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) about 0.20% w/v to about 1.0% w/v of spironolactone;
(b) from about 0.18% w/v to about 0.36% w/v of a xanthan gum;
(c) a pharmaceutically acceptable excipient; and
(d) a sufficient amount of a water vehicle.
2. The ready-to-use liquid formulation of claim 1 , which comprises from about 0.3% w/v to about 0.8% w/v of spironolactone.
3. The ready-to-use liquid formulation of claim 2 , which comprises from about 0.20% w/v to about 0.32% w/v of the xanthan gum.
4. A dosage container comprising the ready-to-use liquid formulation of claim 1 .
5. The ready-to-use liquid formulation of claim 1 , which comprises from about 0.4% w/v to about 0.6% w/v of spironolactone.
6. The ready-to-use liquid formulation of claim 5 , which comprises from about 0.20% w/v to about 0.32% w/v of the xanthan gum.
7. A dosage container comprising the ready-to-use liquid formulation of claim 1 .
8. The container of claim 7 comprised of an enclosed bottle, wherein the bottle comprises a polyethylene terephthalate and an amber colorant.
9. The bottle of claim 8 having a volume of said bottle of 4 oz. or 16 oz.
10. The ready-to-use liquid formulation of claim 1 , which comprises about 0.5% w/v of spironolactone.
11. The ready-to-use liquid formulation of claim 10 , which comprises about 0.25% of the xanthan gum.
12. The ready-to-use liquid formulation of claim 11 , wherein the pharmaceutically acceptable excipient is selected from the group consisting of an anti-foaming agent, a preservative, a dispersing agent, a sweetening agent, a flavoring agent, a buffer to maintain the pH of the formulation from 4.5 to 5.5, and a combination thereof.
13. The ready-to-use liquid formulation of claim 12 , wherein the pharmaceutically acceptable excipient is selected from the group consisting of from 0.2% w/v to 0.6% w/v of an anti-foaming agent, from 0.125% w/v to 0.250% w/v of a preservative, from 1.8% w/v to 2.4% w/v of a dispersing agent, from 0.04% w/v to 0.6% w/v of a sweetening agent, from 0.1% w/v to 0.5% w/v of a flavoring agent, a sufficient amount of a buffer to maintain the pH of the formulation from 4.5 to 5.5, and a combination thereof.
14. The ready-to-use liquid formulation of claim 13 , wherein the buffer is selected from the group consisting of an acetate buffer, an aconitate buffer, a glutarate buffer, a glutamate buffer, a malate buffer, a succinate buffer, a tartrate buffer, a citrate buffer, and a phosphate buffer.
15. The ready-to-use liquid formulation of claim 14 , wherein the sufficient amount of buffer ranges from about 10 mM to about 100 mM.
16. The ready-to-use liquid formulation of claim 13 , wherein the buffer comprises a citrate buffer.
17. A dosage container comprising the ready-to-use liquid formulation of claim 13 .
18. The container of claim 17 comprised of an enclosed bottle, wherein the bottle comprises a polyethylene terephthalate and an amber colorant.
19. The bottle of claim 18 having a volume of said bottle of 4 oz. or 16 oz.
20. The ready-to-use liquid formulation of claim 13 , wherein a uniform content amount of spironolactone of about 100% 1.c. is achieved within about 5 seconds of shaking.