Liposomal Pharmaceutical Products: Methods of Analytical Characterization and Quality Control

被引：0

作者：

Shprakh, Z. S. ^{[1
,2
]}

Burdaev, N. I. ^{[3
]}

Nikolaeva, L. L. ^{[1
,2
]}

Bunyatyan, N. D. ^{[2
,3
]}

机构：

[1] Minist Hlth Russia, Blokhin Natl Med Res Ctr Oncol, 24 Kashirskoe Shosse, Moscow 115478, Russia

[2] Sechenov Univ, Minist Hlth Russia, 8-2 Trubetskaya St, Moscow 119991, Russia

[3] Minist Hlth Russian Federat, Sci Ctr Expert Evaluat Med Prod, 8-2 Petrovskii Blvd, Moscow 127051, Russia

来源：

PHARMACEUTICAL CHEMISTRY JOURNAL | 2024年 / 57卷 / 11期

关键词：

liposomes; critical quality attributes; analytical methods; PERFORMANCE LIQUID-CHROMATOGRAPHY; DRUG-DELIVERY-SYSTEMS; LIGHT-SCATTERING DETECTION; SOLID-PHASE EXTRACTION; IN-VITRO; RELEASE ASSAY; DOXORUBICIN; NANOPARTICLES; FORMULATION; QUANTIFICATION;

D O I：

10.1007/s11094-024-03082-5

中图分类号：

R914 [药物化学];

学科分类号：

100701 ;

摘要：

Modern methods of analytical characterization and quality control of liposomal pharmaceutical products are reviewed. Analytical studies are shown to be extremely important not only for the development and quality control of liposomes but also for understanding the possible clinical safety and efficacy of liposomes with encapsulated drugs. The complicated analytical characteristics of liposomes that are determined by their unique structure, nanoscopic dimensions, and excipients, primarily lipids, are highlighted. Critical quality attributes of liposomes, e.g., qualitative and quantitative determination of the lipid components of the liposomal shell, nanoparticle morphology, encapsulation efficiency, and drug release are discussed. Available analytical approaches and determination methods are summarized. Examples of analytical studies of liposomes with encapsulated anticancer drugs are given.

引用

页码：1807 / 1814

页数：8

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