US-12622907-B2 - Hair loss therapy

Abstract

This disclosure relates to a single pharmaceutical composition comprising a therapeutically effective or prophylactically effective amount of both minoxidil, or a similar antihypertensive vasodilator, and a 5-alpha reductase inhibitor (in some embodiments, the 5-alpha reductase inhibitor is finasteride) for treating or preventing hair loss in a subject. This disclosure also relates to a pharmaceutical package comprising 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 5-alpha reductase inhibitor is finasteride) for treating or preventing hair loss in a subject. The disclosure further provides methods of treating or preventing hair loss in a subject using the disclosed compositions and packages.

Inventors

• Animesh Sinha

Assignees

• NIRMANA BIO, INC.

Dates

Publication Date

20260512

Application Date

20220927

Claims (20)

1. 1 . A pharmaceutical package for treating or preventing hair loss in a subject comprising 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.
2. 2 . The pharmaceutical package of claim 1 , wherein the package comprises a pharmaceutical composition for oral administration of a therapeutically effective or prophylactically effective amount of minoxidil.
3. 3 . The pharmaceutical package of claim 2 , wherein the 5-alpha reductase inhibitor is finasteride.
4. 4 . The pharmaceutical package of claim 3 , wherein the pharmaceutical package is a blister pack.
5. 5 . The pharmaceutical package of claim 3 , wherein either the pharmaceutical composition comprising minoxidil, or the pharmaceutical composition comprising finasteride is in liquid form.
6. 6 . The pharmaceutical package of claim 3 , wherein both the pharmaceutical composition comprising minoxidil, or the pharmaceutical composition comprising finasteride are in liquid form.
7. 7 . The pharmaceutical package of claim 3 , wherein the composition comprising finasteride comprises 1.5 mg to 5 mg finasteride.
8. 8 . The pharmaceutical package of claim 3 , wherein the composition comprising minoxidil comprises 5 mg to 10 mg minoxidil.
9. 9 . The pharmaceutical package of claim 3 , wherein the composition comprising minoxidil comprises 5 mg minoxidil or 10 mg minoxidil.
10. 10 . A single pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator, and 1.5 mg to 5 mg finasteride for treating or preventing hair loss in a subject.
11. 11 . The single composition of claim 10 comprising a therapeutically effective or prophylactically effective amount of minoxidil and 1.5 mg to 5 mg finasteride for treating or preventing hair loss in a subject.
12. 12 . The single composition of claim 11 , wherein the composition comprising minoxidil comprises 5 mg to 10 mg minoxidil.
13. 13 . The single composition of claim 11 , wherein the composition comprising minoxidil comprises 5 mg minoxidil or 10 mg minoxidil.
14. 14 . The single composition of claim 11 , wherein the single composition results from mixing two pharmaceutical compositions in liquid form, a first pharmaceutical composition and a second pharmaceutical composition, together shortly before being administered to the subject, wherein the two 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, and the second pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of 1.5 mg to 5 mg finasteride; wherein the pharmaceutical package is a blister pack.
15. 15 . The single composition of claim 11 , wherein the pharmaceutical package is a blister pack.
16. 16 . A method of treating or preventing hair loss in a subject in need thereof comprising administering by oral administration a single pharmaceutical composition of claim 11 to said subject.
17. 17 . The method of claim 16 , wherein the subject is male.
18. 18 . 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, and a second pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of a 5-alpha reductase inhibitor, wherein the first pharmaceutical composition and the second pharmaceutical composition are contained in a pharmaceutical package of claim 2 .
19. 19 . The method of claim 18 , wherein the first pharmaceutical composition comprises a therapeutically effective or prophylactically effective amount of minoxidil.
20. 20 . The method of claim 18 , wherein the 5-alpha reductase inhibitor is finasteride.

Description

TECHNICAL FIELD This disclosure relates to therapy for hair loss. BACKGROUND 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. Hair loss is a common problem, especially in men, but also in women, or in any person. SUMMARY In one aspect, this disclosure provides a pharmaceutical package comprising two pharmaceutical compositions for oral administration to treat or prevent hair loss in a subject. The two compositions are: a pharmaceutical composition for oral administration comprising 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 for treating or preventing hair loss in a subject. In some embodiments, the 5-alpha reductase inhibitor is finasteride. In another aspect, this disclosure provides a single pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of both minoxidil, or a similar antihypertensive vasodilator, and a 5-alpha reductase inhibitor (in some embodiments, the 5-alpha reductase inhibitor is finasteride) for treating or preventing hair loss in a subject. 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. 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 As used herein, unless otherwise indicated, the word “a” or “plurality” before a noun represents one or more of the particular noun. The term “a single pharmaceutical composition” does not represent more than one composition. 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. “Effective amount,” “prophylactically effective amount,” or “therapeutically effective amount” refers to an amount of an agent or composition that provides a beneficial effect or favorable 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. 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). As used herein, a “patient” and a “subject” are interchangeable terms and may refer to a human patient/subject, a non-human primate, etc. 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. 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. It is further to be understood that the feature or features of one embodiment may generally be applied to other embodim