Anti-androgenic hair loss solution for men

Abstract

The present invention relates to the field of medicine / cosmetics and relates to a formulation that is a combination of several drugs available on the pharmaceutical market that are used to strengthen and regrow hair in men with androgenic alopecia. This solution uses 4 drugs: A: Minoxidil solution 5% B: Tretinoin solution 0.025% C: Finasteride 1% D: Niacinamide 2%, which helps to regrow hair and strengthen hair. Minoxidil dilates blood vessels, bringing more blood to the scalp. Finasteride is used to treat benign prostatic hyperplasia. One of the side effects of this drug is hirsutism. Tretinoin is a topical retinoid derived from vitamin A that is widely used in the treatment of acne and wrinkles. It has a synergistic effect with minoxidil by increasing permeability. Niacinamide is a form of vitamin B3 that is an anti-inflammatory, antioxidant, and skin barrier enhancer.

Description

Description of the invention Title of the invention Anti-androgenic hair loss solution for men Technical background of the relevant invention This invention is in the field of medicine / cosmetics and relates to controlling hair loss and helping to regrow hair in men. Technical problem and statement of invention objectives Currently, the most widely used drug available to prevent and control hair loss is minoxidil solution, which alone is not sufficient to treat and control androgenic alopecia. Therefore, some doctors use oral drugs to treat this type of hair loss. Due to the oral nature and systemic side effects of the drug, it causes many complications after a while, and the treatment process is interrupted for this reason, and the patient is forced to use other methods such as hair transplantation, which can also fail and is very expensive. Also, using only minoxidil solution causes severe dryness and itching of the scalp, which can also prevent the treatment process. In this proposed formulation, four drugs currently available in the Iranian pharmaceutical market have been used to form a solution suitable for the scalp. This formulation does not have the side effects of oral drugs due to its non-edible and topical solution form. The drugs in this formulation are: Minoxidil 5% Finasteride 0.1% Tretinoin 0.025% Niacinamide 2% A description of the state of the prior art and the history of developments related to the claimed invention. By searching the resources provided by the Intellectual Property Organization, a similar product was found, which is listed below with the year of registration and patent number. The combination of minoxidil and finasteride, patent number US20060034903A1, Merck Pharmaceutical Company, 2006 Minoxidil and tretinoin combination, patent number US20170014331A1, Apchan Pharmaceutical Company, 2017 The combination of finasteride and niacinamide, patent number US20180104251A1, Cipla Pharmaceutical Company, 2018 Minoxidil and niacinamide combination patent number US20200009021A1 by Rogaine Pharmaceutical Company in 2020 None of the previously filed patents used the four drugs minoxidil, finasteride, tretinoin, and niacinamide simultaneously in the form of a single product. Providing a solution to an existing technical problem along with an accurate, sufficient, and integrated description of the invention This medicinal solution is a combination of four drugs available on the pharmaceutical market, all of which are used separately for hair growth and have approvals from global organizations. The first drug that is commonly used for hair growth and prevention of androgenic hair loss is minoxidil solution 5%, which is originally a heart drug and has vasodilating properties. The next drug is tretinoin solution, a derivative of vitamin A that causes skin repair. The next drug is finasteride 1%, which is originally used to treat benign prostatic hyperplasia and is also used orally as an off-label use in the treatment of androgenetic alopecia. When this drug is used orally, due to the systemic side effects it has on other organs, the treatment process may not be complete and the treatment may be discontinued, which is why this drug was made as a solution to be used topically and to prevent its side effects. This formulation is specific to men because of the finasteride compounds.Tretinoin, by gently exfoliating and increasing cell turnover, makes the skin barrier more permeable. This increases the local absorption of other ingredients, especially minoxidil. It also stimulates collagen and growth factor synthesis by activating retinoid receptors and prolongs the hair growth phase. Niacinamide, by increasing ceramide synthesis, maintains scalp moisture and reduces inflammation. It also dilates capillaries, delivering more oxygen and nutrients to hair follicles, and its antioxidant properties protect follicles from free radical damage. Niacinamide reduces skin irritation caused by tretinoin. Product components: Minoxide 5%: Stimulates hair growth Finasteride 1%: Inhibits 5-alpha reductase, reduces DHT Tretinoin 0.025%: Increases permeability and follicle regeneration Niacinamide 2%: Reduces inflammation and strengthens the skin barrier. Ingredients and amount of each component in the product: Per 100 ml of solution: 5 grams of 5% minoxidil Finasteride 0.1% g 0.025% gr tretinoin 2% grams of niacinamide Basic and auxiliary values: Ethanol 30 ml Propylene glycol 20 ml Deionized water up to 100 ml Polysediments 80 half grams Sodium edetate 0.05g Methylparaben, one tenth of a gram Aloe vera gel, 1 gram Construction steps: A) Aqueous phase: Dissolve 2 grams of niacinamide in 40 ml of deionized water at 0°C. Add half a gram of sodium hydroxide and stir until completely dissolved. B) Alcoholic phase: In a separate beaker, dissolve one tenth of a gram of finasteride in 10 ml of ethanol, dissolve 5 grams of minoxidil + 25 hundredths of a gram of tretinoin in a mixture of 20 ml of ethanol + 20 ml of propylene glycol. c) Stir with a magnetic stirrer (500rpm) for 10 minutes, slowly add the alcoholic phase to the aqueous phase. While stirring with a magnetic stirrer, add half a gram of polysorbate 80 and stir for 5 minutes. Add one tenth of a gram of methyl paraben + one gram of aloe vera gel and bring the final volume to 100 ml with Dionysian water. Packaging: Fill in an amber bottle with a sterile spray pump. Store for up to 12 months at temperatures below 25°C. Label with warning for men only. Explanation of shapes, maps and diagrams This invention has no drawings or plans. A clear and precise statement of the advantages of the claimed invention over prior inventions. This solution controls hair loss, growth, and regrowth by targeting multiple hair cycles. Minoxidil increases blood flow and follicle nutrition, while finasteride inhibits 5-alpha-ductase, reducing DHT and preventing atrophy of androgen-sensitive follicles. This solution greatly reduces the side effects of oral finasteride. Tretinoin increases the expression of growth genes and stimulates keratinocyte differentiation and increases hair thickness. Niacinamide inhibits inflammation, reduces oxidative stress, and improves the skin barrier, and has a synergistic effect in reducing inflammation with tretinoin. Description of at least one implementation method for implementing the invention First, wash and dry the head, then spray 6 puffs of the medicine on each side of the head that has sparse hair and massage for 1 to 2 minutes. Repeat this twice a day for 3 to 6 months. It should be noted that the drug should not come into contact with pregnant women or women of childbearing age. Explicit mention of the industrial application of the invention This formulation is used for hair control and regrowth and has no other uses than those mentioned.

Claims

Claims What is claimed: Claim 1)(Independent claim) A topical pharmaceutical composition for the treatment of androgenetic alopecia in men comprising: minoxidil 5% w / v, finasteride 0.1% w / v, tretinoin 0.025% w / v, niacinamide 2% w / v and at least one pharmaceutically acceptable carrier. Claim 2) (dependent on claim 1): The pharmaceutical composition of claim 1, wherein the pharmaceutical carrier comprises a mixture of ethanol, propylene glycol, deionized water, polysorbate 80, sodium edetate, methylparaben, and aloe vera gel. Claim 3) (Independent) Method for preparing the pharmaceutical composition of claim 1, comprising: preparing an aqueous phase that includes dissolving 2 grams of niacinamide in 40 ml of deionized water and adding 0.05 grams of sodium edetate. Preparing an alcoholic phase that includes dissolving 0.1 grams of finasteride in 10 ml of ethanol and dissolving 5 grams of minoxidil and 0.025 grams of tretinoin in a mixture of 20 ml of ethanol and 20 ml of propylene glycol. The next step is to gradually add the alcoholic phase to the aqueous phase under stirring at a speed of 500 to 1000 rpm with a magnetic stirrer. After that, 0.5 grams of polysorbate 80 is added and stirred for another 5 minutes. Then, 0.1 grams of methylparaben and 1 gram of aloe vera gel are added and, after stirring, the final volume is adjusted with 100 ml of deionized water.