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 alopecia areata, comprising orally administering a dosage form to a human being experiencing alopecia areata, wherein the dosage form comprises about 8.5 mg of minoxidil or a molar equivalent amount of the pharmaceutically acceptable salt thereof.
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 dosage form comprises a release modifier, and the release modifier comprises a hydroxypropyl methylcellulose.
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 orally administering the dosage form provides a C max that is devoid of cardiac effects.
7 . The method of claim 1 , wherein orally administering the dosage form provides an AUC that is less than the AUC that would result from orally administering 8.5 mg of minoxidil in an immediate release formulation.
8 . The method of claim 1 , wherein the dosage form further comprises a filler.
9 . The method of claim 1 , wherein the dosage form further comprises a glidant.
10 . The method of claim 1 , wherein the dosage form further comprises a lubricant.
11 . The method of claim 1 , wherein the oral administration results in hair regrowth.
12 . The method of claim 1 , wherein the dosage form comprises an enteric coating.
13 . The method of claim 1 , wherein the oral administration of the dosage form results in no tachycardia.
14 . The method of claim 1 , wherein the oral administration of the dosage form results in no symptomatic hypotension.
15 . The method of claim 1 , wherein the oral administration of the dosage form results in no premature ventricular contractions.
16 . The method of claim 1 , wherein the oral administration of the dosage form results in no symptomatic tachyarrhythmias.
17 . The method of claim 1 , wherein the oral administration of the dosage form results in no peripheral edema.
18 . The method of claim 1 , wherein the oral administration of the dosage form results in no lightheadedness.
19 . The method of claim 1 , wherein the human being has been diagnosed with a cardiac condition.
20 . The method of claim 1 , wherein the human being is taking a medication for the treatment of a cardiac condition.