Ready-to-use ascorbic acid compound compositions
Inventors
Akasapu, Prem Sagar • Subramanian, Veerappan • Subramanian, Ilango
Assignees
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Publication Number
US-12128025-B2
Publication Date
2024-10-29
Expiration Date
Abstract
The invention described here provides ready-to-use (RTU) pharmaceutical compositions in single unit dose packaging, such compositions including 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 compositions provided by the invention 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. In certain aspects, the invention comprises methods of using such compositions in the treatment of diseases, conditions, or symptoms related to vitamin C deficiency, such as, in specific embodiments, scurvy.
Core Innovation
The invention is an injectable, ready-to-use pharmaceutical composition that includes a unit dose amount of an ascorbic acid compound component in a concentration of about 20 mg/ml to about 50 mg/ml. The composition includes excipients with a chelation component consisting of an EDTA compound or a suitable EDTA salt, an antioxidant component consisting of a single antioxidant compound, and a buffer in a concentration of between 1-1.5%, and it includes no additional excipients that exhibit antioxidant activity.
The ready-to-use pharmaceutical composition has an osmolality of about 270 mOsm/kg to about 340 mOsm/kg and does not require dilution prior to administration to a patient. The composition is stable according to United States Food and Drug Administration stability standards when stored at 20°C to 25°C and 2°C to 8°C for at least 3 months prior to use.
Effectiveness is established for treating scurvy in a statistically significant population of scurvy patients when administered in an effective daily dose for a sufficient period. The invention further includes bioequivalence to a second pharmaceutical composition, such that administration results in a statistically significant number of scurvy patients being effectively treated in one or more well controlled and adequate studies.
Claims Coverage
The single independent claim provides coverage for a ready-to-use injectable ascorbic acid composition with four inventive features: constrained excipient selection, osmolality and no dilution requirement, FDA stability, and scurvy effectiveness or bioequivalence.
Ready-to-use injectable ascorbic acid composition with constrained EDTA chelation, single antioxidant, and buffer
An injectable, ready-to-use pharmaceutical composition comprising a unit dose amount of an ascorbic acid compound component in a concentration of about 20 mg/ml to about 50 mg/ml, with a chelation component consisting of an EDTA compound or a suitable EDTA salt, an antioxidant component consisting of a single antioxidant compound, and a buffer in a concentration of between 1-1.5%, with no additional excipients present that exhibit antioxidant activity.
Osmolality and no dilution prior to administration
The ready-to-use pharmaceutical composition has an osmolality of about 270 mOsm/kg to about 340 mOsm/kg and does not require dilution prior to administration to a patient.
FDA stability at 20°C-25°C and 2°C-8°C for at least 3 months
The ready-to-use pharmaceutical composition is stable according to United States Food and Drug Administration stability standards when stored at 20°C to 25°C and 2°C to 8°C for at least 3 months prior to use.
Statistically significant scurvy treatment or bioequivalence to a second effective composition
The ready-to-use pharmaceutical composition is effective in treating scurvy in a statistically significant population of scurvy patients when administered in an effective daily dose for a sufficient period, or is bioequivalent to a second pharmaceutical composition wherein administration results in a statistically significant number of scurvy patients being effectively treated in one or more well controlled and adequate studies.
The claim coverage is directed to a specific ready-to-use injectable ascorbic acid formulation defined by EDTA-type chelation, a single antioxidant component, a 1-1.5% buffer, exclusion of antioxidant-active additional excipients, an osmolality of about 270-340 mOsm/kg, no dilution prior to administration, FDA stability at 20-25°C and 2°C-8°C for at least 3 months, and scurvy effectiveness and/or bioequivalence to an effective second composition in well controlled and adequate studies.
Stated Advantages
Stated stability according to United States Food and Drug Administration stability standards at 20°C to 25°C and 2°C to 8°C for at least 3 months prior to use.
Stated effectiveness in treating scurvy in a statistically significant population of scurvy patients.
Stated bioequivalence to a second pharmaceutical composition, with statistically significant treatment outcomes in well controlled and adequate studies.
Ready-to-use composition that does not require dilution prior to administration to a patient.
Decreases wound healing time.
Treats and/or prevents vitamin C deficiency and related symptoms/diseases.
Documented Applications
Treatment of scurvy in a statistically significant population of scurvy patients.
Vitamin C deficiency conditions, including scurvy, as described in the provided summary content.
Clinical/therapeutic use of the ready-to-use injectable pharmaceutical composition to decrease wound healing time.
Therapeutic and preventive use for vitamin C deficiency and related symptoms/diseases.
Treatment of scurvy in scurvy patients with statistically significant effectiveness.
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