suitable material to be used as a container, closed by a deformable seal or having a deformable part.
• the cosmetic products thus packaged are then placed in a high pressure equipment and this equipment called “high pressure chamber” is closed by at least one shutter ensuring tightness.
• This equipment called “high pressure chamber” is closed by at least one shutter ensuring tightness.
• the pressure is transmitted to the samples by a liquid that does not alter the packaging during the treatment with the HHP process according to the invention.
• a gas can be used to save the packaging (especially airless type).
• the pressure increase can be achieved either with one or more pumps (in this case, the volume of the enclosure "High Pressures" is generally constant), or by reducing the volume of the enclosure.
• the various parameters characterizing the HHP treatment to be applied are entered on a PLC or computer (according to the data transmission system to the equipment). Once the treatment is complete, the "High Pressure" chamber is opened and the samples are recovered.
• the cosmetic product has been treated directly in its final packaging (marketing packaging) it can be either repackaged in an overpack, or stored or sent to customers.
• the packaging is a part of the final packaging it is then associated with the various elements of said final packaging.
• the cosmetic product is packaged in a specific device, which allows both to apply the method according to the invention and to preserve the product after treatment.
• This device for applying a high pressure process, in particular the method according to the invention, to a product, in particular to a cosmetic product can take the following form.
• a flexible reservoir shell 10 with an opening 11 in the upper part A product 12, in this case a cosmetic product, is introduced into this envelope by any known means such as a filling spout, not shown.
• This flexible reservoir-shell 10 is, after filling with the cosmetic product, hermetically sealed by a cover 13 so as to make said reservoir-shell hermetic.
• the flexible reservoir shell is either fixed or comprises a head ring 14.
• This reservoir-shell of the cosmetic product is subjected to the treatment method according to the invention, the object of which is to destroy with certainty all the microorganisms possibly present in said product and in said reservoir-shell 10.
• the flexible container-shell 10 is disposed in an over-container 15, forming a rigid peripheral shell capable of carrying the information, communication and any other writing or illustration that would be desirable (Fig.2) .
• the ring 14 associated with the reservoir shell fits on the container 15 especially by screwing or clipping (Fig.3).
• the reservoir casing 10 is provided with an opening 11 equipped with a screw thread or clipping means for receiving a pump dispenser cap 17, of the "airless" type, that is to say that its operation allows dispensing the product without compensating for the volume of product dispensed by a balanced volume air inlet.
• the pump-dispenser stopper 17 comprises a cannula 18 for suctioning the product into the reservoir-envelope adapted to perforate the flexible cover 13 during assembly of the head, and to come into contact with the contents of this reservoir shell. flexible (Fig.3).
• the over-container has an air inlet 19 because if balancing air is not introduced into the rigid over-container 15, to compensate the delivery of the product. It is necessary to balance the decrease of the volume collapsed by an air inlet in said over-container 15. This air is not in contact with the contents of the reservoir envelope, which poses no problem of re-contamination.
• the air inlet may be a simple hole possibly provided with a valve or a valve, if it is desired that access to the volume between the envelope and the overcontainer is limited to air only.
• the pump-dispenser stopper 17 may be made of a polymer material with biocidal properties or may have been previously treated and taken out of a suitable packaging immediately before it is put in place so as to prevent the introduction of microorganisms.
• This device is particularly suitable for containing the cosmetic products during the treatment High Hydrostatic Pressures according to the invention, and for the preservation of products once treated.
• the combination of the different characteristics of the process according to the invention leads to the irreversible destruction of pathogenic microorganisms that may contaminate the treated cosmetic product.
• the microbial agents found in cosmetics are of various types. Various reports or documents specify the nature of these contaminants according to the basic ingredients used, according to the type of cosmetic product and its manufacture, depending on the mode of use (RM BAIRD "Microbial contamination of cosmetics products", J. Soc. Chem (1977), 28, 17-20, R. CAMPANA et al., “Letters in Applied Microbiology (2006),” Microbiological study of cosmetic products for their use by consumers: health risk and efficacy of preservative systems. 43, pp. 301-306, A. VARVARESOU et al., “Self-preserving in cosmetics", Int J Cosmet Sci (2009), 31 (3), p-175, A. DETMER et al. Danish Ministry of Environment Environmental Guideline No. 1336, 2010).
• microbial agents contaminating cosmetic products include bacteria (especially those of the Staphylococcus type), molds (like those of the Aspergillus type) and even sometimes spores (this is particularly the case of floral waters or extracts plants used as ingredients in cosmetic compositions).
• the method can therefore be used to inactivate at least one pathogenic microorganism in the vegetative state or in the sporulated state present in the cosmetic product.
• the invention aims in particular at the use of the method of treating a cosmetic product for the sterilization of cosmetic products and / or to improve their preservation.
• the method allows total and irreversible decontamination equivalent to cold sterilization but retaining the internal structure of the cosmetic product and its organoleptic properties.
• the specific combination of the parameters of the process according to the invention makes it possible to conduct, in a single step, a total inactivation of the microbial agents contaminating the cosmetic product, whether it be vegetative species or sporulated species.
• the treatment method according to the invention can also be used to modify the texture of cosmetic products. It is indeed possible to associate with the microbiological safety treatment by application of the method according to the invention, a modification of the texture of the cosmetic product if one introduces during the formulation an ingredient or component (for example a polysaccharide) capable of gelling irreversibly under the conditions of said cosmetic product treatment method according to the invention.
• an ingredient or component for example a polysaccharide
• the invention also relates to a cosmetic product obtained by the implementation of the process, characterized in that it contains no preservative and has an inactivation rate of pathogenic microorganisms present in the medium at least equal to 6 log (destructive efficiency at least equal to 6) relative to the initial product.
• inactivation rate is meant for example:
• an inactivation rate of 2 log means that 99% of the pathogenic microorganisms present in the medium are inactivated
• an inactivation rate of 4 log means that 99.99% of the pathogenic microorganisms present in the medium are inactivated
• a rate of 5 log means that 99.999% of the pathogenic microorganisms present in the medium are inactivated
• a rate of 6 log means that 99.9999% of the pathogenic microorganisms present in the medium are inactivated.
• the cosmetic product does not contain any preservative and no longer contains any pathogenic microorganism and its properties and structure are identical to those before treatment.
• the cosmetic product thus treated by the process retains its natural character. This process seems particularly suitable for products displaying the name "Bio”.
• the cosmetic product treated according to the invention is not denatured by heat and retains its structure and its properties because the process according to the invention does not heat the cosmetic product at high temperature.
• This treatment is equivalent to cold sterilization.
• the conditions of the process according to the invention can be optimized within the ranges of values claimed according to the cosmetic product to be treated, the nature of the pathogenic microorganisms contaminating the product and according to the use sought to obtain the better inactivation rate possible.
• the conditions can also be optimized within the ranges of values claimed so that the total duration of the treatment process is in agreement with the economic constraints adapted to the treated environment.
• N 1 represents the initial concentration of microorganisms contaminating the cosmetic product and N f the final concentration after application of the process according to the invention.
• ED is the destructive efficiency related to the process
• the cosmetic product tested differs from the previous one by the fact that no initial contamination (before any voluntary inoculation of microorganisms) was observed.
• Table III gives the treatment parameters according to the processes according to the invention which have been used.
• This product has been inoculated with doses of micro-organisms (challenges-tests).
• Two types of microorganisms were used: a Gram + bacterium (Staphylococcus aureus) and a mold (Aspergillus brasiliensis) considered by the community of people in the cosmetic sector as contaminants often encountered.
• Representative images of the cosmetic products have been observed a set of small bubbles characteristic of an emulsion of uniform size covering the entire surface under the microscope.
• the implementation of the method according to the invention therefore leads to a total inactivation of contaminating microorganisms, without altering the intimate structure of the product or its organoleptic properties (color, odor and visual appearance).
• a cosmetic cream without any preservative or additive capable of inducing a bactericidal effect or limiting the growth of microorganisms has been deliberately contaminated (challenges-tests) by 4 microbial species or in the vegetative state [Staphylococcus aureus ATCC 6538, Enterobacter aerogeneses ATCC 13048) or sporulated (Aspergillus brasiliensis ATCC 16404).
• Example 5 The same cosmetic cream as in Example 5, without any preservative or additive likely to induce a bactericidal effect or to limit the growth of microorganisms, was voluntarily contaminated (challenges-tests) by 2 microbial species either at the same time. vegetative state (Staphylococcus aureus ATCC 6538), or in the sporulated state [Bacillus cereus ATCC14579).
• This cream has been placed in a flexible and deformable container in order to be certain to transmit the parameters characteristic of the Hydrostatic High Pressure Process (HHP) to the product.
• This test container is then sealed to prevent recontamination of the cream by the pressure transmitter medium.
• HHP Hydrostatic High Pressure Process
• the duration of application of the pressure for each cycle is 5 minutes
• the untreated control and the treated cream sample are used for sowing in the media suitable for the growth of these microorganisms. After incubation counts are then made. The results of these microbiological analyzes are given in Table XI.

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• 2014
  • 2014-03-31 FR FR1452776A patent/FR3019046B1/fr not_active Expired - Fee Related
• 2015
  • 2015-03-31 WO PCT/FR2015/050833 patent/WO2015150693A1/fr active Application Filing
  • 2015-03-31 EP EP15725707.2A patent/EP3125951A1/de not_active Withdrawn
  • 2015-03-31 US US15/300,621 patent/US20170106107A1/en not_active Abandoned
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