Claims for Patent: 10,624,906
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Summary for Patent: 10,624,906
| Title: | Spironolactone aqueous compositions |
| Abstract: | Disclosed herein is a stable, ready-to-use liquid formulation comprising spironolactone and its method of use. |
| Inventor(s): | Pipho; Anthony (Winterville, NC), DeHart; Michael Paul (Winterville, NC) |
| Assignee: | CMP Development LLC (Farmville, NC) |
| Application Number: | 16/682,477 |
| Patent Claims: |
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; wherein the formulation has a spironolactone content of 100.+-.10% labeled content when stored for about 24-months at 25.+-.2.degree. C. and 40.+-.5% relative
humidity.
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 a xanthan gum. 4. An enclosed bottle comprising the ready-to-use liquid formulation of claim 3. 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 a xanthan gum. 7. An enclosed bottle comprising the ready-to-use liquid formulation of claim 6. 8. The ready-to-use liquid formulation of claim 1, which comprises about 0.5% w/v of spironolactone. 9. The ready-to-use liquid formulation of claim 8, which comprises about 0.25% of a xanthan gum. 10. The ready-to-use liquid formulation of claim 9, 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. 11. The ready-to-use liquid formulation of claim 9, 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. 12. The ready-to-use liquid formulation of claim 11, 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. 13. The ready-to-use liquid formulation of claim 12, wherein the sufficient amount of buffer ranges from about 10 mM to about 100 mM. 14. An enclosed bottle comprising the ready-to-use liquid formulation of claim 9. 15. The bottle of claim 14, wherein the volume of said bottle is 4 oz. or 16 oz. 16. The ready-to-use liquid formulation of claim 15, wherein a uniform content amount of spironolactone of about 100% l.c. is achieved within about 10 seconds of shaking. |
