HGF preparation

Inventors

Adachi, Kiichi • Hanada, Keigo

Assignees

Kringle Pharma Inc

Abstract

The present invention relates to an HGF preparation comprising HGF and purified sucrose. The HGF preparation is characterized by being stable even after a long-term storage.

Core Innovation

The disclosure provides an HGF preparation in which addition of purified sucrose suppresses HGF aggregation and improves long-term stability. The preparation is described as reducing HGF aggregate content during storage, and the composition is preferably freeze-dried.

The composition may further include neutral amino acids such as alanine, buffers such as citric acid/citrate salts, sodium chloride, and surfactants such as Polysorbate. The disclosure also describes sucrose content in aqueous and freeze-dried forms.

Examples compare freeze-dried formulations containing sucrose with or without alanine against alanine-only and sucrose-free controls. The examples show reduced HGF aggregate content after storage and improved molecular-weight distribution as assessed by DLS, along with comparisons of HPLC aggregates content.

Claims Coverage

The provided content explicitly identifies one independent claim and includes six main inventive components in a freeze-dried composition format.

Coverage centers on a freeze-dried HGF composition formulated with sucrose plus alanine, sodium chloride, a citric acid salt, and a Polysorbate.

Stated Advantages

Documented Applications