Discomfort from an alkaline formulation delivered subcutaneously in humans: albumin at pH 7 versus pH 10.

Clinical Drug Investigation
W Kenneth WardJoseph El Youssef

Abstract

There is a paucity of data regarding tolerability of alkaline drugs administered subcutaneously. The aim of this study was to assess the tolerability of alkaline preparations of human albumin delivered subcutaneously to healthy humans. We compared the tolerability of neutral versus alkaline (pH 10) formulations of human albumin in ten volunteers. With an intent to minimize the time required to reach physiological pH after injection, the alkaline formulation was buffered with a low concentration of glycine (20 mmol/L). Each formulation was given at two rates: over 5 seconds and over 60 seconds. A six-point scale was used to assess discomfort. For slow injections, there was a significant difference between pH 7.4 and pH 10 injections (0.4 ± 0.2 vs 1.1 ± 0.2, mean ± SEM; p = 0.025), though the degree of discomfort at pH 10 injections was only 'mild or slight'. For fast injections, the difference between neutral and alkaline formulations was of borderline significance. Inflammation and oedema, as judged by a physician, were very minimal for all injections, irrespective of pH. For subcutaneous drug administration (especially when delivered slowly), there was more discomfort associated with alkaline versus neutral formulations of alb...Continue Reading

References

Oct 1, 1996·The Journal of Pharmacy and Pharmacology·J Fransson, A Espander-Jansson
Jun 11, 1998·Journal of Pharmaceutical Sciences·G A BrazeauP Gupta
Feb 26, 2004·The Annals of Pharmacotherapy·Arun K VermaDavid R Kuhl
Sep 2, 2004·The Annals of Pharmacotherapy·Miguel A GoenagaEdurne Arzellus
Apr 16, 2010·Science Translational Medicine·Firas H El-KhatibEdward R Damiano

❮ Previous
Next ❯

Citations

Sep 14, 2012·Current Diabetes Reports·Melanie A JacksonW Kenneth Ward
Jun 27, 2014·Diabetes Technology & Therapeutics·Nicholas CaputoW Kenneth Ward
Jun 22, 2021·Journal of Controlled Release : Official Journal of the Controlled Release Society·Adam J S McCartanRandall J Mrsny
Jul 1, 2020·ACS Applied Materials & Interfaces·Pamela T WongSeok Ki Choi

❮ Previous
Next ❯

Related Concepts

Related Feeds

Birth Defects

Birth defects encompass structural and functional alterations that occur during embryonic or fetal development and are present since birth. The cause may be genetic, environmental or unknown and can result in physical and/or mental impairment. Here is the latest research on birth defects.