Abstract
Tacrolimus is a potent, narrow therapeutic index, immunosuppressive drug used to avoid organ rejection in patients that have undergone organ transplantation. Dissolution tests are widely used to evaluate drug product quality and performance. Analysis of tacrolimus during dissolution testing is sensitive to several factors, such as sample solution storage time and container material. The filtration process, tacrolimus glass adsorption, and sample solution storage time are found to impact the tacrolimus dissolution results. Based on observations in this work, the use of G4or equivalent filter flush before collection and polypropylene test tubes or vials instead of glass test tubes or vials are recommended for tacrolimus drug product dissolution test.
Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
