Claims for Patent: 10,493,083
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Summary for Patent: 10,493,083
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: | 15/665,014 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent 10,493,083 |
Patent Claims: |
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.degree. 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. |
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