Spironolactone aqueous compositions
Disclosed herein is a stable, ready-to-use liquid formulation comprising spironolactone and its method of use.
1. A ready-to-use liquid formulation, comprising:
(a) 0.50% w/v of spironolactone;
(b) from 0.18% w/v to 0.36% w/v of a xanthan gum;
(c) from 0.2% w/v to 0.6% w/v of an anti-foaming agent;
(d) from 0.125% w/v to 0.250% w/v of a preservative;
(e) from 1.8% w/v to 2.4% w/v of a dispersing agent;
(f) from 0.04% w/v to 0.6% w/v of a sweetening agent;
(g) from 0.1% w/v to 0.5% w/v of a flavoring agent;
(h) a sufficient amount of a citrate buffer to maintain the pH of the formulation from 4.5 to 5.5; and
(i) a sufficient amount of a water vehicle,
wherein the formulation exhibits a spironolactone content of 100 ±10% labeled content for about 24-months when stored at 25±2° C. and 40±5% relative humidity.
2. An enclosed bottle comprising the ready-to-use liquid formulation of claim 1 .
3. The bottle of claim 2 , wherein the volume of said bottle is 4 oz. or 16 oz.