An effective and economical method for the storage of plasma samples using a novel freeze-drying device.
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.
Research Institute of Drug Metabolism and Pharmacokinetics, School of Pharmaceutical Sciences, Central South University, Changsha, Hunan 410013, China.
Lei
L
Wang
Research Institute of Drug Metabolism and Pharmacokinetics, School of Pharmaceutical Sciences, Central South University, Changsha, Hunan 410013, China.
Mengmeng
M
Xie
Research Institute of Drug Metabolism and Pharmacokinetics, School of Pharmaceutical Sciences, Central South University, Changsha, Hunan 410013, China.
Ying
Y
Li
Xian-Janssen Pharmaceutical Ltd, Xi'an, Shanxi 710043, China.
Sen
S
Zhang
Research Institute of Drug Metabolism and Pharmacokinetics, School of Pharmaceutical Sciences, Central South University, Changsha, Hunan 410013, China.
Wei
W
Qiang
Research Institute of Drug Metabolism and Pharmacokinetics, School of Pharmaceutical Sciences, Central South University, Changsha, Hunan 410013, China. Electronic address: chengzn@csu.edu.cn.
Zeneng
Z
Cheng
D002851:Chromatography, High Pressure Liquid; D005612:Freeze Drying; D000077287:Levetiracetam; D010889:Piracetam / Q000031:analogs & derivatives / Q000097:blood / Q000493:pharmacokinetics; D010949:Plasma; D011786:Quality Control; D015203:Reproducibility of Results; D013048:Specimen Handling; D053719:Tandem Mass Spectrometry
D000077287:Levetiracetam; D010889:Piracetam
Freeze-dry; Levetiracetam; Mycophenolic acid; Pharmacokinetics; Sample storage