An effective and economical method for the storage of plasma samples using a novel freeze-drying device

- A novel freeze-drying device was built to store samples at the ambient temperature.
- An effective and economical method of sample storage was proposed using the device.
- The sample preparations integrated in the new storage method were simple and easy.
- This new method has been successfully applied to the PK studies of two drugs.

Biological samples, especially plasma samples, are conventionally stored under freezing conditions to maintain sample integrity prior to the detections of analytes. However, the storage of samples in a low-temperature environment is electric energy consuming, and the preparation of samples prior to analytes detection may be complicated. In this work, an effective and economical method was proposed to freeze-dry the samples using a novel device to allow subsequent storage of samples at ambient temperature. The sample preparations integrated in the new method are simple and easy to follow. Analytes were directly extracted with the extraction agent before sample injections. This new method was validated with quality control (QC) samples of levetiracetam and mycophenolic acid (MPA), and it was also applied to the pharmacokinetic (PK) studies of both drugs in healthy volunteers. When QC samples were stored and prepared with the new method, the detections of analytes were accurate and repeatable, and the analytes maintained stability for a long time. The PK studies of levetiracetam and MPA in healthy volunteers showed that the PK parameters of analytes stored with the new method were consistent with those stored with the conventional method. In conclusion, this effective and economical method is a practical option in reality and can play a big role in clinical and scientific drug researches.