Abstract

Liposomes, sphere-shaped vesicles consisting of one or more phospholipids bilayers. Today, they are a very useful reproduction, reagent, and tool in various scientific disciplines, including mathematics and theoretical physics, biophysics, chemistry, colloid science, biochemistry, and biology. A number of clinical studies have now demonstrated the superiority of liposomal drug formulations over conventional delivery systems. Liposomes characterize an advanced technology to deliver active molecules to the site of action, and at present, several formulations are in clinical use. Research on liposome technology has progressed from conventional vesicles to ‘second-generation liposome's’, in which long-circulating liposome's are obtained by modulating the lipid composition, size, and charge of the vesicle. Liposome with modified surfaces have also been developed using several molecules, such as glycolipids or sialic acid. Antineoplastic agents, doxorubicin, daunorubicin and cytarabine, are in advanced stages of clinical testing in humans. One or more of these should prove to be a medically useful and commercially viable product within the next few years. This paper summarizes exclusively scalable techniques and focuses on strengths, respectively, limitations in respect to industrial applicability and regulatory requirements concerning liposomal drug formulations based on FDA and EMEA documents.

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