Clinical Outcomes of liposomal encapsulation in Patients with drug degradation instability

Ying Zhou; Y. Chen; Y. Liu

doi:10.5281/zenodo.22813178

Authors

Ying Zhou Division of Pharmaceutical Sciences, Godavari Center for Drug Delivery Research Author https://orcid.org/5984-9420-0452-665X
Y. Chen Department of Pharmaceutical Sciences, Thames Center for Drug Delivery Research Author https://orcid.org/3760-4217-2954-0670
Y. Liu Department of Clinical Drug Delivery Research, Dnieper Institute for Advanced Pharmaceutical Sciences Author https://orcid.org/3378-6948-2015-8910

DOI:

https://doi.org/10.5281/zenodo.22813178

Keywords:

liposomal encapsulation, drug degradation instability, pharmacokinetics, clinical outcomes, nanomedicine

Abstract

Graphical abstract

Background: Amphotericin B, doxorubicin, vincristine, cytarabine, and irinotecan are each limited in free solution by chemical degradation, aggregation, or rapid clearance rather than by their intrinsic pharmacology.

Objective: To synthesize comparative clinical trial outcomes for liposomal encapsulation of drugs with documented degradation or clearance instability, and the formulation-stability evidence underlying those outcomes.

Methods: Structured narrative synthesis of randomized and controlled trials of liposomal versus conventional formulations for six agents, alongside pharmaceutical literature on phospholipid hydrolysis and oxidation.

Findings: Liposomal amphotericin B and doxorubicin preserved efficacy while substantially reducing nephrotoxicity and cardiotoxicity; liposomal vincristine, cytarabine, irinotecan, and CPX-351 achieved efficacy gains from corrected pharmacokinetic exposure, with benefit dependent on controlling storage-related lipid hydrolysis and oxidation.

Conclusions: Liposomal encapsulation is a validated, clinically consequential correction for degradation- and clearance-prone agents, with drug-specific benefit that depends on demonstrated manufacturing stability.

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