A Design-Conversed Strategy Establishes the Performance Safe Space for Doxorubicin Nanosimilars.
ACS Nano
; 18(8): 6162-6175, 2024 Feb 27.
Article
in En
| MEDLINE
| ID: mdl-38359902
ABSTRACT
Nanomedicines exhibit multifaceted performances, yet their biopharmaceutics remain poorly understood and present several challenges in the translation from preclinical to clinical research. To address this issue and promote the production of high-quality nanomedicines, a systematic screening of the design space and in vivo performance is necessary. Establishing formulation performance specifications early on enables an informed selection of candidates and promotes the development of nanosimilars. The deconvolution of the pharmacokinetics enables the identification of key characteristics that influence their performances and disposition. Using an in vitro-in vivo rank-order relationship for doxorubicin nanoformulations, we defined in vitro release specifications for Doxil/Caelyx-like follow-on products. Additionally, our model predictions were used to establish the bioequivalence of Lipodox, a nanosimilar of Doxil/Caelyx. Furthermore, a virtual safe space was established, providing crucial insights into expected disposition kinetics and informing formulation development. By addressing bottlenecks in biopharmaceutics and formulation screening, our research advances the translation of nanomedicine from bench to bedside.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Polyethylene Glycols
/
Doxorubicin
Type of study:
Prognostic_studies
Language:
En
Journal:
ACS Nano
/
ACS nano
Year:
2024
Document type:
Article
Affiliation country:
Singapur
Country of publication:
Estados Unidos