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
  • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
  • A61K8/0241—Containing particulates characterized by their shape and/or structure
  • A61K8/0283—Matrix particles
• • 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
  • A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
  • A61K8/25—Silicon; Compounds 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
  • A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
  • A61K8/26—Aluminium; Compounds 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
  • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
  • A61K8/73—Polysaccharides
  • A61K8/735—Mucopolysaccharides, e.g. hyaluronic acid; Derivatives thereof
• • 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
  • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
  • A61Q19/00—Preparations for care of the skin
  • A61Q19/08—Anti-ageing preparations
• • 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
  • A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
  • A61K2800/41—Particular ingredients further characterized by their size
  • A61K2800/412—Microsized, i.e. having sizes between 0.1 and 100 microns
• • 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
  • A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
  • A61K2800/56—Compounds, absorbed onto or entrapped into a solid carrier, e.g. encapsulated perfumes, inclusion compounds, sustained release forms
• • 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
  • A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
  • A61K2800/60—Particulates further characterized by their structure or composition
  • A61K2800/61—Surface treated
  • A61K2800/612—By organic compounds
• • 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
  • A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
  • A61K2800/60—Particulates further characterized by their structure or composition
  • A61K2800/61—Surface treated
  • A61K2800/614—By macromolecular compounds
• • 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
  • A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
  • A61K2800/60—Particulates further characterized by their structure or composition
  • A61K2800/65—Characterized by the composition of the particulate/core
  • A61K2800/651—The particulate/core comprising inorganic material

Definitions

• This disclosure relates to a method of skin treatment, and to compositions for effecting such treatment.
• Hyaluronic acid is a naturally-occurring glycosaminoglycan found throughout the body’s connective tissue. It is the main component of what gives skin structure, and is responsible for providing a plump and hydrated look. As a result, there have emerged over recent years a substantial number of hyaluronic acid-based skin treatment preparations
• a skin treatment preparation comprising hyaluronic acid having a molecular weight of from 10-1000KDa, absorbed into an activated smectite clay, the hyaluronic acid - clay combination having a non-pore specific surface of from 3-10 M 2 /g and a particle size (VSSA) of from 250-500nm.
• hyaluronic acid to the skin, the hyaluronic acid comprising part of a hyaluronic acid-clay combination as hereinabove described.
• an activated smectite clay into which is blended hyaluronic acid, the hyaluronic acid - clay blend having a non-pore specific surface of from 3-10 M 2 /g and a particle size (VSSA) of from 250-500nm.
• VSSA Volume Specific Surface-Area
• Smectite clays are a group of platy phyllosilicate minerals of 2:1 layer and a layer charge from about -0.2 - - 0.6 per formula unit. They have a large specific surface area and exhibit a high degree of swelling in water.
• a particular example of a smectite clay is montmorillonite, more particularly bentonite.
• Combinations of hyaluronic acid (“HA”) and clays are known and commercially available as part of skin-care treatments. However, it has been surprisingly found that combinations as hereinabove defined can penetrate much more deeply into the skin than can simple mixtures of HA and clay.
• the parameters of the HA-clay blends of this disclosure cannot be achieved by simple mixing.
• the preparation of the HA-clay blend of the disclosure is carried out by applying a very high shear in a rotor/stator mixer, similar to the shear produced in an extruder reactor. Any such mixer may be used, for example ball mills, ribbon blenders, paddle blenders, screw blenders and double cone blenders.
• the smectite clay Prior to blending, the smectite clay is activated. This may be any kind of activation known to the art, a typical example being acid activation, as described, for example by Maged et al in Environmental Science and Pollution Research, 27, pp. 32980-32997 (2020). After drying and sieving, the activated smectite clay is subjected to high shear.
• the shearing time will depend on the particular materials and shearing method used, but the skilled person can readily ascertain by simple experimentation a suitable duration in each case. A typical, non-limiting shearing time will be from 15 minutes to 2 hours, particularly from 30 minutes to 1 hour.
• pressure and shear forces have the ability to increase interactions between the clay and the HA.
• pressure >1bar
• shear forces it is believed that the lamellar structure of the clay opens up, making hydroxyl groups on the platelet edges of the clay more available.
• the interactive mechanism is through hydrogen bonding between the hydrophilic moieties in HA (such as carboxylic acid or hydroxyl groups) and hydroxyl groups on the clay.
• the specific surface is from 4-9, more particularly from 5-8 M 2 /g.
• the particle size (VSSA) is from 280-450, more particularly from 300-430nm.
• the activated smectite clay may be used unmodified, but in a particular embodiment, it may be modified with a fatty substance, to enhance absorption into the skin.
• Typical substances include oils and hydrocarbon waxes of animal or vegetable or mineral origin, silicone oils, or their mixture.
• hydrocarbon-based modifiers include vegetable and animal oils and fats, more particularly triglycerides; synthetic ethers; linear or branched hydrocarbons, of mineral or synthetic origin, such as petroleum jelly; synthetic esters such as isopropyl myristate and fatty alcohol benzoates; heptanoates, octanoates, decanoates or ricinoleates of alcohols or polyalcohols; hydroxylated esters such as isostearyl lactate, esters of polyols; fatty alcohols such as octyldodecanol; higher fatty acids such as linolenic acid; silicone oils of polymethylsiloxane type and mixtures thereof.
• Examples of vegetable waxes include carnauba, candelilla, jojoba wax or any other vegetable compound consisting of an ester of ethylene glycol and of two fatty acids or of a monester of fatty acid and of long-chain alcohol; animal waxes such as beeswax.
• Other fatty substances and lipophilic additives include essential oils; natural aromatic compounds and lipophilic syntheses; natural or synthetic fat-soluble vitamins such as tocopherol or alphatocopheryl acetate.
• the proportion of fatty substances in the clay typically varies from 0.05 to 14.5% by weight.
• the hyaluronic acid of the disclosure has a molecular weight of from 10-1000KDa, particularly from 20-1500KDa, more particularly from 50-1400KDa, more particularly from 100-1100KDa, and even more particularly from 300-1000KDa. It may be added as the acid, or as the alkali metal salt (typically sodium) with a suitable acid, such as citric acid, for generation of the acid
• the modified clay may be made into a skin treatment preparation by any known means.
• the preparation may contain all the normal ingredients of such preparations in art- recognised proportions.
• Non-limiting examples include vitamins, antioxidants, thickeners, trace elements, softeners, sequestering agents, perfumes, basifying or acidifying agents, preservatives, UV filters, hydrophilic or lipophilic active ingredients and mixtures thereof.
• the hyaluronic acid is present in such a preparation in the weight proportion of from 5- 15%, particularly from 8-12%, more particularly from 9-11%.
• the surprising effect of this particular combination of the smectite clay and hyaluronic acid is that it penetrates particularly deeply into the skin. It is believed, with restricting the disclosure in any way, that the clay modifies the zeta-potential of the hyaluronic acid, making the combination more negatively charged. It is known that there is a natural gradient of pH in the skin, leading to the existence of more positive charges at the surface. As a result, hyaluronic acid tends to stay at or near the surface of the skin. However, the negative charge imparted by the clay allows the deeper penetration into the skin, with resulting beneficial effects.
• An additional unexpected and surprising benefit is the enhancement of a feeling of wellbeing among people to whose skin a preparation according to the disclosure has been applied. This benefit has been scientifically verified by a testing procedure further described in the examples.
• Figure 1 is a graphical representation of the depth penetration into the skin of hyaluronic acid when applied alone, and in a simple blend with clay, as available commercially.
• Figure 2 is a repeat of Figure 1 , but with the simple clay-hyaluronic acid blend replaced by a hyaluronic acid-clay blend as described in this disclosure.
• the hyaluronic acid- clay blend was prepared by taking a commercially-available bentonite clay, activating it by the method described by Maged et a/ in Environmental Science and Pollution Research, 27, pp. 32980-32997 (2020), drying and sieving it using a 100pm filter, adding to it sodium hyaluronate and then shearing this mixture in a high- shear ribbon blender for one hour
• test skin creams were prepared by blending the following ingredients
• test subjects were 20 women in the age range 35-55, all of whom had dry skin and who had shallow wrinkles and crow’s feet. They were split into two groups, designated Group A and Group B. Group A applied Cream 1, whereas Group B applied Cream 2.
• Untreated clay Hyaluronic acid (HA) HA + clay (“simple mixture”) HA-clay blend according to this description (“HA Clay”)
• HA was used in distilled water at 1% by weight, and both simple mixture and HA Clay were used at 10% in distilled water, both containing 1% by weight of hyaluronic acid.
• the Raman images had a size of Y: 10pm I X: 100pm with a step of 5pm in X and 5pm in Y.
• Each Raman image has 3Y spectra and 21X spectra (63 spectra per image).
• Step in X 5pm
• Step in Y 5pm
• the Raman spectrometer was calibrated with silicon which gives a Raman peak at 520.7 cm -1 . Continuous control of the laser power at the sample level was achieved.
• a pre-processing of Raman images was made by eliminating aberrant spectra (fluorescence, burning, saturation), correcting the baseline, applying a spectral smoothing and despike and a spectral normalization.
• the processing of corrected data maps was performed by using software based on least squares fitting method that operates with Matlab software. This method involved mathematical modelling of reference spectra in the overall spectral image to determine the contribution and distribution of these spectra within the image. In this study, the average spectra of hyaluronic acid and clay were used as reference spectra.
• Cream 3 being the cream with the hyaluronic acid/clay blend
• Cream 4 the placebo
• Testing was performed on 59 subjects, 42 women and 17 men, average age 38, all ordinary members of the public. Testing was double-blind, in that the testers also did not know which of Cream 3 or Cream 4 was being presented to the test subject.
• a well-being metric was used for this study to measure the effects of the test cream on the well-being of test subjects.
• the well-being metric described in detail in International Publication WO 2020/165463, to which reference may be made, was defined by applying experimental psychology and unsupervised clustering of verbal attributes of well-being in order to identify the most relevant dimensions to assess well-being.
• the well-being attributes take into account various aspects of well-being, such as affective, eudaimonic, social, and physical aspects. These aspects may have both affective (emotional) and cognitive (rational) components.
• the weighting of the well-being attributes was determined as follows: a) Having one or more human subject(s) assess their well-being in the absence of a test cream by providing a well-being score wb t for each of the WB-18 attributes; b) Applying a factor analysis, in particular a principal component analysis, on the wellbeing scores obtained in step a), in order to determine the impact of each wellbeing attribute on the overall well-being, resulting in M well-being factors F , i) wherein each of the well-being factors Fj has a variance vj expressed as a percentage of the sum of the variances of all well-being factors; ii) wherein each of the well-being factors Fj comprises a finite number n 7 - of wellbeing attributes, having a loading l if expressed as a percentage of the sum of the nj loadings ; and iii) wherein none of the well-being attributes appears in more than one well-being factor; and c) Calculating the well-being score in the absence of the
• the well-being attributes "not anxious”, “not sad”, “not restless”, “not frustrated”, “not stressed” are associated with a first well-being factor F having a variance v ⁇
• the well-being attributes "happy”, “optimistic”, “excited”, “satisfied”, “motivated”, “invigorated” are associated with a second well-being factor F 2 having a variance v 2 '
• the well-being attributes "interested” and “not bored” are associated with a third well-being factor F 3 having a variance v 3
• the well-being attributes "not fatigued” and “mentally alert” are associated with a fourth well-being factor F 4 having a variance v 4
• the well-being attributes "calm”, “relaxed", and "patient” are associated with a fifth well-being factor F 5 having a variance v 5
• the variance is 48% of the sum of the variances of all well-being factors
• the variance v 2 is 24% of the sum of the variances
• Table 1 Using this methodology, the numerical results from the tests were summed to provide a mean for each attribute for each cream, and then these individual attribute scores were summed to provide an overall well-being score for each cream.
• Cream 3 has higher mean scores for all of the individual positive attributes, both before and after application
• Cream 3 provides a significantly higher change in perception of well-being than does Cream 4
• the overall result was that, of the 59 test subjects, 46 experienced an enhanced feeling of well-being when tested with Cream 3, that is, 78% of the subjects experienced a feeling of enhanced well-being as a result of exposure to the cream containing the hyaluronic acid, as hereinabove described.
• the overall before and after scores for the test subjects with respect to cream 3 are in Table 5.

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• 2023
  • 2023-01-11 WO PCT/EP2023/050544 patent/WO2023135170A1/en not_active Ceased
  • 2023-01-11 US US18/721,526 patent/US20250057737A1/en active Pending
  • 2023-01-11 EP EP23700743.0A patent/EP4463131A1/en active Pending
  • 2023-01-11 JP JP2024542141A patent/JP2025501783A/ja active Pending
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