AU2009222500A1 - A green emulsifying system for cosmetic and/or pharmaceutical emulsion composition - Google Patents

Description

Editorial Note Application No. 2009222500 Description There are 23 pages of description BACKGROUND OF THE INVENTION Emulsification is the process of preparing emulsions which are heterogeneous systems consisting of at least one immiscible liquid intimately dispersed in another. An emulsion consists, then, of a dispersed phase (internal phase), a discontinuous medium (external phase, continuous phase) and a third component known as an emulsifier/stabiliser system. Oil in water emulsions are miscible with water, are water washable, will absorb water and are generally non greasy. Oil in water emulsions are used for many cosmetics and pharmaceuticals creams, lotions and serums. The type of emulsion can be determined by some simple tests including the drop dilution test, dye solubility test, electrical conductivity test and the filter paper test. The design of a cosmetic or pharmaceutical oil-in -water emulsion is quite complex and often requires several iterations to produce a stable, efficacious, safe, cost effective and elegant product. Emulsions do not form spontaneously when liquids are mixed, but rather require emulsifying agents and energy. This energy input can be in the form of mechanical agitation and heat. The strongest mixing and homogenization will not be sufficient to maintain an emulsion of unlike materials (e.g. oil and water) as a single homogenous mass. Stable emulsions are formed by the incorporation of emulsifying and stabilising agents. Emulsifier / stabiliser system can be constructed with: 1. Surface Active Agents (Surfactants) 2. Consistency factors 3. Hydrophilic Colloids 4. Synthetic polymers Surfactants tend to migrate and align themselves at the contact surfaces between unlike phases acting as a buffer or go between, this prevents separation of the unlike materials. A hydrophilic colloid and /or a synthetic polymer form multi-molecular films about dispersed particles and work as a stabiliser by increasing viscosity of the aqueous continuous phase. In addition, stabilizers attract water molecules and reduce their activity in the aqueous phase as a result interfacial tension is lowered and lead to increased emulsion. Surfactants are classified as cationic, anionic, amphoteric and non-ionic based on the type of polar group on the surfactant. Cationic and anionic surfactants have electrical charge in water while non-ionic surfactants do not have an overall electrical charge. Amphoteric may have positive or negative charges depending on the pH of the solution. HLB stands for hydrophile-lipophile balance and is an empirically calculated constant. An emulsifier (surface active agent) consists of molecules with a hydropohile end, which is polar of ionic or non-ionic nature and a lipophile end which is a hydrocarbon chain of certain length. Hydrophobic or lipophilic groups may be large, straight or branched chain hydrocarbons, cyclic hydrocarbons, aromatic hydrocarbons and or combinations of them. HLB describes the balance between the solubility properties of hydrophile end in the polar solvent, usually water, and the lipophile end in the non-polar solvent for example oil. When HLB is less than 10, the lipophilic property is stronger. When the HLB is greater than 10, the hydrophilic property is stronger. An HLB of 8 to 18 can form oil in water emulsion, an HLB of 13 to 15 increases the washability function, and an HLB of 15 to 18 possess a solubilising function. A brief knowledge is necessary about widely used ethoxylated emulsifiers/solubilises and their properties to evaluate their Potential impact. Ethoxylation is a chemical process in which ethylene oxide (IUPAC name: 1, 2-epoxyethane) is added to fatty acids/fatty alcohols in order to make them more soluble in water. An example is the ethoxylation of sodium dodecyl sulfate to form sodium laureth sulfate, which is used as a foaming agent in shampoos and toothpastes, and as an industrial detergent. Ethylene oxide is produced by reacting ethylene with oxygen in the presence of a silver catalyst. Ethylene oxide is a known carcinogen and highly reactive chemical, an intermediate in the production of a wide range of derivative chemicals, which have applications in a huge number of industrial and consumer products. In an industrial ethoxylation plant, the raw material is preheated and fed to a stainless steel chemical reactor, where it is mixed with ethylene oxide and potassium hydroxide (KOH), which acts as the catalyst. The reactor is pressurised with nitrogen to 5 bars and heated to 150 0 C. Many types of "substrate" chemicals may undergo ethoxylation: for example, alcohols, fatty acids, amines and phenols. Why are ethoxylated fatty materials soluble in water? The answer is hydrogen bonding between the epoxide oxygen of ethylene oxide, and the hydrogen of water. Many have observed the reverse cloud point seen with ethoxylated materials. It is well known that as temperature is increased, ethoxylated surfactants become less water-soluble. This somewhat surprising observation is easily explained by considering that, as the temperature increases, the molecules exhibit more movement/energy. Thus, hydrogen bonding is inhibited; the ethoxylate loses its water solubility, and cloudiness results Ethylene Oxide Derivatives . Fatty Alcohol Ethoxylate * Fatty Acid Ethoxylate * Fatty Amines Ethoxylate * Alkyl Phenol Ethoxylate * Castor Oil Ethoxylates * Hydrogenated Castor Oil Ethoxylates * Glycerine Ethoxylates * Polyethylene Glycols * Silicon Oil Emulsifier . Amino Oil Emulsifier * Paraffin Wax Emulsifier . Non-Ionic Self Emulsifying Wax . Esterification Unless manufactured under a low pressure environment (vacuum stripping), small amounts of potentially carcinogenic 1, 4-Dioxane is produced in the process of conversion. So, there is a need for an emulsifier/stabilizer combination where there would be no inclusion of ethoxylated emulsifiers in order to obtain stable emulsions. Accordingly, the problem addressed by the present invention is to provide such an emulsifier/stabilizer combination to produce dermo-cosmetic products without using ethoxylated materials. Hydrocolloids are used in creams and lotions to stabilize and add to rheological properties of the emulsion. Water soluble gums or hydrocolloids consist of various types of naturally occurring plant polysaccharides or high molecular weight carbohydrates. Types of water soluble gums and natural hydrocolloids: * Acacia Gum * Karaya Gum * Tragacanth Gum * Guar Gum * Locust bean Gum * Carrageen Gum * Agar agar * Alginate . Xanthan Gum * Pectin * Inulin * Konjac Mannan * Sclerotium Gum Synthetic polymers like carbomer, pre-neutralized cross linked sodium acrylates copolymer, sulfonic acid polymer are predominantly high molecular weight acrylic acid polymers. Polyvinylpyrolidone or polymers of ethylene oxide and propylene oxide are also used in cosmetics for adjusting rheology and viscosity of the products. Most widely used synthetic polymer is Carbomer. Carbomer is a generic name for synthetic polymers of acrylic acid used as emulsion stabilizers or thickening agents in pharmaceuticals and cosmetic products. They may be homopolymers of acrylic acid, cross linked with an allyl ether pentaerythritol, allyl ether of sucrose, or allyl ether of propylene. Carbopol polymers have very good water sorption property. They swell in water up to 1000 times their original volume and 10 times their original diameter to form a gel when exposed to a pH environment above 4.0 to 6.0. Because the pKa of these polymers is around 6.0, the carboxylate moiety on the polymer backbone ionizes, resulting in repulsion between the native charges, which adds to the swelling of the polymer. Acrylic acid is used widely for polymerization, including production of polyacrylates. Because of water solubility and vapor pressure, most (about 90%) acrylic acid released to the environment is expected to end up in water. The chemical can be removed from the atmosphere in rain. If released to soil the chemical leaches into groundwater or surface waters. Leaching into ground or surface waters is the major route of removal of acrylic acid from soils due to the chemical's high water solubility and low vapor pressure. Acrylic acid exists in the atmosphere in the gas phase. The dominant atmospheric loss process for acrylic acid is by reaction with the hydroxyl radical. Based on this reaction, the atmospheric life is only expected to be a few days. In the air acrylic acid reacts with ozone to produces glyoxylic acid and formic acid. Wet and dry deposition of gaseous acrylic acid may also be important. It is, therefore, an object of the present invention to provide a "Green", Gentle and Versatile Emulsifying System comprising natural bio degradable polymers for the water phase for preparing oil in water emulsions, which are eco-friendly, non-sticky and non-greasy. It is also an object of the invention to provide a "Green" solution to thicken and stabilize variety of emulsions with a wide range of active ingredients and to deliver beneficial effects of the products. SUMMARY QF THE INVENTION: World consumers are nowadays more focused on their health and appearance. This trend is creating heightened demand for products formulated with natural and nutraceuticall ingredients. The present invention provides safe, effective, aesthetically appealing and stable oil in water emulsions for cosmetic and pharmaceutical products such as creams, lotions, serums and milks. "The invention is an emulsifying system comprising an oil-in-water emulsion containing 0.1 to 1 % by weight of the emulsion, a combination of Sclerotium gum and Konjac glucomannan in the water phase; the emulsion further comprising: 1.20 to 7.00% by weight of the emulsion, a combination of vegetable based anionic and non-ionic oil-in-water emulsifiers selected from the group consisting of Sodium Stearoyl Lactylate and Glyceryl Stearate Citrate, Polyglyceryl-3 Stearate and Polyglyceryl-3 Palmitate; the emulsion further comprising: 0.3%-3.5% by weight of the emulsion, low HLB emulsifiers selected from the group consisting of Glyceryl Monostearate, Glyceryl Laurate, Sorbitan Stearate and Glyceryl Oleate and; the emulsion further comprising: 0.3 to 3% by weight of the emulsion a fatty alcohol and/or fatty acid as consistency factor in the oil phase. The present invention also describes the process of emulsification via emulsion phase inversion to achieve finely dispersed droplets. The final emulsion is suitable for general skincare and dermatological products". Description of the Invention: The present emulsifying system is made with naturally derived ingredients, which are non-hazardous to human health and the environment. The system is completely free of ethoxylated emulsifiers and synthetic polymers. The system is extremely mild and possesses a unique affinity for skin, which is not available with ethoxylated emulsifiers, acrylic acid and other synthetic polymers. The present invention comprises emulsifiers that are natural and functional, and that can deliver both aesthetic and skincare benefits to the formulations. The emulsifiers in the present invention are all food grade emulsifiers derived from vegetable oils, combined with polar groups such as citric and lactic acid to improve skin elasticity and firmness with lactates and citrates. The Natural Moisturising Factor releasing emulsifiers Glyceryl Stearate Citrate and Sodium Stearoyl Lactylate can improve skin elasticity and firmness without irritant effects. They are anionic surfactants at intermediate to high pH values and are preferably combined with non ionic emulsifiers to enhance the liquid crystal forming capacity of the system. Stearoyl lactylates are good moisturisers and also known for enhancing lipid synthesis in the skin and promoting skin health. The emulsifying system may consist of the following emulsifiers and consistency factors in the oil phase: * Citric Acid Ester of Fatty Acids (Palmitic and Stearic acid) HLB 10 12. INCI: Glyceryl Stearate Citrate; * Sodium salt of stearic acid ester of lactyl lactate. HLB 15-17. INCI: Sodium Stearoyl Lactylate; * Polyglycerol ester of edible fatty acids. HLB 8-10. INCI Polyglyceryl-3 Stearate; and/or Polyglyceryl-2 Palmitate; * Glycerol ester of stearic acid with high purity that contains no soaps. INCI: Glyceryl Monostearte HLB 3.8-4; and/or Glycerol ester of lauric acid. INCI: Glyceryl Laurate; and/or Sorbitol ester of stearic acid. INCI: Sorbitan Stearate; and/or Glycerol ester of oleic acid. INCI: Glyceryl Oleate ;or a mixture of the above; and " C-18 fatty alcohol derived from palm oil as a consistency factor in the oil phase. INCI: Stearyl Alcohol; and/or C-16 fatty alcohol INCI: Cetyl Alcohol, and/or a combination of C-16 and C-18 fatty alcohols. INCI: Cetearyl Alcohol. " Stearic acid, Palmitic acid and Coconut fatty acids derived from palm oil, coconut oil or other vegetable sources, can be used as consistency factors in the oil phase of the present invention. The emulsifying system consists of following natural thickeners and stabilizers in the water phase: * Sclerotium Gum * Konjac Glucomannan OIL PHASE: The present invention contains oil phase emulsifiers and consistency factors, which comprise from about 2 % to 1 0% by weight of the total composition. Preferably from about 2.2% to about 5% by weight of the total composition for producing lotions and serums, and from about 6% to about 8.5% by weight of the total composition for producing creams. Polar and non-polar oils, vegetable and plant oils, mineral oils, fatty acids, fatty alcohols, esters and waxes can be easily emulsified by using the present invention. The total oil phase, including components of emulsifying system, and other ingredients constitute from 5% to 4 0% by weight of the total oil in water emulsion. Glyceryl Stearate Citrate is an anionic emulsifier. It is a partially neutralised citric acid ester of mono/diglycerides, making it dispersible in water and suitable for cold processing applications. It releases citric acid by hydrolysis on skin contact, supplementing the Natural Moisturising Factor (NMF). Citric acid esters such as Glyceryl Stearate Citrate have skin firming and smoothing properties. The released citric acid also stabilises the skin pH value by the buffering action of citrates. Glyceryl Stearate Citrate is capable of forming liquid crystals if combined with non-ionic emulsifiers such as mono/diglycerides, and polyglycerol esters. Glyceryl Stearate Citrate comprises from about 0.5% to about 3% by weight of the total composition, preferably from about 0.5% to about 1.

7 5% by weight of total composition for lotions and serums and from about 1% to 2.7% by weight of total composition for creams. Sodium Stearoyl Lactylate is also an anion emulsifier, which is a mixture of sodium salts of stearoyl lactylic acid and minor proportions of other salts of related acids, formed by the esterification of stearic acid with lactic acid and neutralized to the sodium salts. It improves the skin feel and functionality of creams and lotions developed for intensive skin care. It releases lactic acid by hydrolysis on skin contact, contributing to the Natural Moisturising Factor (NMF), one of the essential mechanisms for skin moisturisation. Being part of the NMF, lactic acid and lactates are also important contributors to skin pH stabilisation. Sodium Stearoyl Lactylate is an anionic emulsifier with good skin tolerability, showing no irritation or sensitization. Sodium Stearoyl Lactylate derives its efficiency as emulsion stabiliser from its ability to stabilise liquid crystalline phases formed with non-ionic surfactants. Such liquid crystalline phases also contribute to moisture retention, lubricity and generally improves skin feel in emulsion based skin care products. Sodium Stearoyl Lactylate comprises from about 0.5% to about 3% by weight of the total composition, preferably from about 0.5% to about 1.75% by weight of total composition for lotions and serums, and from about 1% to 2.7% by weight of total composition for creams. Polyglyceryl-3 Stearate and/or Polyglyceryl-2 Palmitate are non ionic oil-in water emulsifiers. Polyglycerol esters of edible fatty acids offer a class of substances which on the basis of their manufacturing process provide a huge variety of different molecular species and properties. Each product formed in this process is a mixture of different sized and shaped molecules. Depending on the composition of the oil phase, a formulator can pick from this selection of polyglycerol esters, which ones are most appropriate to effectively reduce the interfacial tension. In addition these products are based on natural raw materials and are toxicologically safe. In contrast to PEG-derivatives the polyglyceryl esters are: " Vegetable based " UV stable * Readily biodegradable * Free from potential toxic impurities By choosing the polymerization grade of the glycerol chain, the appropriate fatty acid and the degree of esterification, the average HLBvalues of the polyglyceryl ester can be manipulated, and the emulsifying properties of the compound can be adjusted precisely to the demands of formulation. Polyglyceryl-3 Stearate and/or Polyglyceryl-3 Palmitate comprises from about 0.1% to about 3% by weight of the total composition, preferably from about 0.1 % to about 1.75% by weight of total composition for lotions and serums, and from about 0.

3 % to 2

.

7 % by weight of total composition for creams. Glyceryl Monostearate is a high purity distilled monoglyceride based on vegetable sources with minimum 90% monoglyceride. It can be used as a co-surfactant with other more hydrophilic emulsifiers. If combined with anionic surfactants, it readily forms liquid crystalline phases that act as emulsion stabilisers, moisturisers and lubricious in cosmetic formulations. Due to its high monoglyceride content, it can be added at lower concentrations and will give a stronger emulsifying action compared to less concentrated products. Glyceryl Monostearate comprises from about 0.5% to about 4% by weight of the total composition, preferably from about 0.3% to about 2 % by weight of total composition for lotions and serums, and from about 0.3% to 3% by weight of total composition for creams. Glyceryl Laurate, Sorbitan Stearate and Glyceryl Oleate or a blend of the above can also be used as a low HLB vegetable based emulsifier for the present invention. Stearyl Alcohol is a fatty alcohol. Fatty alcohols are aliphatic alcohols derived from natural fats and oils, originating in plants, but also synthesized in animals and algae. Fatty alcohols usually have even number of carbon atoms. Production from fatty acids yields normal-chain alcohols-the alcohol group (-OH) attaches to the terminal carbon. Fatty acids are produced from oils and fats by the well-known fat splitting process. The fatty acids are divided into a cut to be marketed and a cut for producing fatty alcohol. The short chain fraction as well as the C16/18 fraction can be economically separated as fatty acid, or can be hydrogenated to fatty alcohols. In this route, only the fatty acid fraction desired as fatty alcohol is fed to the wax ester process. The process to produce the fatty alcohol in a fixed bed reactor covers the preparation of methyl ester or wax ester and the subsequent hydrogenation of the ester to form fatty alcohol. In the fatty alcohol fractionation and distillation stages, distilled fatty alcohols are obtained as final products. Depending on product requirements, a carbonyl conversion may be added to attain an extremely low carbonyl level. The final products may be defined cuts such as C6/10, C12/14, C16/18 or C12/18, or pure individual cuts like C12, C14, C16, and C18. Stearyl Alcohol is C18 fatty alcohol. Stearyl Alcohol comprises from about 0.3% to about 3% by weight of the total composition; preferably from about 0.3% to about 2% by weight of total composition for lotions and serums, and from about 0.3% to 3% by weight of total composition for creams. C-16 Cetyl alcohol or Cetearyl alcohol, which is a blend of C-16 and C-18 fatty alcohols can also be used as consistency factors for the present invention. AQUEOUS PHASE: The emulsions prepared by using the invention have aqueous phase, polysaccharides will be dispersed and completely dissolved in the hot water. Konjac polyglucomannan and Sclerotium gum are readily dispersible in hot water with temperatures between 60 degrees to 70 degree Celsius. The aqueous phase may also contain electrolytes selected from the group consisting of sodium chloride, potassium chloride, magnesium chloride, citric acid, lactic acid, ascorbic acid, ascorbic acid phosphate ester, salicylic acid, and humectants such as glycerol and glycols. The aqueous phase including components of emulsifying system and other ingredients constitute 60% to 95% by weight of the total oil-in water emulsion. Polysaccharides are produced universally by living organisms. They exhibit a large variety of complex chemical structures, physiological functions and a wide range of potential applications in various industrials areas as food engineering, biodegradable plastics, cosmetics, agronomy, fuel and others. So, these polymers are renewable resources which offer real and potential uses for man. Even though ~40 monosaccharides have been described, the majority of polysaccharides are formed from a limited range of sugars and more especially from hexoses and pentoses. These polysaccharides can be heteropolysaccharides, containing different monomers or homopolysaccharides constituted of a single sugar. The latter often contains D-glucose linked by either alpha or beta glycosidic bond in linear or branched backbone. Additionally various substituent such as acyl groups, amino acids or inorganic residues may be present in the side chain.

Sclerotium Gum, the present invention contains an active ingredient comprising natural polysaccharides, more preferably glucan polysaccharides, especially those having a three-dimensional structure of crosslinked triple helices, a preferable mean molecular weight of 1x106 to 12x10 6 , and containing in its structure p- 1,3 bonded glucopyranose units as the main chain and 0-1,6 bonded glucopyranose as the side chains. Scleroglucan is a general term used to designate a class of glucans of similar structure produced by fungi, especially those of the genus Sclerotium. The commercial product is termed Scleroglucan or Sclerotium Gum, but it is also known with other names according to the company that produces the polysaccharide (e.g., Amigel, Actigum, Clearogel Polytetran,Polytran FS, Sclerogum).Sclerotilum gum is a polymerized glucose. In nature, sclerotium gum is secreted for moisture retention by fungi (sclerotium rolfsii) growing on wood and root vegetables. This capsular O-D-glucan can be produced from a variety of fungi grown in media containing either glucose or sucrose as carbon sources and sodium nitrate and yeast as nitrogen sources. Scleroglucan, a neutral homopolysaccaride consisting of a linear chain of 0-d-(1-3) glucopyranosyl and f-d-(1-6)-glucopyranosyl groups, can be produced by pure culture fermentation from Sclerotium rolfsii MTCC 2156. Because of its peculiar rheological properties and its resistance to hydrolysis, temperature and electrolytes, Sclerotium gum has various industrial applications. * SG provides long-lasting hydration to the skin and helps maintain its barrier function. * It offers a very pleasant skin feeling. Sclerotium Gum comprises from about 0.1% to about 0.8% by weight of the total composition; preferably from about 0.1% to about 0.45% by weight of total composition for lotions and serums, and from about 0.2% to 0.

7 % by weight of total composition for creams. Konjac Polyglucomannan is a water soluble polyglucomannan which is derived from ground winnowed tubers of Amorphophallus Riveri. Amorphophallus is a large genus of some 170 tropical tuberous herbaceous plants from the Arum family (Araceae). These plants typically grow in tropical and subtropical zones. Sometimes called Konjac mannan, glucomannan is a water-soluble dietary fibre derived from konjac flour, which comes from the tubers of various species of Amorphophallus, a plant related to the common philodendron house plant. It has been used for thousands of years in China, where it is known as Moyu or Juruo, and in Japan, where it is known as Konnyaku or Shirataki. Konjac polyglucomannan products are widely used in Japan and China as general health aids, especially in cleansing toxins from the bowels; topically, for skin care; and as a thickening agent for foods, among other things. Glucomannan has demonstrated some usefulness in the management of obesity, diabetes and constipation, and has been shown to reduce cholesterol and discourage blood-sugar abnormalities such as hyperglycaemia.

Konjac polyglucomannan comprises from about 0.1% to about 0.8% by weight of the total composition; preferably from about 0.05% to about 0.

4 % by weight of total composition for lotions and serums, and from about 0.1% to 0.6% by weight of total composition for creams. When high molecular weight polysaccharides are hydrated in water, lumping problems may occur. It is suggested to set specifications for viscosity and particle size for the gum ingredient that will help reduce significant variations per lot and minimize processing problems. Konjac polyglucomannan and sclerotium gum are readily dispersible in hot water with temperatures between 60 degrees to 70 degrees Celsius. . The aqueous phase may also contain electrolytes selected from the group consisting of sodium chloride, potassium chloride, magnesium chloride, citric acid, lactic acid, ascorbic acid, ascorbic acid phosphate ester, salicylic acid, and humectants such as glycerol and glycols. The combination of Sclerotium gum and konjac mannan as thickener and emulsion stabilizer is particularly advantageous and provides rheology modification with added moistiurisation. A ratio of Sclerotium gum to Konjac polyglucomannan, from about 1: 8 to about 8:1, with more desirable results obtained in the range about 1:6 to about 6:1. The use of polysaccharide combination even at a very low concentrations e.g. as low as 0.2% by weight of the emulsion can provide adequate emulsion stability. However, higher amounts of polysaccharide combination will provide better thickening and more viscosity for the emulsion. The emulsion made and stabilized using the invention can have exceptionally high stability even at elevated temperatures up to about 51 degree Celsius. However, Sclerotoium gum and Konjac mannan combinations are sensitive to high % of ionic materials, alcohol and salts. Low viscosity milky lotions and high viscosity creamy emulsions can be made by varying the concentration of oil phase and or water phase constituents of the emulsifying system. The emulsifying system forms an extensive lamellar liquid crystal structure in 'oil in water' emulsion due to oil phase constituents and self bodying action of fatty alcohol. Liquid crystals are highly anisotropic fluids that exist as a result of long-range orientational ordering among constituent molecules, these structures suspends oil droplets resulting in extremely efficient product stabilization. The gelification of water phase with Sclerotium gum and Konjac glucomannan is achieved and heat stable thixotropic gels are made with good yield value. 100% water soluble Konjac Glucomannan presents a unique viscosity profile and ease of use if the pH is kept between 5 and 7.5. Oil phase constituents of the emulsifying system are able to form a reticular organised structure in liquid crystal form thus eliminating the need to use waxy components in large quantities that are no longer in harmony with modern demand of light and easy to spread emulsions Virtually all types of cosmetic and pharmaceutical skin care oil in water emulsions can be made and stabilized by the present invention. From both the dermatological and cosmetic points of view natural vegetable polar oils are better emollients than mineral or paraffin oils. However, pure natural polar oils are not easily emulsified. The present invention of natural emulsifying system offers versatility of use and suitability for wide range of emollients including polar and non-polar oils. The following table shows polarity index for commonly used emollients: Polarity Substance Value Non-Polar Squalane, C12-14 Isoparaffin, Paraffinum liquidium Polar Ceterayl Octanoate, 30-25 Olea Europa (Unsaponifiables), Dimethicone, Isopropyl Myristate, Isopropyl Palmitate, Octyl Dodecanol Polar Octal Palmitate, 25-20 Caprylic-Capric Triglyceride, Buxus Chinensis Oil, Prunas Dulces Oil Polar Helianthus Annus Oil, 20-15 Decyl Oleate, Octyl Stearate, Olea Europea Oil Polar Cannabis Sativa Oil, 15-10 Ricinus Communis Oil, Octyldodecyl Lactate, Triticum Vulgare N.B. Consider the index of polarity as the value of the surface tension in comparison with water (73 dynes per cm). Processing Method &Guidelines: The emulsifying system and method presents one of the best ways to deliver active ingredients and botanical substances without much heating of oil phase and water phase. Inverse emulsification method is adopted i.e. adding the hot water phase55- 60 degree C to the hot oil phase 55-60 degree C with stirring, followed by intensive homogenization by commonly used rotor stator type mixer for the production of oil in water emulsion. It is necessary that the formulations using Emulsifying system be homogenized either during the emulsification process or at the beginning of the cool down phase of the manufacturing. It is advisable to form emulsions at lower processing temperatures (not higher than 60 degree C) thus allowing for less heat expenditure and faster processing.

The present invention presents an energy efficient processing method. For the present invention, a rotor/stator type mixer in the oil phase tank, and a disperser-disk type impeller or an agitator with the capacity to disperse each particle of solid and break agglomerates, is used in the water phase tank. When using Rotor/ stator, tank circulation and turn over is critical. The rotor/stator must be capable of circulating the entire batch at high frequency through the shearing zone. This will provide uniform mixing, particle size reduction and also uniform temperature throughout the batch. The rotor/stator mixer must generate very high flow rate in addition to high shear rate, this will result in substantially more throughput of material through the mixing head. A rotor/stator with an increased height to diameter ratio will provide both high suction and pumping capability, which will increase mixing efficiency Where a very high degree of homogenization and a further particle size reduction is required, an In-Line Mixer and recirculation of the batch is recommended. The batch is drawn from the bottom of the vessel, processed through the high-shear rotor/stator work-head and passed back into the top of the vessel. In small vessels this will ensure adequate in tank movement but in large vessels an auxiliary in-tank mixer will be required. Generally, the preparation of emulsions with droplet size reduction is performed mechanically, which involves high-energy input that is generally achieved by high-shear stirring and high-pressure homogenizers. The high-energy input leads to deforming forces that are able to break the droplets into smaller ones, provided the Laplace pressure is overcome. Additionally, an increase of the surfactant content at the interface reduces the Laplace pressure. Therefore, the smaller the droplet size, the more energy and/or surfactant is required, making this preparation route unfavourable for general industrial applications. The present invention also describes a process for preparing o/w emulsions with very fine droplets and good storage stability. The droplet size distribution of an emulsion governs emulsion properties such as long term stability, texture and optical appearance. Finely dispersed emulsion droplets do not undergo sedimentation or creaming because these processes are prevented by the Brownian motion of such small droplets. A common process for the preparation of such shining emulsions is the phase inversion temperature (PIT) method. The PIT method makes use of the low interfacial tension that is obtained in the region of phase inversion from a water-in-oil (w/o) to an oil-in-water (o/w) emulsion upon cooling. This low interfacial tension in the phase inversion region allows the spontaneous formation of finely dispersed shiny o/w emulsions (PIT emulsions). We heat both the phases to 65 degree C, and add the water phase to the oil phase at the temperature below 60 degree C, because at higher temperatures the hydrogen bonding is not found. Thus, emulsifiers that normally, at room temperature have high HLB, at high temperatures have low HLB. They want to form a water-in-oil (w/o) emulsion and, in fact, do. As the emulsion cools, the hydrogen bonding and the HLB of the emulsifier increase. There is a temperature, the PIT, at which the emulsion is now inverted from w/o to o/w, as this happens, the particle size decreases and the distribution of particles narrows. Both conditions make for a good emulsion. The PIT for the present invention using anionic emulsifiers is 45 degree Celsius to 50 degree Celsius. It is understood that if the PIT is at least 20C above the typical storage temperature (25C), then we can be quite confident that the emulsion will exhibit excellent stability. Using PIT: Suppose an emulsion has a PIT of 45 degree C, and you would like to raise it to at least 50 degree C. Alter the ratio or the concentration of the emulsifiers and change emollients to see the effect on the PIT and, thus, the particle size and final stability. The emulsifiers will continue to orient towards forming w/o emulsions (low HLB) at increased temperatures above 60 degree C. An increag by % weight of an anionic emulsifier for one of the non-ionics will make PIT dramatically rise. A critical surfactant concentration is necessary for emulsification via the emulsion phase inversion method. While low interfacial tension might facilitate the droplet formation, the resulting droplet size distribution mainly depends on the surfactant-to-oil ratio, suggesting that the size of the droplets is governed by the lamellar structure formed at the inversion point. In order to illustrate the mechanisms involved in this low energy emulsification process, the steps of very fine droplet formation by phase inversion are given in the following. As the water phase is poured into the oil phase, the system starts as a W/O emulsion .Upon increasing the volume fraction of water, water droplets merge together and lamellar structures are formed, which, decompose into smaller oil droplets upon further increasing the water content. Further dilution with water does not change the droplet size at this stage of droplet formation. If the oil phase is added to the water phase, no such transition through lamellar structures occurs since a critical volume fraction of the oil phase cannot be reached. Example 1: Natural & Nourishing Day & Night Cream: PHASE A (Preservative Blend) INCI Name/ Weight % Chemical Name Naticide (Parfum) .7 Benzoic Acid .2 Butylene Glycol 6.5 PHASE B Delonised Water 0/ PHASE C Green Tea Ext. 65% .2 EGCG Gingko Biloba Ext .2 Panthenol 2 PHASE D Konjac Glucomannan .2 Sclerotium Gum .5 PHASE E Glyceryl Monostearate 3 Stearyl Alcohol 2 Glyceryl Stearate 1 Citrate Sodium Stearoyl 1.5 Lactylate Polyglycereyl-3 .5 Stearate Shea Unsaponifiable 2 Rosemary Ext .15 PHASE F Macadamia ternifolia 5 Prunus Dulcis 5 Prunus Armeniaca 5 Persea Gratissima 5 Tocopherol .1 Procedure: 1. Heat & melt phase A to 60 degree C until completely uniform. 2. Add phase B to A whilst heating and stirring. 3. Add ingredients of phase C to (B + A) at 65 degree C. 4. Add phase D to (A+B+C) at 65 degree C, while stirring. Thoroughly mix by using a deflocculating type propeller mixer. 5. Combine phase E in a suitable container and heat to 65 degree C. 6. Add phase F to E and keep (E+F) heated to 60C. 7. Add (A+B+C+D) at 55 degree C to premixed (E+F) at 60 degree C. Homogenize by using a rotor-stator type mixer at 2500-3500 rpm until uniform. 8. Fragrance can be added below 40C. Cool to desired fill temperature. Results & Discussion: The inversion behaviour is not at all typical of cosmetic emulsions without ethoxylated emulsifiers, but occurs so perfectly with the use of the present invention. The resultant emulsion is shiny in appearance and has a liquid crystal structure where the multi layered micelles tend to create a lamellar structure, which act as a stabilizer of the emulsion by limiting fluctuation of the components between phases. The emulsion has an elegant feel, and pleasant to apply and leaves the skin smooth. The pH of the emulsion is 5.5, which is very close to natural pH value of human skin. Most of the synthetic and natural polymers due to their high molecular weight tend to exhibit a whitish-drag when applied on the skin but the emulsifying system with the added benefit of moisturisation and yield value does not leave any whitish-drag when applied. Example 2: O1W Lotion Phase A INCI Name/ Chemical Weight % Name Naticide (Parfum) .6 Sodium .2 Dehydroacetate 1,3 Butylene Glycol 6 Phase B water 0/0 Phase C Green Tea Ext .2 Gingko Biloba Ext .2 Panthenol 15 Glycerol 1.5 Phase D Konjac Glucomann .1 (Amorphophallus River) Sclerotium Gum .35 Phase E Glyceryl Stearate .8 Glyeeryl Stearate 1 Citrate Sodium Stearoyl 1.5 Lactylate Stearyl Alcohol .7 Polyglyceryl-3 Stearate .4 Caprylic/Capric 3 Triglyceride Dimethicone 2 Olive Squalane 3 Shea Unsaponifiable 1.5 Phase F Oenothera biennis 2 (Evening Primrose Oil) Corylus avellana 2 (hazelnut oil) Tocopherol .05 Rosemary Ext .05 Procedure: 1. Heat & melt phase A to 60 degree C until completely uniform. 2. Add phase B to A whilst heating and stirring. 3. Add phase C ingredients to (B + A) and heat to 65 degree C. 4. Add phase D to (A+B+C) at 65 degree C with stirring. Thoroughly mix by using a deflocculating type propeller mixer. 5. Combine phase E in a suitable container and heat to 65C. 6. Add phase F to E and keep it (E+ F) heated to 60C. 7. Add (A+B+C+D) to premixed (E+F). Homogenize by using a rotor stator type mixer at 2500-3500 rpm until uniform. 8. Fragrance can be added below 40C. Cool to desired fill temperature. Results & Discussion: A fine milky emulsion is obtained, which is very shiny in appearance and beautiful to apply. The milky lotion has additional moisturising properties due to the components of the emulsifying system. As it can be seen from the example 2 that the emulsifying system is suitable with non-polar silicone fluid and squalane. The choice of emollients has a crucial influence on the development of emulsions. Key selection criteria are spreading properties, skin-feel and polarity of the emollients. The invention can be used to make oil in water emulsion with many types of oils, fatty esters and waxes. Example 3: Sunscreen Lotion: Phase A INCI Name / Chemical Weight % Name Phenoxyethanol .6 Dehydroacetic Acid .25 1,3 Butylene Glycol 6.5 Phase B water 0/0 Phase C Green tea Ext 4 Aloe Barbadensis .2 Panthenol 2.2 Phase D Konjac Glucomannan .2 Sclerotium Gum 4 Phase E Glyceryl Stearate 2 Glyceryl Stearate 1.2 Citrate Sodium Stearoyl 1.2 Lactylate Polyglyceryl-3 Stearate 1.1 Stearyl Alcohol 1.1 Ethylhexyl 5 (Sunscreen filter) Methoxycinnamate Zinc Oxide & 4(Sunscreen Block) triethoxycapryl silane Benzophenone 3 4 (UV filter) Rice Bran Oil 4 Kukui Nut Oil 4 Tocopherol Acetate .2 Jojoba oil 5 Procedure: 1. Heat & melt phase A to 60 degree C until completely uniform. 2. Add phase B to A whilst heating and stirring. 3. Add phase C ingredients to B + A, and heat to 65 degree C. 4. Add phase D to (A+B+C) at 65 degree C, while stirring. Thoroughly mix by using a deflocculating type propeller mixer. 5. Combine phase E in a suitable container and heat to 65C and keep it heated. 6. Add A+B+C+D to premixed and heated E. Homogenize by using a rotor-stator type mixer at 2500-3500 rpm until uniform. 7. Fragrance can be added below 40C. Cool to desired fill temperature. Example 4: Hand & Body Cream Phase A INCI Name/ Chemical Weight % Name Benzoic Acid .2 Naticide (Parfum) .7 1,3 Butylene Glycol 16 Phase B water% Phase C Aloe barbadensis .3 (Konjac .4 Gluccomannan) Sclerotium Gum .2 Phase D Glyceryl Stearate 3 Glyceryl Steareate 2 Citrate Sodium Stearoyl .8 Lactylate Polyglyceryl-3 Stearate .4 Stearyl Alcohol 1.8 Elaeis guineensis (palm 10 oil) Vitis Vinifera 10 (grapeseed oil) Rosemary Ext .1 Procedure: 1. Heat & melt phase A to 60 degree C until completely uniform. 2. Add phase B to A whilst heating and stirring, keep it heated to 65 degree C 3. Add components of phase C to A+B while stirring. Thoroughly mix by using a deflocculating type propeller mixer. 4. Combine phase D in a suitable container and heat to 65C. 5. Add (A+B+C) at 55 degree Celsius to D at 60 degree C. Homogenize by using a rotor-stator type mixer at 2500-3500 rpm until uniform. 6. Fragrance can be added below 40C. Cool to desired fill temperature. Example 5: Intensive Moisturising serum INCI Name/ Chemical Weight % Name Phase A Water 0/0 Phase B Sucrose, Serine, 4 Arginine, PCA, Alanine, Theronine and Mouera Fluviatilis Extract Panthenol 3 Glycerol 2.3 Phase C Konjac Glucomannan E.05 Sclerotium Gum .18 Phase D Glyceryl Stearate .5 Glyceryl Stearate .8 Citrate Sodium Stearoyl .9 Lactylate Polyglyceryl-3 Stearate .3 Stearyl Alcohol .5 Sweet Almond Oil 4 Rice Bran Oil 4 Kukui Nut Oil 2 Tocopherol Acetate .2 Jojoba oil 5 Rosemary Ext .15 Phase E Green tea Ext 14 Organic Rooibos Ext. powder .2 Phase F Preservative system .5%-1.5% Procedure: 1. Heat phase A to 65 degree C. 2. Add phase B to A whilst heating and stirring. 3. Add phase C to (A+B) at 65 degree C with stirring. Thoroughly mix by using a deflocculating type propeller mixer. 4. Combine phase D in a suitable container and heat to 65C and keep it heated. 6. Add (A+B+C) at 55 degree C to premixed and heated D at 60 degree C. Homogenize by using a rotor-stator type mixer at 2500 3500 rpm until uniform. 7. Add Phase E to (A+B+ C+ D) below 50 degree C and mix. 8. When temperature is under 40 degree C, add phase F. Example 6: Fair Complexion Whitening Serum INCI Name/ Chemical Weight % Name Phase A water % Phase B Mannitol, Sodium 4 Gluconate, Citric Acid, Sodium Citrate, Waltheria Indica Leaf extract, Dextrin and Freulic Acid Sodium Lactate 3 Phase C IKonjac Glucomannan .05 Sclerotium Gum 15 Phase D Glyceryl Stearate .4 Glyceryl Stearate .6 Citrate Sodium Stearoyl .6 Lactylate Polyglyceryl-3 Stearate .3 Stearyl Alcohol .3 Rice Bran Oil 4 Caprylic/ Capric 4 Triglyceride Lecithin, Tocopherol, .5 Ascorbyl Palmiate, Hydrogenated Palm Glycerides Citrate Rosemary Ext .15 Phase E Glycerine and Moringa 3 Pterygosperma Extract Phase F Preservative system .5%-1.5% Procedure: 1. Heat phase A to 65 degree C. 2. Add phase B to A whilst stirring. 3. Add phase C to (A+B) at 65 degree C, while stirring. Thoroughly mix by using a deflocculating type propeller mixer. 4. Combine phase D in a suitable container and heat to 65C and keep it heated.

6. Add (A+B+C) at 55 degree C to premixed and heated D at 60 degree C. Homogenize by using a rotor-stator type mixer at 2500 rpm until uniform. 7. Add Phase E to (A+B+ C+ D) below 50 degree C and mix. 8. When temperature is under 40 degree C, add phase F. Example 7: Cream PHASE A (Preservative Blend) INCI Name/ % Chemical Name Naticide( Parum ) .7 Benzoic Acid .2 Butylene Glycol 6 PHASE B Deionised Water % PHASE C Green Tea Ext. 65% .2 EGCG Glycerol 2.5 Panthenol 2 PHASE D Sclerotium Gum .8 PHASE E Sorbitan Monostearate 2.5 Glyceryl Oleate .5 Cetaryl Alcohol 2 Glyceryl Stearte Citrate 1 Sodium Stearoyl 1.5 Lactylate Polyglycereyl-3 .5 Palmitate Shea Unsaponifiable 2 Rosemary Ext .15 PHASE F Macadamia ternifolia 5 Prunus Dulcis 5 Prunus Armeniaca 5 Persea Gratissima 5 Tocopherol .1 Procedure: 1. Heat & melt phase A to 60 degree C until completely uniform. 2. Add phase B to A whilst heating and stirring. 3. Add ingredients of phase C to (A + B) and heat to 65C. 4. Add phase D to (A+B+C) at 65 degree C with stirring. Thoroughly mix by using a deflocculating type propeller mixer. 5. Combine phase E in a suitable container and heat to 65C. 6. Add phase F to E and keep (E+F) heated to 60C.

7. Add (A+B+C+D) at 55 degree C to premixed (E+F) at 60 degree C. Homogenize by using a rotor-stator type mixer at 2500-3500 rpm until uniform. 8. Fragrance can be added below 40C. Cool to desired fill temperature. N.B. In the above formulation, a combination of Glyceryl Oleate and Sorbitan Stearate is used instead of Glyceryl monosteartae, Cetearyl Alcohol is used instead of Stearyl alcohol and Ployglyceryl-3 PalImitate is used instead of Polyglyceryl-3 Stearate. Results & Discussion: The emulsifying system can be incorporated into a wide range of personal care products and is flexible to be used in pharmaceutical emulsions for dermatological applications. Emulsifying system is compatible with various emollients, extracts, active ingredients and humectants to deliver cosmetic or therapeutic benefits of the final emulsion. When formulating with pigments, including inorganic sunscreens, it is recommended to disperse them in the oil phase with an appropriate hydrophobic dispersant. Furthermore, the emulsifying system possesses a predictable linear responsiveness of finished product viscosity with changing emulsifier concentrations, thereby taking much of the guess work and extensive trial and error out of product development efforts. In all emulsion gel networks, there is an optimum ratio of hydrocolloid gellant to oil phase emulsifier swellant. When desired viscosity (swelling) is achieved, the emulsifier blend is considered to be balanced. Some materials that can cause a change in viscosity and swelling are alcohols, acids, polyols and cations. Each of these materials may have the effect of reducing the viscosity and yield value of the system. Emulsion stability: Viscosity v/s Time - After the emulsion is made, we measured the original viscosity and periodically thereafter checked the emulsion to detect any large changes. We did not observe a deviation from the original viscosity in the first 6 months; this is a sign of a stable emulsion. Centrifuge - The emulsion was subjected to a gravitational force for several minutes to test the resistance for creaming and separation. Although this test artificially exerted gravitational force on the emulsion, it did not produce phase separation or creaming proving emulsion is stable. Heat storage test - the emulsion sample was stored at 45 degree C for four weeks. We did not observe any substantial increase in viscosity, and neither creaming was noticed. These emulsions are also stable to repeated freeze-thaw cycles.

Benefits of the "Green" Emulsifying system for cosmetic and/or pharmaceutical oil-in water emulsion: * Supports the lipid bilayer of skin found in the stratum corneum. * Good barrier and moisturisation function. * Suitable for sensitive skin. * Suitable for sunscreens. * A wide range of emollients can be emulsified. * A high or low oil phase can be formulated. * Excellent stability when pH is in the range of from 4.4 to 7. * Serves the need to formulate stable emulsions based on green chemistry.

Claims (19)

1. A "Green" emulsifying system for oil-in-water (O/W) emulsion comprising: A) a combination of vegetable based anionic and non-ionic emulsifiers and consistency factors in the oil phase, including anionic emulsifier Sodium Stearoyl Lactylate; B) a combination of a branched homo-polysaccharide and a glucomannan polysaccharide as thickener/stabilizer in the water phase; and C) an energy efficient process for making shiny oil-in-water emulsion by phase inversion emulsification.

2. The emulsion as claimed in claim 1, wherein oil phase comprises anionic and non-ionic emulsifiers that are selected from the group consisting of Sodium Stearoyl Lactylate, Glyceryl Stearate Citrate, Polyglyceryl-3 Stearate, Polyglyceryl-3 Palmitate, Glyceryl Monostearate, Glyceryl Laurate, Sorbitan Stearate, Glyceryl Oleate.

3. The emulsion as claimed in claim 1, wherein vegetable based emulsifiers comprises low HLB emulsifiers selected from the group consisting of Glyceryl Monostearate, Glyceryl Laurate, Sorbitan Stearate and Glyceryl Oleate,

4. The emulsion as claimed in claim 1, wherein the consistency factor comprises a fatty alcohol and/or a fatty acid selected from the group consisting of Stearyl Alchol, Cetyl Alchol, Cetearyl Alchol, Stearic acid, Palmitic Acid and Coconut Fatty Acids.

5. The emulsion as claimed in claim 2, wherein vegetable based emulsifiers comprises at least two emulsifiers selected from the group consisting of Sodium Stearoyl Lactylate, Glyceryl Stearate Citrate, Polyglyceryl-3 Stearate, and Polyglyceryl-3 Palmitate.

6. The emulsion as claimed in claim in 1, wherein natural thickener / stabilizer in the aqueous phase is a combination of a branched homo polysaccharide of d-glucose and a glucomannan polysaccharide derived from ground winnowed tubers of Amorphophallus River (Konjac).

7. The emulsion as claimed in claim 6, wherein the branched homopolysaccharide of d-glucose is Sclerotium Gum, and glucomannan polysaccharide is Konjac Polyglucomannan, and wherein the weight ratio of Sclerotium Gum to Konjac Polyglucomannan is from 6:1 to 1:6.

8. The emulsion as claimed in claim 7, wherein said polysaccharide combination of Sclerotium Gum and Konjac Polyglucomannan is present in an amount from 0.1% to 1% by weight of the emulsion.

9. The emulsion as claimed in claim 3, wherein the amount of the low HLB emulsifier is from 0.3% to 3.50% by weight of the emulsion.

10. The emulsion as claimed in claim 4, wherein the amount of consistency factor fatty alcohol, fatty acid, or a mixture thereof; is from 0.3% to 3% by weight of the emulsion.

11. The emulsion as claimed in claim 5, wherein the amount of medium to high HLB emulsifier combination is from 1. 2 0% to 7.00% by weight of the emulsion.

12. The method of making an emulsion as claimed in claim 1 by phase inverse emulsification comprising the steps of: (A) natural thickener/stabilizer Sclerotium Gum and Konjac Polyglucomannan are incorporated into the heated aqueous phase at 65 degree Celsius; (B) aqueous phase is subjected to high intensity mixing using a deflocculating type propeller mixer; and (C) the aqueous phase is then added into 60 degree Celsius hot oil phase with mixing until the system inverts to form an oil-in-water emulsion.

13. The method of making an emulsion as claimed in claim 12, wherein the emulsion is further homogenized either during the emulsification process or at the beginning of the cool down phase, using a rotor-stator type mixer at 2500-3500 rpm, until completely homogenous.

14. The emulsion as claimed in claim 1, wherein natural polysaccharide based thickener/stabilizer is a combination of a homo-polysaccharide of d glucose known as Sclerotium Gum and a glucomannan polysaccharide known as Konjac Polyglucomannan; and wherein the weight ratio of Sclerotium Gum to Konjac Polyglucomannan is from 6:1 to 1:6, and the combination is present in the aqueous phase in an amount from 0.1% to 1% by weight of the emulsion.

15. The emulsion as claimed in claim 1, wherein vegetable based emulsifiers comprises at least two emulsifiers selected from the group consisting of Sodium Stearoyl Lactylate, Glyceryl Stearate Citrate, Polyglyceryl-3 Stearate, and Polyglyceryl-3 Palmitate; and wherein the amount of said combination is from 1.20% to 7 .00% by weight of the emulsion.

16. The emulsion according to any one of claims 1 to 15, which is in the form of a cream.

17. The emulsion according to any one of claims 1 to 15, which is in the form of a lotion and/or a serum.

18. The emulsion according to any one of claims 1 to 15, which is in the form of an oil-in-water emulsion.

19. A cosmetic and/or a pharmaceutical emulsion composition according to any preceding claim.