RESUMEN
Compatibility and stability of the polygeline-based blood plasma expander/plasma substitute Haemaccel with different drug products i.e., Profenid, Stemetil, and Lasix were examined in the context of its potential use in surgical, spinal, septic shock and in circulatory insufficiency, because treatment, safety, acceptability and efficacy of drug product may be affected by drug instability or incompatibility. Therefore, drug stability and compatibility are critical elements in accurate and appropriate delivery of drug therapy to patients. This study was initiated to specifically and critically assess the compatibility of Haemaccel with different drug products with the aim of delivering safe, suitable, acceptable and efficacious administration of two different drug products simultaneously in emergency conditions. All of these different brands of drug products were physically and chemically compatible with Haemaccel and all of the test results were almost similar before and after mixing different drugs in Haemaccel. This study revealed that Lasix, Profenid and Stemetil can be administered/co-administered with Haemaccel safely. Different drug product must be studies in detail before it's co-administration with Haemaccel.
RESUMEN
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.