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US 10,632,150 B1Granted
Potassium phosphates composition for injection
AssigneeCmp Development LLC
InventorsH. Greg Thomas, Richard LeVasseur, Jeffrey S. Kiel, Anthony Reid Pipho
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Abstract
Disclosed herein is a sterile composition for injection comprised of potassium phosphates having no visible particulate. Also disclosed herein is a manufacturing process for the sterile composition and its use.
Claims21
A sterile composition for injection, consisting of:
- (a) 175 mg/mL potassium monobasic phosphate;
- (b) 300 mg/mL of potassium dibasic phosphate;
- and
- (c) a sufficient amount of a sterile water vehicle;
- wherein the sterile composition has a total amount of phosphate content of 3 mmol/mL, a potassium content of 185 mg/mL, and an aluminum content of not more than 15 ppm;
- wherein the sterile composition for injection has no visible particles after (i) storage at 4-8° C. for 24-months or (ii) storage at 25° C. and 60% relative humidity for 24-months;
- wherein the composition is contained in a vial;
- and
- wherein the vial is comprised of glass or plastic.
6 more elements
A sterile composition for injection, consisting of:
- (a) 175 mg/mL potassium monobasic phosphate;
- (b) 300 mg/mL of potassium dibasic phosphate;
- and
- (c) a sufficient amount of a sterile water vehicle;
- wherein the sterile composition for injection has a phosphate content of 3 mmol/mL, a potassium content of 185 mg/mL, and an aluminum content of not more than 15 ppm;
- wherein the composition is contained in a glass vial;
- and
- wherein the sterile composition for injection has no visible particles after (i) storage at 4-8° C. for 24-months or (ii) storage at 25° C. and 60% relative humidity for 24-months.
5 more elements
A sterile composition for injection, consisting of:
- a potassium phosphate solution in a sterile water vehicle;
- wherein the sterile composition for injection has:
- (i) a pH of from 6.5 to 7.5, (ii) a phosphate content of 3 mmol/mL, (iii) a potassium content of 4.7 mEq/mL, and (iv) an aluminum content of not more than 15 ppm;
- wherein the sterile composition for injection has no visible particles after (a) storage at 4-8° C. for 24-months or (b) storage at 25° C. and 60% relative humidity for 24-months;
- wherein the composition is contained in a vial;
- and
- wherein the vial is comprised of glass or plastic.
4 more elements
Dependencies are inferred from the claim text.