Methods of efficiently treating vitamin C deficiency-related diseases and other conditions
Inventors
Akasapu, Prem Sagar • Subramanian, Veerappan • Subramanian, Ilango
Assignees
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Publication Number
US-12097178-B2
Publication Date
2024-09-24
Expiration Date
Abstract
The invention described here provides methods of efficiently treating vitamin C deficiency-related diseases and other conditions comprising the administration of pharmaceutical compositions comprising ascorbic acid compound(s), such as sodium ascorbate, and one or more pharmaceutically acceptable excipients (e.g., a carrier and optionally other agents, such as a tonicity agent, a chelator, or both). The methods comprise administration of such compositions in ready-to-use (RTU) form, provided in single unit dose packaging, wherein the compositions are stable when stored at 20° C. to 25° C.±2° C. for at least about 3 months. Compositions provided by the invention comprise an osmolality of between about 270 mOsm/kg to about 340 mOsm/kg and do not require dilution or further manipulation prior to use.
Core Innovation
The invention provides an injectable pharmaceutically acceptable composition in a container component in ready-to-use form for treating a disease related to vitamin C deficiency. The composition comprises an effective unit dose amount of an ascorbic acid compound component at about 20 mg/ml to about 50 mg/mL, together with one or more excipients.
The excipients include a chelation component consisting of an ethylenediaminetetraacetic acid (EDTA) compound or a suitable EDTA salt, an antioxidant component consisting of a single antioxidant compound, and a buffer in a concentration between 1-1.5%. The composition has an osmolality of about 270 mOsm/kg to about 340 mOsm/kg, and there are no additional excipients present that exhibit antioxidant activity.
The composition is stable when stored at 20°C to 25°C and 2°C to 12°C for at least 3 months prior to use. It is directly administered by parenteral administration to a subject having a vitamin C deficiency, and if necessary, the administering step is repeated for a number of times effective to treat the vitamin C deficiency.
Claims Coverage
The patent includes one independent claim directed to treating a vitamin C deficiency-related disease, with one independent inventive combination of formulation and administration features.
Ready-to-use injectable composition with EDTA chelation, single antioxidant, and 1-1.5% buffer
An injectable pharmaceutically acceptable composition in ready-to-use form comprising an effective unit dose amount of an ascorbic acid compound component at about 20 mg/ml to about 50 mg/mL, together with a chelation component consisting of an EDTA compound or suitable EDTA salt, an antioxidant component consisting of a single antioxidant compound, and a buffer in a concentration between 1-1.5%, with no additional excipients that exhibit antioxidant activity.
Defined osmolality and storage stability for parenteral use
The ready-to-use composition has an osmolality of about 270 mOsm/kg to about 340 mOsm/kg and is stable when stored at 20°C to 25°C and 2°C to 12°C for at least 3 months prior to use.
Direct parenteral administration to treat vitamin C deficiency with optional repetition
The composition is directly administered by parenteral administration to a subject having a vitamin C deficiency, and the administering step is repeated if necessary for a number of times effective to treat the vitamin C deficiency.
Overall, the claim coverage centers on a ready-to-use injectable ascorbic acid composition with defined EDTA chelation, a single antioxidant, buffer, osmolality, and storage stability, for direct parenteral administration to treat vitamin C deficiency, with optional repeated administration.
Stated Advantages
Stable ready-to-use injectable composition stored at 20°C to 25°C and 2°C to 12°C for at least 3 months prior to use.
Osmolality defined between about 270 mOsm/kg to about 340 mOsm/kg.
Treats a disease related to vitamin C deficiency by parenteral administration of the defined ready-to-use composition.
Documented Applications
Wound healing time reduction in the disclosed context using a ready-to-use parenteral ascorbic acid composition.
Treating and preventing vitamin C deficiency-related diseases, explicitly including scurvy.
Treating a vitamin C deficiency by directly administering an effective amount of the ready-to-use injectable composition by parenteral administration to a subject.
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