By Ryan Memmer, Supervisor Quality Control, Singota Solutions
Intravenous (IV) drug administration has expanded as proteins have become increasingly complicated, interacting with the body more quickly and targeting therapeutic areas more precisely. To avoid adverse effects to patients, some drugs must be diluted and administered slowly using IV bags.
Characterization of such drugs, for clinical or commercial use, requires proper execution of stability and/or compatibility studies. These types of stability studies determine a drug’s response to being held in an IV bag for a set amount of time across a range of conditions, including elevated temperature or humidity. Compatibility testing determines whether a drug can be administered to a patient using certain IV bags, pump systems, or formulations (e.g., diabetes patients cannot use a drug formulated with dextrose).
The manner in which these studies are designed, conducted, and documented directly impacts the study sponsor’s cost, time, and the amount of consumed materials. It is imperative that pharmaceutical sponsors understand the optimal time and means to test their IV products, as well as their regulatory obligations relevant to that study.
This article reviews when to test, the testing scope and challenges, and Singota's IV solution expertise.