title: Shelf life of diluted human interferon-α for veterinary clinical use.
abstract: BACKGROUND
  Oral, low-dose, human interferon (IFN)-α treatments have shown efficacy in different models of viral and autoimmune diseases. Human IFN-α is commonly used at a daily dose between 1 and 10 IU/kg body weight. Registered products matching these doses at convenient concentrations are lacking.
  
  
  OBJECTIVE
  The stability of sterile, diluted, human leukocyte IFN-α was investigated under cold-chain and room temperature conditions.
  
  
  RESULTS
  Diluted IFN-α displayed moderate decay at room temperature (20-23 °C), which should restrict the shelf life to 3-4 days after compounding. On the contrary, a substantial stability was demonstrated over 6 months under cold-chain conditions. Such a stability of IFN-α was correlated with the maintenance of Class I MHC-modulating properties.
  
  
  CONCLUSIONS
  A shelf life of six months can be envisaged for sterile, diluted preparations of human IFN-α under cold-chain conditions, and batch size should be adjusted in accordance with this property.
authors.affiliation: Laboratory of Cellular Immunology, IZSLER, Brescia, Italy. Electronic address: massimo.amadori@izsler.it.
authors.forename: Massimo
authors.initials: M
authors.lastname: Amadori
authors.affiliation: Apothecary Fiorentini dr Carlo, Brescia, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Fiorentini
mesh_terms: D000818:Animals; D001327:Autoimmune Diseases / Q000188:drug therapy* / Q000662:veterinary*; D004355:Drug Stability; D006801:Humans; D016898:Interferon-alpha / Q000737:chemistry / Q000627:therapeutic use
chemical_list: D016898:Interferon-alpha
keywords: Clinical use; Interferon-α; Low-dose; Oral treatment; Stability