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.

Aim: 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.

Conclusion: 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.

Keywords: Clinical use; Interferon-α; Low-dose; Oral treatment; Stability.