Liposomes have been considered promising and versatile drug vesicles. Compared with traditional drug delivery systems, liposomes exhibit better properties, including site-targeting, sustained or controlled release, protection of drugs from degradation and clearance, superior therapeutic effects, and lower toxic side effects. Given these merits, several liposomal drug products have been successfully approved and used in clinics over the last couple of decades. In this review, the liposomal drug products approved by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) are discussed. Based on the published approval package in the FDA and European public assessment report (EPAR) in EMA, the critical chemistry information and mature pharmaceutical technologies applied in the marketed liposomal products, including the lipid excipient, manufacturing methods, nanosizing technique, drug loading methods, as well as critical quality attributions (CQAs) of products, are introduced. Additionally, the current regulatory guidance and future perspectives related to liposomal products are summarized. This knowledge can be used for research and development of the liposomal drug candidates under various pipelines, including the laboratory bench, pilot plant, and commercial manufacturing.

No abstract

A kind of serial-parallel hybrid polishing machine tool based on the elastic polishing theory is developed and applied to finish mould surface with using bound abrasives. It mainly consists of parallel mechanism of three dimensional moving platform, serial rotational mechanism of two degrees of freedom and the elastic polishing tool system. The active compliant control and passive conformity of polishing tool are provided by a pneumatic servo system and a spring, respectively. Considering the contradiction between the machining quality and efficiency, the optimization model of process parameters is found according to different machining requirements, namely single objective optimization and multi-objective optimization, which provide a choice of parameters as a basis for the operators in practice. Many polishing experiments are conducted to collect the data samples. The genetic algorithm integrated with artificial neural network is used for researching for the optimal process parameters in term of the various optimization objectives. This research also lays the foundation for further establishing polishing expert system.

This study focused on the chiral characteristics of methamphetamine seizures in Shanghai for inferring the synthetic pathways of drugs. Capillary electrophoresis coupled to time-of-flight mass spectrometry was used for simultaneous chiral separation of amphetamine-type stimulants and ephedrine, including S(+)-amphetamine/R(-)-amphetamine, S(+)-methamphetamine/R(-)-methamphetamine, (±)-MDA (3,4-methylenedioxyamphetamine), (±)-MDMA (3,4-methylenedioxymethamphetamine), (±)-MDEA (3,4-methylenedioxy-N-ethylamphetamine), d,l-N-ethylamphetamine, methylephedrine/methylpseudoephedrine, and 1S,2R(+)-ephedrine/(-)-ephedrine. The running buffer was 50-mM ammonium formate (pH 2.2 was adjusted by 1-M formic acid) containing 0.26% highly sulfated γ-cyclodextrin as the chiral selector. All enantiomers were well resolved within 40 minutes by capillary electrophoresis at 20 kV in an uncoated fused-silica capillary (50-μm I.D. × 375-μm O.D. × 90-cm length) and detected by micro time-of-flight mass spectrometry. Twenty seized methamphetamine samples were determined by the established method. They were classified into two groups through their chiral characteristics.

No abstract