Guidelines for the implementation of ANMAT Provision Nº 9943/19: nanopharmaceutical products, liposomal doxorubicin
DOI:
https://doi.org/10.62035/rca.1.11Keywords:
nanosimilar, sistemas de administración de fármacos, formulación liposomal, doxorrubicinaAbstract
The use of liposomes as drug delivery systems has seen a great development in the last decades. In the particular case of doxorubicin, its encapsulation inside lipidic vesicles allows a reduction in its toxic effects while maintaining its therapeutic efficacy. Due to their complexity, changes in the elaboration method, in the composition, or in the quality of the raw materials of these products can lead to significant variations in the physicochemical properties and in the efficacy of the liposomal formulation. Therefore, the characterization of these products requires an exhaustive evaluation of their physicochemical, pharmacotechnical and microbiological parameters, including preclinical trials for the study of the products’ pharmacokinetics, pharmacodynamics and toxicity. Thus, the objective of this article is to provide a regulatory vision about the main characteristics that must be evaluated for the registry of liposomal doxorubicin nanosimilar products.
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