Phil Morton, chief technical officer, Albumedix discusses the effects that albumin can infer on APIs in formulations, and the proposed mechanism behind them.
Recombumin
Development of safe and stable formulations is a challenge of pharmaceutical drug development, and the choice of excipients can become an important factor for their successful formulation. For hard-to-formulate active pharmaceutical ingredients (APIs) this becomes more critical and can be the determinate of whether such a drug candidate gets discontinued in development or becomes a successful pharmaceutical. Albumin has been shown to offer benefits over other excipients in the formulation of various APIs, and can help overcome certain formulation challenges.
Formulating drugs with albumin
Human albumin is the most ubiquitous protein in blood and is present at amounts around 40 g/L. Its role in blood is the shuttling of numerous smaller entities such as metals, hormones, fatty acids and toxins. However, it also makes up about 75% of the colloidal oncotic (or colloidal osmotic) pressure of blood and the single free cysteine of albumin (at position 34) makes up the majority of the reducing equivalents present in blood. All these properties are traits which are functional in employing albumin in formulation.