Liquid composition comprising glucose
AssigneeHikma Pharmaceuticals USA Inc.
InventorsBarbara Fumic, Stipica Tomic
Life of this patent
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Abstract
The present disclosure relates to an aqueous composition stored in a single unit dosage container, where the aqueous composition consists of glucose, sodium bicarbonate, water, and a pH adjusting agent if needed to adjust the pH, wherein the pH of the composition is from 6.7 to 8.1. Such composition is stable for at least 3 months at room temperature conditions.
Claims13
An aqueous composition stored in a single unit dosage container, where the aqueous composition consists of glucose in a concentration from 1 mg/ml to 50 mg/ml, sodium bicarbonate in concentration from 4 mg/ml to 15 mg/ml, water, and a pH adjusting agent to adjust the pH, wherein the pH of the composition is from 6.7 to 8.1,
- wherein, after storing the composition for 3 months at 30° C., the composition contains less than or equal to 2% of fructose as determined by high pressure liquid chromatography (HPLC).
A method of treating a human having metabolic acidosis, wherein the method comprises:
- (i) preparing an aqueous composition, the composition consisting of glucose in a concentration from 1 mg/ml to 50 mg/ml, sodium bicarbonate in concentration from 4 mg/ml to 15 mg/ml, a pH adjusting agent, water, and a pH control agent to adjust the pH, wherein the pH of the composition is from 6.7 to 8.1;
- (ii) storing the composition in a unit dosage container for at last 3 months at 30° C. after the preparation;
- and (iii) after storing, administering the composition to the human;
- wherein the composition that is administered to the human contains less than or equal to 2% of fructose as determined by HPLC.
Dependencies are inferred from the claim text.