Stable radiopharmaceutical compositions and uses thereof
AssigneeAlpha-9 Oncology, Inc.
InventorsAlison Fleming, Megan Bumgarner, Thomas Kostelnik, Imma Carbo-Bague, Julie Rousseau, Chengcheng Zhang, Kaveh Matinkhoo, Jutta Wanner, Mark Dornan
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Abstract
Stabilized radiopharmaceutical formulations or dosage forms comprising radiolabeled conjugates of formula RC-L-TM are disclosed. Methods of making and using stabilized radiopharmaceutical formulations or dosage forms comprising the radiolabeled conjugates are also disclosed, including the preparation and stabilization of targeted radiodiagnostic and radiotherapeutic compounds comprising the radiolabeled conjugate.
Claims18
A dosage form comprising a frozen aqueous pharmaceutically acceptable composition, the frozen aqueous composition comprising a pH buffer and a radiolabeled conjugate comprising 225Ac coordinated by a chelator corresponding to Formula I:
- wherein, upon thawing, the frozen aqueous composition has a pH value in the range of 5-8 and is suitable for intravenous administration, and
- wherein the frozen aqueous composition has a radiochemical purity (RCP) of at least 95% after 120 hours storage at a temperature of −20° C. as determined by TLC.
A dosage form comprising a frozen aqueous pharmaceutically acceptable composition, the frozen aqueous composition comprising a pH buffer and a radiolabeled conjugate comprising 225Ac coordinated by a chelator corresponding to Formula I:
- wherein the frozen aqueous composition has a radiochemical purity (RCP) of at least 95% after 120 hours storage at a temperature of −20° C. as determined by TLC.
Dependencies are inferred from the claim text.