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 a dosage form to a human being experiencing hair loss, wherein the dosage form comprises about 4.5 mg of minoxidil or a molar equivalent amount of the pharmaceutically acceptable salt thereof, and about 65% to about 85% of hydroxypropyl methylcellulose by weight of the dosage form.
2 . The method of claim 1 , wherein the dosage form is administered once daily.
3 . The method of claim 1 , wherein the dosage form is administered twice daily.
4 . The method of claim 1 , wherein the hydroxypropyl methylcellulose provides modified release of the minoxidil, and orally administering the dosage form provides an AUC 0-inf that is less than the AUC 0-inf provided by a dosage form containing an immediate release formulation of 4.5 mg of minoxidil.
5 . The method of claim 1 , wherein a blood level of minoxidil or the pharmaceutically acceptable salt thereof of about 1 ng/ml to about 20 ng/ml is maintained for at least about 8 hours.
6 . The method of claim 1 , wherein the dosage form further comprises a filler, a glidant, a lubricant, or a combination thereof.
7 . The method of claim 1 , wherein the hair loss comprises female pattern hair loss.
8 . The method of claim 1 , wherein the hair loss comprises hereditary hair loss.
9 . The method of claim 1 , wherein the hair loss comprises telogen effluvium.
10 . The method of claim 1 , wherein the hair loss comprises alopecia areata.
11 . The method of claim 1 , wherein the hair loss comprises central centrifugal cicatricial alopecia.
12 . The method of claim 1 , wherein the hair loss comprises lichen planopilaris.
13 . The method of claim 1 , wherein the hair loss comprises traction alopecia.
14 . The method of claim 1 , wherein the oral administration results in hair regrowth.
15 . The method of claim 1 , wherein the dosage form comprises an enteric coating.
16 . The method of claim 1 , wherein the oral administration of the dosage form results in no tachycardia.
17 . The method of claim 1 , wherein the oral administration of the dosage form results in no symptomatic hypotension.
18 . The method of claim 1 , wherein the oral administration of the dosage form results in no premature ventricular contractions.
19 . The method of claim 1 , wherein the oral administration of the dosage form results in no symptomatic tachyarrhythmias.
20 . The method of claim 1 , wherein the oral administration of the dosage form results in no peripheral edema.
21 . The method of claim 1 , wherein the oral administration of the dosage form results in no lightheadedness.