Claims for Patent: 10,624,879
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Summary for Patent: 10,624,879
| Title: | Liquid pharmaceutical composition |
| Abstract: | The present invention provides a physically and chemically stable pharmaceutical liquid composition including sodium picosulfate, magnesium oxide, citric acid and malic acid and methods of making and using such a composition. |
| Inventor(s): | Nam; Bong Gil (Seoul, KR), Lee; Byeung Jun (Gyeonggi-do, KR), Jin; Shunji (Gyeonggi-do, KR) |
| Assignee: | FERRING INTERNATIONAL CENTER S.A. (St. Prex, CH) |
| Application Number: | 15/822,298 |
| Patent Claims: |
1. A pharmaceutical composition comprising sodium picosulfate, magnesium oxide, citric acid, and malic acid, wherein the pharmaceutical composition is a solution with
a pH in the range from 4.1 to 5.4.
2. The pharmaceutical composition of claim 1, wherein the sodium picosulfate, the magnesium oxide, the citric acid, and the malic acid are present in a weight ratio of 0.003 to 0.009:1 to 3:3.5 to 10.5:0.01 to 13 (sodium picosulfate:magnesium oxide:citric acid:malic acid). 3. The pharmaceutical composition of claim 1, wherein Substance A related to sodium picosulfate is generated in an amount of about 2.0 wt. % or less when the composition is left at room temperature for 24 months. 4. The pharmaceutical composition of claim 1, wherein precipitation occurs at about 5.0 vol. % or less when the composition is left at room temperature for 24 months. 5. The pharmaceutical composition of claim 1, wherein the composition further comprises one or more excipients chosen from pH adjusters, stabilizers, preservatives, sweeteners, and fragrance ingredients. 6. The pharmaceutical composition of claim 1, wherein the composition further comprises acesulfame potassium. 7. The pharmaceutical composition of claim 1, wherein the composition further comprises disodium edetate. 8. The pharmaceutical composition of claim 1, wherein the composition further comprises sodium benzoate. 9. The pharmaceutical composition of claim 1, wherein the composition further comprises sodium hydroxide. 10. The pharmaceutical composition of claim 1, wherein the composition further comprises sucralose. 11. A pharmaceutical composition comprising sodium picosulfate, magnesium oxide, citric acid, and malic acid, wherein the pharmaceutical composition is a liquid with a pH ranging from 4.1 to 5.4, and further wherein the sodium picosulfate, the magnesium oxide, the citric acid, and the malic acid are present in a weight ratio of about 0.005:1.75:6:4.19 (sodium picosulfate:magnesium oxide:citric acid:malic acid). 12. The pharmaceutical composition of claim 11, wherein Substance A related to sodium picosulfate is generated in an amount of about 2.0 wt. % or less when the composition is left at room temperature for 24 months. 13. The pharmaceutical composition of claim 11, wherein when the composition is left at room temperature for 24 months, precipitation occurs at about 5.0 vol. % or less. 14. The pharmaceutical composition of claim 11, wherein the composition further comprises one or more excipients chosen from pH adjusters, stabilizers, preservatives, sweeteners, and fragrance ingredients. 15. The pharmaceutical composition of claim 11, wherein the composition further comprises acesulfame potassium. 16. The pharmaceutical composition of claim 11, wherein the composition further comprises disodium edetate. 17. The pharmaceutical composition of claim 11, wherein the composition further comprises sodium benzoate. 18. The pharmaceutical composition of claim 11, wherein the composition further comprises sodium hydroxide. 19. The pharmaceutical composition of claim 11, wherein the composition further comprises sucralose. |
