Hair loss therapy

Abstract

A pharmaceutical package for treating / preventing hair loss in a subject comprising a first pharmaceutical composition for oral administration of a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator, a second pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of a 5-α reductase inhibitor and a third pharmaceutical composition for oral administration, or either / and the first or second pharmaceutical composition, comprising a therapeutically effective or prophylactically effective amount of one or more hair growth / hair loss prevention supplements. A single pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator, a therapeutically effective or prophylactically effective amount of a 5-α reductase inhibitor and a therapeutically effective or prophylactically effective amount of one or more hair growth / hair loss prevention supplements. Methods of treating or preventing hair loss using the disclosed compositions and packages

Description

HAIR LOSS THERAPYTECHNICAL FIELD

[0001] This disclosure relates to therapy for hair loss.BACKGROUND

[0002] Hair loss (alopecia) is a loss of hair from part of the head or body of a person, though typically at least the head is involved. Hair loss can be quite severe and results in baldness. Hair loss in some people causes psychological distress. But hair loss is a common problem.SUMMARY

[0003] In one aspect, this disclosure provides a pharmaceutical package for treating or preventing hair loss in a subject comprising:a first pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator; a second pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of a 5a-reductase inhibitor;and either or both a third pharmaceutical composition for oral administration and / or the first or the second pharmaceutical composition, or both, comprising a therapeutically effective or prophylactically effective amount of one or more hair growth / hair loss prevention supplements.

[0004] In another aspect, this disclosure provides a single pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator, a therapeutically effective or prophylactically effective amount of a 5a-reductase inhibitor, and a therapeutically effective or prophylactically effective amount of one or more hair growth / hair loss prevention supplements.

[0005] In yet another aspect, this disclosure provides a method of treating or preventing hair loss in a subject in need thereof comprising administering the disclosed single composition or the disclosed compositions in the disclosed pharmaceutical package to a subject in need thereof.

[0006] In another aspect, a single pharmaceutical composition for oral administration is provided. The composition comprises a therapeutically effective or prophylactically effectiveamount of minoxidil, or a similar antihypertensive vasodilator, and a 5-alpha reductase inhibitor for treating or preventing androgenic alopecia in a subject.

[0007] In another aspect, this disclosure provides a method of treating or preventing androgenic alopecia in a subject in need thereof comprising administering by oral administration a disclosed single pharmaceutical composition to said subject.

[0008] In another aspect, a pharmaceutical package is provided for treating or preventing androgen alopecia in a subject comprising a pharmaceutical composition for oral administration of a therapeutically effective or prophylactic ally effective amount of minoxidil, or a similar antihypertensive vasodilator, and a pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of a 5-alpha reductase inhibitor.

[0009] In yet another aspect, this disclosure provides a method of treating or preventing androgenic alopecia in a subject in need thereof comprising administering by oral administration a disclosed pharmaceutical package to said subject.

[0010] Numerous other aspects are provided in accordance with these and other aspects of the invention. Other features and aspects of the present invention will become more fully apparent from the following detailed description and the appended claims.DETAILED DESCRIPTION

[0011] As used herein, unless otherwise indicated, the word “a” or “plurality” before a noun represents one or more of the particular noun.

[0012] Unless otherwise stated herein, the term “a single pharmaceutical composition” does not represent more than one composition.

[0013] For the terms “for example” and “such as,” and grammatical equivalences thereof, the phrase “and without limitation” is understood to follow unless explicitly stated otherwise. As used herein, the term “about” is meant to account for variations due to experimental error. All measurements reported herein are understood to be modified by the term “about,” whether or not the term is explicitly used, unless explicitly stated otherwise. As used herein, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.

[0014] “Effective amount,” “prophylactically effective amount,” or “therapeutically effective amount” refers to an amount of an agent or composition that provides a beneficial effect orfavorable result to a subject, or alternatively, an amount of an agent or composition that exhibits the desired in vivo or in vitro activity. “Effective amount,” “prophylactically effective amount,” or “therapeutically effective amount” refers to an amount of an agent or composition that provides the desired biological, therapeutic, and / or prophylactic result. That result can be reduction, amelioration, palliation, lessening, delaying, and / or alleviation of one or more of the signs, symptoms, or causes of a disease, disorder or condition in a patient / subject, or any other desired alteration of a biological system. “Effective amount,” “prophylactically effective amount,” or “therapeutically effective amount” can be an amount administered as more than one dose of a formulation / composition. That more than one dose can be administered, for example, daily.

[0015] In cases where more than one drug is administered to a subject, “effective amount,” “prophylactically effective amount,” or “therapeutically effective amount” refers to an amount of one of the drugs that either is effective, prophylactically effective, or therapeutically effective by itself or in combination with an amount of the other drug(s).

[0016] As used herein, a “patient” and a “subject” are interchangeable terms and may refer to a human patient / subject. a non-human primate, etc.

[0017] All ranges disclosed herein are to be understood to encompass any and all subranges subsumed therein. For example, a stated range of “1.0 to 10.0” should be considered to include any and all subranges beginning with a minimum value of 1.0 or more and ending with a maximum value of 10.0 or less, e.g., 1.0 to 5.3, or 4.7 to 10.0, or 3.6 to 7.9.

[0018] All ranges disclosed herein are also to be considered to include the end points of the range, unless expressly stated otherwise. For example, a range of “between 5 and 10” or “5 to 10” or “5-10” should be considered to include the end points 5 and 10.

[0019] It is further to be understood that the feature or features of one embodiment may generally be applied to other embodiments, even though not specifically described or illustrated in such other embodiments, unless expressly prohibited by this disclosure or the nature of the relevant embodiments. Likewise, compositions and methods described herein can include any combination of features and / or steps described herein not inconsistent with the objectives of the present disclosure. Numerous modifications and / or adaptations of the compositions and methods described herein will be readily apparent to those skilled in the art without departing from the present subject matter.

[0020] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Methods and materials are described herein for use in the present invention; other, suitable methods and materials known in the art can also be used. The materials, methods, and examples are illustrative only and not intended to be limiting. All publications, patent applications, patents, sequences, database entries, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present specification, including definitions, will control.

[0021] HAIR LOSS

[0022] Hair loss (alopecia) is a loss of hair from part of the head or the body, though typically at least the head is involved. Hair loss can be quite severe and can result in baldness. Hair loss in some people causes psychological distress. Hair loss is a common problem, especially in men, but also in women. It can be temporary or permanent.

[0023] Hair loss in humans is caused by a number of conditions, including, without limitation, androgenic alopecia, telogen effluvium, anagen effluvium, alopecia areata, tinea capitis, cicatricial alopecia, hair shaft abnormalities, and hypotrichosis.

[0024] Androgenic alopecia is the most common type of hair loss, affecting more than 50 million men and 30 million women in the United States. It is commonly known as “male pattern hair loss” or “female pattern hair loss.”

[0025] Telogen effluvium occurs when large numbers of follicles on the scalp enter the resting phase of the hair growth cycle, called telogen, but the next growth phase does not begin. This causes hair to fall out all over the scalp without new hair growth. Telogen effluvium does not generally lead to complete baldness. A medical event or condition, such as a thyroid imbalance, childbirth, surgery, or a fever, typically triggers this type of hair loss. Telogen effluvium may also occur as a result of vitamin or mineral deficiency. Iron deficiency is a common cause of this type of hair loss in women. Use of certain medications, such as isotretinoin, prescribed for acne, or warfarin, a blood thinner and starting or stopping oral contraceptives may also cause this type of hair loss.

[0026] Anagen effluvium is a rapid hair loss resulting from medical treatment, such as chemotherapy. These potent and fast-acting medications kill cancer cells, but they may also shut down hair follicle production in the scalp and other parts of the body.

[0027] Alopecia areata is an autoimmune condition; the body’s immune system attacks the person’s hair follicles. This causes hair to fall out and prevents new hair from growing. This condition can affect adults and children, and hair loss can begin suddenly and without warning. Hair from the scalp typically falls out in small patches and is not painful. Hair in other parts of the body, including the eyebrows and eyelashes, may also fall out. Over time, this disease may lead to alopecia totalis, or complete hair loss.

[0028] Tinea capitis, also called scalp ringworm, is a fungal infection of the scalp that is a common cause of hair loss in children. This condition causes hair to fall out in patches, sometimes circular, leading to bald spots that may get bigger over time.

[0029] Cicatricial alopecia, also known as scarring alopecia, is a rare type of hair loss in which inflammation destroys hair follicles and causes scar tissue to form in their place. After scar tissue forms, hair does not regrow. This type of hair loss can occur at any age and affects men and women. Types of cicatricial alopecia include lichen planopilaris, discoid lupus erythematosus, fooliculitis decalvans, dissecting cellulitis of the scalp, and central centrifugal cicatricial alopecia.

[0030] Several types of hair shaft abnormalities can lead to hair loss. These conditions cause strands of hair to thin and weaken, making them vulnerable to breaking. The hair loss does not occur in the follicle but as a result of a break somewhere along the hair shaft, which is the visible part of a hair strand. This can result in overall thinning, as well as in many small, brittle hairs. Types of hair shaft abnormalities include loose anagen syndrome, trichotillomania, and traction alopecia.

[0031] Hypotrichosis is a rare genetic condition in which very little hair grows on the scalp and body. Babies born with this condition may have typical hair growth at first; however, their hair falls out a few months later and is replaced with sparse hair. Many people with hypotrichosis are bald by age 25.

[0032] Finasteride (C23H36N2O2) is usually prescribed as a 1 mg pill for oral administration to treat hair loss in a subject; a topical formulation does exist although not commonly used.

[0033] Results of phase III clinical studies in 1,879 men have shown that oral finasteride at 1 mg / day promotes hair growth and prevents further hair loss in a significant proportion of men with male pattern hair loss. Evidence suggests that the improvement in hair count reported after 1 year is maintained during 2 years of treatment. In men with vertex hair loss, global photographsshowed improvement in hair growth in 48% of finasteride recipients at 1 year and in 66% at 2 years compared with 7% of placebo recipients at each time point. Furthermore, hair counts in these men showed that 83% of finasteride versus 28% of placebo recipients had no further hair loss compared with baseline after 2 years.

[0034] Minoxidil (C9H15N5O) is relatively successful for hair treatment, applied topically on to scalp of a subject / patient as a scalp tonic or foam. This is the preferred and first choice of minoxidil treatment as topical minoxidil products are well established for their safety and effectiveness.

[0035] There are certain circumstances that minoxidil can be taken orally as a tablet. Oral minoxidil can be considered for hair loss especially if: topical minoxidil preparations cause a rash, irritation, or allergy; there is a lack of any benefit from topical minoxidil after 6 months of diligent use; topical minoxidil causes poor hair texture - sometimes minoxidil can cause dry, tangled hair that is prone to breakage; and other difficulties using topical minoxidil, causing compliance problems.

[0036] Oral minoxidil is mainly used for male and female pattern hair loss. However, there can be benefit with other types of hair loss too including telogen effluvium, traction alopecia and loose anagen syndrome.

[0037] The studies with oral minoxidil are very small but indicate that about one third of patients will notice a reduction in shedding, and a third will notice improved growth in 6 months or more. This means that up to 2 in 3 people out of 10 will benefit from oral minoxidil at 6 months. It is best to take treatment for 6 to 12 months to give it enough time to work.

[0038] The only head to head study comparing oral minoxidil to topical minoxidil in women with Female Pattern Hair Loss showed that 1 mg of minoxidil gave comparable effects to 5% solution (1 ml) once a day. Ramos, P. M. et al., J Am Acad Dermatol 2020; 82: 252-253. In this study. 26 women received oral minoxidil and 26 women received topical minoxidil. After 24 weeks of treatment, there was a 12% increase in hair density for women on oral minoxidil and 7.2% increase for women applying topical minoxidil. The difference was not statistically significant but the oral minoxidil group also had less hair shedding.

[0039] Minoxidil is available in 2.5 mg, 5 mg and 10 mg tablets. A common starting dose is 0.625 mg per day. The optimum dose for hair loss is not entirely clear. It may be in the region of 0.625 mg to 2.5 mg per day. For men, a slightly higher dose may sometimes be required.

[0040] Doses of minoxidil for hair loss are considered ‘low dose’. This is because the doses used for hair loss are a lot lower than the doses which are used for conditions such as hypertension. The doses used for hypertension are 10-40 mg per day.

[0041] Side effects are very uncommon at the low doses which are used to treat hair loss. The largest study looking at side effects (Vano-Galvan S. et al.. J Am Acad Dermatol 2021; 84: 1644-1651) showed that in 943 women and 461 men, 2.5% of women and 0.5% of men had to stop treatment because of a side effect.

[0042] Several hair growth / hair loss prevention supplements are available for purchase. These supplements can be used to treat or to prevent hair loss. These include: NourishVita®; Nutrafol; Viviscal™; SugarBearHair; Vegamour; Moon Juice; and HAIRtamin.

[0043] At least one version of NourishVita® comprises the following ingredients: vitamin A, vitamin C, vitamin D3, thiamin, riboflavin (vitamin B2), niacinamide, folate, vitamin B12, zinc, copper, pantothenic acid, L-lysine hydrochloride, L-cysteine, citrus bioflavonoids, L-proline, horsetail extract, and biotin.

[0044] At least one version of Nutrafol comprises the following ingredients: vitamin A, vitamin C, vitamin D, vitamin E, iodine from organic kelp, selenium, zinc, biotin, collagen, Indian ginseng (Ashwagandha), saw palmetto extract, curcumin, tocotrienol, tocopherol, hyaluronic acid, L-cysteine, L-lysine, L-methionine, solubilized keratin, horsetail extract, resveratrol, black pepper, and capsicum extract.

[0045] At least one version of Viviscal™ comprises the following ingredients: niacin, calcium, a blend of shark and mollusk powder, biotin, zinc, vitamin C, horsetail extract, millet seed extract, and iron.

[0046] At least one version of SugarBearHair comprises the following ingredients: vitamin A, vitamin C, vitamin D, vitamin E, vitamin B-6, folic acid, vitamin B-12, biotin, pantothenic acid, iodine, zinc, choline, and inositol.

[0047] At least one version of Vegamour comprises the following ingredients: tapioca syrup, cane sugar, dextrose, citric acid, and medium-chain triglyceride (MCT) oil.

[0048] At least one version of Moon Juice comprises the following ingredients: organic Indian ginseng (ashwagandha), organic Acerola cherry, organic Amla, astaxanthin, organic vitamin B1, organic vitamin B2, organic vitamin B3, organic vitamin B5, organic vitamin B6, organic vitamin B9, vitamin B12 (methylcobalamin), ginseng, horsetail, beta glucans, hyaluronic acid,kelp, reduced L-glutathione, L-theanine, magnesium chelate, vitamin A, vitamin Bl, vitamin B2, vitamin B3, vitamin B6, vitamin B 12, vitamin C, vitamin D3, vitamin E, vitamin K2, wildcrafted rhodiola, wildcrafted saw palmetto, schisandra, shatavari, silica, silver ear mushroom, tocos, liposomal vitamin C, and chelated zinc.

[0049] At least one version of HAIRtamin® comprises the following ingredients: vitamin A, vitamin C, vitamin D3, vitamin D, riboflavin, vitamin B6, folate, vitamin B12, pantothenic acid, biotin, thiamin, cayenne, stinging nettle, turmeric, zinc, selenium, aloe vera leaf powder, brahmi extract (Bacopa monnien), rosemary leaf powder, stinging nettle root powder, lutein, horsetail herb extract, piperine, hydroxypropyl methyl capsule, magnesium stearate and rice flour.

[0050] METHODS AND COMPOSITIONS

[0051] In one aspect, this disclosure provides pharmaceutical package for treating or preventing hair loss in a subject comprising:a first pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator; a second pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of a 5a-reductase inhibitor;and either or both a third pharmaceutical composition for oral administration and / or the first or the second pharmaceutical composition, or both, comprising a therapeutically effective or prophylactically effective amount of one or more hair growth / hair loss prevention.

[0052] In some embodiments, the package comprises a first pharmaceutical composition for oral administration of a therapeutically effective or prophylactically effective amount of minoxidil. In some embodiments, the pharmaceutical package comprises a second pharmaceutical composition for oral administration of a therapeutically effective or prophylactically effective amount of finasteride. In other embodiments, the pharmaceutical package comprises a second pharmaceutical composition for oral administration of a therapeutically effective or prophylactically effective amount of dutasteride.

[0053] In some embodiments, the first composition comprises minoxidil at about 2.5 mg to about 5 mg. In some embodiments, the second pharmaceutical composition comprises finasteride at about 1 mg to about 5 mg. In certain embodiments, the first composition comprises minoxidil at about 2.5 mg and the second composition comprises finasteride at about 1 mg or about 5 mg. Insome embodiments, the first composition comprises minoxidil at about 2.5 mg or about 5 mg and the second composition comprises finasteride at about 2.5 mg.

[0054] Any hair growth supplement(s) and / or hair loss prevention supplement(s) can be a part of the disclosed package or disclosed composition, or used in the disclosed methods.

[0055] In some embodiments, these include one or more of: NourishVita®; Nutrafol; Viviscal™; SugarBearHair; Vegamour; Moon Juice; and HAIRtamin. In some embodiments, the supplements are one or more ingredients of any of NourishVita®; Nutrafol; Viviscal™;SugarBearHair; Vegamour; Moon Juice; and HAIRtamin. Any version of NourishVita®;Nutrafol; Viviscal™; SugarBearHair; Vegamour; Moon Juice; and HAIRtamin is included.

[0056] In some embodiments, either or both the third pharmaceutical composition and / or the first or the second pharmaceutical composition, or both, comprises one or more hair growth / hair loss prevention supplements selected from the group consisting of zinc, B-vitamins, tocotrienols, and saw palmetto. In some embodiments, the B-vitamins are one or more of vitamin B2 (Riboflavin), B3 (Niacin), B7 (Biotin), B9 (Folic acid), and B 12 (Cobalamin).

[0057] In some embodiments, either or both the third pharmaceutical composition and / or the first or the second pharmaceutical composition, or both, comprises hair growth / hair loss prevention supplements selected from the group consisting of vitamin A, vitamin Bl, vitamin B2, vitamin B3, vitamin B5, vitamin B-6, vitamin B9, vitamin B-12, vitamin C, vitamin D3, vitamin D, vitamin E, vitamin K2, thiamin, biotin, niacin, folate, iron, iodine, zinc, copper, pantothenic acid, L-lysine, L-cysteine, L-methionine, L-proline, citrus bioflavonoids, horsetail extract, iodine from organic kelp, selenium, collagen, Indian ginseng (Ashwagandha), saw palmetto extract, curcumin, tocotrienol. tocopherol, hyaluronic acid, solubilized keratin, horsetail extract. resveratrol, black pepper, capsicum extract, calcium, a blend of shark and mollusk powder, millet seed extract, choline, inositol, tapioca syrup, cane sugar, dextrose, citric acid, medium-chain triglyceride (MCT) oil, Indian ginseng (ashwagandha). Acerola cherry, Amla, astaxanthin, ginseng, beta glucans, hyaluronic acid, kelp, reduced L-glutathione, L-theanine, magnesium chelate, wildcrafted rhodiola, wildcrafted saw palmetto, schisandra, shatavari, silica, silver ear mushroom, tocos, chelated zinc, cayenne, stinging nettle, turmeric, aloe vera leaf powder, brahmi extract (Bacopa monnieri). rosemary leaf powder, stinging nettle root powder, lutein, horsetail herb extract, piperine, hydroxypropyl methyl capsule, magnesium stearate and rice flour.

[0058] In some embodiments, the hair growth / hair loss prevention supplements comprise one or more of zinc, B-vitamins, tocotrienols, saw palmetto, and biotin. In other embodiments, the hair growth / hair loss prevention supplements further comprise one or more of hydrolyzed collagen, keratin, vitamin-C, and iron.

[0059] In some embodiments, the hair growth / hair loss prevention supplements comprise one or more of hydrolyzed collagen, keratin, vitamin-C, and iron.

[0060] In some embodiments, the pharmaceutical package comprises either or both a third pharmaceutical composition, and / or either of the first or the second pharmaceutical composition, or both, comprises or comprise hair growth / hair loss prevention supplements. The hair growth / hair loss prevention supplements comprise one or more hair growth / hair loss prevention supplements selected from the group consisting of vitamin A, vitamin C, vitamin D3, thiamin, riboflavin (vitamin B2), niacinamide, folate, vitamin B12, zinc, copper, pantothenic acid, L-lysine hydrochloride, L-cysteine, citrus bioflavonoids, L-proline, horsetail extract, and biotin.

[0061] In some embodiments, the pharmaceutical package comprises either or both a third pharmaceutical composition, and / or either of the first or the second pharmaceutical composition, or both, comprises or comprise hair growth / hair loss prevention supplements. The hair growth / hair loss prevention supplements comprises one or more hair growth / hair loss prevention supplements selected from the group consisting of vitamin A, vitamin C, vitamin D, vitamin E, iodine from organic kelp, selenium, zinc, biotin, collagen, Indian ginseng (Ashwagandha), saw palmetto extract, curcumin, tocotrienol, tocopherol, hyaluronic acid, L-cysteine, L-lysine, L-methionine, solubilized keratin, horsetail extract, resveratrol, black pepper, and capsicum extract.

[0062] In some embodiments, the pharmaceutical package comprises the pharmaceutical package comprising either or both a third pharmaceutical composition, and / or either of the first or the second pharmaceutical composition, or both, comprises or comprise hair growth / hair loss prevention supplements. The hair growth / hair loss prevention supplements comprises one or more hair growth / hair loss prevention supplements selected from the group consisting of niacin, calcium, a blend of shark and mollusk powder, biotin, zinc, vitamin C, horsetail extract, millet seed extract, and iron.

[0063] In some embodiments, the pharmaceutical package comprises either or both a third pharmaceutical composition, and / or either of the first or the second pharmaceutical composition, or both, comprises or comprise hair growth / hair loss prevention supplements. The hairgrowth / hair loss prevention supplements comprise one or more hair growth / hair loss prevention supplements selected from the group consisting of vitamin A, vitamin C, vitamin D, vitamin E, vitamin B-6, folic acid, vitamin B-12, biotin, pantothenic acid, iodine, zinc, choline, and inositol.

[0064] In some embodiments, the pharmaceutical package comprises either or both a third pharmaceutical composition, and / or either of the first or the second pharmaceutical composition, or both, comprises or comprise hair growth / hair loss prevention supplements. The hair growth / hair loss prevention supplements comprise one or more hair growth / hair loss prevention supplements selected from the group consisting of, tapioca syrup, cane sugar, dextrose, citric acid, and medium-chain triglyceride (MCT) oil.

[0065] In some embodiments, the pharmaceutical package comprises either or both a third pharmaceutical composition, and / or either of the first or the second pharmaceutical composition, or both, comprises or comprise hair growth / hair loss prevention supplements. The hair growth / hair loss prevention supplements comprise one or more hair growth / hair loss prevention supplements selected from the group consisting of organic Indian ginseng (ashwagandha), organic Acerola cherry, organic Amla, astaxanthin, organic vitamin B1, organic vitamin B2, organic vitamin B3, organic vitamin B5, organic vitamin B6, organic vitamin B9, vitamin B12 (methylcobalamin), ginseng, horsetail, beta glucans, hyaluronic acid, kelp, reduced L-glutathione, L-theanine, magnesium chelate, vitamin A, vitamin Bl, vitamin B2, vitamin B3, vitamin B6, vitamin B 12, vitamin C, vitamin D3, vitamin E, vitamin K2, wildcrafted rhodiola, wildcrafted saw palmetto, schisandra, shatavari, silica, silver ear mushroom, tocos, liposomal vitamin C, and chelated zinc.

[0066] In some embodiments, the pharmaceutical package comprises either or both a third pharmaceutical composition, and / or the first or the second pharmaceutical composition, or both, comprises or comprise one or more hair growth / hair loss prevention supplements selected from the group consisting of vitamin A, vitamin C, vitamin D3, vitamin D, riboflavin, vitamin B6, folate, vitamin B12, pantothenic acid, biotin, thiamin, cayenne, stinging nettle, turmeric, zinc, selenium, aloe vera leaf powder, brahmi extract (Bacopa monnieri), rosemary leaf powder, stinging nettle root powder, lutein, horsetail herb extract, piperine, hydroxypropyl methyl capsule, magnesium stearate and rice flour.

[0067] In cases where the disclosed pharmaceutical package comprises two pharmaceutical compositions, either or both comprise hair growth / hair loss prevention supplements. In caseswhere the disclosed pharmaceutical package comprises three pharmaceutical compositions, any of the three, any two of the three, or all of the three comprise hair growth / hair loss prevention supplements.

[0068] In some embodiments, the pharmaceutical package comprises a first pharmaceutical composition comprising minoxidil at about 2.5 mg or about 5 mg, a second pharmaceutical composition comprising finasteride at about 2.5 mg. In further embodiments, the pharmaceutical package comprises composition further comprises hair growth / hair loss prevention supplements either / and in a third pharmaceutical composition or in either or both first and second composition.

[0069] In certain embodiments, any of the first, second or third pharmaceutical composition is in liquid form.

[0070] In some embodiments, the package is administered to a patient either once or twice a day, each time the first, the second, and the third (if present) pharmaceutical compositions are administered to the patient.

[0071]

[0072] In some embodiments, the pharmaceutical package is a capsule, a tablet, a caplet, a blister pack, or a combi pack blister pack.

[0073] In some embodiments, the pharmaceutical package is a multi-component oral tablets / capsules in blister-pack format labeled with dosing instructions for day 1, day 2, day 3 etc.

[0074] In some embodiments, the hair loss is due to androgenic alopecia. In some embodiments, the hair loss is due to telogen effluvium and the first composition comprises about 25 mg to about 30 mg minoxidil.

[0075] In some embodiments, the hair loss is due to alopecia areata. In further embodiments, the hair loss is due to alopecia areata and the first composition comprises about 3 mg to about 30 mg minoxidil.

[0076] In some embodiments, a method of treating or preventing a patient with hair loss due to androgenic alopecia is provided; the method comprising administering to a patient in need thereof a disclosed pharmaceutical package comprising a tablet, a caplet, a blister pack, or a combi pack blister pack.

[0077] In some embodiments, a method of treating or preventing a patient with hair loss due to alopecia areata is provided; the method comprising administering to a patient in need thereof a disclosed pharmaceutical package comprising a tablet, a caplet, a blister pack, or a combi pack blister pack.

[0078] In some embodiments, the pharmaceutical package is a solution or a bottle of minoxidil for topical administration, a tablet, caplet, blister pack, or combi pack blister pack of finasteride for oral administration and hair growth / hair loss prevention supplements comprising one or more of zinc, B-vitamins, tocotrienols, saw palmetto, and biotin. In some embodiments, the package is a combo-pack labeled with dosing instructions for day 1, day 2, day 3 etc.

[0079] In some embodiments, the pharmaceutical package comprises a solution or a bottle of minoxidil at about 5% or about 8% (or between about 5% to about 8%) for topical administration, and a tablet, caplet, blister pack, or combi pack blister pack of finasteride at about 2.5 mg for oral administration. In further embodiments, the package further comprises hair growth / hair loss prevention supplements.

[0080] In some embodiments, the pharmaceutical package comprises a solution or a bottle of minoxidil at about 5% or about 8% (or between about 5% to about 8%) for topical administration; a tablet, caplet, blister pack, or combi pack blister pack of finasteride at about 2.5 mg for oral administration; a tablet, caplet, blister pack, or combi pack blister pack of minoxidil at about 2.5 mg or about 5 mg for oral administration. In further embodiments, the package further comprises hair growth / hair loss prevention supplements.

[0081] In some embodiments, a method of treating or preventing a patient with hair loss due to androgenic alopecia is provided; the method comprising administering to a patient in need thereof the pharmaceutical package comprising a solution or a bottle of minoxidil for topical administration, and a tablet, caplet, blister pack, or combi pack blister pack of finasteride for oral administration and hair growth / hair loss prevention supplements comprising one or more of zinc, B-vitamins, tocotrienols, saw palmetto, and biotin. In some embodiments, the pharmaceutical package is a tablet, a caplet, a blister pack, or a combi pack blister pack comprising minoxidil and finasteride, both for oral administration, hair growth / hair loss prevention supplements comprising one or more of zinc, B-vitamins, tocotrienols, saw palmetto, and biotin and a solution or a bottle of minoxidil for topical administration. In some embodiments, the package is a combo-pack labeled with dosing instructions for day 1, day 2, day 3 etc.

[0082] In some embodiments, a method of treating or preventing a patient with hair loss due to androgenic alopecia is provided; the method comprising administering to a patient in need thereof the pharmaceutical package comprising a tablet, a caplet, a blister pack, or a combi pack blister pack comprising minoxidil and finasteride, both for oral administration, hair growth / hair loss prevention supplements comprising one or more of zinc, B-vitamins, tocotrienols, saw palmetto, and biotin and a solution or a bottle of minoxidil for topical administration.

[0083] Any hair growth supplement^ ) / hair loss prevention supplement(s) can be part of the package. In some embodiments, the pharmaceutical package comprises either a third pharmaceutical composition or either of the first or the second pharmaceutical composition, or both, comprising hair growth / hair loss prevention supplements. The hair growth / hair loss prevention supplements comprises one or more hair growth / hair loss prevention supplements selected from the group consisting of, vitamin A, vitamin Bl, vitamin B2, vitamin B3, vitamin B5, vitamin B-6, vitamin B9, vitamin B-12, vitamin C, vitamin D3, vitamin D, vitamin E, vitamin K2, thiamin, biotin, niacin, folate, iron, iodin, zinc, copper, pantothenic acid, L-lysine, L-cysteine, L-methionine, L- proline, citrus bioflavonoids, horsetail extract, iodine from organic kelp, selenium, collagen, Indian ginseng (Ashwagandha), saw palmetto extract, curcumin, tocotrienol, tocopherol, hyaluronic acid, solubilized keratin, horsetail extract, resveratrol, black pepper, capsicum extract, calcium, a blend of shark and mollusk powder, millet seed extract, choline, inositol, tapioca syrup, cane sugar, dextrose, citric acid, medium-chain triglyceride (MCT) oil, Indian ginseng (ashwagandha), Acerola cherry, Amla, astaxanthin, ginseng, beta glucans, hyaluronic acid, kelp, reduced L- glutathione, L-theanine, magnesium chelate, wildcrafted rhodiola, wildcrafted saw palmetto, schisandra, shatavari, silica, silver ear mushroom, tocos, chelated zinc, cayenne, stinging nettle, turmeric, aloe vera leaf powder, brahmi extract (Bacopa monnieri), rosemary leaf powder, stinging nettle root powder, lutein, horsetail herb extract, piperine, hydroxypropyl methyl capsule, magnesium stearate and rice flour. The disclosed composition comprises any of these supplements or any combination thereof.

[0084] In some embodiments, any of the first composition, second composition or third pharmaceutical composition of the pharmaceutical package is in liquid form. In some embodiments, two or three pharmaceutical compositions of the disclosed package are in liquid form. In some embodiments, the two or three compositions are mixed together shortly before been administered to the subject. In some embodiments, the two or three compositions are mixedtogether immediately before administration. In other embodiments, the three compositions are mixed together within a day before administration. Any person can mix the compositions together, including, without limitation, the subject, a caregiver for the subject, and a pharmacist or another person at the pharmacy. Liquid form includes, without limitation, liquid (a solution), semi-liquid and suspension. The liquid form is in any suitable liquid, semi-liquid or suspension.

[0085] The hair loss can be caused by any condition or disease. In some embodiments, the hair loss is due to androgenic alopecia. In some embodiments, the hair loss is due to telogen effluvium and the first composition comprises about 25 mg to about 30 mg minoxidil, with or without the third composition. In some embodiments, the hair loss is due to alopecia areata and the first composition comprises about 3 mg to about 30 mg minoxidil, with or without the third composition.

[0086] The pharmaceutical package can be any suitable package. In some embodiments, the pharmaceutical package is a blister pack.

[0087] In another aspect, this disclosure provides a single pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator, a therapeutically effective or prophylactically effective amount of a 5a-reductase inhibitor, and a therapeutically effective or prophylactically effective amount of one or more hair growth / hair loss prevention supplements. In some embodiments, the 5a-reductase inhibitor is finasteride. In other embodiments, the 5a-reductase inhibitor is dutasteride.

[0088] In some embodiments, the single pharmaceutical composition comprises minoxidil at about 2.5 mg to about 5 mg. In some embodiments, the single pharmaceutical composition comprises finasteride at about 1 mg to about 5 mg. In some embodiments, the single pharmaceutical composition comprises minoxidil at about 2.5 mg and finasteride at about 1 mg or about 5 mg. In some embodiments, the single pharmaceutical composition comprises minoxidil at about 2.5 mg or about 5 mg and finasteride at about 2.5 mg. In further embodiments, the single composition further comprises hair growth / hair loss prevention supplements.

[0089] In some embodiments, the single pharmaceutical composition comprises one or more hair growth / hair loss prevention supplements selected from the group consisting of zinc, B-vitamins,tocotrienols, and saw palmetto. In some embodiments, the B-vitamins are one or more of vitamin B2 (Riboflavin), B3 (Niacin), B7 (Biotin), B9 (Folic acid), and B12 (Cobalamin).

[0090] In some embodiments, the single pharmaceutical composition comprises one or more hair growth / hair loss prevention supplements selected from the group consisting of vitamin A, vitamin Bl, vitamin B2, vitamin B3, vitamin B5, vitamin B-6, vitamin B9, vitamin B-12, vitamin C, vitamin D3, vitamin D, vitamin E, vitamin K2, thiamin, biotin, niacin, folate, iron, iodin, zinc, copper, pantothenic acid, L-lysine, L-cysteine, L-methionine, L-proline, citrus bioflavonoids, horsetail extract, iodine from organic kelp, selenium, collagen, Indian ginseng (Ashwagandha), saw palmetto extract, curcumin, tocotrienol, tocopherol, hyaluronic acid, solubilized keratin, horsetail extract, resveratrol, black pepper, capsicum extract, calcium, a blend of shark and mollusk powder, millet seed extract, choline, inositol, tapioca syrup, cane sugar, dextrose, citric acid, medium-chain triglyceride (MCT) oil, Indian ginseng (ashwagandha), Acerola cherry, Amla, astaxanthin, ginseng, beta glucans, hyaluronic acid, kelp, reduced L-glutathione, L-theanine, magnesium chelate, wildcrafted rhodiola, wildcrafted saw palmetto, schisandra, shatavari, silica, silver ear mushroom, tocos, chelated zinc, cayenne, stinging nettle, turmeric, aloe vera leaf powder, brahmi extract (Bacopa monnieri), rosemary leaf powder, stinging nettle root powder, lutein, horsetail herb extract, piperine, hydroxypropyl methyl capsule, magnesium stearate and rice flour.

[0091] In some embodiments, the hair loss is due to androgenic alopecia. In further embodiments, the hair loss is due to androgenic alopecia and the single pharmaceutical composition comprises about 0.2 mg to about 5 mg finasteride. In other embodiments, the hair loss is due to androgenic alopecia and the single pharmaceutical composition comprises about 0.625 mg to about 10 mg minoxidil. In other embodiments, the hair loss is due to androgenic alopecia and the single pharmaceutical composition comprises about 0.625 mg, about 2.5 mg, about 5 mg, or about 10 mg minoxidil.

[0092] In certain embodiments, the hair loss is due to telogen effluvium. In other embodiments, the hair loss is due to telogen effluvium a and the single pharmaceutical composition comprises and the composition comprises about 25 mg to about 30 mg minoxidil.

[0093] In some embodiments, the hair loss is due to alopecia areata. In further embodiments, the hair loss is due to alopecia areata and the single pharmaceutical composition comprises about 3 mg to about 30 mg minoxidil.

[0094] In some embodiments, the single pharmaceutical composition results from mixing three pharmaceutical compositions in liquid form, a first pharmaceutical composition, a second pharmaceutical composition, and a third pharmaceutical composition, together shortly before been administered to the subject, wherein the three compositions are contained in a pharmaceutical package for treating or preventing hair loss in the subject, said package comprising the first pharmaceutical composition for oral administration of a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator, the second pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of about 1.5 mg to about 5 mg finasteride, and a third pharmaceutical composition comprising one or more hair growth / hair loss prevention supplements; wherein the pharmaceutical package is combi pack blister pack.

[0095] In some embodiments, the single composition comprises hair growth / hair loss prevention supplements comprising one or more hair growth / hair loss prevention supplements selected from the group consisting of vitamin A, vitamin C, vitamin D3, thiamin, riboflavin (vitamin B2), niacinamide, folate, vitamin B 12, zinc, copper, pantothenic acid, L-lysine hydrochloride, L-cysteine, citrus bioflavonoids, L-proline, horsetail extract, and biotin.

[0096] In some embodiments, the single composition comprises hair growth / hair loss prevention supplements comprising one or more hair growth / hair loss prevention supplements selected from the group consisting of vitamin A, vitamin C, vitamin D, vitamin E, iodine from organic kelp, selenium, zinc, biotin, collagen, Indian ginseng (Ashwagandha), saw palmetto extract, curcumin, tocotrienol, tocopherol, hyaluronic acid, L-cysteine, L-lysine, L-methionine, solubilized keratin, horsetail extract, resveratrol, black pepper, and capsicum extract.

[0097] In some embodiments, the single composition comprises hair growth / hair loss prevention supplements comprising one or more hair growth / hair loss prevention supplements selected from the group consisting of niacin, calcium, a blend of shark and mollusk powder, biotin, zinc, vitamin C, horsetail extract, millet seed extract, and iron.

[0098] In some embodiments, the single composition comprises hair growth / hair loss prevention supplements comprising one or more hair growth / hair loss prevention supplements selected from the group consisting of vitamin A, vitamin C, vitamin D, vitamin E, vitamin B-6, folic acid, vitamin B-12, biotin, pantothenic acid, iodine, zinc, choline, and inositol.

[0099] In some embodiments, the single composition comprises hair growth / hair loss prevention supplements comprising one or more hair growth / hair loss prevention supplements selected from the group consisting of tapioca syrup, cane sugar, dextrose, citric acid, and medium-chain triglyceride (MCT) oil.

[0100] In some embodiments, the single composition comprises hair growth / hair loss prevention supplements comprising one or more hair growth / hair loss prevention supplements selected from the group consisting of organic Indian ginseng (ashwagandha), organic Acerola cherry, organic Amla, astaxanthin, organic vitamin B1, organic vitamin B2, organic vitamin B3, organic vitamin B5, organic vitamin B6, organic vitamin B9, vitamin B12 (methylcobalamin), ginseng, horsetail, beta glucans, hyaluronic acid, kelp, reduced L-glutathione, L-theanine, magnesium chelate, vitamin A, vitamin Bl, vitamin B2, vitamin B3, vitamin B6, vitamin B12, vitamin C, vitamin D3, vitamin E, vitamin K2, wildcrafted rhodiola, wildcrafted saw palmetto, schisandra, shatavari, silica, silver ear mushroom, tocos, liposomal vitamin C, and chelated zinc.

[0101] In some embodiments, the single composition comprises hair growth / hair loss prevention supplements comprising one or more hair growth / hair loss prevention supplements selected from the group consisting of vitamin A, vitamin C, vitamin D3, vitamin D, riboflavin, vitamin B6, folate, vitamin B12, pantothenic acid, biotin, thiamin, cayenne, stinging nettle, turmeric, zinc, selenium, aloe vera leaf powder, brahmi extract (Bacopa monnieri), rosemary leaf powder, stinging nettle root powder, lutein, horsetail herb extract, piperine, hydroxypropyl methyl capsule, magnesium stearate and rice flour.

[0102] Any hair growth / hair loss prevention supplement(s) can be part of the single composition. In some embodiments, the single composition comprises hair growth / hair loss prevention supplements comprising one or more hair growth / hair loss prevention supplements selected from the group consisting of vitamin A, vitamin Bl, vitamin B2, vitamin B3, vitamin B5, vitamin B-6, vitamin B9, vitamin B-12, vitamin C, vitamin D3, vitamin D, vitamin E, vitamin K2, thiamin, biotin, niacin, folate, iron, iodin, zinc, copper, pantothenic acid, L-lysine, L-cysteine, L-methionine, L-proline, citrus bioflavonoids, horsetail extract, iodine from organic kelp, selenium, collagen, Indian ginseng (Ashwagandha), saw palmetto extract, curcumin, tocotrienol, tocopherol, hyaluronic acid, solubilized keratin, horsetail extract, resveratrol, black pepper, capsicum extract, calcium, a blend of shark and mollusk powder, millet seed extract, choline, inositol, tapioca syrup, cane sugar, dextrose, citric acid, medium-chain triglyceride(MCT) oil, Indian ginseng (ashwagandha), Acerola cherry, Amla, astaxanthin, ginseng, beta glucans, hyaluronic acid, kelp, reduced L- glutathione, L-theanine, magnesium chelate, wildcrafted rhodiola, wildcrafted saw palmetto, schisandra, shatavari, silica, silver ear mushroom, tocos, chelated zinc, cayenne, stinging nettle, turmeric, aloe vera leaf powder, brahmi extract (Bacopa monnieri), rosemary leaf powder, stinging nettle root powder, lutein, horsetail herb extract, piperine, hydroxypropyl methyl capsule, magnesium stearate and rice flour. The disclosed composition comprises any of these supplements or any combination thereof.

[0103] In some embodiments, the single pharmaceutical composition is in liquid form.

[0104] The hair loss can be due to any condition or disease.

[0105] In some embodiments, the hair loss is due to androgenic alopecia and the disclosed single pharmaceutical composition further comprises one or more hair growth / hair loss prevention supplements selected from the group consisting of zinc, B-vitamins, tocotrienols, and saw palmetto. In further embodiments, the B-vitamins are one or more of vitamin B2 (Riboflavin), B3 (Niacin), B7 (Biotin), B9 (Folic acid), and B 12 (Cobalamin).

[0106] In some embodiments, the single composition results from mixing three pharmaceutical compositions in liquid form, a first pharmaceutical composition, a second pharmaceutical composition, and a third pharmaceutical composition, together shortly before been administered to the subject, wherein the three compositions are contained in a disclosed pharmaceutical package. In some embodiments, the pharmaceutical package is a blister pack.

[0107] In some embodiments, the single composition results from mixing two or three pharmaceutical compositions in liquid form shortly before been administered to the subject, wherein the two or three compositions are contained in a disclosed pharmaceutical package. In some embodiments, the pharmaceutical package is a blister pack.

[0108] In another aspect, a method of treating or preventing hair loss in a subject in need thereof comprising administering by oral administration a disclosed single pharmaceutical composition to said subject.

[0109] In some embodiments, the hair loss is due to telogen effluvium. A method is provided of treating or preventing hair loss due to telogen effluvium comprising administering to a subject in need thereof a disclosed single pharmaceutical composition. In some embodiments, the single pharmaceutical composition comprises about 25 mg to about 30 mg minoxidil, with or without hair growth / hair loss prevention supplement.

[0110] In some embodiments, the hair loss is due to alopecia areata. A method is provided of treating or preventing hair loss due to alopecia areata comprising administering to a subject in need thereof a disclosed single pharmaceutical composition. In some embodiments, the single pharmaceutical composition comprises about 3 mg to about 30 mg minoxidil, with or without hair growth / hair loss prevention supplement(s).

[0111] In some embodiments, the hair loss is due to androgenic alopecia. A method is provided of treating or preventing hair loss due to androgenic alopecia in a subject in need thereof comprising administering to said subject by oral administration a disclosed single pharmaceutical composition. In some embodiments, the single pharmaceutical composition is administered to the subject once or twice daily. In some embodiments, a method is provided of treating or preventing hair loss due to androgenic alopecia in a subject in need thereof comprising administering to the subject a first pharmaceutical composition comprising finasteride at about 2.5 mg and administering by topical administration once or twice daily a second pharmaceutical composition comprising minoxidil at about 5% or about 8%.

[0112] In another aspect, this disclosure provides a method of treating or preventing hair loss in a subject in need thereof comprising administering to said subject by oral administration a first pharmaceutical composition of a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator, a second pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of a 5-alpha reductase inhibitor, and either or both a third pharmaceutical composition for oral administration and / or the first or the second pharmaceutical composition, or both, comprising a therapeutically effective or prophylactically effective amount of one or more hair growth / hair loss prevention supplements, and wherein the first pharmaceutical composition, the second pharmaceutical composition, and the third pharmaceutical composition are contained in a disclosed pharmaceutical package. In some embodiments, the package is a blister pack.

[0113] In some embodiments, the hair loss is caused by androgenic alopecia. Thus, in some embodiments, a method is provided of treating or preventing androgenic alopecia in a subject in need thereof comprising administering by oral administration a first pharmaceutical composition of a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator, a second pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of a5a-reductase inhibitor, and either a third pharmaceutical composition for oral administration or the first or the second pharmaceutical composition, or both, comprising a therapeutically effective or prophylactically effective amount of one or more hair growth / hair loss prevention supplements, and wherein the first pharmaceutical composition, the second pharmaceutical composition, and the third pharmaceutical composition (in embodiments when a third pharmaceutical composition exists) are contained in a disclosed pharmaceutical package. In some embodiments, the package is a blister pack.

[0114] In some embodiments, a method is disclosed of treating or preventing telogen effluvium in a subject in need thereof comprising administering by oral administration a first pharmaceutical composition of a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator, wherein, in some embodiments, said composition comprises about 25 mg to about 30 mg minoxidil, a second pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of a 5 -reductase inhibitor, and either or both a third pharmaceutical composition for oral administration and / or the first or the second pharmaceutical composition, or both, comprising a therapeutically effective or prophylactically effective amount of one or more hair growth / hair loss prevention supplements, and wherein the first pharmaceutical composition, the second pharmaceutical composition, and the third pharmaceutical composition are contained in a disclosed pharmaceutical package. In some embodiments, the package is a blister pack. In some embodiments, the 5a-reductase inhibitor is finasteride. In other embodiments, the 5a-reductase inhibitor is dutasteride.

[0115] In some embodiments, a method is disclosed of treating or preventing alopecia areata in a subject in need thereof comprising administering by oral administration a first pharmaceutical composition of a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator, wherein, in some embodiments, said composition comprises about 3 mg to about 30 mg minoxidil, a second pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of a 5 -reductase inhibitor, and either or both a third pharmaceutical composition for oral administration, and / or the first or the second pharmaceutical composition, or both, comprising a therapeutically effective or prophylactically effective amount of one or more hair growth / hair loss prevention supplements, and wherein the first pharmaceuticalcomposition, the second pharmaceutical composition, and the third pharmaceutical composition are contained in a disclosed pharmaceutical package. In some embodiments, the package is a blister pack. In some embodiments, the 5a-reductase inhibitor is finasteride. In other embodiments, the 5a-reductase inhibitor is dutasteride. The pharmaceutical package is any suitable package. In some embodiments, the pharmaceutical package is a blister pack.

[0116] In another aspect, a single pharmaceutical composition for oral administration is provided for treating or preventing androgenic alopecia in a subject. This composition comprises a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator, and a 5-alpha reductase inhibitor. In some embodiments, the single composition comprises a therapeutically effective or prophylactically effective amount of minoxidil and a 5-alpha reductase inhibitor for treating or preventing androgenic alopecia in a subject. In some embodiments, the 5a-reductase inhibitor is finasteride. In other embodiments, the 5a-reductase inhibitor is dutasteride. In some embodiments, the 5-alpha reductase inhibitor is finasteride. In some embodiments, the composition comprises about 0.2 mg to about 5 mg finasteride. In some embodiments, the composition comprising minoxidil comprises about 0.625 mg to about 10 mg minoxidil. In some embodiments, the composition comprises about 0.625 mg, about 2.5 mg, about 5 mg minoxidil, or about 10 mg minoxidil.

[0117] In some embodiments, the single composition results from mixing two pharmaceutical compositions in liquid form, a first pharmaceutical composition and a second pharmaceutical composition, together shortly before been administered to the subject, wherein the two compositions are contained in a pharmaceutical package for treating or preventing androgen alopecia in the subject, said package comprising the first pharmaceutical composition for oral administration of a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator, and the second pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of a 5-alpha reductase inhibitor. In further embodiments, the first composition comprises a therapeutically effective or prophylactically effective amount of minoxidil. In some embodiments, the 5-alpha reductase inhibitor is finasteride. In some embodiments, the pharmaceutical package is a blister pack. In some embodiments, the 5a-reductase inhibitor is finasteride. In other embodiments, the 5a-reductase inhibitor is dutasteride.

[0118] In another aspect, a pharmaceutical package for treating or preventing androgen alopecia in a subject is provided. The pharmaceutical package comprises a pharmaceutical composition for oral administration of a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator, and a pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of a 5-alpha reductase inhibitor. In some embodiments, the package comprises a pharmaceutical composition for oral administration of a therapeutically effective or prophylactically effective amount of minoxidil, and a pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of a 5-alpha reductase inhibitor. In some embodiments, the 5a-reductase inhibitor is finasteride. In other embodiments, the 5a-reductase inhibitor is dutasteride. In some embodiments, the 5-alpha reductase inhibitor is finasteride. In some embodiments, the pharmaceutical package is a blister pack. In some embodiments, either the pharmaceutical composition comprising minoxidil, or a similar antihypertensive vasodilator, or the pharmaceutical composition comprising a 5-alpha reductase inhibitor is in liquid form. In some embodiments, both the pharmaceutical composition comprising minoxidil, or a similar antihypertensive vasodilator, and the pharmaceutical composition comprising a 5-alpha reductase inhibitor are in liquid form. In some embodiments, the 5-alpha reductase inhibitor is finasteride. In some embodiments, the package comprises a pharmaceutical composition comprising minoxidil. In some embodiments, the composition comprising finasteride comprises about 0.2 mg to about 5 mg finasteride. In some embodiments, the composition comprising minoxidil comprises about 0.625 mg to about 10 mg minoxidil. In some embodiments, the composition comprising minoxidil comprises about 0.625 mg, about 2.5 mg, about 5 mg minoxidil, or about 10 mg minoxidil.

[0119] In another aspect, this disclosure discloses a method of treating or preventing androgenic alopecia in a subject in need thereof comprising administering by oral administration a disclosed pharmaceutical package, with or without hair growth / hair loss prevention supplement(s) to the subject.

[0120] In another aspect, this disclosure provides a method of treating or preventing hair loss due to androgenic alopecia in a subject in need thereof comprising administering to said subject by oral administration once or twice daily a pharmaceutical composition comprising minoxidil at about 2.5 mg or about 5 mg and finasteride at about 1 mg or about 5 mg. In furtherembodiments, the composition further comprises one or more hair growth / hair loss prevention supplements selected from the group consisting of zinc, B-vitamins, tocotrienols, and saw palmetto. In yet further embodiments, the B-vitamins are one or more of vitamin B2 (Riboflavin), B3 (Niacin), B7 (Biotin), B9 (Folic acid), and B 12 (Cobalamin). In certain embodiments, the pharmaceutical composition is in a pharmaceutical package selected from a blister pack, a tablet, a caplet, a blister pack, or a combi pack blister pack.

[0121] In another aspect, this disclosure provides a method of treating or preventing hair loss due to androgenic alopecia in a subject in need thereof comprising administering to said subject by oral administration once or twice daily a first pharmaceutical composition comprising finasteride at about 2.5 mg and administering by topical administration once or twice daily a second pharmaceutical composition comprising minoxidil at about 5% or about 8%. In some embodiments, the first composition further comprises one or more hair growth / hair loss prevention supplements selected from the group consisting of zinc, B-vitamins, tocotrienols, and saw palmetto. In further embodiments, the B-vitamins are one or more of vitamin B2 (Riboflavin), B3 (Niacin), B7 (Biotin), B9 (Folic acid), and B 12 (Cobalamin). In certain embodiments, the first pharmaceutical composition is in a pharmaceutical package selected from a blister pack, a tablet, a caplet, a blister pack, or a combi pack blister pack; and the second pharmaceutical composition is a solution in a bottle. In some embodiments, a combi pack blister pack comprises the first pharmaceutical composition and the second pharmaceutical composition.

[0122] In yet another aspect, this disclosure provides a method of treating or preventing hair loss due to androgenic alopecia in a subject in need thereof comprising administering to said subject by oral administration once or twice daily a first pharmaceutical composition comprising finasteride at about 2.5 mg or about 5 mg; administering to said subject by oral administration once or twice daily a second pharmaceutical composition comprising minoxidil at about 2.5 mg or about 5 mg; and administering by topical administration once or twice daily a third pharmaceutical composition comprising minoxidil at about 5% or about 8%. In some embodiments, the first or the second composition, or both, further comprises one or more hair growth / hair loss prevention supplements selected from the group consisting of zinc, B-vitamins, tocotrienols, and saw palmetto. In further embodiments, the B-vitamins are one or more of vitamin B2 (Riboflavin), B3 (Niacin), B7 (Biotin), B9 (Folic acid), and B12 (Cobalamin). Insome embodiments, the first pharmaceutical composition is in a pharmaceutical package selected from a blister pack, a tablet, a caplet, a blister pack, or a combi pack blister pack; wherein the second pharmaceutical composition is in a pharmaceutical package selected from a blister pack, a tablet, a caplet, a blister pack, or a combi pack blister pack; and wherein the third pharmaceutical composition is a solution in a bottle. In some embodiments, a combi pack blister pack comprises the first pharmaceutical composition, the second pharmaceutical composition, and the third pharmaceutical composition.

[0123] In another aspect, a method is provided of treating or preventing hair loss due to androgenic alopecia in a subject in need thereof comprising administering to said subject by oral administration once or twice daily a first pharmaceutical composition comprising finasteride at about 2.5 mg and administering by topical administration once or twice daily a second pharmaceutical composition comprising minoxidil at about 5% or about 8%. In some embodiments, the first composition further comprises one or more hair growth / hair loss prevention supplements selected from the group consisting of zinc, B-vitamins, tocotrienols, and saw palmetto. In further embodiments, the B-vitamins are one or more of vitamin B2 (Riboflavin), B3 (Niacin), B7 (Biotin), B9 (Folic acid), and B 12 (Cobalamin). In some embodiments, the first pharmaceutical composition is in a pharmaceutical package selected from a blister pack, a tablet, a caplet, a blister pack, or a combi pack blister pack; and wherein the second pharmaceutical composition is a solution in a bottle. In some embodiments, a combi pack blister pack comprises the first pharmaceutical composition and the second pharmaceutical composition.

[0124] In another aspect, a method is provided method of treating or preventing hair loss due to androgenic alopecia in a subject in need thereof comprising administering to said subject by oral administration once or twice daily a first pharmaceutical composition comprising finasteride at about 2.5 mg or about 5 mg; administering to said subject by oral administration once or twice daily a second pharmaceutical composition comprising minoxidil at about 2.5 mg or about 5 mg; and administering by topical administration once or twice daily a third pharmaceutical composition comprising minoxidil at about 5% or about 8%. In some embodiments, the first or the second composition, or both, further comprises one or more hair growth / hair loss prevention supplements selected from the group consisting of zinc, B-vitamins, tocotrienols, and saw palmetto. In further embodiments, the B-vitamins are one or more ofvitamin B2 (Riboflavin), B3 (Niacin), B7 (Biotin), B9 (Folic acid), and B12 (Cobalamin). In some embodiments, the first pharmaceutical composition is in a pharmaceutical package selected from a blister pack, a tablet, a caplet, a blister pack, or a combi pack blister pack; wherein the second pharmaceutical composition is in a pharmaceutical package selected from a blister pack, a tablet, a caplet, a blister pack, or a combi pack blister pack; and wherein the third pharmaceutical composition is a solution in a bottle. In some embodiments, a combi pack blister pack comprises the first pharmaceutical composition, the second pharmaceutical composition, and the third pharmaceutical composition.

[0125] In further embodiments, any of the disclosed methods further comprises administering to the subject by topical administration a topical pharmaceutical composition comprising a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator, and / or a topical composition comprising a therapeutically effective or prophylactically effective amount of a 5-alpha reductase inhibitor (in some embodiments, the 5-alpha reductase inhibitor is finasteride; in other embodiments, the 5a-reductase inhibitor is dutasteride).

[0126] By having all the drugs in a package, the disclosed package allows for greater patient compliance and patient convenience, and less mistake in taking the medicines.

[0127] 5a-reductase inhibitors, also known as dihydrotestosterone blockers, inhibit the enzyme 5a-reductase. Any suitable 5a-reductase inhibitor is included in the disclosed compositions, disclosed packages, and used in the disclosed methods. 5a-reductase inhibitors include, without limitation, finasteride, epristeride, dutasteride, alfatradiol. In some embodiments, the 5a-reductase inhibitor is finasteride.

[0128] A similar antihypertensive vasodilator to minoxidil includes, without limitation, hydralazine, nitroglycerin, losartan, diltiazem, benazepril, lisinopril. Minoxidil is a direct vasodilator, thus a similar antihypertensive vasodilator to minoxidil includes any and all direct vasodilator, including, without limitation, hydralazine, sodium nitroprusside.

[0129] The subject is any subject, including a male subject and a female subject. In certain embodiments, the subject is a human being.

[0130] In some embodiments, the disclosed composition for oral administration comprises about 0.2 to about 5 mg of finasteride; in further embodiments, the disclosed composition for oral administration comprises about 1 to about 3 mg finasteride. In someembodiments, the disclosed composition for oral administration comprises about 1 or about 3 mg finasteride.

[0131] In some embodiments, the disclosed composition for oral administration comprises about 0.625 to about 10 mg minoxidil. In further embodiments, the disclosed composition for oral administration comprises about 0.625 mg, about 2.5 mg, about 5 mg minoxidil, or about 10 mg minoxidil.

[0132] In some embodiments, the disclosed composition for oral administration comprises about 1 or about 3 mg finasteride and about 0.625 to about 5 mg minoxidil. In further embodiments, the disclosed composition for oral administration comprises about 1 mg or about 3 mg finasteride and about 0.625 mg, about 2.5 mg, about 5 mg or about 10 mg minoxidil.

[0133] FORMULATING AND ADMINISTERING COMPOSITIONS

[0134] The disclosed composition may be administered to a subject in need thereof at any suitable frequency, and at any suitable, effective dosage.

[0135] The disclosed single composition is for oral administration and is provided in a form suitable for oral administration, such as a tablet, pill, lozenge, capsule, liquid suspension, liquid solution, or any other conventional oral dosage form. The oral dosage forms may provide immediate release, delayed release, sustained release, or enteric release, and, if appropriate, comprise one or more coating. The composition can be in any suitable form, such as solid or liquid.

[0136] The disclosed package contains compositions for oral administration and the compositions are provided in a form suitable for oral administration, such as a tablet, pill, lozenge, capsule, liquid suspension, liquid solution, or any other conventional oral dosage form. The oral dosage forms may provide immediate release, delayed release, sustained release, or enteric release, and, if appropriate, comprise one or more coating.

[0137] The topical composition is for topical administration and is provided in a form suitable for topical administration, such as a gel, foam, solution, or any other conventional topical formulation.

[0138] The composition can be produced by methods employed in accordance with general practice in the pharmaceutical industry, such as, for example, the methods illustrated in Remington: The Science and Practice of Pharmacy (Pharmaceutical Press; 21st revised ed. (2011) (hereinafter “Remington”).

[0139] In some embodiments, the composition comprises at least one pharmaceutically acceptable vehicle or excipient. These include, for example, diluents, carriers, excipients, fillers, disintegrants, solubilizing agents, dispersing agents, preservatives, wetting agents, preservatives, stabilizers, buffering agents (e.g. phosphate, citrate, acetate, tartrate), suspending agents, emulsifiers, and penetration enhancing agents such as DMSO, as appropriate. The composition can also comprise suitable auxiliary substances, for example, solubilizing agents, dispersing agents, suspending agents and emulsifiers.

[0140] In certain embodiments, the composition further comprises suitable diluents, glidants, lubricants, acidulants, stabilizers, fillers, binders, plasticizers or release aids and other pharmaceutically acceptable excipients.

[0141] A complete description of pharmaceutically acceptable excipients can be found, for example, in Remington's Pharmaceutical Sciences (Mack Pub., Co., N. J. 1991) or other standard pharmaceutical science texts, such as the Handbook of Pharmaceutical Excipients (Shesky et al. eds., 8th ed. 2017).

[0142] Large macromolecules that are slowly metabolized, such as proteins, polysaccharides, polylactic acids, polyglycolic acids, polymeric amino acids, copolymers of amino acids, can also be used as carrier compounds for the composition. Pharmaceutically acceptable carriers in therapeutic compositions may additionally contain liquids, such as water, saline, glycerol or ethanol. Moreover, the said compositions may further comprise excipients, such as wetting agents or emulsifiers, buffering substances, and the like. Such excipients include, among others, diluents and carriers conventional in the art, and / or substances that promote penetration of the active compound into the cell, for example, DMSO, as well as preservatives and stabilizers.

[0143] It is to be understood that while the invention has been described in conjunction with the detailed description thereof, the foregoing description is intended to illustrate and not limit the scope of the invention, which is defined by the scope of the appended claims. Other aspects, advantages, and modifications are within the scope of the appended claims. Thus, while only certain features of the invention have been illustrated and described, many modifications and changes will occur to those skilled in the art. It is therefore to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the invention.

Claims

CLAIMSWhat is claimed is:

1. A pharmaceutical package for treating or preventing hair loss in a subject comprising: a first pharmaceutical composition for oral administration of a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator; a second pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of a 5a-reductase inhibitor;and either or both a third pharmaceutical composition for oral administration and / or the first or the second pharmaceutical composition, or both, comprising a therapeutically effective or prophylactically effective amount of one or more hair growth / hair loss prevention supplements.

2. The pharmaceutical package of claim 1, wherein the package comprises:a first pharmaceutical composition for oral administration of a therapeutically effective or prophylactically effective amount of minoxidil;a second pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of a 5a-reductase inhibitor;and either or both a third pharmaceutical composition for oral administration and / or the first or the second pharmaceutical composition, or both, comprising a therapeutically effective or prophylactically effective amount of one or more hair growth / hair loss prevention supplements.

3. The pharmaceutical package of claim 1 or claim 2, wherein the 5a-reductase inhibitor is finasteride.

4. The pharmaceutical package of claim 1 or claim 2, wherein the 5a-reductase inhibitor is dutasteride.

5. The pharmaceutical package of claims 1-4, wherein the minoxidil is about 2.5 mg to about 5 mg.

6. The pharmaceutical package of any of claims 1-3 or claim 5, wherein the finasteride is about 1 mg to about 5 mg.

7. The pharmaceutical package of any of claims 1-3 or 5-6, wherein the first composition comprises minoxidil at about 2.5 mg or 5 mg and the second composition comprises finasteride at about 2.5 mg.

8. The pharmaceutical package of any of claims 1-7, wherein either or both the third pharmaceutical composition and / or the first or the second pharmaceutical composition, or both, comprises one or more hair growth / hair loss prevention supplements selected from the group consisting of zinc, B-vitamins, tocotrienols, and saw palmetto.

9. The pharmaceutical package of claim 8, wherein the B-vitamins are one or more of vitamin B2 (Riboflavin), B3 (Niacin), B7 (Biotin), B9 (Folic acid), and B 12 (Cobalamin).

10. The pharmaceutical package of any of claims 1-6, wherein either or both the third pharmaceutical composition and / or the first or the second pharmaceutical composition, or both, comprises hair growth / hair loss prevention supplements selected from the group consisting of vitamin A, vitamin Bl, vitamin B2, vitamin B3, vitamin B5, vitamin B-6, vitamin B9, vitamin B-12, vitamin C, vitamin D3, vitamin D, vitamin E, vitamin K2, thiamin, biotin, niacin, folate, iron, iodine, zinc, copper, pantothenic acid, L-lysine, L-cysteine, L-methionine, L-proline, citrus bioflavonoids, horsetail extract, iodine from organic kelp, selenium, collagen, Indian ginseng (Ashwagandha), saw palmetto extract, curcumin, tocotrienol, tocopherol, hyaluronic acid, solubilized keratin, horsetail extract, resveratrol, black pepper, capsicum extract, calcium, a blend of shark and mollusk powder, millet seed extract, choline, inositol, tapioca syrup, cane sugar, dextrose, citric acid, medium-chain triglyceride (MCT) oil. Indian ginseng (ashwagandha), Acerola cherry, Amla, astaxanthin, ginseng, beta glucans, hyaluronic acid, kelp, reduced L-glutathione, L-theanine, magnesium chelate, wildcrafted rhodiola, wildcrafted saw palmetto, schisandra, shatavari, silica, silver ear mushroom, tocos, chelated zinc, cayenne, stinging nettle, turmeric, aloe vera leaf powder, brahmi extract (Bacopa mormieri), rosemary leaf powder, stinging nettle root powder, lutein, horsetail herb extract, piperine, hydroxypropyl methyl capsule, magnesium stearate and rice flour.

11. The pharmaceutical package of cany of claim 1-10, wherein any of the first, second or third pharmaceutical composition is in liquid form.

12. The pharmaceutical package of any of claims 1-11, wherein the hair loss is due to androgenic alopecia.

13. The pharmaceutical package of any of claims 1-3, wherein the hair loss is due to telogen effluvium and the first composition comprises about 25 mg to about 30 mg minoxidil.

14. The pharmaceutical package of any of claims 1-3, wherein the hair loss is due to alopecia areata and the first composition comprises about 3 mg to about 30 mg minoxidil.

15. The pharmaceutical package of any of claims 1-14, wherein the pharmaceutical package is a capsule, a tablet, a caplet, a blister pack, or a combi pack blister pack.

16. A single pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator, a therapeutically effective or prophylactically effective amount of a 5o.-reductase inhibitor and a therapeutically effective or prophylactically effective amount of one or more hair growth / hair loss prevention supplements.

17. The single pharmaceutical composition of claim 16, wherein the 5a-reductase inhibitor is finasteride.

18. The single pharmaceutical composition of claim 16, wherein the 5a-reductase inhibitor is dutasteride.

19. The single pharmaceutical composition of any of claims 16-19, wherein the minoxidil is about 2.5 mg to about 5 mg.

20. The single pharmaceutical composition of any of claims 16-17 or 19, wherein the finasteride is about 1 mg to about 5 mg.

21. The single pharmaceutical composition of any of claims 16-17 or 19-20, wherein the composition comprises minoxidil at about 2.5 mg or about 5 mg and finasteride at about 2.5 mg.

22. The single pharmaceutical composition of any of claims 16-21, wherein the composition comprises one or more hair growth / hair loss prevention supplements selected from the group consisting of zinc, B-vitamins, tocotrienols, and saw palmetto.

23. The single pharmaceutical composition of claim 22, wherein the B-vitamins are one or more of vitamin B2 (Riboflavin), B3 (Niacin), B7 (Biotin), B9 (Folic acid), and B12 (Cobalamin).

24. The single pharmaceutical composition of any of claims 16-21, wherein the composition comprises hair growth / hair loss prevention supplements selected from the group consisting of vitamin A, vitamin Bl, vitamin B2, vitamin B3, vitamin B5, vitamin B-6, vitamin B9, vitamin B-12, vitamin C, vitamin D3, vitamin D, vitamin E, vitamin K2, thiamin, biotin, niacin, folate, iron, iodin, zinc, copper, pantothenic acid, L-lysine, L-cysteine, L-methionine, L-proline, citrus bioflavonoids, horsetail extract, iodine from organic kelp, selenium, collagen, Indian ginseng (Ashwagandha), saw palmetto extract, curcumin, tocotrienol, tocopherol, hyaluronic acid, solubilized keratin, horsetail extract, resveratrol, black pepper, capsicum extract, calcium, a blend of shark and mollusk powder, millet seed extract, choline, inositol, tapioca syrup, cane sugar, dextrose, citric acid, medium-chain triglyceride (MCT) oil, Indian ginseng (ashwagandha), Acerola cherry, Amla, astaxanthin, ginseng, beta glucans, hyaluronic acid, kelp, reduced L-glutathione, L-theanine, magnesium chelate, wildcrafted rhodiola, wildcrafted saw palmetto, schisandra, shatavari, silica, silver ear mushroom, tocos, chelated zinc, cayenne, stinging nettle, turmeric, aloe vera leaf powder, brahmi extract (Bacopa monnieri), rosemary leaf powder, stinging nettle root powder, lutein, horsetail herb extract, piperine, hydroxypropyl methyl capsule, magnesium stearate and rice flour.

25. The single pharmaceutical composition of any of claims 16-24, wherein the hair loss is due to androgenic alopecia.

26. The single pharmaceutical composition of claim 25, wherein the composition comprises about 0.2 mg to about 5 mg finasteride.

27. The single pharmaceutical composition of any of claims 25-26, wherein the composition comprises about 0.625 mg to about 10 mg minoxidil.

28. The single pharmaceutical composition of any of claims 25-27, wherein the composition comprises about 0.625 mg, about 2.5 mg, about 5 mg, or about 10 mg minoxidil.

29. The single pharmaceutical composition of any of claims 16-24, wherein the hair loss is due to telogen effluvium and the composition comprises about 25 mg to about 30 mg minoxidil.

30. The single pharmaceutical composition of any of claims 16-25, wherein the hair loss is due to alopecia areata and the composition comprises about 3 mg to about 30 mg minoxidil.

31. The single pharmaceutical composition of any of claims 16-30, wherein the single composition results from mixing three pharmaceutical compositions in liquid form, a first pharmaceutical composition, a second pharmaceutical composition, and a third pharmaceutical composition, together shortly before been administered to the subject, wherein the three compositions are contained in a pharmaceutical package for treating or preventing hair loss in the subject, said package comprising the first pharmaceutical composition for oral administration of a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator, the second pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of about 1.5 mg to about 5 mg finasteride, and a third pharmaceutical composition comprising one or more hair growth / hair loss prevention supplements; wherein the pharmaceutical package is combi pack blister pack.

32. A method of treating or preventing hair loss in a subject in need thereof comprising administering by oral administration a single pharmaceutical composition of any of claims 16-24 or 31 to said subject.

33. A method of treating or preventing androgenic alopecia in a subject in need thereof comprising administering by oral administration a single pharmaceutical composition of any of claims 25-28 to said subject.

34. A method of treating or preventing telogen effluvium in a subject in need thereof comprising administering by oral administration a single pharmaceutical composition of claim 29 to said subject.

35. A method of treating or preventing alopecia areata in a subject in need thereof comprising administering by oral administration a single pharmaceutical composition of claim 30 to said subject.

36. A method of treating or preventing hair loss in a subject in need thereof comprising administering to said subject by oral administration:a first pharmaceutical composition of a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator;a second pharmaceutical composition comprising a therapeutically effective or prophylactically effective amount of a 5a-reductase inhibitor;and either a third pharmaceutical composition for oral administration or either the first or the second pharmaceutical composition, or both, comprising a therapeutically effective or prophylactically effective amount of one or more hair growth / hair loss prevention supplements, and wherein the first pharmaceutical composition, the second pharmaceutical composition, and the third pharmaceutical composition are contained in a pharmaceutical package of any of claims 1-11 or claim 15.

37. A method of treating or preventing androgenic alopecia in a subject in need thereof comprising administering by oral administration:a first pharmaceutical composition of a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator,a second pharmaceutical composition comprising a therapeutically effective or prophylactically effective amount of a 5a-reductase inhibitor,and either a third pharmaceutical composition for oral administration or either the first or the second pharmaceutical composition, or both, comprising a therapeutically effective or prophylactically effective amount of one or more hair growth / hair loss prevention supplements; wherein the first pharmaceutical composition, the second pharmaceutical composition, and the third pharmaceutical composition are contained in a pharmaceutical package of claim 12.

38. A method of treating or preventing telogen effluvium in a subject in need thereof comprising administering by oral administration:a first pharmaceutical composition of a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator,a second pharmaceutical composition comprising a therapeutically effective or prophylactically effective amount of a 5 a- reductase inhibitor,and either a third pharmaceutical composition for oral administration or either the first or the second pharmaceutical composition, or both, comprising a therapeutically effective or prophylactically effective amount of one or more hair growth / hair loss prevention supplements, and wherein the first pharmaceutical composition, the second pharmaceutical composition, and the third pharmaceutical composition are contained in a pharmaceutical package of claim 13 to said subject.

39. A method of treating or preventing alopecia areata in a subject in need thereof comprising administering by oral administration:a first pharmaceutical composition of a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator,a second pharmaceutical composition comprising a therapeutically effective or prophylactically effective amount of a 5a-reductase inhibitor,and either a third pharmaceutical composition for oral administration or either the first or the second pharmaceutical composition, or both, comprising a therapeutically effective orprophylactically effective amount of one or more hair growth / hair loss prevention supplements, and wherein the first pharmaceutical composition, the second pharmaceutical composition, and the third pharmaceutical composition are contained in a pharmaceutical package of claim 14 to said subject.

40. A method of treating or preventing hair loss due to androgenic alopecia in a subject in need thereof comprising administering to said subject by oral administration once or twice daily a pharmaceutical composition comprising minoxidil at about 2.5 mg or about 5 mg and finasteride at about 2.5 mg.

41. The method of claim 40, wherein the composition further comprises one or more hair growth / hair loss prevention supplements selected from the group consisting of zinc, B-vitamins, tocotrienols, and saw palmetto.

42. The method of claim 42, wherein the B-vitamins are one or more of vitamin B2 (Riboflavin), B3 (Niacin), B7 (Biotin), B9 (Folic acid), and B 12 (Cobalamin).

43. The method of any of claims 40-42, wherein the pharmaceutical composition is in a pharmaceutical package selected from a blister pack, a tablet, a caplet, a capsule, a blister pack, or a combi pack blister pack.

43. A method of treating or preventing hair loss due to androgenic alopecia in a subject in need thereof comprising administering to said subject by oral administration once or twice daily a first pharmaceutical composition comprising finasteride at about 2.5 mg and administering by topical administration once or twice daily a second pharmaceutical composition comprising minoxidil at about 5% or about 8%.

44. The method of any of claim 43, wherein the first pharmaceutical composition is in a pharmaceutical package selected from a blister pack, a tablet, a caplet, a capsule, a blister pack, or a combi pack blister pack; and wherein the second pharmaceutical composition is a solution in a bottle.

45. The method of claim 43, wherein the pharmaceutical package further comprises one or more hair growth / hair loss prevention supplements selected from the group consisting of zinc, B-vitamins, tocotrienols. and saw palmetto, wherein the supplements are contained in the first pharmaceutical composition and / or a third pharmaceutical composition.

46. The method of claim 45, wherein the B-vitamins are one or more of vitamin B2 (Riboflavin), B3 (Niacin), B7 (Biotin), B9 (Folic acid), and B 12 (Cobalamin).46.

47. The method of claim 43, wherein a combi pack blister pack comprises the first pharmaceutical composition and the second pharmaceutical composition.

48. A method of treating or preventing hair loss due to androgenic alopecia in a subject in need thereof comprising administering to said subject by oral administration once or twice daily a first pharmaceutical composition comprising finasteride at about 2.5 mg or about 5 mg; administering to said subject by oral administration once or twice daily a second pharmaceutical composition comprising minoxidil at about 2.5 mg or about 5 mg; and administering by topical administration once or twice daily a third pharmaceutical composition comprising minoxidil at about 5% or about 8%.

49. The method of claim 48, wherein the first pharmaceutical composition and / or the second pharmaceutical composition, and / or a fourth pharmaceutical composition, further comprises one or more hair growth / hair loss prevention supplements selected from the group consisting of zinc, B-vitamins, tocotrienols, and saw palmetto.

50. The method of claim 49, wherein the B-vitamins are one or more of vitamin B2 (Riboflavin), B3 (Niacin), B7 (Biotin), B9 (Folic acid), and B 12 (Cobalamin).

51. The method of any of claims 48-48, wherein the first pharmaceutical composition and the second pharmaceutical compositionare in a pharmaceutical package selected from a blister pack,a tablet, a caplet, a capsule, a blister pack, or a combi pack blister pack; and wherein the third pharmaceutical composition is a solution in a bottle.

52. The method of claim 49 or claim 50, wherein a combi pack blister pack comprises the first pharmaceutical composition, the second pharmaceutical composition, the fourth pharmaceutical composition.