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US 10,493,083 B2Granted
Spironolactone aqueous compositions
AssigneeCmp Development LLC
InventorsAnthony Pipho, Michael Paul DeHart
Life of this patent
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Abstract
Disclosed herein is a stable, ready-to-use liquid formulation comprising spironolactone and its method of use.
Claims3
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.
8 more elements
Dependencies are inferred from the claim text.