title: Comparison between liposomal formulations of amphotericin B.
abstract: Given the clinical success of commercial amphotericin B lipid products, investigators have begun making generic formulations of liposomal amphotericin B. Generic medicines are an attractive approach to help decrease the cost and accessibility to healthcare, provided that appropriate studies are performed to ensure bioequivalence with the parent product. This is of particular concern for liposomal drugs such as amphotericin B where liposomes are used as a carrier system to reduce the toxicity of the active agent. A favorable therapeutic profile for this form of the drug has to include the proper chemical composition along with strictly controlled manufacturing processes. Studies have shown that a comparison of liposomal amphotericin B products with different or the same chemical compositions, using different methods of production, will vary in size, and have significantly dissimilar in vitro and in vivo toxicities along with reduced efficacy. These results underscore the importance of establishing appropriate bioequivalence testing for liposome products to ensure uniformity of their therapeutic index.
authors.affiliation: Department of Biological Sciences, California State Polytechnic University, Pomona, California, USA jpadler@cpp.edu.
authors.forename: Jill P
authors.initials: JP
authors.lastname: Adler-Moore
authors.affiliation: Centre Hospitalier Universitaire de Rennes, Laboratoire de Parasitologie-Mycologie, Rennes, France INSERM U1085, IRSET (Institut de Recherche en Santé Environnement Travail), Université Rennes 1, Rennes, France.
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Gangneux
authors.affiliation: Division of Infectious Diseases, University of Alabama at Birmingham, 1900 University Blvd, 229 THT, Birmingham, Alabama 35294-0006, USA.
authors.forename: Peter G
authors.initials: PG
authors.lastname: Pappas
mesh_terms: D000666:Amphotericin B / Q000009:adverse effects / Q000737:chemistry* / Q000494:pharmacology*; D000935:Antifungal Agents / Q000009:adverse effects / Q000737:chemistry* / Q000494:pharmacology*; D004339:Drug Compounding; D006801:Humans; D013810:Therapeutic Equivalency
chemical_list: D000935:Antifungal Agents; C068538:liposomal amphotericin B; D000666:Amphotericin B
keywords: amphotericin B; bioequivalence; invasive fungal infections; leishmaniasis; liposomes