title: [Stability study of oxaliplatin and doxorubicin for intraperitoneal administration with hyperthermia].
abstract: OBJECTIVE
  To evaluate the in vitro physicochemical stability of oxaliplatin and doxorubicin when the in vivo hyperthermic intraperitoneal conditions are reproduced.
  
  
  METHODS
  Three solutions were prepared, A (oxaliplatin 200 mg/L), B(doxorubicin 15 mg/L) and C (oxaliplatin 200 mg/L with doxorubicin 15mg/L) in glucose 5%. The three solutions were subjected to the maximum temperature reached in vivo (49° C) for two hours. Physical stability was focused on visual control of particles or precipitates in solutions, discharge of gases, odor and color. Samples were taken every 15 minutes and the chemical stability was evaluated by determining the concentration of oxaliplatin and doxorubicin remaining in the samples. Oxaliplatin concentrations were determined by atomic absorption graphite chamber while doxorubicin was determined by high performance liquid chromatography.The chemical stability criteria selected was the one described by the American Pharmacopoeia, which sets a permissible variation range between the 90-110% of the initial concentration.
  
  
  RESULTS
  During the assay there was no appearance of particles, precipitates in the samples, discharge of gases, nor colour changes in the solutions. The samples showed a remaining concentration of oxaliplatin and doxorubicin within the 90-110% limit. The stability of the samples that follow to two cycles of freeze-thaw after hyperthermia was also found within the specified limits.
  
  
  CONCLUSIONS
  A, B and c solutions in 5% glucose, are physically and chemically stable at 49° C for two hours. Under these conditions, these solutions could be used with guarantees of stability in patients with peritoneal carcinomatosis subsidiary of intraperitoneal hyperthermic chemotherapy based in these antineoplastic agents.
authors.affiliation: Plataforma de Oncología. Hospital Quirón. Torrevieja. Alicante.. vanesa.escudero@quiron.es.
authors.forename: V
authors.initials: V
authors.lastname: Escudero-Ortiz
authors.affiliation: Profesora del Área de Farmacia y Tecnología Farmacéutica. Departamento de Ingeniería. Universidad Miguel Hernández. Alicante..
authors.forename: M J
authors.initials: MJ
authors.lastname: Duart-Duart
authors.affiliation: Departamento de Farmacia y Tecnología Farmacéutica. Universidad de Valencia. Valencia. Consulting Projects for Research. Valencia..
authors.forename: C
authors.initials: C
authors.lastname: Pérez-Ruixo
authors.affiliation: Director Científico. Translational Sciences. AMGEN, Inc. España..
authors.forename: J J
authors.initials: JJ
authors.lastname: Pérez-Ruixo
authors.affiliation: Plataforma de Oncología. Hospital Quirón. Torrevieja. Alicante..
authors.forename: B
authors.initials: B
authors.lastname: Valenzuela
mesh_terms: D000903:Antibiotics, Antineoplastic / Q000009:adverse effects*; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000032:analysis*; D002277:Carcinoma / Q000188:drug therapy; D003131:Combined Modality Therapy; D004317:Doxorubicin / Q000008:administration & dosage*; D004355:Drug Stability; D006801:Humans; D006979:Hyperthermia, Induced; D007274:Injections, Intraperitoneal; D009944:Organoplatinum Compounds / Q000008:administration & dosage*; D000077150:Oxaliplatin; D010534:Peritoneal Neoplasms / Q000188:drug therapy; D019999:Pharmaceutical Solutions
chemical_list: D000903:Antibiotics, Antineoplastic; D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D019999:Pharmaceutical Solutions; D000077150:Oxaliplatin; D004317:Doxorubicin