Key result
A novel doxorubicin hydrochloride liposome injection demonstrated a longer apparent half-life (>50 h) compared to non-targeted drug references (<10 h) in 3 Chinese patients with breast cancer.
Why the study?
A novel doxorubicin hydrochloride liposome injection was prepared to reduce toxicity and side effects and extend plasma half-life in breast cancer, requiring a rapid and sensitive bioanalytical method to characterize its pharmacokinetic profile.
A newly developed LC-MS/MS method successfully quantified free and total doxorubicin in patients receiving a novel liposomal formulation, demonstrating a prolonged half-life that may reduce cardiotoxicity.
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May warrant further PK studies in breast cancer; leaves open efficacy, safety, and dosing implications.
A novel doxorubicin hydrochloride liposome injection was prepared to reduce toxicity and side effects, as well as extend plasma half-life in the treatment of breast cancer. In this study, a rapid and sensitive bioanalytical method was developed and validated to characterize the pharmacokinetic profile of total and free doxorubicin in plasma of 3 Chinese patients after intravenous infusion of this injection. Plasma samples were prepared by protein precipitation for the determination of total doxorubicin, while solid phase extraction was used to determine free doxorubicin. After plasma sample pre-treatment, total and free concentrations were quantified individually using a validated LC-MS/MS method. The calibration curves were found to be linear in the range of 0.20–500.0 ng mL −1 for total doxorubicin and in the range of 1.00–1,000 ng mL −1 for free doxorubicin. The free concentrations in plasma were only one sixth to one quarter of the total levels. Liposomal doxorubicin had a longer apparent half-life (>50 h) than the non-targeted drug (<10 h) reported in the reference. and a lower volume of distribution. This novel injectable formulation steadily released free doxorubicin from liposomes over a long period of time to reduce cardiac toxicity and side effects, while ensuring a clinical curative effect.
Zhang et al. (2023) studied Breast cancer (n=3). Novel doxorubicin hydrochloride liposome injection vs. Non-targeted drug (historical reference) was evaluated on Pharmacokinetic profile of total and free doxorubicin in plasma. A novel doxorubicin hydrochloride liposome injection demonstrated a longer apparent half-life (>50 h) compared to non-targeted drug references (<10 h) in 3 Chinese patients with breast cancer.