一般論文
人血清アルブミンを含まないインターフェロン-α凍結乾燥製剤の製剤設計
2011 年 71 巻 1 号 p. 58-64
詳細
2011 年 71 巻 1 号 p. 58-64
The purpose of this study was to develop a freeze-dried human serum albumin (HSA)-free formulation of interferon-α (IFN-α) that had high safety and stability to reduce the risk of contamination in preparation of a pathogenic virus, an infectious prion and unknown infection factor.
As a result, the usefulness of L-leucine as not only a new stabilizer of IFN-α, but also an excipient for improving appearance and foaming at reconstitution of lyophilized cake was discovered. Moreover, a combination of polysorbate 80, sucrose, L-leucine, glycine and citrate buffer was found to the most stable, improving the appearance and foaming of a freeze-dried HSA-free formulation of IFN-α.
