Formulations for reducing hair loss and / or enhancing hair regeneration.

Abstract

The present invention relates to a formulation comprising 2% to 10% minoxidil, 0.01% to 15% prostaglandin analog, and optionally 0.01% to 15% finasteride, and a formulation comprising 0.1 to 60% dapsone and / or 0.1 to 20% minocycline, tetracycline, or doxycycline as active ingredients. In one embodiment, the prostaglandin analog is latanoprost. In a preferred embodiment, the composition comprises 5% minoxidil and 0.03% latanoprost. In another preferred embodiment, the composition further comprises 0.1% finasteride. The present invention also relates to the use of the formulation for reducing hair loss and / or enhancing hair regrowth in a human subject.

Description

Technical Field

[0001] The present invention relates to a formulation for reducing hair loss and / or enhancing hair regeneration. More specifically, the present invention relates to a formulation for reducing hair loss and / or enhancing hair regeneration, which contains minoxidil, prostaglandin analogs, and optionally finasteride. The formulation can also contain sulfones such as dapsone, which can be used alone as an active ingredient for the topical treatment of various forms of alopecia. Formulations containing minocycline, tetracycline or doxycycline as active ingredients are also described.

Background Art

[0002] Hair loss, in any form, affects a very large number of individuals at some point in their lives. Androgenetic alopecia (AGA) is hair loss (at the scalp level) caused by follicular miniaturization. AGA is commonly seen in men aged 19 to 70 years old. Notably, more than 50% of white men in their 50s are affected by AGA. Hair loss in women mainly becomes a problem after menopause. Alopecia areata (AA) is considered an autoimmune disease that causes hair loss through inflammation. AA tends to affect individuals earlier than AGA, and children and teenagers in their teens suffer from extensive scalp hair loss (total AA) or complete body hair loss (universal AA) (Gilhar A et al., J Clin Invest, 117(8); 2019 - 2027, 2007).

[0003] Individuals affected by AGA and AA show a decrease in self-esteem and may negatively affect many aspects of their lives.

[0004] Several hair loss prevention products are available on the market. For example, minoxidil has been used topically since the 1990s in 2% concentration (over-the-counter) and 3% and 5% concentrations (with prescription). Studies have shown that 5% minoxidil is more efficient than 2%, but minoxidil promotes hair regeneration in less than 40% of cases. Minoxidil is considered the absolute standard for topical use in treating hair loss.

[0005] Another hair loss prevention product is finasteride. It is usually administered orally at a dose of 1 mg / day. There are several side effects associated with finasteride administration, including decreased libido, impotence, ejaculatory dysfunction, allergic reactions, testicular pain, male infertility, male breast cancer, and depression. At higher concentrations (5 mg), finasteride may cause benign prostatic hyperplasia.

[0006] PGF 2α Latanoprost, a prostaglandin analog, is widely used in ophthalmology to treat open-angle glaucoma and ocular hypertension. One of its side effects was increased periorbital hypertrichosis, including increased thickness, length, and pigmentation of the eyelashes, which should be distinguished from hair growth. Some of the other adverse effects include erythema, folliculitis, burning, and erysipelas. Latanoprost eye drops have a concentration of 0.005%. It should be noted that scalp hair follicles and eyelash hair follicles are not identical, and the drug's effect on one type of hair cannot be easily inferred from the drug's effect on another type of hair. [Prior art documents] [Non-patent literature]

[0007] [Non-Patent Document 1] Gilhar A et al., J Clin Invest, 117(8);2019~2027, 2007 [Non-Patent Document 2] Prostaglandin Metabolism in Human Hair Follicle, Exp Dermatol., September 2007, 16(9):762~769 [Non-Patent Document 3] Michelet et al., Activation of Cytoprotected Prostaglandin Synthase-1 by Minoxidil as a Possible Explanation for Its Hair Growth-Stimulating Effect, J. Invest Dermatol, 1997:108:205~209 [Non-Patent Document 4] Muller-Decker et al., Expression of Cyclo-Oxygenase Isozymes During Morphogenesis and Cycling of Telage Hair Follicles in Mouse Skin, J. Invest Dermatol, 2003:121:661~668 [Non-Patent Document 5] Goyal R et al., J Control Release, 240:77~92, 2016. [Overview of the project] [Means for solving the problem]

[0008] According to an aspect of the present invention, a formulation for reducing hair loss and / or promoting hair growth is provided, comprising about 2% to about 10% minoxidil; about 0.01% to about 5% finasteride; about 0.01% to about 1% prostaglandin analog; and about 35% to about 45% labrafil.

[0009] In one embodiment, a formulation is provided in the form of a foam, the foam comprising about 33.33% labrafil M2130CS; about 8.33% labrafil M1944CS; about 8.33% propylene glycol; about 5% minoxidil; about 0.1% finasteride USP; about 0.03% latanoprost; about 5% acrylic polymer; about 1.67% water; about 0.03% sodium hydroxide; about 0.33% carbomer 934P; and about 38.18% anhydrous ethyl alcohol.

[0010] In another embodiment, a formulation is provided in the form of a gel, wherein the gel comprises about 33.33% labrafil M2130CS; about 8.33% labrafil M1944CS; about 8.33% propylene glycol; about 5% minoxidil; about 0.1% finasteride USP; about 0.03% latanoprost; about 0.016017% silicon dioxide; about 1.67% water; about 0.03% sodium hydroxide; about 0.33% carbomer 934P; and about 42.83% anhydrous ethyl alcohol.

[0011] In another embodiment, a formulation is provided in the form of an oily substance, wherein the oily substance comprises about 33.33% labrafil M2130CS; about 8.33% labrafil M1944CS; about 8.33% propylene glycol; about 5% minoxidil; about 0.1% finasteride USP; about 0.03% latanoprost; about 0.17% lavender or other fragrance; and about 44.71% mineral oil, almond oil, avocado oil, argan oil, coconut oil, or a combination thereof.

[0012] In another embodiment, a formulation is provided in the form of an emulsion, wherein the emulsion comprises about 33.33% Labrafil M2130CS; about 8.33% Labrafil M1944CS; about 8.33% Transktol; about 8.33% propylene glycol; about 5% minoxidil; about 0.1% finasteride USP; about 0.03% latanoprost; about 0.83% triethanolamine acetate (TEA); about 1% Carbopol 940; and about 34.72% water.

[0013] In another embodiment, a formulation is provided in the form of a stick, wherein the stick comprises about 21.37% hydrocarbon wax, mineral wax, hard wax, microcrystalline wax, or a combination thereof; about 6.67% titanium dioxide; about 33.33% Labrafil M2130CS; about 8.33% Labrafil M1944CS; about 8.33% propylene glycol; about 5% minoxidil; about 0.1% finasteride USP; about 0.03% latanoprost; about 0.17% lavender or other fragrance; and about 16.67% mineral oil, almond oil, avocado oil, argan oil, coconut oil, or a combination thereof.

[0014] In another embodiment, a formulation for reducing hair loss and / or promoting hair growth is provided, comprising about 2% to about 10% minoxidil; about 0.01% to about 1% prostaglandin analog; and about 35% to about 45% labrafil.

[0015] In yet another embodiment, a formulation is provided in the form of a foam, the foam comprising about 33.33% labrafil M2130CS; about 8.33% labrafil M1944CS; about 8.33% propylene glycol; about 5% minoxidil; about 0.03% latanoprost; about 5% acrylic polymer; about 1.67% water; about 0.03% sodium hydroxide; about 0.33% carbomer 934P; and about 37.95% anhydrous ethyl alcohol.

[0016] In another embodiment, a formulation is provided in the form of a gel, wherein the gel comprises about 33.33% labrafil M2130CS; about 8.33% labrafil M1944CS; about 8.33% propylene glycol; about 5% minoxidil; about 0.03% latanoprost; about 0.017% silicon dioxide; about 1.67% water; about 0.03% sodium hydroxide; about 0.33% carbomer 934P; and about 42.93% anhydrous ethyl alcohol.

[0017] In another embodiment, a formulation is provided in the form of an oily substance, the oily substance comprising about 33.33% labrafil M2130CS; about 8.33% labrafil M1944CS; about 8.33% propylene glycol; about 5% minoxidil; about 0.03% latanoprost; about 0.17% lavender or other fragrance; and about 44.81% mineral oil, almond oil, avocado oil, argan oil, coconut oil, or a combination thereof.

[0018] In another embodiment, a formulation is provided in the form of an emulsion, wherein the emulsion comprises about 33.33% labrafil M2130CS; about 8.33% labrafil M1944CS; about 8.33% transktol; about 8.33% propylene glycol; about 5% minoxidil; about 0.03% latanoprost; about 0.83% triethanolamine acetate (TEA); about 1% carbopol 940; and about 34.82% water.

[0019] In another embodiment, a formulation in the form of a stick, the stick comprising about 21.48% hydrocarbon wax, mineral wax, hard wax, microcrystalline wax, or a combination thereof; about 6.67% titanium dioxide; about 33.33% Lubrafill M2130CS; about 8.33% Lubrafill M1944CS; about 8.33% propylene glycol; about 5% minoxidil; about 0.03% latanoprost; about 0.17% lavender or other fragrance; and about 16.67% mineral oil, almond oil, avocado oil, argan oil, coconut oil, or a combination thereof, is provided.

[0020] In another embodiment, a formulation comprising about 2% to about 6% dapsone; about 5% to about 10% tranexamic acid; and about 35% to about 45% Lubrafill is provided.

[0021] In yet another embodiment, a formulation in the form of an oil, the oil comprising about 33.33% Lubrafill M2130CS; about 8.33% Lubrafill M1944CS; about 8.33% propylene glycol; about 8.33% tranexamic acid; about 8.33% absolute alcohol; about 3.33% dapsone; about 0.17% fragrance; and about 29.85% mineral oil, almond oil, avocado oil, argan oil or coconut oil, is provided.

[0022] In yet another embodiment, a formulation in the form of an oil, the oil comprising about 33.33% Lubrafill M2130CS; about 8.33% Lubrafill M1944CS; about 8.33% propylene glycol; about 8.33% tranexamic acid; about 5% dapsone; about 0.17% fragrance; and about 36.51% mineral oil, almond oil, avocado oil, argan oil or coconut oil, is provided.

[0023] In another embodiment, a formulation comprising about 2% to about 4% minocycline, tetracycline, or doxycycline; about 5% to about 10% tranexamic acid; about 35% to about 45% Lubrafill; and cyclodextrin is provided.

[0024] In yet another embodiment, a formulation is provided in the form of an oily substance, wherein the oily substance comprises about 33.33% labrafil M2130CS; about 8.33% labrafil M1944CS; about 8.33% propylene glycol; about 8.33% transktol; about 8.33% anhydrous alcohol; about 3.33% minocycline; about 0.17% fragrance; and about 29.85% mineral oil, almond oil, avocado oil, argan oil, or coconut oil.

[0025] In another embodiment, a formulation is provided comprising about 2% to about 10% minoxidil; about 0.01% to about 5% finasteride; about 0.01% to about 1% prostaglandin analog; about 0.1% to about 60% dapsone, preferably about 2% to about 6% dapsone; and about 0.1% to about 20% minocycline, doxycycline, or tetracycline, preferably about 2% to about 4% minocycline, doxycycline, or tetracycline.

[0026] Another aspect of the present invention provides the use of the formulations described herein for reducing hair loss and / or enhancing hair regeneration in human subjects, and the use of the formulations described herein for reducing hair loss and / or enhancing hair regeneration in human subjects in the manufacture of pharmaceuticals. [Modes for carrying out the invention]

[0027] The present invention relates to formulations comprising minoxidil, a prostaglandin analog, and optionally finasteride, which exhibit improved properties in reducing hair loss and enhancing hair regeneration in human subjects compared to the administration of minoxidil, finasteride, and latanoprost alone. Such compositions show superior improvements compared to the improvements observed when each component of the composition is administered individually, and the results obtained so far suggest that the improvements may be superior to the improvements compared to the overall improvements of the components. The present invention also relates to formulations comprising dapsone or minocycline as an active ingredient.

[0028] In a preferred embodiment, the present invention relates to various forms of formulations for topical or transdermal administration.

[0029] Minoxidil or (6-(1-pipedidinyl)-2,4-pyrimidinediamine 3-oxide) has the following structural formula.

[0030] [ka]

[0031] Minoxidil is a crystalline solid with solubility of 75 mg / ml in propylene glycol, 44 mg / ml in methanol, 29 mg / ml in ethanol, 6.7 mg / ml in 2-propanol, 6.5 mg / ml in DMSO, 2.2 mg / ml in water, 0.5 mg / ml in chloroform, and <0.5 mg / ml in acetone. Minoxidil has a pKa of 4.61.

[0032] Finasteride or ((5α,17β)-N-(1,1-dimethylethyl)-3-oxo-4-azaandrosta-1-ene-17-carboxamide) has the following structural formula.

[0033] [ka]

[0034] Finasteride is usually administered orally at a daily dose of 1 mg.

[0035] Finasteride is an anhydrous crystalline solid. It is readily soluble in chloroform, DMSO, ethanol, methanol, and n-propanol; slightly soluble in propylene glycol and polyethylene glycol 400; and very slightly soluble in 0.1N HCl and 0.1N NaOH. Finasteride is insoluble in water.

[0036] Finasteride is teratogenic and may cause birth defects. For this reason alone, its use is often not recommended in premenopausal women, and specifically, women who are pregnant or planning to become pregnant are advised not to use it.

[0037] Latanoprost or ((5Z)-7-[(1R,2R,3R,5SO-3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoic acid 1-methylethyl ester) has the following structural formula.

[0038] [ka]

[0039] Latanoprost is an oily substance. It is very soluble in acetonitrile and readily soluble in acetone, ethanol, ethyl acetate, isopropanol, methanol, and octanol. Latanoprost is practically insoluble in water.

[0040] Prostaglandins regulate several physiological functions. Most hair cell types are conjugated with a prostaglandin metabolic machinery, and therefore PGE2 and / or PGF. 2αIt has been found that it can produce [the substance]. The epithelial portion of the hair follicle is the main source of prostaglandin synthesis and interconversion. Colombe et al. (Prostaglandin Metabolism in Human Hair Follicle, Exp Dermatol., September 2007, 16(9):762~769) have also shown that minoxidil enhances prostaglandin endoperoxide synthase-1 (PGHS-1) activity, which suggests that prostaglandins are involved in the regulation of hair growth and differentiation, and that there is a relationship between prostaglandin synthesis and hair growth. Minoxidil has been shown to be a potent activator of purified PGHS-1 by assaying oxygen consumption in prostaglandin PGE2 production, suggesting that the mechanism of minoxidil's effect beyond hair growth stimulation is stimulation of PGE2 synthesis (Michelet et al., Activation of Cytoprotected Prostaglandin Synthase-1 by Minoxidil as a Possible Explanation for Its Hair Growth-Stimulating Effect, J. Invest Dermatol, 1997:108:205~209). This was confirmed by the role of PGHS-2 in regulating the hair cycle (Muller-Decker et al., Expression of Cyclo-Oxygenase Isozymes During Morphogenesis and Cycling of Telage Hair Follicles in Mouse Skin, J. Invest Dermatol, 2003:121:661~668). Human hair follicles contain complete PGE2 and PGF 2α It was shown that metabolism can be sustained. Human hair follicles (i) mPGES-1, mPGES-2, and cPGES catalyze the synthesis of PGE2 from PGH2, and (ii) PGF 2α Convert to AKR1C3 / PGFS, (iii)PGE2 / PGF 2αIt expresses CDR1 and AKR1C1 aldo-keto reductases that can regulate interconversion. Therefore, it has been shown that human hair follicles appear to be sufficiently enzymatically equipped to self-process prostaglandin synthesis and metabolism. This is related to PGE2 and PGF. 2α This means that it is produced by hair follicles and can be interconverted. The composition tested was PGF 2α The product contained latanoprost, a prostaglandin analog, but considering the role that prostaglandins play in hair growth and differentiation, it is presumed that other prostaglandin analogs can also be used. Examples of other suitable prostaglandin analogs include travoprost, bimatoprost, tafluprost, and unoprostone.

[0041] In some formulations, dapsone and other sulfones can be used in combination with minoxidil and the above-mentioned prostaglandin analogs. This formulation may be particularly beneficial for the treatment of alopecia areata. In some embodiments, steroids such as finasteride can be added to the formulation to improve the functionality of the active ingredient. In yet another embodiment, dapsone can be used alone as a topical treatment for all forms of alopecia areata, including androgenic alopecia, female pattern hair loss, and alopecia universalis, as well as for frontal fibrous alopecia and other inflammatory alopecia, in both children and adults.

[0042] In some formulations, minocycline serves as the active ingredient. Minocycline is a tetracycline antibiotic frequently used in the treatment of acne vulgaris. It can be administered topically or orally. In embodiments where minocycline is the active ingredient, the formulation can be used in the treatment of various hair loss conditions in women, including, for example, androgenetic alopecia, alopecia areata, female pattern hair loss, and age-related hair loss.

[0043] The active ingredient may be delivered to the skin via topical formulations described herein, or by using a vehicle, such as nanoparticles or nanofibers (Goyal R et al., J Control Release, 240:77-92, 2016) or cyclodextrin. When nanoparticles are used for delivery, the active ingredient may be encapsulated inside and / or outside the nanoparticles. Cyclodextrin can be used as a selective drug delivery system by enhancing solubility, stability, and penetration of the active pharmaceutical ingredient (API) into the target site. The absorption of cyclodextrin is limited. Cyclodextrin works by delivering a payload, which is the API. The target group / mole may be chemically bound to the cyclodextrin, and the API is encapsulated and delivered to target cells as guided by the target group, and the API is subsequently released to the site of desired action and acts selectively on the target cells.

[0044] Labrafil® (e.g., Labrafil® M21030CS or Labrafil® M1944CS) is a water-dispersible nonionic surfactant that can be used as a coemulsifier in topical formulations to improve emulsion stability.

[0045] Propylene glycol (C3H8O2) is a synthetic liquid substance that absorbs water and is miscible with a wide range of solvents. It can be used to absorb excess water and maintain moisture levels in pharmaceuticals, cosmetics, and other products.

[0046] Carbomer 934P is a high molecular weight polymer compound commonly used in the cosmetics industry, and more specifically, an acrylic acid homopolymer crosslinked with allyl curese or allyl pentaerythritol, designed for use in topical formulations of gels, emulsions, and suspensions. Carbomer can absorb large amounts of water, increasing in volume by up to 1,000 times, forming stable, spoilage-resistant gels and concentrated solutions.

[0047] Carbopol® 940 is a water-soluble polyvinyl carboxypolymer used as a viscosity enhancer, gelling agent, or suspension agent.

[0048] Transktol® is a highly purified form of diethylene glycol monoethyl ether (DEGEE), a solubilizer associated with enhanced skin penetration in topical dosage forms.

[0049] Triethanolamine acetate (TEA) is an emulsifying stabilizer and serves as a pH balancer in many different cosmetic products, including cleansing creams, skin lotions, eye gels, moisturizers, shampoos, and shaving foams.

[0050] Anhydrous ethyl alcohol acts as a preservative.

[0051] Acrylic polymers such as Fixate® G-100 (soluble in water and alcohol) may be included in the composition of the present invention to enhance the ease of brushing hair and to adjust the formation of the hair styling structure.

[0052] Waxes such as hydrocarbon waxes, mineral waxes, hard waxes, and / or microcrystalline waxes may be included as curing agents in the compositions of the present invention. Examples of hard waxes include, but are not limited to, Mycra wax (melting point "MP" approximately 45°C to 55°C), beeswax (MP approximately 61°C to 65°C), berry wax (MP approximately 48°C to 54°C), and rice bran wax (MP approximately 79°C to 85°C).

[0053] It is further intended that the compositions of the present invention be incorporated into various types of formulations for topical use, including but not limited to foams, gels, oils, emulsions, and sticks.

[0054] In the art, foams are known to consist of particle dispersions in a continuous medium, and / or colloidal systems in which the particles are bubbles and the medium is a liquid (i.e., clusters of small bubbles typically formed on or in a liquid by stirring or fermentation).

[0055] In the art, gels are known to be sols in which solid particles are meshed to produce a rigid or semi-rigid mixture. Crosslinking within the polymer or colloid network of a gel causes it to behave as a solid in its steady state and to be viscous. The majority of a gel mass is liquid, and therefore gels can flow under relatively low stress.

[0056] Oily substances are nonpolar chemicals that are viscous liquids at room temperature and are both hydrophobic and lipophilic.

[0057] An emulsion is a mixture of two immiscible liquids (i.e., two liquids that do not normally mix). An emulsion is a colloid in which both phases are liquids, and it contains fine particles of one liquid suspended in the other.

[0058] The stick intended by the present invention is a solid substance having a wax base and suitable for topical application. A suitable stick is solid (i.e., has a certain level of hardness as understood by those skilled in the art) but also retains the properties of the wax component so that the formulation can be easily applied to the target by rubbing it into, for example, a beard, mustache, eyebrows, etc.

[0059] The formulation of the present invention comprises 2% to 10% minoxidil, 0.01% to 15% prostaglandin analog, and optionally 0.01% to 15% finasteride, or the formulation comprises a sulfone such as dapsone, or the antibiotic minocycline (or tetracycline or doxycycline) as an active ingredient. In embodiments, the formulation comprises 2% to 5% minoxidil, 0.01% to 15% prostaglandin analog, and optionally 0.01% to 5% finasteride. In some embodiments, the formulation comprises minoxidil, a prostaglandin analog, dapsone, minocycline (or tetracycline or doxycycline), and optionally finasteride.

[0060] In a preferred embodiment, the formulation comprises 5% minoxidil and 0.03% prostaglandin analog. In another preferred embodiment, the composition also comprises 0.1% finasteride. In yet another preferred embodiment, the prostaglandin analog is latanoprost, travoprost, bimatoprost, tafluprost, unoprostone, or nitric oxide. In yet another preferred embodiment, the prostaglandin analog is a complex drug such as latanoprosten (a complex of latanoprost and nitric oxide).

[0061] In another embodiment, the formulation contains about 0.1% to about 60% dapsone. In a preferred embodiment, the formulation contains about 2% to about 6% dapsone. In yet another preferred embodiment, the formulation contains about 3.33% dapsone. In yet another preferred embodiment, the formulation contains about 5% dapsone.

[0062] In another embodiment, the formulation contains about 0.1% to about 20% minocycline, doxycycline, or tetracycline, and optionally cyclodextrin. In a preferred embodiment, the formulation contains about 2% to about 4% minocycline. In yet another preferred embodiment, the formulation contains about 3.33% minocycline.

[0063] In another embodiment, the use of the formulations of the present invention is intended to reduce hair loss and / or enhance hair regeneration in human subjects, and / or to manufacture pharmaceuticals for reducing hair loss and / or enhancing the regeneration of hair, such as scalp hair, beard or eyebrows, in human subjects. In another embodiment, some formulations of the present invention are intended for use in men and postmenopausal women. In another embodiment, some compositions of the present invention are intended for use in premenopausal women.

[0064] Some non-limiting examples of preferred embodiments of these formulations of the present invention are shown in Tables 1 to 13 below.

[0065] [Table 1]

[0066] [Table 2]

[0067] The hair foam formulations in Tables 1 and 2 enhance ease of application, extend retention time, and improve the ease of combing / brushing the hair. They also add volume to the hair, enhance hair shine, and help form the structure of the desired hair style.

[0068] [Table 3]

[0069] [Table 4]

[0070] The hair gel formulations in Tables 3 and 4 enhance ease of application and extend retention time. They also add volume to the hair and enhance its shine.

[0071] [Table 5]

[0072] [Table 6]

[0073] The hair oil formulations in Tables 5 and 6 enhance ease of application and extend retention time. They also add volume to the hair, enhance hair shine, and help form the structure of the desired hair style.

[0074] [Table 7]

[0075] [Table 8]

[0076] [Table 9]

[0077] [Table 10]

[0078] The hair stick formulations in Tables 9 and 10 can be used at least on the beard and eyebrow areas of the target area.

[0079] [Table 11]

[0080] [Table 12]

[0081] [Table 13]

[0082] Various methods for preparing the formulations of the present invention will be apparent to those skilled in the art.

[0083] While the present invention has been described in relation to its specific embodiments and uses, those skilled in the art will notice various modifications. The claims should not be limited by preferred embodiments or examples, but should be given the broadest possible interpretation that is generally consistent with the description.

Claims

1. A topical formulation for reducing hair loss and / or promoting hair growth, a) 2% (w / v) to 10% (w / v) minoxidil; b) 0.01% (w / v) to 5% (w / v) finasteride; c) A prostaglandin analog in an amount of 0.01% (w / v) to 1% (w / v), wherein the prostaglandin analog is latanoprost, travoprost, bimatoprost, tafluprost, unoprostone, or latanoprosten; and d) Labrafil® containing 35% (v / v) to 45% (v / v) of oleoyl polyoxyl-6 glyceride (Labrafil M1944CS) and lauroyl polyoxyl-6 glyceride (Labrafil M2130CS). A topical preparation containing [specific ingredient / material].

2. The topical formulation according to claim 1, wherein the prostaglandin analog is latanoprost.

3. The topical formulation according to claim 1, wherein the labrafil M2130CS accounts for 33% (v / v) of the total volume of the composition, and the labrafil M1944CS accounts for 8% (v / v) of the total volume of the composition.

4. A topical formulation according to claim 1, which is in the form of a foam, gel, oil, or emulsion.

5. A topical formulation for reducing hair loss and / or promoting hair growth, a) 2% (w / v) to 10% (w / v) minoxidil; b) A prostaglandin analog in an amount of 0.01% (w / v) to 1% (w / v), wherein the prostaglandin analog is latanoprost, travoprost, bimatoprost, tafluprost, unoprostone, or latanoprosten; and c) Labrafil® containing 35% (v / v) to 45% (v / v) of oleoyl polyoxyl-6 glyceride (Labrafil M1944CS) and lauroyl polyoxyl-6 glyceride (Labrafil M2130CS). A topical preparation containing [specific ingredient / material].

6. The topical formulation according to claim 5, wherein the prostaglandin analog is latanoprost.

7. The topical formulation according to claim 5, wherein the labrafil M2130CS accounts for 33% (v / v) of the total volume of the formulation, and the labrafil M1944CS accounts for 8% (v / v) of the total volume of the formulation.

8. The topical formulation according to claim 5, which is in the form of a foam, gel, oil, or emulsion.

9. A topical formulation according to any one of claims 1 to 8, comprising 8% (v / v) propylene glycol.

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