DESC:TECHNICAL FIELD
The present disclosure relates to an oleo gel composition which provides a topical delivery system.

BACKGROUND
Hair and scalp care comprises three main functions – Hair growth, delay or stop greying and dandruff free scalp. The most common way to address these issues involves the topical application of active compounds. Traditionally these actives have been delivered in liquid, semisolid or injectable formulations.

Liquid and Semisolid formulations are available in various different forms, including tonic, ointments, creams, foams, gels, or lotions etc. But theses formats have significant limitations. For example, most liquid and semisolid formulations usually contain solvent(s), such as water and ethanol, which are volatile and thus evaporate shortly after application. The evaporation of such solvents can cause undesirable effects like a decrease or end of dermal delivery. Also, high amount of ethanol may cause skin itching.

WO2016055961A1 discloses a pharmaceutical formulation of minoxidil for topical use (gel or viscose solution), its use for the treatment of alopecia and relative kit for its preparation.

WO2009017767A2 discloses adhesive solidifying formulations containing minoxidil that can be used for treating neuropathies including diabetic neuropathy. The formulation can include an amount of minoxidil, a solvent vehicle, and a solidifying agent. The solvent vehicle can include a volatile solvent system including at least one volatile solvent, and a non-volatile solvent system including at least one non-volatile solvent capable of facilitating the delivery of the minoxidil at therapeutically effective rates over a sustained period of time. The volatile solvent system comprises ethanol, propanol, or a combination thereof. The formulation can have a viscosity suitable for application to a skin surface prior to evaporation of the volatile solvents system. When applied to the skin, the formulation can form a solidified layer after at least a portion of the volatile solvent system is evaporated.

JP2006199648A discloses a composition for hair comprising an anionic water-soluble polymer and a non-ionic water-soluble polymer. The hair composition of this document has a function of imparting firmness to the hair and having excellent usability and the like.

Considering the limitations of many of the current delivery systems for treating hair/scalp related issues, it would be desirable to provide systems, formulations, and/or methods that- i) can provide long term hydration; ii) are not susceptible to loss by solvent evaporation; iii) be applied to an area subject to stretching and expansion like skin/scalp without causing discomfort or poor contact with enhanced sensory; and/ or iv) be easily removed after application.

OBJECTIVES
The main objective of the present disclosure is to provide an oleo gel composition.

An objective of the present disclosure is to provide a stable composition incorporating actives.

Yet another objective of present disclosure is to provide topical delivery system using oleo gel composition.

SUMMARY
An aspect of present disclosure provides an oleo gel composition comprising:
(a) 10-60 wt% of mixture of glycerides;
(b) 1-25 wt% of polyols;
(c) 0.2-0.5 wt % of a thickener;
(d) 0.5-10 wt% of a surfactant; and
(e) 5 to 88.3 wt% of excipients.

These and other features, aspects, and advantages of the present subject matter will become better understood with reference to the following description. This summary is provided to introduce a selection of concepts in a simplified form. This summary is not intended to identify key features or essential features of the subject matter, nor is it intended to be used to limit the scope of the subject matter.

BRIEF DESCRIPTION OF DRAWINGS
The above and other features, aspects, and advantages of the subject matter will be better understood with regard to the following description and accompanying drawings where:
Fig. 1 shows a skin hydration vs. time graph.
Fig. 2 shows a comparative graph for % increase in the hydration level on day 10.

DETAILED DESCRIPTION
The present disclosure provides an oleo gel composition comprising:
(a) 10-60 wt% of mixture of glycerides;
(b) 1-25 wt% of polyols;
(c) 0.2-0.5 wt % of a thickener;
(d) 0.5-10 wt% of a surfactant; and
(e) 5 to 88.3 wt% of excipients.

In an embodiment of the present disclosure, the mixture of glycerides are selected from the group consisting of dicapricmonolaurin, dilauricmonocaprin, trilaurin, dilauricmonomyristin, dimyristicmonolaurin and monolaurin or a combination thereof.

Another embodiment of present disclosure provides that mixture of glycerides comprises 10-20 wt% dicapricmonolaurin, 15-25 wt% dilauricmonocaprin, 15-25 wt% trilaurin, 12-22 wt% dilauricmonomyristin, 5-15 wt% dimyristicmonolaurin and 1-10 wt% monolaurin.

In yet another embodiment of present disclosure, the oleo gel composition further comprises 0.001-1 wt% of an active agent selected from the group consisting of kopexil and minoxidil or a combination thereof.

Another embodiment of present disclosure provides that the polyols are selected from the group consisting of Glycerin, Polyethylene Glycol, Propylene Glycol, and Pentylene Glycol or a combination thereof.

In yet another embodiment of present disclosure, the thickener is a glycol phase thickener which is selected from the group consisting of Hydroxypropyl Guar, Hydroxyethyl Cellulose, and Hydroxypropyl cellulose or a combination thereof.

Further, an embodiment of present disclosure provides that the surfactant is an amphoteric surfactant. The amphoteric surfactants which can be used in the compositions of the present invention are those which can be broadly described as derivatives of aliphatic secondary and tertiary amines in which the aliphatic radical can be straight chain or branched and wherein one of the aliphatic substituents contains from about 8 to about 18 carbon atoms and one contains an anionic water solubilizing group, e.g., carboxy, sulfonate, sulfate, phosphate, or phosphonate. Examples of compounds falling within this definition are CDMA, sodium 3-dodecylaminopropionate, sodium 3-dodecylaminopropane sulfonate. Other amphoterics such as betaines are also useful in the present composition. Examples of betaines useful herein include the high alkyl betaines such as coco dimethyl carboxymethyl betaine, lauryl dimethyl carboxy-methyl betaine, lauryl dimethyl alpha-carboxyethyl betaine, cetyl dimethyl carboxymethyl betaine, lauryl bis-(2-hydroxyethyl)carboxy methyl betaine, stearyl bis-(2- hydroxypropyl)carboxymethyl betaine, oleyl dimethyl gamma-carboxypropyl betaine, lauryl bis-(2-hydro-xypropyl)alpha-carboxyethyl betaine, etc. The sulfobetaines may be represented by coco dimethyl sulfopropyl betaine, stearyl dimethyl sulfopropyl betaine, amido betaines, amidosulfobetaines, and the like. Preferably, the surfactant is alkyl (C10-C20) betain.

In another embodiment of the present disclosure, the excipients are selected from the group consisting of one or more emollient, antioxidants, vegetable oil, Palm kernel Oil, Mineral Oil, Isopropyl Myristate, and C16-C18 alkane. Furthermore, the excipients may include, but not limited to, plasticizers, polymers, binders, preservatives, color, fragrance (perfume), emotives, pH regulator, secondary emulsifier, electrolytes (salts), humectants, structurants, conditioners and solubilizers or combinations thereof. In preferred embodiment, the excipients are used in the range of 0.000001 to 99.99wt%.

In an embodiment of the present disclosure, the plasticizer is selected from group consisting of stearic acid, triglycerides; fatty acids, their esters and their alkanolamines, such as glyceryl monostearate, palmitic acid, lauric acid, and myristic or combinations thereof.

In another embodiment of the present disclosure, the polymers are used in the range of 0.01-99 wt% and are selected from the group consisting of silicone polymers; water soluble polymers such as polyurethanes, polyacrylates, polyalkylene glycol with molecular weight between 200 and 20,000, preferably between 400 and 10,000 such as PEG 200, PEG 400, PEG600, PEG 1500, PEG 4000, PEG 6000, PEG 8000 and the like; anionic, zwitterionic, amphoteric and nonionic polymers that can be used are, for example, vinylacetate/crotonic acid-copolymers, vinylpyrrolidone/vinylacrylate copolymers, vinylacetate/butylmaleate/ isobornylacrylate-copolymers, methylvinylether /maleic acid anhydride-copolymers and their esters, which are not cross-linked and with polyols linked polyacrylacids which are cross-linked, acryl amidopropyltrimethylammonium chloride/ acrylate-copolymers, octylacrylamide/methylmethacrylate/tert-butylaminoethylmethacrylate/2-hydroxypropylmethacrylate copolymers, polyvinylpyrrolidone, vinylpyrrolidone/vinylacetate-copolymers, vinylpyrrolidone/ dimethylaminoethylmethacrylate/vinyl caprolactam-terpolymers as well as optionally derivatized cellulose ethers and silicones.

In another embodiment of the present disclosure, the binders include high molecular weight PEGs like PEG 6000, PEG 8000, poly acrylates, high molecular weight poly-ox, silicates, fatty alcohols, lanolin, sugars, tallow alcohol ethoxylates, and mixtures thereof.

In another embodiment of the present disclosure, the preservatives are used in the range of 0.0001 to 2 wt% and the preservatives may be selected from the group consisting of BHT, EDTA, phenoxy ethanol and hydantoin.

In another embodiment of the present disclosure, pH regulator is used in the range of 0.0001 to 2% and the pH regulator includes citric acid, lactic acid, oxalic acid, acetic acid, triethanolamine, sulphuric acid etc.

In another embodiment of the present disclosure, the structurants are selected from the group consisting of polymers.

In another embodiment of the present disclosure, the conditioners are selected from the group consisting of silicones, and polyquats or combinations thereof. In a preferred embodiment of the invention, the conditioner is silicones and present in amount of ¬¬¬¬0.01 to 99wt. % in the final product.

In another embodiment of the present disclosure, the solubilizers can be chosen from, PEG/PPG 18/18 dimethicone, PEG-3 dimethicone, PEG 12 dimethicone, PEG 10 dimethicone, PEG 60/35/40/n hydrogenated castor oil, oleth-5, C12-15 Alkyl Benzoate, Dibutyl Adipate, Dicaprylyl Carbonate, Propylheptyl Caprylate, Capramide DEA, Potassium Caprylate, Potassium Caprylate/caprate, Arlatone 975, Oleth-2, PEG 75 lanolin, Octoxynol-11, Lauryl PEG-9 Polydimethylsiloxyethyl 8 dimethicone, Isoceteth-20 and PEG-7 Olivate.

In another embodiment of the present disclosure, the oleo gel composition of present disclosure may comprise phospholipids. Suitable phospholipids may include phosphatidylcholine (lecithin) (PC), phosphatidyl ethanolamine (PE), phosphatidyl serine (PS), lyso phospholipids, Phosphatidic acid (phosphatidate) (PA), phosphoinositides such as Phosphatidylinositol (PI), phosphatidylinositol phosphate (PIP), phosphatidylinositol bisphosphate (PIP2), phosphatidylinositol triphosphate (PIP3), phosphosphingolipids such as ceramidephosphorylcholine (Sphingomyelin) (SPH), ceramidephosphorylethanolamine (Sphingomyelin) (Cer-PE), ceramidephosphoryllipid, natural phospholipids such as egg PC, egg PG, soy PC, hydrogenated soy PC, sphingomyelin, lecithin separated from soya lecithin, egg lecithin, rice bran lecithin, combinations and derivatives thereof. In the preferred embodiment of the invention, the phospholipid is phosphatidylcholine (lecithin) (PC).
In an embodiment of the present disclosure, the active agent may be a hair growth agent which is selected from the group consisting of kopexil, minoxidil, apigenin, luteolin, and epigallocatechin gallate, or a combination thereof.

In further embodiment of the present disclosure, the active agent may be an antigrey agent which may be apigenin or forskolin, or a combination thereof.

In another embodiment of the present disclosure, the active agent may be an antidandruff agent which may be selected from the group consisting of Zinc Pyrithione, Piroctone Olamine, Ketoconazole, Tropolone, Hinokitol, Selenium Sulfide, Salicylic Acid, Climbazole, Sodium Salicylate, Ciclopiroxolamine, lchtammol, Sulfur, Clotrimazole, Crotamiton, Zinc Salicylate, Tussilago farfara, Arctium lappa, Zinc Sulfate, Rosmarinus officinalis, Myrtrimonium Bromid, Lactic Acid, Chlorohexidine Digluconate, Phenoxyisopropanol, Isopropanol, Farnesol, Glycolic Acid, Tannic acid, Alcohol, Triclosan, Zinc Gluconate, Zinc PCA, Camphor, Aluminium salts, Sodium Lactate, Polyaminopropyl Biguanide, Zinc Acetate, Triethyl Citrate, Ethylhexylglycerol, Aluminium Circonium, Tetrachlorohydrex GLY, Pentetic Acid, Diisopropylamine Aminoethylpropanol, Zinc Ricinoleate, Aluminium Sesquichlorohydrate, Lactic Acid, imidazole derivatives, glycolic acid, steroids, climbazole and its derivatives.

In another embodiment of the present disclosure, said oleo gel composition may be transparent, suspending, translucent or opaque in nature. In a preffered embodiment of the present disclosure, the oleo gel composition is transparent in nature.

In one embodiment of present disclosure, the oleo gel composition comprises:
(a) 10-60 wt% of mixture of glycerides containing 10-20 wt% dicapricmonolaurin, 15-25 wt% dilauricmonocaprin, 15-25 wt% trilaurin, 12-22 wt% dilauricmonomyristin, 5-15 wt% dimyristicmonolaurin and 1-10 wt% monolaurin;
(b) 0.001-1 wt% of an active agent;
(c) 1-25 wt% of polyols;
(d) 0.2-0.5 wt % of a thickener;
(e) 0.5-10 wt% of a surfactant; and
(f) 5 to 88.3 wt% of excipients.

In another embodiment of the present disclosure, the personal care composition is a topical composition.

Further an embodiment of present disclosure provides that the personal care composition has hair growth, antigrey and antidandruff benefits.

The composition of the present disclosure can be formulated as an oleo gel or a thickened oil.

Generally, oils have low vapor pressure which helps in longer contact time of an oil when applied to any topical skin/surface. This property can make oil as better sustain delivery vehicle if it contains any skin/scalp care active. Oleogels are semi-solid, non-crystalline, thermo-reversible viscoelastic systems, in which an external apolar phase gets immobilized within the spaces of the three-dimensional networked structure formed via physical interactions amongst the self-assembled structures of organogelators. They are resistant to the effects of moisture and do not require the addition of stabilizers or preservatives and hence possess an edge as a drug delivery system over conventional gel. It is worth noting that many oil gels require relatively small amounts of organogelators and thus can be considered as bulk-like fat materials as they contain a large amount of liquid oil.

EXAMPLES
The following examples are given by way of illustration of the present invention and should not be construed to limit the scope of present disclosure. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are intended to provide further explanation of the subject matter.

Example 1: An oleo gel composition without mineral oil is prepared by a method provided below:
• Adding polyols to main vessel and heat it to 80 °C;
• Slowly adding active agents under continuous stirring at a speed of 500 - 1000 rpm until complete dissolution of active agents;
• Slowly adding thickeners under continuous stirring;
• Shear using mixing blades (high speed) until the solution is clump free;
• Adding surfactants under slow stirring at a speed of 50 - 100 rpm;
• Adding preservatives and maintainining temperature at 80 °C;
• Heating the mixture of glycerides and mineral oil/isopropyl mysirate/parrafin in another vessel by heating at a temperature of 80 °C;
• Slowly adding the heated oil phase ingredients to main vessl under continuous stirring at a speed of 1000 - 2000 rpm to obtain a gel;
• Cooling the main vessel to room temperature and adding perfume color to it while stirring at a speed of 300 - 500 rpm to obtain a oleo gel formulation.
The oleogel compostion has ingredients as below:

Sr. No. Ingredients Weight %
1 Mixture of Glycerides 50
3. Isopropyl myristate 12
4. C16-C18 alkane 5.1785
5. Glycerine 20
6. Propylene glycol 4
7. Cetyl betaine 4.5
8. Lauryl betaine 2
9. Hydroxypropyl Guar 0.4
10. Kopexil 0.4
11. Minoxidil 0.6
12. Perfume 0.9
13. Phenoxyethanol 0.02
14. Color Quinizarine Green - D&C Green No.6 (C.I. 61565) 0.0015

The mixture of glycerides used above has following composition:
Triglyceride Composition Range (wt%)
dicapricmonolaurin 12
dilauricmonocaprin 15
trilaurin 25
dilauricmonomyristin 22
Dimyristicmonolaurin 15
monolaurin 10

Example 2: Comparative: An oleo gel composition prepared by the process given in Example 1, having ingredients as below:
Sr. No. Ingredients Weight %
1 Mixture of Glycerides 9
2. Mineral oil 66
3. Glycerine 20
4. Propylene glycol 3.7
5. Cetyl betaine 0.5
6. Hydroxypropyl Guar 0.3
7. Perfume 0.5

The mixture of glycerides used above has following composition:
Triglyceride Composition Range (wt%)
Dicapricmonolaurin 20
Dilauricmonocaprin 25
Trilaurin 25
Dilauricmonomyristin 20
Dimyristicmonolaurin 5
monolaurin 5
Example 3: Comparative: An oleo gel composition prepared by the process given in Example 1, having ingredients as below:
Sr. No. Ingredients Weight %
1 Mixture of Glycerides 65
2. Mineral oil 10
3. Glycerine 20
4. Propylene glycol 3.7
5. Cetyl betaine 0.5
6. Hydroxypropyl Guar 0.3
7. Perfume 0.5

The mixture of glycerides used above has following composition:
Triglyceride Composition Range (wt%)
dicapricmonolaurin 16
dilauricmonocaprin 21
trilaurin 21
dilauricmonomyristin 19
dimyristicmonolaurin 13
monolaurin 10

Example 4: Comparative: An oleo gel composition prepared by the process given in Example 1, having ingredients as below:
Sr. No. Ingredients Weight %
1 Mixture of Glycerides 60
2. Mineral oil 37.8
3. Glycerine 0.8
4. Propylene glycol 0.1
5. Cetyl betaine 0.5
6. Hydroxypropyl Guar 0.3
7. Perfume 0.5

The mixture of glycerides used above has following composition:
Triglyceride Composition Range (wt%)
dicapricmonolaurin 16
dilauricmonocaprin 21
trilaurin 21
dilauricmonomyristin 19
dimyristicmonolaurin 13
monolaurin 10

Example 5: Comparative: An oleo gel composition prepared by the process given in Example 1, having ingredients as below:
Sr. No. Ingredients Weight %
1 Mixture of Glycerides 60
2. Mineral oil 11.7
3. Glycerine 20
4. Propylene glycol 7
5. Cetyl betaine 0.5
6. Hydroxypropyl Guar 0.3
7. Perfume 0.5

The mixture of glycerides used above has following composition:
Triglyceride Composition Range (wt%)
dicapricmonolaurin 12
dilauricmonocaprin 16
trilaurin 25
dilauricmonomyristin 22
dimyristicmonolaurin 15
monolaurin 10

Example 6: Comparative: An oleo gel composition prepared by the process given in Example 1, having ingredients as below:

Sr. No. Ingredients Weight %
1 Mixture of Glycerides 60
2. Mineral oil 15.1
3. Glycerine 20
4. Propylene glycol 3.8
5. Cetyl betaine 0.5
6. Hydroxyethyl cellulose 0.1
7. Perfume 0.5

The mixture of glycerides used above has following composition:
Triglyceride Composition Range (wt%)
dicapricmonolaurin 20
dilauricmonocaprin 25
trilaurin 25
dilauricmonomyristin 20
dimyristicmonolaurin 5
monolaurin 5

Example 7: Comparative: An oleo gel composition prepared by the process given in Example 1, having ingredients as below:
Sr. No. Ingredients Weight %
1 Mixture of Glycerides 60
2. Mineral oil 14.6
3. Glycerine 20
4. Propylene glycol 3.8
5. Cetyl betaine 0.5
6. Hydroxypropyl Guar 0.1
7. Hydroxyethyl Cellulose 0.4
8. Hydroxypropyl Cellulose 0.1
9. Perfume 0.5

The mixture of glycerides used above has following composition:
Triglyceride Composition Range (wt%)
dicapricmonolaurin 16
dilauricmonocaprin 21
trilaurin 21
dilauricmonomyristin 19
dimyristicmonolaurin 13
monolaurin 10

Example 8: Comaparative: An oleo gel composition prepared by the process given in Example 1, having ingredients as below:
Sr. No. Ingredients Weight %
1 Mixture of Glycerides 60
2. Mineral oil 15.1
3. Glycerine 20
4. Propylene glycol 3.8
5. Cetyl betaine 0.3
6. Hydroxypropyl Guar 0.3
7. Perfume 0.5

The mixture of glycerides used above has following composition:
Triglyceride Composition Range (wt%)
dicapricmonolaurin 12
dilauricmonocaprin 16
trilaurin 25
dilauricmonomyristin 22
dimyristicmonolaurin 15
monolaurin 10

Example 9: Comparative: An oleo gel composition prepared by the process given in Example 1, having ingredients as below:

Sr. No. Ingredients Weight %
1 Mixture of Glycerides 60
2. Mineral oil 4.1
3. Glycerine 20
4. Propylene glycol 3.8
5. Cetyl betaine 0.3
6. Cocamidopropyl betaine 11
7. Hydroxypropyl Guar 0.3
8. Perfume 0.5

The mixture of glycerides used above has following composition:
Triglyceride Composition Range (wt%)
dicapricmonolaurin 20
dilauricmonocaprin 25
trilaurin 25
dilauricmonomyristin 20
dimyristicmonolaurin 5
monolaurin 5

Example 10: An oleo gel composition prepared by the process given in Example 1, having ingredients as below:
Sr. No. Ingredients Weight %
1 Mixture of Glycerides 50
2. Mineral oil 15
3. Isopropyl myristate 9.7
4. Glycerine 10
5. Pentylene Glycol 10
6. Propylene glycol 3.7
7. Cetyl betaine 0.4
8. Lauryl betaine 0.1
9. Hydroxypropyl Guar 0.3
10. Kopexil 0.1
11. Perfume 0.5

The mixture of glycerides used above has following composition:
Triglyceride Composition Range (wt%)
dicapricmonolaurin 16
dilauricmonocaprin 21
trilaurin 21
dilauricmonomyristin 19
dimyristicmonolaurin 13
monolaurin 10

Example 11: An oleo gel composition prepared by the process given in Example 1, having ingredients as below:
Sr. No. Ingredients Weight %
1 Mixture of Glycerides 50
2. Mineral oil 14
3. Isopropyl myristate 5
4. C16-C18 alkane 5
5. Glycerine 10
6. Pentylene Glycol 5
7. Propylene glycol 3.7
8. Polyethylene glycol-400 5
9. Cetyl betaine 0.3
10. Cocamidopropyl betaine 0.4
11. Lauryl betaine 0.3
12. Hydroxypropyl Guar 0.3
13. Hydroxypropyl cellulose 0.1
15. Minoxidil 0.4
16. Perfume 0.5
The mixture of glycerides used above has following composition:
Triglyceride Composition Range (wt%)
dicapricmonolaurin 12
dilauricmonocaprin 16
trilaurin 25
dilauricmonomyristin 22
dimyristicmonolaurin 15
monolaurin 10

Example 12: An oleo gel composition prepared by the process given in Example 1, having ingredients as below:
Sr. No. Ingredients Weight %
1 Mixture of Glycerides 50
3. Isopropyl myristate 15
4. C16-C18 alkane 10
5. Glycerine 20
6. Propylene glycol 3.7
7. Cetyl betaine 0.5
8. Hydroxypropyl Guar 0.3
11. Perfume 0.5

Example 13: Comparative: Mineral Oil Oleo gel: An oleo gel composition prepared by the process given in Example 1, having ingredients as below:
Sr. No. Ingredients Weight %
1. Mineral oil 60
2. Isopropyl myristate 15
3. Glycerine 20
4. Propylene glycol 3.7
5. Cetyl betaine 0.5
6. Hydroxypropyl Guar 0.3
7. Perfume 0.5

Example 14: An oleo gel composition prepared by the process given in Example 1, having ingredients as below:
Sr. No. Ingredients Weight %
1 Mixture of Glycerides 60
2. Isopropyl Myristate 15
3. Glycerine 20
4. Propylene glycol 3.7
5. Cetyl betaine 0.5
6. Hydroxypropyl Guar 0.3
7. Perfume 0.5

The mixture of glycerides used above has following composition:
Triglyceride Composition Range (wt%)
dicapricmonolaurin 16
dilauricmonocaprin 21
trilaurin 21
dilauricmonomyristin 19
dimyristicmonolaurin 13
monolaurin 10

Example 15: An oleo gel composition prepared by the process given in Example 1, having ingredients as below:
Sr. No. Ingredients Weight %
1 Mixture of Glycerides 10
2. Mineral oil 15
3. Isopropyl myristate 50
4. Glycerine 20
5. Propylene glycol 3.7
6. Cetyl betaine 0.5
7. Hydroxypropyl Guar 0.3
8. Perfume 0.5
The mixture of glycerides used above has following composition:
Triglyceride Composition Range (wt%)
dicapricmonolaurin 12
dilauricmonocaprin 16
trilaurin 25
dilauricmonomyristin 22
dimyristicmonolaurin 15
monolaurin 10

Example 16: An oleo gel composition prepared by the process given in Example 1, having ingredients as below:
Sr. No. Ingredients Weight %
1 Mixture of Glycerides 20
2. Mineral oil 15
3. Isopropyl myristate 40
4. Glycerine 20
5. Propylene glycol 3.7
6. Cetyl betaine 0.5
7. Hydroxypropyl Guar 0.3
8. Perfume 0.5

The mixture of glycerides used above has following composition:
Triglyceride Composition Range (wt%)
dicapricmonolaurin 20
dilauricmonocaprin 25
trilaurin 25
dilauricmonomyristin 20
dimyristicmonolaurin 5
monolaurin 5

Example 17: An oleo gel composition prepared by the process given in Example 1, having ingredients as below:
Sr. No. Ingredients Weight %
1 Mixture of Glycerides 40
2. Mineral oil 15
3. Isopropyl myristate 20
4. Glycerine 20
5. Propylene glycol 3.7
6. Cetyl betaine 0.5
7. Hydroxypropyl Guar 0.3
8. Perfume 0.5

The mixture of glycerides used above has following composition:
Triglyceride Composition Range (wt%)
dicapricmonolaurin 16
dilauricmonocaprin 21
trilaurin 21
dilauricmonomyristin 19
dimyristicmonolaurin 13
monolaurin 10

Example 18: An oleo gel composition prepared by the process given in Example 1, having ingredients as below:
Sr. No. Ingredients Weight %
1 Mixture of Glycerides 50
2. Mineral oil 15
3. Isopropyl myristate 10
4. Glycerine 20
5. Propylene glycol 3.7
6. Cetyl betaine 0.5
7. Hydroxypropyl Guar 0.3
8. Perfume 0.5

The mixture of glycerides used above has following composition:
Triglyceride Composition Range (wt%)
dicapricmonolaurin 12
dilauricmonocaprin 16
trilaurin 25
dilauricmonomyristin 22
dimyristicmonolaurin 15
monolaurin 10

Example 19: Comparative: A hydrogel gel composition is prepared be emethod having following steps:
• Adding water in main vessel and heating it to 50 °C;
• Slowly Adding thickeners to the heated water under stirring at a speed of 500 - 1000 rpm;
• Shear using mixing blades (high speed) to obtain a clump free solution;
• Adding polyols and surfactants one by one under continuous stirring;
• Cooling the main vessel to room temperature;
• Adding perfume, preservative and color one by one under continuous stirring to obtain a hydrogel formulation.
The hydrogel formulation has ingredients as below:
Sr. No. Ingredients Weight %
1. Glycerine 19.8
2. Pentylene glycol 1
3. Propylene glycol 1
4. Polyethylene glycol-400 1
5. Cetyl betaine 0.1
6. Hydroxypropyl Guar 0.1
7. Hydroxyethyl Cellulose 0.3
8. Hydroxypropyl Cellulose 0.1
9. Perfume 0.5
10. Water 76.0785
11. Phenoxyethanol 0.02
12. Color Quinizarine Green - D&C Green No.6 (C.I. 61565) 0.0015

Example 20: Stability of the formulations:
The prepared formulations were kept in borosil glass container. The container was then kept at different temperatures from room temperature to 45 °C, then again to room temperature and then to at 5 °C. This cycle is run for three times and the product was then centrifuged at 3000 rpm for 15 minutes to observe the separation of the composition. Further, the visual stability of the composition was also analysed after one month at 25 °C. The stability data is given in below table:
Example 1(Inv.) 2(comp) 3(comp) 4(comp) 5(comp) 6(comp) 7(comp) 8(comp)
Visual stability Stable Unstable Unstable Unstable Unstable Unstable Unstable Unstable
Phase separation No Yes Yes Yes Yes Yes Yes Yes
Formulation 9(comp) 10(Inv) 11 (Inv) 12(Inv) 13(Comp.) 14(Inv) 15(Inv) 16(Inv)
Visual stabilitity Unstable Stable Stable Stable Stable Stable Stable Stable
Phase separation Yes No No No No No No No
Formulation 17 (Inv) 18(Inv) 19(Comp)
Visual stabilitity Stable Stable Stable
Phase separation No No No
*Inv.: Example as per Invention; Comp.: Comparative Example
The examples as per the invention are stable and have no phase separation, wherein the comparative examples having ingredients outside the ranges are unstable and observed with phase separation

Example 21: Sensory Data
The composition described in the examples were tested on healthy human volunteers and they were asked to give ratings to the formulations in terms of sensory effect on the scale of 0-5, 5 being the highest rating. The questions asked around hair sensory like smoothness, softness, moisturizing, absorption & overall likeability of the product. The data collected is given below:

Examples 1(Inv.) 2(comp.) 3(comp.) 4(comp.) 5(comp.) 6(comp.) 7(comp.) 8(comp.)
Sensory rating 4.75 0 2 0 0.75 0.75 1.75 0
Formulation 9(comp) 10(inv) 11(inv) 12(inv) 13(comp) 14 (Inv) 15(inv) 16(inv)
Sensory rating 1.75 3.75 3.75 3.75 2 4.75 3 3.25
Formulation 17(inv) 18(inv) 19 (comp)
Sensory Rating 3.5 4 1
*Inv.: Example as per Invention; Comp.: Comparative Example

Example 22: Hydration level test by corneometer
The electrical properties of the skin are dependent on the water content of the stratum corneum of the epidermis. Epidermal hydration was assessed for volunteers by measuring the electrical capacitance with the help of the Corneometer CM 825. The principle of the method is based on the difference between the dielectric constant of water and other substances by measuring the capacitance of a dielectric medium. Any change in the dielectric constant subsequent to the variation in skin surface hydration leads to an impaired calculated capacitance of a capacitor. The Corneometer contains two electrodes with different electrical charges that form an electromagnetic field that determines the dielectricity of the stratum corneum. The depth of measurement is low (the first 10-20 µm of the stratum corneum) due to the construction of the measuring head. The range of variation of the values of skin hydration degree is between 0-130 arbitrary units (AU).
The composition described in the examples were tested on healthy human volunteers with visible dry skin to assess the extended skin moisture over a period of 10 days. The volunteers were made to wash their arms with a surfactant solution and acclimatized in a temperature and humidity controlled chamber for 30 minutes. The initial hydration was measured at the start of the study (“time 0”) for each volunteer using a Corneometer. This was taken as the baseline. Then an amount of 0.5 gm per volar arm was used for the evaluation studies. The formulations were applied on different forearms of each volunteer. The applications were repeated twice daily for 10 days. On the eleventh day, the hydration was measured using a Corneometer without any product being applied on the skin. The % increase in the hydration over the baseline was calculated.

A skin hydration vs. time graph for the formulations of Examples 13 and 14 are given in Figure 1. The hydration test data obtained for these formulations is provided below:

Timepoint Formulation of Example 13 (Mineral Oil Oleogel) Formulation of Example 14 (As per invention)
Baseline 41.17 42.37
0h 50.53 66.57
0.5h 50.07 67.47
1h 53.20 68.23
1.5h 58.43 68.87
2h 57.73 69.43
2.5h 58.43 68.23
3h 56.37 69.47
3.5h 56.17 68.57
4h 57.47 69.66
4.5h 56.37 71.79
5h 57.53 72.37

It can been be seen that the oleogel formulation as per the invention (Example 14) has significantly better effect on the hydration level of the skin with the period of time as compared to the Mineral Oil oleogel.
The % increase in hydration over baseline after 10 days measured by Corneometer and the graph obtained in given in Fig. 2 on the basis of the data below:
Product Oleogel Hydrogel
Example No. 13(Comp) 14(Inv) 15(Inv) 16(Inv) 17(Inv) 18(Inv) 19(Comp)
% increase in hydration on day 10 37.7 109.2 64.4 79.8 92.5 104.8 44.5
*Inv.: Example as per Invention; Comp.: Comparative Example

It is evident that the % increase in hydration on day 10 is up to 109.2 % on applying the formulation as per the present invention as compared to the mineral oil oleo gel (Example 13) and hydrogel formulation (Example 19). Thus, the oleo gel composition of the present disclosure is able to achieve a significantly enhanced hydration effect for a long period of time as compared to mineral oil oleo gels and hydrogels.

Although the subject matter has been described in considerable detail with reference to certain preferred embodiments thereof, other embodiments are possible. As such, the spirit and scope of the subject matter should not be limited to the description of the preferred embodiment contained therein. ,CLAIMS:WE CLAIM:

1. An oleo gel composition comprising:
(a) 10-60 wt% of mixture of glycerides;
(b) 1-25 wt% of polyols;
(c) 0.2-0.5 wt % of a thickener;
(d) 0.5-10 wt% of a surfactant; and
(e) 5 to 88.3 wt% of excipients.

2. The composition as claimed in claim 1, wherein the oleo gel composition comprises 0.001-1 wt% of an active agent.

3. The composition as claimed in claim 3, wherein the active agent is selected from the group consisting of kopexil and minoxidil or a combination thereof.

4. The composition as claimed in claim 1, wherein the mixture of glycerides comprises 10-20 wt% dicapricmonolaurin, 15-25 wt% dilauricmonocaprin, 15-25 wt% trilaurin, 12-22 wt% dilauricmonomyristin, 5-15 wt% dimyristicmonolaurin and 1-10 wt% monolaurin.

5. The composition as claimed in claim 1, wherein the polyols are selected from the group consisting of Glycerin, Polyethylene Glycol, Propylene Glycol, and Pentylene Glycol or a combination thereof.

6. The composition as claimed in claim 1, wherein the thickener is a glycol phase thickener which is selected from the group consisting of Hydroxypropyl Guar, Hydroxyethyl Cellulose, and Hydroxypropyl cellulose or a combination thereof.

7. The composition as claimed in claim 1, wherein the surfactant is an amphoteric surfactant selected from the group consisting of CDMA, sodium 3-dodecylaminopropionate, sodium 3-dodecylaminopropane sulfonate, coco dimethyl carboxymethyl betaine, lauryl dimethyl carboxy-methyl betaine, lauryl dimethyl alpha-carboxyethyl betaine, cetyl dimethyl carboxymethyl betaine, lauryl bis-(2-hydroxyethyl)carboxy methyl betaine, stearyl bis-(2-hydroxypropyl)carboxymethyl betaine, oleyl dimethyl gamma-carboxypropyl betaine, lauryl bis-(2-hydro-xypropyl)alpha-carboxyethyl betaine, coco dimethyl sulfopropyl betaine, stearyl dimethyl sulfopropyl betaine, amido betaines and amidosulfobetaines or a combination thereof.

8. The composition as claimed in claim 1, wherein the excipients are selected from the group consisting of emollient, antioxidants, plasticizers, polymers, binders, preservatives, color, perfume, Vegetable oil, Palm kernel Oil, Mineral Oil, Isopropyl Myristate, C16-C18 alkane, emotives, pH regulator, secondary emulsifier, electrolytes (salts), humectants, structurants, conditioners, and solubilizers or combinations thereof.

9. The composition as claimed in claim 1, wherein the oleogel composition is transparent, suspending, translucent or opaque in nature.

10. The composition as claimed in claimed 1, wherein the oleogel composition is transparent.