Stability Studies of Two Different Polygelin (Haemaccel and Gelofusine) According to ICH Guidelines.

UNLABELLED: The stability of polygeline-based blood plasma expanders Haemaccel and Gelofusine were examined in context of their sensitivity to environmental factors, because drug stability is critical element in accurate and appropriate delivery of drug therapy to patients. This study was initiated to specifically and critically assess stability of Haemaccel and Gelofusine according to ICH guidelines with the aim of delivering safe, appropriate, acceptable, and efficacious administration of drug product in any situation. This study revealed that Haemaccel and Gelofusine are suitable for storage at different temperature and at different storage conditions until its expiry date, shelf life, or utility time, for their quality, safety, suitability, acceptability, and efficacy.

LAY ABSTRACT: Stability studies of two different plasma substitutes, Haemaccel and Gelofusine, were examined according to ICH guidelines for their expiry or utility time, because drug stability is very important element in accurate, suitable, and correct delivery of drug therapy to patients. The aim of present study is to deliver the safe, appropriate, acceptable, and right drug product in any situation. The results indicate negligible changes in different parameters during stability study, except for pH and viscosity. This study shows that both drug products are suitable for storage at different temperature and at different storage conditions till their expiry date or utility time, for their quality, safety, suitability, acceptability, and strength.