Confirmation of the suitability and stability of the imatinib mesylate drug product formulation for intravenous administration in the INVENT-COVID clinical trial
Description
Abstract: An isotonic sterile aqueous solution of imatinib mesylate was formulated and then manufactured according to cGMP by KABS Laboratories. A solution pH of 5.0 is optimum for imatinib mesylate solubility and stability and this is maintained by a sodium acetate buffer. The drug product for the clinical study was presented as a sterile solution in a Type 1 clear glass vial with chlorobutyl stopper and seal. Stability studies on the drug product have confirmed an excellent stability profile and these data are presented in Table 1. The drug product specification detailed in this table is consistent with Regulatory Authority requirements for this stage in clinical development. These data support the conclusion that the drug product used in the INVENT-COVID trial was fully compliant with all cGMP and EU Regulatory Authority requirements.
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http://data.europa.eu/88u/dataset/oai-zenodo-org-7640138 |
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http://data.europa.eu/88u/dataset/oai-zenodo-org-7640138 |