Lyophilised pharmaceutical formulation and its use
AssigneeFaron Pharmaceuticals Oy
InventorsMarkku Jalkanen, Mikael Maksimow, Ilse Piippo
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Abstract
A pharmaceutical formulation in a lyophilised form, which comprises pharmacologically effective amount of interferon beta-1a as an active ingredient, disaccharides as a bulking agent and a non-ionic surfactant. After reconstitution, the composition can be administered intravenously.
Claims23
A pharmaceutical formulation in a lyophilised form, comprising unpegylated interferon beta-1a as an active ingredient in an amount of 2.0-15 μg in a single dosage form, a disaccharide as a bulking agent in an amount of 30-50 mg, and a non-ionic surfactant selected from the group consisting of polysorbate and polyethylene glycol, wherein the disaccharide is trehalose dihydrate or a mixture of trehalose dihydrate and sucrose, and wherein the interferon beta-1a is recombinantly produced interferon beta-1a with a biological activity higher than 150 Million International Units (MIU)/mg.
Dependencies are inferred from the claim text.