WO2020022988A2

WO2020022988A2 - Plant-based topical compositions for baby skin care

Info

Publication number: WO2020022988A2
Application number: PCT/TR2019/050250
Authority: WO
Inventors: Ahmet Toksoz; Zafer Toksoz
Original assignee: Montero Gida Sanayi Ve Ticaret Anonim Sirketi
Priority date: 2018-05-02
Filing date: 2019-04-17
Publication date: 2020-01-30
Also published as: WO2020022988A3

Abstract

The present invention relates to emollient and moisturizing topical compositions that are suitable for use in baby skin care. The composition of the invention contains one main emollient oil that comprises at least one of Prunus amygdalus dulcis oil and Sesamum Indicum oil as well as at least one adjuvant emollient oil that is selected from the group comprising Macadamia Ternifolia oil, Simmondsia chinensis oil and Helianthus Annuus oil.

Description

PLANT-BASED TOPICAL COMPOSITIONS FOR BABY SKIN CARE

Field of the Invention

The present invention relates to topical compositions that contain plant-based emollient oils for use in baby skin care. In particular, the invention relates to topical compositions that contain at least one main emollient oil and at least one adjuvant oil.

Background of the Invention

A baby's skin is thin, sensitive and less oily. Therefore, it has low resistance to germs and irritation. On the other hand, babies that are born past the expected delivery date have wrinkly skin and it peels within the weeks following birth. A red rash that looks like small pimples appears especially on the baby's face with the effect of hormones passed from the mother to the baby in the first days following birth and it can disappear within a short period only by paying attention to the cleanliness of skin. However, the risk of developing eczema is high in babies that are susceptible to allergies and that have atopic nature. Such skin types require more attention and should be prevented from getting irritated. Infant eczema is the most important problem in atopic babies and in order to prevent the development of eczema, the baby's diaper should be changed in every 2-3 hours, the area should be washed with warm water and dried each time, and a thin layer of baby oil should be applied after leaving the diaper off for a short while and making sure the area is completely dry.

The main purpose of baby oil is to provide the necessary moisture for the skin and prevent it from drying and cracking. When baby oil is applied by massaging the skin, it also relaxes the baby.

In state of the art, many synthetic and natural topical compositions have been developed in order to prevent eczema formation and dry skin, eliminate or reduce the dryness and provide skin care. Since a baby's skin is very sensitive and long-term use of synthetic compositions may harm the skin, natural compositions are rather preferred. In literature, there are studies on various plant- based oils and many compositions obtained by mixing these oils for baby skin care.

Patent application no. US 2003/0157196 A1 provides a topical composition for the treatment of diaper rash and irritation in babies. The composition contains one carrier oil and this oil is selected from the group that comprises almond oil, coconut oil, sunflower oil, apricot kernel oil, avocado oil, canola oil, primrose oil, grape seed oil, hazelnut oil, jojoba oil, macadamia oil, olive oil, sesame oil, rosehip seed oil and mixtures thereof.

Patent no. US 8,932,656 B1 relates to a topical composition that contains Cocos nucifera, olive oil, Jojoba ( Simmondsia chinensis ) oil, Calendula oil, Melaleuca tree oil and Matricaria chamomilla extract for use in the treatment of diaper rash and burns or skin irritation. The composition in this document is intended to overcome problems associated with the distribution on the skin.

The present invention, on the other hand, aims to boost the emollient and moisturizing effects of the composition by providing topical compositions that contain at least one main emollient oil and at least one adjuvant oil as emollient and natural oil. The mentioned main emollient oil contains at least one of Prunus amygdalus dulcis oil and Sesamum Indicum oil, preferably both. The mentioned adjuvant oil phase is selected from the group that comprises Macadamia Ternifolia oil, Simmondsia chinensis (Jojoba) oil and Helianthus Annuus oil. In addition, compositions of the present invention may optionally contain at least one skin care agent selected from Malva sylvestris extract, Calendula officinalis extract, Chamomilla Recutita extract and Anthemis nobilis extract

Prunus amygdalus dulcis oil mentioned in the invention has been used for skin care since the past and it is commonly preferred today. It is used in the treatment of blemishes on the face, blackheads and scaly skin. It nourishes the skin, provides softness and meets the need of vitamin E.

Sesamum Indicum oil mentioned in the invention contains complex vitamins E, A and B, phosphorus, copper, calcium, zinc and magnesium minerals. It is also rich in Omega 6 and Omega 9 fatly acids. With these properties, Sesamum Indicum oil moisturizes and nourishes the skin and delays aging.

The present invention may contain Macadamia Ternifolia oil, which contains palmitoleic acid that cannot be found in any fruit. This acid is produced by the human body and its production decreases with aging. The oil provides significant visible improvement in scars, treatment of sunburns, small wounds, skin irritation and skin blemishes due to its highly moisturizing properties and easy absorption. Simmondsia chinensis (JojobaJ, on the other hand, is a xerophytic plant. Jojoba is among the plants that balance body functions and have a recuperative effect on the general state of health. The most important benefit of jojoba oil is that it provides skin flexibility and moisturizes the skin. This plant supports collagen production in the skin due to its protein and mineral content Helianthus annuus oil that can be used in the composition of the invention prevents acne and accelerates wound healing. It is also used in healing urticaria and boils as well as against infections. It is known that Malva sylvestris extract that can be used in the present invention facilitates reducing the swelling in the skin. It provides a much more radiant appearance of the skin while rejuvenating skin cells. It delays skin aging and can also be used for treatment purposes in wounds and burns on the skin. Calendula officinalis extract that can also be used in the invention helps wounds heal faster. It is also used in the treatment of fungal infection, psoriasis and eczema. Being a rich essential oil, Chamomilla Recutita extract is contained in various drugs. It can be used for inflamed skin and mucosa, oral and periodontal diseases, anal and genital disorders. Anthemis nobilis extract that can be contained in the present invention can be used as an anti-inflammatory, anti-spasmodic agent, fatigue and pain reliever. Due to its anti-inflammatory effect, it kills toxins that cause infections. Soaps and lotions that contain effective amounts of Anthemis nobilis thoroughly cleanse the skin. It can be used for makeup removal due to the disinfectant effect. It cleans and moisturizes the skin.

The above-mentioned natural oils and extracts should be formed into a topical dosage form in order to be easily applied on the skin. However, it is not always easy to obtain effective and safe compositions due to the physical and chemical stability problems of the compositions known in the art that contain natural oils. Since each natural oil has different solubility properties, phase stability and homogeneity problems are encountered in the process of mixing these oils. From the aspect of use by patients, the topical composition should have suitable viscosity, phase stability and homogeneity in order to enable easy application of the composition on the area that will be treated. This composition, which is made into a dosage form, should also be compatible with the baby's skin and should not cause any harm or a new irritation after long periods of storage.

In conclusion, in state of the art, there is still a need for novel plant-based compositions, which exhibit emollient and moisturizing properties, that are also stable and suitable for use in babies. The present invention proposes a topical composition that is provided in accordance with the appended claims in order to meet the above-mentioned need.

Detailed Description of the Invention

The present invention provides topical compositions that contain at least one main emollient oil and at least one adjuvant emollient oil. The mentioned main emollient oil contains at least one of Prunus amygdalus dulcis oil and Sesamum Indicum oil, preferably both. The mentioned adjuvant oil phase is selected from the group that comprises Macadamia Ternifolia oil, Simmondsia chinensis (Jojoba) oil and Helianthus Annuus oil. The composition of interest is extremely suitable for use especially in baby skin care. In an embodiment of the invention, main emollient oil contains a combination of Prunus amygdalus dulcis oil and Sesamum Indicum oil.

In an embodiment of the invention, adjuvant emollient oil contains a combination of Macadamia Ternifolia oil, Simmondsia chinensis oil and Helianthus Annuus oil.

In an embodiment of the invention, the composition contains a combination of Prunus amygdalus dulcis oil, Sesamum Indicum oil, Macadamia Ternifolia oil, Simmondsia chinensis oil and Helianthus Annuus oil.

In an embodiment of the invention, the composition also contains a plant-based extract phase.

Compositions of the invention may optionally contain at least one skin care agent selected from Malva sylvestris extract, Calendula officinalis extract, Chamomilla Recutita extract and Anthemis nobilis extract. By providing these agents, it becomes possible for the composition to provide complete care and also exhibit improved antimicrobial and antifungal properties in the meantime.

The composition has to meet certain criteria such as suitable pH, viscosity and phase stability in order to obtain an effective and safe topical form of the composition. The composition of the invention can surprisingly provide the desired phase stability even without the use of emulsifying agents. Plant-based oils and extracts used within the scope of the invention are extremely compatible with each other from the physicochemical aspect They mix homogenously therefore eliminating the need for emulsifying agents, which is an unexpected case in such multiple combinations.

With the use of main and adjuvant oils, that are used within the scope of the present invention, together, baby skin care and moisturizing can be achieved more effectively. It was determined that provided compositions are stable and safe and they don't cause any side effects. Therefore, compositions of the invention are extremely suitable for use in babies especially in head and groin regions.

Sesamum Indicum oil that is included in the main embodiment of the invention also provides the desired viscosity value and phase stability while boosting the baby skin care and moisturizing properties of the composition. Active ingredient in an effective and safe topical composition, i.e. natural oils in the case of the present invention, should be homogenously distributed within the composition. Oils that do not dissolve sufficiently lead to an instable topical composition with visible phase separation. For such topical compositions, the active ingredient cannot be distributed evenly within the area of application. This causes penetration problems on the skin and makes it impossible to achieve the desired effective treatment In the present invention, Sesamum Indicum oil was used to overcome phase stability and homogeneity problems. In state of the art, Sesamum Indicum oil is used as a source of vitamins and minerals to nourish the skin. In the present invention, it was also seen that Sesamum Indicum oil provided the phase stability and homogeneity of the topical composition that contains the mentioned natural oils. Therefore, an effective and safe topical composition that contains Prunus amygdalus dulcis oil, Macadamia Ternifolia seed oil, Simmondsia chinensis oil, Malva sylvest s extract, Calendula officinalis extract, Chamomilla Recutita extract, Anthemis nobilis oil, Melissa Officinalis oil was obtained.

Composition of the invention is provided in a form that is selected from the group that comprises ointment, pomade, soap, gel, emulsion, spray, shampoo, mousse, balm, lotion, cream and oil emulsion. The composition is more preferably in an oil emulsion form.

In an embodiment of the present invention, topical composition of the invention may also contain at least one additional agent selected from skin care agents, rheology agents, cleansers, masking agents, emollients, solvents, preservatives, surfactants, perfumes, humectants, chelating agents, viscosity agents, buffers, antioxidants, antimicrobial preservatives, opacifiers and denaturing agents.

Additional skin care agents may be selected from the group that contains glycerin, tocopherol, olive oil hydrolyzed wheat protein, mallow extract, marigold extract, caprylyl glycol, zinc oxide and mixtures thereof.

Suitable additional emollients may be selected from the group that contains lemon balm oil, glyceryl stearate, glyceryl stearate citrate, glyceryl oleate, polyglyceryl-3-stearate, CIO-18 triglycerides, glyceryl caprilate, glyceryl caprate, cetearyl alcohol, behenyl alcohol, beeswax, shea butter, lanolin, lecithin, argania spinosa kernel oil, rosmarinus officinalis oil, triticum vulgare (wheat germ] extract, fish oil, aloe vera oil, rice bran oil, foeniculum vulgare oil, rosehip oil, avocado oil, centella asiatica extract, coconut-caprilate/caprate, fumatrice propolis extract, cremerlin pura and mixtures thereof.

Suitable solvents may be selected from the group that contains water, dicaprylyl ether, glycerol, ethanol, methanol, propylene glycol, polyethylene glycol, 2 -propanol, cetyl alcohol, stearyl alcohol, dimethylsulfoxide, benzyl alcohol, 1-3 butylene glycol, polyoxyethylene, lauryl alcohol, 1- 3 propanediol and mixtures thereof.

Suitable preservatives maybe selected from the group than contains sodium benzoate, potassium sorbate, rosmarinus officinalis (rosemary] leaf extract, Melaleuca alternifolia leaf oil, hamamelis virginiana (hamamelis] extract, tea tree essential oil, thyme essential oil, grapefruit seed extract, bitter orange extract, propolis extract, caprylhydroxamic acid, caprylyl glycol, glycerin and mixtures thereof.

Suitable surfactants may be selected from castile soap, yucca extract, soapwort, quillaja bark extract, lanolin, candelilla, carnauba, jojoba, rice bran, beeswax, lanolin, xanthan gum, quince seed, lecithin, glyceryl oleate, glyceryl stearate citrate and mixtures thereof.

Suitable humectants may be selected from the group that contains oenothera biennis (evening primrose] oil, jojoba oil, foeniculum vulgare (fennel] oil, calendula officinalis (marigold] oil, prunus armeniaca (apricot] oil, citrus aurantium (bitter orange] oil, jasminum officinale oil, tilia cordata flower extract, vitis vinifera oil, aloe vera oil, daucus carota oil, rosmarinus officinalis oil, triticum vulgare (wheat germ] oil, red tangerine oil, shea (butyrosperum parkii] butter, lecithin, panthenol (pro-vitamin b5], glycerin and mixtures thereof.

Suitable chelating agents can be selected from the group than contains tetrasodium glutamate diacetate, glutamic acid, ethylenediaminotetraacetic acid (EDTA] or any salt thereof, dimercaprol disodium, deferoxamine and mixtures thereof.

Suitable viscosity agents can be selected from the group that contains glycerin, acacia, agar, alginic acid, bentonite, carbomer copolymer, carbomer homopolymer, carbomer interpolymer, carboxymethylcellulose calcium, carboxymethylcellulose sodium, carboxymethylcellulose, carrageenan, microcrystalline cellulose, carboxymethylcellulose sodium, dextrin, gelatin, gellan gum, guar gum, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, maltodextrin, methylcellulose, pectin, polyethylene oxide, polyvinyl alcohol, povidone, propylene glycol alginate, pullulan, colloidal silica, silicone dioxide, sodium alginate, corn starch, xanthan gum and mixtures thereof.

Suitable buffers can be selected from the group than contains citric acid, epolamine, triethanolamine, diethanolamine, tromethamine and mixtures thereof.

Suitable antioxidants can be selected from the group that contains lecithin, ascorbyl palmitate, tocopherol, sunflower oil, ascorbic acid (vitamin C] or ascorbyl palmitate, propolis extract, allium cepae (onion] bulb extract, vitamin E (tocopheryl acetate/tocopherol], licorice (organic licorice] extract and mixtures thereof.

Suitable antimicrobial preservatives can be selected from the group that contains propylene glycol, phenoxyethanol, methyl paraben, propyl paraben and salts thereof (sodium, potassium], sodium benzoate, citric acid, benzoic acid, butylated hydroxytoluene, boric acid, sorbic acid, benzyl alcohol, benzalconium chloride, parahydroxybenzoic acids or butylated hydroxyanisole and mixtures thereof.

Topical composition of the present invention is intended for use in baby skin care. It is suitable for daily use in newborn skin treatment and prevents skin dryness, cracking and eczema development by providing moisture. Topical composition of the invention can be applied by massaging as a thin layer at each diaper change.

It may be preferred that compositions of the invention contain a perfuming component. For this purpose, it is again advantageous to use plant-based oils and this is of utmost importance for compositions intended for babies. For example, the mentioned perfuming agent may be Melissa Officinalis leaf oil. In prior art, it is known that Melissa Officinalis leaf oil is substantially effective in the treatment of many diseases from stress to stomach problems and that it has soothing properties due to its smell. It also rejuvenates the skin and provides removal of wrinkles, rash and itching in the skin. It also has anti-irritation effects and accelerates healing in small skin lesions. In addition, it preserves the oil balance of extremely oily skin types.

According to another aspect, the present invention relates to a production method of the compositions provided herein including the following steps:

Providing a main oil phase that contains at least one of Prunus amygdalus duicis oil and Sesamum Indicum oil,

Providing an adjuvant oil phase that contains at least one oil selected from the group that comprises Macadamia Ternifoiia oil, Simmondsia chinensis (Jojoba) oil and Heiianthus Annuus oil,

mixing the mentioned oil phases while heating,

cooling the mixture and obtaining the final product

Under these conditions, the production method of the topical composition is easy and low cost.

Present inventors subjected the composition they obtained to a series of physicochemical tests. These tests are explained by means of the examples below and they are not intended to limit the scope of protection of the invention.

Examples Example 1

Example 2

The above-mentioned topical compositions can be prepared by a method that contains the following steps:

Mixing the ingredients in a suitable manner according to the order provided below: a. Prunus amygdalus dulcis oil

b. Macadamia Ternifolia oil

c. Simmondsia chinensis (Jojoba] oil

d. Malva sylvestris extract

e. Chamomilla Recutita flower extract

f. Calendula officinalis flower extract

g. Tocopheryl acetate

h. Perfume

i. Sesamum Indicum oil

j. Anthemis nobilis oil

k. Melissa Officinalis leaf oil

Example 3 Stability test:

Method: The composition was stored at various temperatures (4 °C, 25 °C, 40 °C and in thermal shock 4 °C / 40 °C] for 3 months and its stability was evaluated at certain times (t: 0, day 15, month 1, month 3] 4 samples that correspond to control days were analyzed for each environmental status. Samples were evaluated at each control time by keeping one sample sealed all the time and others open. Thermal shock was applied once a week in two stages starting in the cooler followed by cooler/heater.

For example, organoleptic and chemical-physical properties at room temperature (25 ° C] remained unchanged. Expected and usual changes inherent in the raw materials were observed under hot and cold conditions. The composition was sealed tightly in order to prevent it from oxidation and possible chemical-physical or temperature-related changes and stored at room temperature.

Conclusion: The composition is stable under reasonable storage conditions (room temperature: 25 °C] when used in a commercial process or in its container for more than 30 months (preserves its chemical and physical properties until the date of expiry]. Example 4

Patch test:

Possible irritation effect of the composition was evaluated according to Draize classification.

Method: The test was applied to 25 male and female patients between the ages 18-70 that were selected according to the inclusion criteria, i.e. a] well general state of health b] absence of dermatopathy c] absence of ongoing pharmacological treatment d] acceptance of not changing the ordinary daily routine and e] absence of atopy in anamnesis, in order to provide outpatient treatment

Application of the Examples

According to the ordinary use of the composition, it was applied as a leave on or 10% standard concentration rinse-off composition. Liquid composition was applied to the skin at 20 mΐ dose. Solid and semi solid composition was applied at a dose of 20 pg. Finn chamber (plastic that contains 7 mm aluminum disc and absorbent paper discs] is a patch test device that provides good occlusion. For liquid compositions, Finn chamber contains blotting papers that were immersed in a certain amount (20 mΐ] of the sample that will be tested. For solid compositions, the compositions (20 pg] that will be tested are directly applied to the skin.

Application of the Test

The relevant area on the skin (surface of the back] was cleansed using 70% alcoholic solution. The composition was applied at an amount of 0,02 g or ml/cm² skin.

The relevant area of the skin was covered by the Finn chamber.

Composition was maintained in contact with the skin for 24 hours.

Finn chamber was removed.

Skin reactions were analyzed at minute 15, hour 1 and 24 after removing the Finn chamber. Conclusion; There were no edema and erythema in the patients after the test.

Claims

1. A topical composition that contains a main emollient oil that comprises at least one of Prunus amygdalus dulcis oil and Sesamum Indicum oil and at least one adjuvant emollient oil that is selected from the group that comprises Macadamia Ternifolia oil, Simmondsia chinensis oil and Helianthus Annuus oil.

2. The topical composition according to Claim 1, wherein the main emollient oil contains a combination of Prunus amygdalus dulcis oil and Sesamum Indicum oil.

3. The topical composition according to Claim 1 or 2, wherein the adjuvant emollient oil contains a combination of Macadamia Ternifolia oil, Simmondsia chinensis oil and Helianthus Annuus oil.

4. The topical composition according to Claim 1, wherein the composition contains a combination of Prunus amygdalus dulcis oil, Sesamum Indicum oil, Macadamia Ternifolia oil, Simmondsia chinensis oil and Helianthus Annuus oil.

5. The topical composition according to Claim 1, wherein the composition also contains a plant extract phase.

6. The topical composition according to Claim 5, wherein the mentioned plant extract phase contains at least one skin care agent selected from Malva sylvestris extract, Calendula officinalis extract, Chamomilla Recutita extract and Anthemis nobilis extract.

7. The topical composition according to any one of the preceding claims, wherein it contains the following components:

8. The topical composition according to Claim 1, wherein the composition is provided in a form that is selected from the group that comprises ointment, pomade, soap, gel, emulsion, spray, shampoo, mousse, balm, lotion, cream and oil emulsion.

9. The topical composition according to Claim 8, wherein the composition is in oil emulsion form.

10. A method that contains the following steps for producing the topical composition according to Claim 4:

Providing a main emollient oil phase that contains at least one of Prunus amygdalus dulcis oil and Sesamum Indicum oil,

Providing an adjuvant emollient oil phase that contains at least one oil selected from the group that comprises Macadamia Ternifolia oil, Simmondsia chinensis (Jojoba) oil and Helianthus Annuus oil,

mixing the mentioned oil phases while heating,

cooling the mixture and obtaining the final product

11. A method that contains the following steps for producing the topical composition according to Claim 7:

Mixing the ingredients according to the order provided below:

l. Prunus amygdalus dulcis oil

m. Macadamia Ternifolia oil

n. Simmondsia chinensis (Jojoba] oil

o. Malva sylvestris extract

p. Chamomilla Recutita flower extract

q. Calendula officinalis flower extract

r. Tocopheryl acetate

s. Perfume

t. Sesamum Indicum oil u. Anthemis nobilis oil v. Melissa Officinalis leaf oil