Development of liposomal drug formulations: quality attributes and methods for quality control

Melnikova EV, Goryachev DV, Chaplenko AA, Vodyakova MA, Sayfutdinova AR, Merkulov VA
About authors

Scientific center for expert evaluation of medicinal products of the Ministry of health of the Russian Federation, Moscow

Correspondence should be addressed: Alexander A. Chaplenko
Shchukinskaya, 6 bl. 1, Moscow, 127051; ur.dempxe@oknelpahc

Received: 2018-06-29 Accepted: 2018-09-02 Published online: 2018-12-31

The use of nanostructured components in drug manufacturing and, more specifically, targeted drug delivery has recently become a major trend in the pharmaceutical industry. Nanodrugs encompass a wide range of pharmaceutical agents containing dendrimers, nanocrystals, micelles, liposomes, and polymer nanoparticles. Liposomes are the most well-studied nanoparticles and effective drug carriers. However, the more complex their structure is, the more process controls are needed and the more quality attributes have to be monitored, including the chemical properties of the liposomal fraction such as the shape, size and charge of the nanoparticle, conjugation efficacy, and distribution of the active ingredient. We believe that quality control of key liposome characteristics should rely on dynamic and laser light scattering coupled with electrophoresis, differential scanning calorimetry, cryo-electron microscopy, nuclear magnetic resonance, laser diffraction analysis, and gel filtration chromatography.

Keywords: liposomes, nanodrugs, quality control, guidance documents