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Liposomes provide a number of advantages in controlled release of bioactives via parenteral administration. They mimic the natural transport systems in our body that utilize specialized vesicles with similar properties than liposomes as used in drug delivery.
In this workshop we address key issues in the manufacturing of parenteral liposomes, including raw material, equipment, analytics,uses etc. In addition we welcome discussion around newer developments and trends in parenteral liposomal delivery, targeting, and RNAi delivery.
Important elements of a scalable process for manufacturing of liposomes are: selection of synthesis route, raw material, process development, optimal equipment, isolation, purification, analysis, specification, stability, quality control. Today we have tight definitions of phospholipids to consider when using them for parenteral drug delivery. However even with current analytical technology, it may not be easy to detect minor quantities of impurities within isolated and purified lipids. Several basic routes to manufacture phospholipids have been employed. Some lipids are made starting from Glycero-3-phosphate, Iso-propyliden-glycerol, Phophatidylcholine or glycerophosphocholine. Other synthesis routes are fully chemical or use bio-catalysis in the process. Over the last decade many methods were published for the production of various kinds of liposomal specialties as well as equipment used in the process. As was demonstrated, the choice of manufacturing method and process can have crucial influence on the characteristics of liposomes such as size, lammelarity, encapsulation rate, or biological performance. The choice of liposome manufacturing must scale-up in pharmaceutical manufacturing. The requirements of the health authorities globally for quality of pharmaceutical products have been increasing steadily. Consequently, the development of a parenteral liposomal drug product requires a careful selection of raw materials and processes to meet the guideline requirement globally