US 12,128,025 B2
Ready-to-use ascorbic acid compound compositions
Prem Sagar Akasapu, Chesterfield, NJ (US); Veerappan Subramanian, Warren, NJ (US); and Ilango Subramanian, Warren, NJ (US)
Assigned to Somerset Therapeutics, LLC, Hollywood, FL (US)
Filed by Somerset Therapeutics, LLC, Hollywood, FL (US)
Filed on Dec. 9, 2022, as Appl. No. 18/064,204.
Claims priority of provisional application 63/288,383, filed on Dec. 10, 2021.
Prior Publication US 2023/0181525 A1, Jun. 15, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/375 (2006.01); A61K 9/00 (2006.01); A61K 9/08 (2006.01); A61K 47/02 (2006.01); A61K 47/18 (2017.01); A61K 47/26 (2006.01)
CPC A61K 31/375 (2013.01) [A61K 9/0019 (2013.01); A61K 9/08 (2013.01); A61K 47/02 (2013.01); A61K 47/183 (2013.01); A61K 47/26 (2013.01)] 16 Claims
 
1. An injectable, ready-to-use pharmaceutical composition comprising (a) a unit dose amount of an ascorbic acid compound component in a concentration of between about 20 mg/ml about 50 mg/ml, (b) one or more excipients, wherein the one or more excipients comprise (1) a chelation component consisting of an ethylenediaminetetraacetic acid (EDTA) compound or a suitable EDTA salt, (2) an antioxidant component consisting of a single antioxidant compound, and (3) a buffer in a concentration of between 1-1.5%; wherein there are no additional excipients present in the composition that exhibit antioxidant activity, wherein (c) the ready-to-use pharmaceutical composition has an osmolality of about 270 mOsm/kg to about 340 mOsm/kg, (d) the ready-to-use pharmaceutical composition does not require dilution prior to administration to a patient, (e) 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.±2° C. for at least 3 months prior to use, and (f) (I) the ready-to-use pharmaceutical composition has been demonstrated to be effective in treating scurvy in a statistically significant population of scurvy patients when administered in an effective daily dose for a sufficient period, (II) the ready-to-use pharmaceutical composition is bioequivalent to a second pharmaceutical composition, wherein the second pharmaceutical composition when administered to a population of scurvy patients results in a statistically significant number of the scurvy patients being effectively treated in one or more well controlled and adequate studies, or (III) both (I) and (II) are true.