title: Liposomal formulations of amphotericin B: differences according to the scientific evidence.
abstract: This article presents an overview of the characteristics of liposomes as drug carriers, particularly in relation to liposomal formulations of amphotericin B. General features regarding structure, liposome-cell interactions, stability, encapsulation of active substances and elimination of liposomes are described. Up to the present time extensive efforts to produce similar or bioequivalent products of amphotericin B formulations, in particular in the case of liposomal amphotericin B, have been unsuccessful in spite of having a very similar composition and even an apparently identical manufacturing process. Guidelines for the development of generic liposomal formulations developed by the FDA and EMA are also summarized. Based on the available evidence of the composition of liposomes, any differences in the manufacturing process even if the same lipid composition is used may result in different final products. Therefore, it seems unreasonable to infer that all amphotericin B liposomal formulations are equal in efficacy and safety.
authors.affiliation: José Ramón Azanza, Servicio de Farmacología Clínica Clínica Universidad de Navarra, Spain. jrazanza@unav.es.
authors.forename: José Ramón
authors.initials: JR
authors.lastname: Azanza
authors.forename: Belén
authors.initials: B
authors.lastname: Sádada
authors.forename: Joana
authors.initials: J
authors.lastname: Reis
mesh_terms: D000666:Amphotericin B / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000818:Animals; D000935:Antifungal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002626:Chemistry, Pharmaceutical; D002986:Clinical Trials as Topic; D004337:Drug Carriers; D004339:Drug Compounding; D004353:Drug Evaluation, Preclinical; D006801:Humans; D008081:Liposomes / Q000008:administration & dosage / Q000737:chemistry / Q000493:pharmacokinetics; D009181:Mycoses / Q000188:drug therapy; D010743:Phospholipids / Q000737:chemistry; D053835:Unilamellar Liposomes / Q000493:pharmacokinetics
chemical_list: D000935:Antifungal Agents; D004337:Drug Carriers; D008081:Liposomes; D010743:Phospholipids; D053835:Unilamellar Liposomes; C068538:liposomal amphotericin B; D000666:Amphotericin B