Improving patient tolerability in immunoglobulin treatment: focus on stabilizer effects

Abstract

Various types of excipients are added to immunoglobulin preparations to stabilize the product and prevent aggregation and dimer formation. These excipients, which are also called stabilizers or additives, are not inert chemicals and may have clinical implications. This is one reason why immunoglobulin products are not interchangeable. Herein, immunoglobulin preparation, excipient types and the differences among sugar stabilizers and the amino acids, glycine and proline as excipients, are presented. Preclinical studies that unravel the complexities of dimer reduction are summarized. Details of patient considerations with respect to excipient content are outlined focusing on patients with renal insufficiency, diabetes, corn allergy, hereditary fructose intolerance, inborn errors of proline metabolism, DiGeorge Syndrome and neuropsychiatric disorders associated with hyperprolinemia. Excipients are essential components of immunoglobulin preparations and their presence should be a consideration when matching patient needs to product characteristics.

Keywords::

• adverse event
• contraindications
• excipient
• IgG
• immunoglobulin
• stabilizer

Financial & competing interests disclosure

A Sun is an employee of Baxter Bioscience. W Teschner is an employee of Baxter Innovations GmbH, Vienna, Austria. L Yel is an employee of Baxter Healthcare Corporation/BioScience, Westlake Village, California. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Writing and editorial assistance was provided, which was contracted by Baxter Healthcare Corporation.

Notes

ACE: Angiotensin-converting enzyme; BUN: Blood urea nitrogen; IVIG: Intravenous immunoglobulin; TRALI: Transfusion-related acute lung injury.

Data taken from [32,44–52].