COMPOSITIONS AND METHODS OF USE FOR MODIFIED RELEASE MINOXIDIL
The compositions and methods provided herein include a pharmaceutical formulation for oral administration comprising a daily dose of a modified release formulation of minoxidil or a pharmaceutically acceptable salt thereof. Also provided herein are pharmaceutical formulations for oral administration comprising a daily dose of a modified release formulation of minoxidil or a pharmaceutically acceptable salt thereof and one or more additional active agents. Also provided herein are methods of treating hair loss by administering to a subject in need thereof a daily dose of a modified release formulation of minoxidil or a pharmaceutically acceptable salt thereof. Further provided herein is a kit including a slow modified release vehicle comprising oral minoxidil or a pharmaceutically acceptable salt thereof.
1 . A method of treating hair loss, comprising orally administering to a human subject who is experiencing hair loss a modified release pharmaceutical formulation comprising about 8.5 mg of minoxidil or a molar equivalent amount of the pharmaceutically acceptable salt thereof; wherein the modified release pharmaceutical formulation provides:
a C max of minoxidil that is about 0.25 ng/ml to about 20 ng/ml; and
a T max of minoxidil that is about 30 to about 360 minutes.
2 . The method of claim 1 , wherein a blood level of minoxidil is maintained in a range of about 1 ng/ml to about 20 ng/ml for at least about 8 hours.
3 . The method of claim 1 , wherein the modified release pharmaceutical formulation further comprises a release modifier.
4 . The method of claim 1 , wherein the modified release pharmaceutical formulation further comprises a filler, a glidant, a lubricant, or combination thereof.
5 . The method of claim 1 , wherein the hair loss comprises male pattern hair loss.
6 . The method of claim 1 , wherein the hair loss comprises alopecia areata.
7 . The method of claim 1 , wherein the hair loss comprises telogen effluvium.
8 . The method of claim 1 , wherein the hair loss comprises central centrifugal cicatricial alopecia.
9 . The method of claim 1 , wherein the hair loss comprises lichen planopilaris.
10 . The method of claim 1 , wherein the hair loss comprises traction alopecia.
11 . The method of claim 1 , wherein the oral administration results in hair regrowth.
12 . The method of claim 1 , wherein the modified release pharmaceutical formulation exhibits a zero order release of minoxidil.
13 . The method of claim 1 , wherein the modified release pharmaceutical formulation exhibits a pseudo zero order release of minoxidil.
14 . The method of claim 1 , wherein the modified release pharmaceutical formulation exhibits a first order release of minoxidil.
15 . The method of claim 1 , wherein the modified release pharmaceutical formulation exhibits a pseudo first order release of minoxidil.
16 . The method of claim 1 , wherein the modified release pharmaceutical formulation exhibits a second order release of minoxidil.
17 . The method of claim 1 , wherein the modified release pharmaceutical formulation comprises an enteric coating.
18 . The method of claim 1 , wherein the modified release pharmaceutical formulation is administered at least once daily.
19 . The method of claim 1 , wherein the oral administration of the modified release pharmaceutical formulation results in no cardiac effects.
20 . The method of claim 15 , wherein the cardiac effects are selected from tachycardia, hypotension, premature ventricular contractions, and other tachyarrhythmias.