Aqueous solution formulations, useful for treating viral, tumorous and immune diseases, comprises interferon alpha, buffer system, stabilizing agent, nonionic surfactant, osmotic pressure regulator, and injection water

摘要

An aqueous solution formulation comprises: (1) interferon alpha (a); (2) buffer system (b) to maintain pH 4.5 - 9; (3) stabilizing agent (c); (4) nonionic surfactant (d); (5) osmotic pressure regulator (e), and (6) injection water (f). Independent claims are included for: (1) Use of a combination of (a) - (c) and an isotonicity agent for preparing the formulation; and (2) A medicament comprising pre-filled syringe containing the formulation. ACTIVITY : Virucide; Cytostatic; Immunomodulator. A solution containing recombinant interferon alpha -2 (3X10 8IU), citric acid (0.02 g), sodium dihydrogen phosphate (0.25 g), sodium chloride (0.4 g), dextran (2 g), Tween 80(RTM) (0.1 ml), mannitol (1 g), and (f) (balance) was prepared and stored at 8[deg]C. The initial/after 36 months biological activities of the solution were 4.1/3 respectively. MECHANISM OF ACTION : None given.