A lyophilised pharmaceutical formulation and its use

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.

Description

field of invention [0001] The present invention relates to a freeze-dried pharmaceutical preparation of interferon beta-1a and the use of the preparation. Background of the invention [0002] Interferon beta-la, an interferon beta1 agonist, is able to upregulate CD73, a molecule that produces anti-inflammatory adenosine, which enhances endothelial barrier function and leads to the prevention of vascular leakage, a major pathophysiological event in ARDS. Vascular leakage in ARDS allows plasma to leak into the alveolar spaces, leading to potentially life-threatening hypoxemia. Interferon beta-la has the potential to reduce the effects of ARDS by reducing vascular leakage, but is not limited to this example. [0003] As with all protein-based drugs, a major hurdle that must be overcome in the use of interferon beta (IFN-β) as a therapeutic agent is the loss of drug utility that may result from its instability in pharmaceutical formulations. Physical instability that threatens...

AI Technical Summary

Problems solved by technology

Due to the high content of lipophilic amino acid residues in IFN-β, it adheres to container surfaces and forms aggregates, resulting in loss of active pharmaceutical ingredients

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