STABILIZED OIL-IN-WATER EMULSION
20210353513 · 2021-11-18
Inventors
- Johan ENGBLOM (Lund, SE)
- Abdullah Ali (Skurup, SE)
- Marie Wahlgren (Åkarp, SE)
- Christopher Anderson (Linköping, SE)
- Malin Sjöö (Kävlinge, SE)
Cpc classification
A61K2800/412
HUMAN NECESSITIES
A61K8/361
HUMAN NECESSITIES
A61K8/732
HUMAN NECESSITIES
International classification
Abstract
An oil-in-water emulsion composition contains a) at least one liquid continuous aqueous phase (X) containing alcohol in water; b) at least one dispersed fatty phase (Y), of at least one oil; c) stabilizing particles (Z), being selected from solid particles and soft-gel particles. The oil-in-water emulsion composition is useful as a topical sanitizing composition.
Claims
1-18. (canceled)
19. An oil-in-water emulsion composition, comprising: a) 40-98% of at least one liquid continuous aqueous phase (X) comprising at least one linear or branched C.sub.1-C.sub.4 alcohol selected from the group consisting of ethanol, isopropyl alcohol, and n-propanol; b) 1-40% of at least one dispersed fatty phase (Y), comprising at least one oil having biological origin, selected from triglyceride oils comprising fatty acids selected from the group consisting of myristic acid, palmitic acid, stearic acid, oleic acid, linolic acid, linolenic acid, pelargonic acid, capric acid, caprylic acid, lauric acid, and a mixture thereof; c) 0.25-20% of stabilizing particles (Z), consisting of components which are solid particles; wherein the emulsion is a Pickering emulsion; wherein the emulsion is surfactant free; wherein the emulsion composition comprises at least 20%, by weight, of said C.sub.1-C.sub.4 alcohol, and wherein the dispersed fatty phase is selected to have no, or at least very limited solubility in the continuous aqueous phase (X); and wherein the solid particles (Z) consists of starch.
20. The oil-in-water emulsion composition according to claim 19, which comprises at least 35% by weight of C.sub.1-C.sub.4 alcohol.
21. The oil-in-water emulsion composition according to claim 19, wherein the at least one dispersed fatty phase (Y) have a melting point below 50° C.
22. The oil-in-water emulsion composition according to claim 19, which comprises between 40 and 80% C.sub.1-C.sub.4 alcohol as the at least one liquid continuous phase.
23. The oil-in-water emulsion composition according to claim 19, wherein the at least one dispersed fatty phase (Y) is in solid phase.
24. The oil-in-water emulsion composition according to claim 19, wherein the at least one dispersed fatty phase (Y) is in liquid phase.
25. The oil-in-water emulsion composition according to claim 19, wherein the at least one dispersed fatty phase is a mixture of the oil having biological origin, selected from triglyceride oils; wherein the triglyceride comprises fatty acids selected from the group consisting of myristic acid. palmitic acid, stearic acid. oleic acid, linolic acid, linolenic acid, pelargonic acid, capric acid, caprylic acid, lauric acid, and a mixture thereof; and mineral oil.
26. The oil-in-water emulsion composition according to claim 19, wherein the solid particles have a size of 0.005-20 μm.
27. The oil-in-water emulsion composition according to claim 19, wherein the starch is obtained from any botanical source.
28. The oil-in-water emulsion composition according to claim 19, wherein the ratio of b) at least one dispersed fatty phase (Y), and the c) stabilizing particles (Z), is between 2.5:1 to 5:1.
29. The oil-in-water emulsion composition according to claim 19, further comprising one or more additives.
30. A topical sanitizing composition, comprising: the oil-in-water emulsion composition according to claim 19.
31. The topical sanitizing composition according to claim 30, which is in form of a cream; in form of a foam; in form of a gel; in form of a lotion; or in form of a solution.
32. The topical sanitizing composition according to claim 30, which has an antimicrobial effect.
33. A method for preparing the oil-in-water emulsion composition according to claim 19, wherein the method comprises: a) providing at least one liquid continuous aqueous phase (X) comprising at least one linear or branched C.sub.1-C.sub.4-alcohol; b) providing at least one dispersed fatty phase (Y), comprising at least one oil; c) providing stabilizing particles (Z); d1) dispersing the stabilizing particles (Z) in the continuous aqueous phase (X) of a) during mixing, or d2) dispersing the stabilizing particles (Z) in the dispersed fatty phase (Y); e) adding the dispersed fatty phase (Y) to the mixture (X+Z) of d1), or adding the continuous aqueous phase (X) to the mixture (Y+Z) of d2), during mixing, at a temperature below 45° C.; f) optionally, emulsification by further mixing; and g) optionally, adding of additives during or after any of a) to e).
34. A method for preparing a topical sanitizing composition as defined in claim 30, the method comprising: a) providing at least one liquid continuous aqueous phase (X) comprising at least one linear or branched C.sub.1-C.sub.4-alcohol; b) providing at least one dispersed fatty phase (Y), comprising at least one oil; c) providing stabilizing particles (Z); d1) dispersing the stabilizing particles (Z) in the continuous aqueous phase (X) of a) during mixing, or d2) dispersing the stabilizing particles (Z) in the dispersed fatty phase (Y); e) adding the dispersed fatty phase (Y) to the mixture (X+Z) of d1), or adding the continuous aqueous phase (X) to the mixture (Y+Z) of d2), during mixing, at a temperature below 45° C.; f) optionally, emulsification by further mixing; and g) optionally, adding of additives selected from the group consisting of antimicrobial agent, denaturizing agent, thickener, humectants, antipruritic agent, fragrances, essential oils, and propellants, during or after any of a) to e).
Description
DESCRIPTION OF THE FIGURES
[0131]
[0132]
[0133]
[0134]
[0135]
[0136]
[0137]
[0138]
[0139] Average friction coefficients measured on hydrated VITRO-SKIN® (IMS Inc, USA) after application of a traditional ethanol-based handsanitizer (Sterisol® Handdesinfektion Etanol (Sterisol AB, Sweden)) and two water-based Pickering emulsions containing tricaprin (PemTC-H2O, C10:0) and triolein (PemTO-H2O, C18:1), respectively. Both Pickering emulsions comprised 30 wt % triglyceride (C10:0), 10 wt % modified quinoa starch and 60 wt % water. Finger friction measurements were also performed on VITRO-SKIN® alone as a reference accounting for effects of dehydration of the substrate over time. While the traditional handsanitizer gave high friction coefficients during application, they rapidly returned to the reference value (i.e that of the bare surface) as a result of ethanol evaporation. For both Pickering emulsions the friction coefficients increase from initial low values to reach a stable platau within the first 2.5 minutes, most probalby due to formation of a lipid film on the skin. No difference could be obseved from changing the oil from tricaprin to triolein.
[0140]
[0141] Average friction coefficients measured on hydrated VITRO-SKIN® (IMS Inc, USA) after application of two alcohol-based Pickering emulsions comprising 30 wt % tricaprin (C10:0), 10 wt % modified quinoa starch and 60 wt % ethanol solution (55 wt % (PemTC-55EtOH) and 70 wt % (PemTC-70EtOH) ethanol in water) and compared to a water-based Pickering emulsion, based on the same recipee with 60 wt % water (PemTC-H20). Finger friction measurements were also performed on VITRO-SKIN® alone as a reference accounting for effects of dehydration of the substrate over time. The results for emulsion treated skin show that during the evaporation of water and ethanol, the remaining lipid film on the skin occludes and smoothens the skin resulting in higher friction coefficients. No difference in tactile perception (i.e. friction) could be obseved from replacing parts of the water with increasing amounts of alcohol.
[0142]
[0143] Average friction coefficients measured on hydrated VITRO-SKIN® (IMS Inc, USA) after application of two alcohol-based Pickering emulsions comprising 30 wt % triolein (C18:1), 10 wt % modified quinoa starch and 60 wt % ethanol solution (55 wt % (PemTO-55EtOH) and 70 wt % (PemTO-70EtOH) ethanol in water) and compared to a water-based Pickering emulsion, based on the same recipee with 60 wt % water (PemTO-H20). Finger friction measurements were also performed on VITRO-SKIN® alone as a reference accounting for effects of dehydration of the substrate over time. The results for emulsion treated skin show that during the evaporation of water, the remaining lipid film on the skin occludes and smoothens the skin resulting in higher friction coefficients. No difference in tactile perception (i.e. friction) could be obseved from changing the oil from tricaprin to triolein.
[0144]
[0145] Average friction coefficients measured on hydrated VITRO-SKIN® (IMS Inc, USA) after application of two commercial reference products, a thickened solution (tilted lines) and an alcohol gel (horizontal lines), and two alcohol-based Pickering formulations in form of a 5 wt % emollient hand sanitizing gel (tiles) and 28 wt % cream (emollient antimicrobial cream) (black dots). Formulations of the current invention maintains higher friction coefficients over longer periods in comparison to reference commercial products.
[0146]
[0147] Sensory profile of a Pickering formulation (A), comprising 20% oil in ethanol/water 70/30 (by weight), and two classical hand sanitizers, Sterisol® Handdesinfektion Etanol (Sterisol AB, Sweden) (B) (active ingredient: Ethanol (70% w/w), Propane-2-ol (10% w/w), Further ingredients: Aqua, Glycerin (humectant), t-Butyl Alcohol (denaturating agent), Carbomer (part of a thickener system) Aminomethyl Propanol (buffer), and DAX Clinical Handdesinfektion' (CCS Healthcare AB, Sweden) (C) (Ethanol (about 68-70%), Aqua, 2-propanol, Glycerin, Caprylyl glycol, t-butanol). The main differences between the Pickering formulation and the two classical hand sanitizers were related to the afterfeel, where the test panel experienced a dryer, less smooth and smaller residual coating, despite the fact that a Pickering formulation contains more non-volatile excipients which will remain on the skin after application.
EXAMPLE
[0148] By way of examples, and not limitation, the following examples identify a variety of oil-in-water emulsions and hand sanitizing compositions pursuant to embodiments of the present invention.
[0149] Oil-in-water emulsions comprising different components and corresponding topical sanitizing compositions are shown in the following examples.
[0150] The compositions are then analysed and tested regarding physical stability and tactile sensation.
[0151] Material
[0152] Ethanol (99.8%) was purchased from VWR Chemicals (Stockholm, Sweden), while tricaprin (Captex 1000, 98.5% purity) and triolein (Captex GTO, 90.2% purity) were obtained from Abitec Corporation (Janesville, USA). Glycerol was purchased from Sigma-Aldrich (Stockholm, Sweden).
[0153] Modified quinoa starch, used as Pickering particles, was provided by Speximo AB (Lund, Sweden), and prepared according to WO2012/082065.
[0154] Ultrahigh quality (UHQ) water, purified at 25° C. by Elgastat UHQ II Model UHQ-PS-MK3 (Elga Ltd., High Wycombe, Bucks, UK) was used throughout the study. The artificial skin (i.e. Vitro-Skin®) used in friction measurements was purchased from IMS Inc. (USA). Two commercially available ethanol based hand sanitizers (Hand Desinfect Ethanol (Sterisol AB, Sweden) and DAX Clinical Handdesinfektion (CCS Healthcare Aft Sweden)) were sourced from a local pharmacy.
[0155] Methods
Example 1A
Sample Preparation of Oil-Ethanol-Water Mixtures, and Visual Evaluation of Their Mixing Behviour
[0156] Samples were prepared by mixing ethanol-water solutions, comprising 55 wt %, 70 wt %, 85 wt % and pure (99.8 wt %) ethanol, with liquid triglycerides (i.e., tricaprin at 40° C. or triolein at room temperature) in the following triglyceride-ethanol solution weight ratios: 30:70, 50:50 and 70:30 (For simplicity, ethanol-water solutions will be hereafter referred to as ethanol solutions together with the specific concentration). The samples were then left to equilibrate in the dark in flame-sealed glass ampoules at 25° C. and 40° C. reflecting relevant stability study temperatures. The sample set is summarized in table 1. All samples were photographed directly after mixing, 24 hours after preparation and weekly during storage for 8 (50:50 samples) and 2 weeks (30:70 and 70:30 samples). Macroscopic phase behavior, including phase separation, was noted and ampoules were then opened to extract individual phases for further analysis. The results are illustrated in phase diagrams provided as
Example 1B
Thermogravimetric Analysis
[0157] Thermogravimetric analysis (TGA) was primarily used to determine the amount of triglyceride dissolved into the ethanol-water phase in samples suffering phase separation (
Example 1C
Differential Scanning Calorimetry (DSC).
[0158] The thermal phase behavior of the triglyceride fraction in samples suffering phase separation was studied by DSC (DSC 1, Mettler Toledo, Greifensee, Switzerland) (
[0159] For comparison, the commercial triglycerides (C18:1) and (C10:0) were also analyzed as received before mixing.
Example 1D
Preparation of Pickering Formulations
[0160] Pickering formulations were prepared with two alternative triglycerides, tricaprin or triolein, as the dispersed oil phase and ethanol solutions as the continuous polar phase. Modified quinoa starch was added as 400 mg starch per ml oil in all emulsions for particle stabilization. The compositions were chosen within the two-phase region of the ternary triglyceride-ethanol-water phase diagrams (
[0161] In
Example 1E
Optical Microscopy
[0162] Pickering formulations were also analyzed by optical light microscopy to evaluate emulsion stability. 1-2 drops of formulation was diluted (5×) with water and spread on a glass-slide without using a cover glass(
Example 1F
Ex Vivo Perception Testing Utilizing ForceBoard™ with VITRO-SKIN®
[0163] Tactile friction measurements were performed using a ForceBoard™(Industrial Dynamics Sweden AB, Järfälla, Sweden), equipped with both a horizontal and tangential load cell, consisting of strain gauges in a Wheatstone bridge configuration. A mechanical load results in voltage changes that are proportional to the applied load. The friction force (F) and applied load (L) were continuously recorded, with a sampling rate of 100 Hz, as a finger interrogated the model skin surface by moving the index finger back and forth, and the friction coefficients (μ) were calculated as the ratio of the friction force and load according to:
[0164] VITRO-SKIN® (IMS Inc., USA) was used as a model skin as it mimics human skin surface properties in terms of topography, pH, elasticity, surface tension and ionic strength [www.ims-usa.com/vitro-skin-substrates/vitro-skin/]. The model skin was cut into pieces of 2.5 cm×5 cm and placed in a desiccator on the internal shelf above a beaker with a mixture of 85 wt % water and 15 wt % glycerol for 16-24 hours before use. This allowed for reproducible hydration of the skin samples prior to friction measurements.sup.2. Prior to each measurement, the model skin was taken from the desiccator and weighed before attachment to the ForceBoard™ with double-adhesive tape. The ForceBoard™ was heated to 32° C. by using a heating block. A finger friction measurement with 10 strokes was recorded without any formulation before each measurement series as a reference measurement on the model skin and clean finger. Approximately 6-7 mg/cm.sup.2 of emulsion was applied to the model skin and the friction measurement was started by using the index finger, inclined at about 30°, to spread the emulsion by stroking forward (away from the body) and back (towards the body) 10-12 times over a sample area of 7.5 cm.sup.2. The friction was measured again after 2.5 minutes, 5 minutes and 10 minutes without washing the index finger.
[0165] However, between each experiment the finger was cleaned with soap, thoroughly rinsed with water and allowed to dry for 3 minutes before next experiment. The moisture content of the finger was also measured using a Corneometer (CM825, Courage Khazaka Electronic GmbH) prior to each test. The measurement time period was based on evaporation experiments where >50 wt % of the hydrophilic phase evaporated within 10 minutes in all formulations. All experiments were performed in triplicate and in controlled environment (T=21° C. and RH=50%). The load, stroking distance and inclination of the finger were all controlled. To minimise the variability in the measurements further, the same experimenter performed all measurements with the same finger.
[0166] There is a clear and persistent increase in friction coefficient for the Pickering emulsions compared to the reference product (a traditional ethanol based hand disinfectant) and the reference on VITRO-SKIN® alone (
[0167] The results show a clear benefit from using Pickering-emulsion-based formulations in terms of tactile perception over conventional alcohol-based hand sanitizers. In addition, ethanol-based Pickering formulations comprising higher amounts of emollients (e.g. about 30 wt % triglycerides) show a great potential to be a better alternative to conventional hand sanitizers in terms of skin dehydration and tactile perception of the skin
Example 2
Oil-in-Water Emulsions as Pickering Formulations
[0168] Ternary diagrams for triolein and tricaprin were used to prepare oil-in-water emulsion composition according to the invention (
[0169] Analysis with microscopy, compositions comprising 28 wt % triglyceride (tricaprin/triolein), 12 wt % quinoa starch and 60 wt % of aqueous ethanol (58/42 wt % ethanol/water) for triolein and tricaprin respectively, confirmed particle based stabilization where the starch particles cover the oil droplets (
Example 3
Emollient Hand Sanitizer
[0170] Compositions with oil/(alcohol+water) of ratio 30/70, in form of lotion, cream are prepared according to the method as described in herein
[0171] The hand sanitizing composition as described below is prepared according to the method for preparing herein described.
[0172] All the aqueous components are mixed together while the oil soluble components are mixed together in a separate container. The thickener is dispersed in the aqueous phase during mixing until it is fully dispersed, before addition of quinoa starch particles during mixing. The oil phase is finally added to the aqueous blend during mixing followed by homogenization using a high shear mixer.
Example 3A
[0173]
TABLE-US-00007 Oil (emollient)-tricaprin: 26.7 Starch-quinoa 8.9 Alcohol-ethanol 43.6 Denaturizing agent-MEK 1.2 Humectant Thickener-HPC 0.9 Water 18.7 Sum: 100
Example 3B
[0174]
TABLE-US-00008 Oil (emollient)-triolein: 27.0 Starch-quinoa 9.0 Alcohol-ethanol 38.7 Alcohol-isopropyl alcohol 5.4 Denaturizing agent-butanol 0.01 Humectant Thickener-HPC 0.9 Water 19.0 Sum: 100
Example 3C
[0175]
TABLE-US-00009 Oil (emollient)-trieicosenoin: 26.9 Starch-quinoa 9.0 Alcohol-ethanol 43.4 Alcohol-n-propanol 0.5 Denaturizing agent: MEK 0.5 Bitrex 10 ppm Humectant — Thickener-Carbopol 0.9 Water 18.8 Sum: 100
Example 3D
[0176]
TABLE-US-00010 Oil (emollient)-triolein: 12.9 Oil (emollient)-trilinolein: 12.9 Starch-quinoa 8.6 Alcohol-isopropyl alcohol 36.2 Denaturizing agent: — Humectant: glycerol 4.3 Thickener-HPC 0.9 Water 24.2 Sum: 100
Example 3E
[0177]
TABLE-US-00011 Oil (emollient)-trierucin: 25.9 Starch-quinoa 8.6 Alcohol-n-propanol 36.2 Denaturizing agent: — Humectant: urea 4.3 Thickener-HPC 0.9 Water 24.1 Sum: 100
Example 3F
[0178]
TABLE-US-00012 Oil (emollient)-MCT: 25.6 Starch-quinoa 8.5 Alcohol-isopropyl alcohol 36.4 Denaturizing agent: — Humectant: glycerol 4.3 Thickener-HPC 0.9 Water 24.3 Sum: 100
[0179] Following Examples 3G-3L are prepared as emollient hand sanitizers comprising oil/alcohol:water in an amount of 1/99 to 50/50 w/w. The compositions obtained are semisolid, liquid like.
Example 3G
[0180]
TABLE-US-00013 Oil (emollient)-trimyristin 49.8 Starch-quinoa 16.6 Alcohol-ethanol 22.9 Denaturizing agent: MEK 0.7 Humectant: glycerol — Thickener-HPC — Water 10.0 Sum: 100
Example 3H
[0181]
TABLE-US-00014 Oil (emollient)-ttriolein 48.2 Starch-quinoa 16.0 Alcohol-ethanol 35.1 Denaturizing agent: MEK 0.7 Humectant: glycerol — Thickener-HPC — Water 0 Sum: 100
Example 3I
[0182]
TABLE-US-00015 Oil (emollient)-MCT 26.7 Starch-quinoa 8.9 Alcohol-ethanol 35.6 Denaturizing agent: MEK 1.2 Humectant: glycerol — Thickener-HPC 0.9 Water 26.7 Sum: 100
Example 3J
[0183]
TABLE-US-00016 Oil (emollient)-triolein 25.6 Starch-quinoa 8.5 Alcohol-ethanol 35.8 Denaturizing agent: MEK 1.2 Humectant: glycerol 4.3 Thickener-Xanthan gum 0.7 Water 23.9 Sum: 100
Example 3K
[0184]
TABLE-US-00017 Oil (emollient)-petrolatum 9.5 Starch-quinoa 3.1 Alcohol-ethanol 59.8 Denaturizing agent: MEK — Humectant: glycerol — Thickener-HPC 1.9 Water 25.7 Sum: 100
Example 3L
[0185]
TABLE-US-00018 Oil (emollient)-trierucin 1.2 Starch-quinoa 0.3 Alcohol-ethanol 55.7 Denaturizing agent: MEK — Humectant: urea 4.7 Thickener-HPC 0.9 Water 37.2 Sum: 100
[0186] Following Examples 3M -3R are prepared as emollient hand sanitizers Another aspect of the invention is a topical sanitizing composition comprising oil and alcohol+water in a ratio of 1/99-10/90 (w/w). Generally, such hand sanitizer comprises:
TABLE-US-00019 Oil (emollient) 1.0-10 Starch 0.3-3.5 Alcohol (C1-C4 alcohol) 50-70 Denaturizing agent: n.a. Humectant: (0-5) Thickener 0.2-1 Water 20-40 Sum: 100
Example 3M
[0187]
TABLE-US-00020 Oil (emollient)-tricaprin 4.8 Starch-quinoa 1.6 Alcohol-ethanol 63.9 Denaturizing agent: MEK 1.8 Humectant: — Thickener: HPC 0.5 Water 27.6 Sum: 100
Example 3N
[0188]
TABLE-US-00021 Oil (emollient)-triolein 4.7 Starch-quinoa 1.6 Alcohol-ethanol 57.4 Alcohol-isopropyl alcohol 9.0 Denaturizing agent: butanol 0.01 Humectant: — Thickener: HPC 0.3 Water 27.1 Sum: 100
Example 3O
[0189]
TABLE-US-00022 Oil (emollient)-trieicosenoin 4.8 Starch-quinoa 1.6 Alcohol-ethanol 59.6 Alcohol-isopropyl alcohol 8.5 Denaturizing agent: butanol 0.01 Humectant: — Thickener: HPC 0.2 Water 25.3 Sum: 100
Example 3P
[0190]
TABLE-US-00023 Oil (emollient)-triolein 2.3 Oil (emollient)-trilinolein 2.3 Starch-quinoa 1.6 Alcohol-isopropyl alcohol 56.0 Denaturizing agent: butanol — Humectant: glycerol Thickener: HPC 0.5 Water 37.3 Sum: 100
Example 3Q
[0191]
TABLE-US-00024 Oil (emollient)-trierucin 4.7 Starch-quinoa 1.6 Alcohol-isopropyl alcohol 53.2 Denaturizing agent: butanol — Humectant: urea 4.7 Thickener: HPC 0.5 Water 35.3 Sum: 100
Example 3R
[0192]
TABLE-US-00025 Oil (emollient)-tricaprin 4.6 Starch-quinoa 1.6 Alcohol-isopropyl alcohol 61.1 Denaturizing agent: MEK 1.6 Humectant: urea 4.6 Thickener: HPC 0.5 Water 26.0 Sum: 100
Example 4A-G
Ex Vivo Perception Testing Utilizing ForceBoard™ with VITRO-SKIN®
Example 4A
Reference Product (Provided by Sterisol)
[0193]
TABLE-US-00026 Alcohol-ethanol 70 Alcohol-isopropyl alcohol 10 Water 20 Sum: 100
Example 4B
[0194]
TABLE-US-00027 Oil (emollient)-tricaprin 0 Starch-quinoa 10 Alcohol-ethanol 60 Water 60 Sum: 100
Example 4C
[0195]
TABLE-US-00028 Oil (emollient)-tricaprin 30 Starch-quinoa 10 Alcohol-ethanol 33 Water 27 Sum: 100
Example 4D
[0196]
TABLE-US-00029 Oil (emollient)-tricaprin 30 Starch-quinoa 10 Alcohol-ethanol 42 Water 18 Sum: 100
Example 4E
[0197]
TABLE-US-00030 Oil (emollient)-triolein 0 Starch-quinoa 10 Alcohol-ethanol 60 Water 60 Sum: 100
Example 4F
[0198]
TABLE-US-00031 Oil (emollient)-triolein 30 Starch-quinoa 10 Alcohol-ethanol 33 Water 27 Sum: 100
Example 4G
[0199]
TABLE-US-00032 Oil (emollient)-triolein 30 Starch-quinoa 10 Alcohol-ethanol 42 Water 18 Sum: 100
Example 4H
Emollient Handsanitizer Gel
[0200]
TABLE-US-00033 Oil (emollient)-triolein: 5 Starch-modified quinoa 1.95 Alcohol-ethanol 55.1 Humectant-glycerin 1 Thickener-Carbomer 0.25 Amino methyl propyl (AMP) 0.11 Water 36.69 Sum: 100
Example 4I
Antimicrobial Cream
[0201]
TABLE-US-00034 Oil (emollient)-triolein: 28 Starch-modified quinoa 11 Alcohol-ethanol 34.4 Humectant-glycerin 1 Thickener-Carbomer 0.25 Water 36.69 Sum: 100
Example 4J
In Vivo Perception Testing—Panel with Volunteers
[0202] A sensory evaluation was performed as a blind ranking test including three samples; i.e. a Pickering formulation (A), comprising 20% oil in ethanol/water 70/30 (by weight), and two classical hand sanitizers, Sterisol® Handdesinfektion Etanol (Sterisol AB, Sweden) (B) and DAX Clinical Handdesinfektion (CCS Healthcare Aft Sweden). The panel included 29 volunteers. Equal amounts of each sample was applied on a marked area on the palm of the hand. Properties were evaluated on application (i.e., spreadability, absorbency, and stickiness) and after application (i.e., after feeel in terms of residual coating, dryness, smoothness and stickiness). The participants of the panel were also asked to rate the products with respect to their preferences. From the results summarized in
[0203] The pickering formulation was also deemed as the most prefered product of the three.
Example 5
Antimicrobial Efficacy
[0204] The antimicrobial efficacy of the compositions was tested following the standard method EN 13727, Bacterial efficacy in suspension test (log10 RF≥5) (“Chemical Disinfectants and antiseptics: Quantitative Suspension Test for the Evaluation of Bactericidal Activity for Instruments Used in the Medical Area”)
[0205] Further standard methods are designed to evaluate bactericidal, fungicidal, yeasticidal, basic sporicidal, or mycobactericidal activity of a product used under various conditions. Examples of standard methods are EN 13727 for testing bacteria, EN 13624 for testing yeast (such as Candida albicans), EN 14476 for virus test, and EN 14348 for test of bacteria, like tuberculocidal bacteria.
[0206] Standard methods are also designed for different applications, for example EN 1500 for Hygienic hand disinfection, and EN 12791 for surgical hand disinfection.
[0207] Herein, the test organism is exposed to hand sanitizer compositions as defined herein in a manner which simulates the desired claim. Following exposure, the test system is neutralized and quantitatively assayed for survivors. The plates are incubated, enumerated, and a reduction in viability or microbiocidal effect is determined as compared to a population control.
[0208] Following organisms are included in the test:
[0209] Staphylococcus aureus (tested)
[0210] Escherichia coli K12 (tested)
[0211] Escherichia hirae
[0212] Pseudomyses aeruginosa
[0213] Typical performance criteria (Requirements may vary by claim): 3-5 log reduction in 1-5 minutes depending on claim. For hygienic handwashing it is 3 log, for other performances 5 log, during 30-60 seconds (mandatory for hygienic handwashing and hand rub).
Example 5A
[0214] Method EN 13727 (Bactericidal efficacy in suspension test, log.sub.10 RF≥5), Escherichia coli K12 and Staphylococcus aureus, Dilution to 80%.
TABLE-US-00035 Formulation E. coli/log.sub.10 RF S. aureus/log.sub.10 RF 80% 80% 58% EtOH (aq) >5.1 >5.3 58% EtOH (aq) >5.4 >5.3 42% EtOH (aq) 6.4 4.8 35% EtOH (aq) >5.1 <2.7 35% EtOH (aq) >5.4 3 Pickering 6.3 6.4 42% EtOH Pickering 4.8 >5.2 35% EtOH Pickering >5.4 >5.3 35% EtOH Pickering <2.4 <2.7 0% EtOH Pickering <2.7 <2.6 0% EtOH
REFERENCES
[0215] .sup.1 (Eiteman et al., 1994; McClements, 2015)
[0216] .sup.2 Skedung et al., 2013