Lipid nanoparticles (LNPs) have shown great success in the pharmaceutical industry, leading to 23 approved products in the U.S. and Europe over the past 30 years. They offer promising formulation options for drugs limited by low therapeutic indexes in traditional dosage forms and current "undruggable" targets. Analytical characterization of LNPs is critical to drug design, formulation development, understanding in vivo performance, as well as quality control . To address these challenges and facilitate future applications of LNPs in drug development, Alfa Chemistry offers a variety of available analytical approaches for physicochemical characterizations of LNPs-based pharmaceutical modalities. The characterization items include identification and quantification of lipid, drug encapsulation efficiency, nanoparticle characteristics, product stability, drug release and others.
In 2018, a guidance for industry on the development of liposome drug products was published by the U.S. FDA, and several critical quality attributes (CQAs) that have to be addressed were pointed out . The CQAs are:
(1) Identification and quantification of lipid species;
(2) Quantification of the encapsulated, free, and total API;
(3) Nanoparticle characterization including morphology, structure, particle size distribution, and surface charge;
(4) Physical (fusion and aggregation) and chemical (lipid and API degradation) stability of the product;
(5) In vitro drug release kinetics.
Although LNPs characterization faces many challenges due to their unique preparation processes and complex physicochemical properties, Alfa Chemistry is happy to help with the challenges. Based on the CQAs, we offer our customer with the following LNPs characterization services. These analytical strategies is critical to formulation development, quality control, and clinical translation of new products. If you want more details about the characterization services, please contact us.
|Classification||Service items||Available analytical technology|
|Identification and quantification of lipid species||Identification of lipid molecules|
|Quantification of drug encapsulation||-|
|Nanoparticle characterizations||Nanoparticle morphology|
|Nanoparticle crystallinity and polymorphism|
|Nanoparticle surface charge (zeta potential)|
|In vitro drug release||-|