Compositions for the effective treatment of vitamin C deficiency-related diseases and other conditions
The invention described here provides compositions for the efficient and effective treatment of vitamin C deficiency-related diseases and other conditions comprising the administration of pharmaceutical compositions comprising ascorbic acid compound(s), such as sodium ascorbate, and an antioxidant component. Compositions can further comprise one or more additional excipient(s), such as, e.g., a buffer component, a chelating component, or both. Compositions are provided in ready-to-use (RTU) form, not requiring dilution or further manipulation prior to their use, and are provided in single unit dose packaging. Compositions are stable when stored at 20° C. to 25° C.±2° C. for at least about 3 months. Further provided are methods of efficiently and effectively treating diseases(s) and condition(s) related to vitamin C deficiency using disclosed compositions.
1 . An injectable, single unit dose pharmaceutical composition wherein
(1) the single unit dose composition is provided in a ready-to-use form and does not require dilution prior to administration to a patient;
(2) the single unit dose composition comprises
(a) a unit dose of an ascorbic acid compound component present in a concentration of between about 20 mg/mL and about 50 mg/ml;
(b) sodium bicarbonate present in a concentration of between about 10 mg/ml and about 15 mg/ml;
(c) edetate disodium in a concentration of between about 0.01 mg/ml and about 1 mg/ml;
(3) the single unit dose composition is stable according to United States Food and Drug Administration stability standards when stored at 20° C. to 25° C.±2° C. for at least 3 months prior to use;
(4) the single unit dose composition does not comprise sodium pyrosulfite, sodium chloride, or sodium diethyldithiocarbamate; and
(5) the single unit dose composition does not comprise any additional excipients that exhibit antioxidant activity.
2 . The single unit dose pharmaceutical composition of claim 1 , wherein the ascorbic acid compound component comprises sodium ascorbate.
3 . The single unit dose pharmaceutical composition of claim 2 , wherein the concentration of the sodium ascorbate in the composition is about 25 mg/mL.
4 . The single unit dose pharmaceutical composition of claim 1 , wherein the ratio of the % w/v of the edetate disodium to the % w/v of the sodium bicarbonate is between about 1:100 and about 1:1500.
5 . The single unit dose pharmaceutical composition of claim 4 , wherein the composition is provided in a container comprising between about 2 mL and about 10 mL of the composition.
6 . The single unit dose pharmaceutical composition of claim 1 , wherein the composition is provided in a container comprising between about 2 mL and about 10 mL of the composition.
7 . The single unit dose pharmaceutical composition of claim 1 , wherein the composition is stable when stored at 20° C. to 25° C.±2° C. for at least 12 months prior to use.
8 . The pharmaceutical composition of claim 1 , wherein the composition is adapted for parenteral administration.
9 . The composition of claim 8 , wherein the parenteral administration comprises injection or intravenous infusion.
10 . The composition of claim 9 , wherein the parenteral administration is intravenous infusion.
11 . A method of treating a disease related to vitamin C deficiency, the method comprising: (1) providing the single unit dose pharmaceutical composition of claim 1 in a container component (2) directly administering the single unit dose pharmaceutical composition by parenteral administration to a subject having a vitamin C deficiency, and (3) if necessary, repeating steps (1) and (2) for a number of times effective to treat the vitamin C deficiency in the subject.
12 . The method of claim 11 , wherein part (3) of the method comprises repeating steps (1) and (2) at least once per day for a period of about 2 days to about 7 days.
13 . The method of claim 12 , wherein the disease is scurvy, the parenteral administration comprises intravenous infusion, and part (3) of the method comprises repeating steps (1) and (2) at least once per day for a period of about 2 days to about 7 days.
14 . A method of treating a disease related to vitamin C deficiency, the method comprising (1) providing the unit dose pharmaceutical composition of claim 4 in a container component, (2) directly administering the unit dose pharmaceutical composition by parenteral administration to a subject having a vitamin C deficiency, and (3) if necessary, repeating steps (1) and (2) for a number of times effective to treat the vitamin C deficiency in the subject.
15 . The method of claim 14 , wherein the disease is scurvy, the parenteral administration comprises intravenous infusion, and part (3) of the method comprises repeating steps (1) and (2) at least once per day for a period of about 2 days to about 7 days.