"Quality by Design" in Liposomal Drugs Creation

Abstract

Nanobiotechnological preparations creation is one of the promising areas of modern pharmacy, since it allows creating products of a qualitatively new level. The procedure development, based on an understanding of the product characteristics and the technological process, confirmed by reliable scientific data. The article is devoted to the pharmaceutical development of liposomal drugs. On the basis of our own experience in the development of liposomal medicinal forms, as well as on the basis of literature data, the main components in their composition were detected and these components impact on the quality indicators of liposomes were studied. Individual lipids function in nanoparticle membrane and their interaction, which determines the stability both in the technological process and upon storage of the product, were considered. The advantages and disadvantages of cholesterol incorporation into liposomes with hydrophilic and hydrophobic active pharmaceutical ingredients were described. Cryoprotectors and buffer systems role in ensuring nanopreparation stability is discussed.