In Vivo and In Vitro Stability Analysis of Oligonucleotide Drugs
The stability of oligonucleotide drugs is the ability of the drug and its preparation to retain their physical, chemical, biological and microbial properties. The stability study can investigate the law of its properties changing with time under the influence of different environmental conditions, such as temperature, humidity and light, providing scientific basis for the determination of production, packaging, storage, transportation conditions and period of validity of drugs to ensure the safety of clinical medication. The stability study of oligonucleoic acid API is the basis for the design of appropriate formulation prescriptions and the formulation of stability measures, and is an important component of pre-prescription research. The stability study is an important factor related to whether the drug can be put into the market, and is also an essential condition for the promotion and application of drugs with good efficacy and low toxicity.
According to the environment of product use, packaging, storage and transportation, Creative Biolabs strictly follows the ICH Q1A (R2) and the guiding principle of the chinese pharmacopoeia, to provide customers with comprehensive stability research services.
We provide but are not limited to:
- Influence factor experiment. The influence factor experiment is carried out under intense conditions. The experiment can assist customers to understand the factors affecting the stability of the drug, the possible degradation pathway and degradation products, providing the basis for the screening of the preparation process, the selection of packaging materials and containers, and the determination of storage conditions. It provides the basis for the temperature and humidity conditions that will be used in accelerated test and long-term test, and also provides the basis for the selection of analytical methods.
- High temperature test.
- High humidity test.
- Light test.
- Accelerated test. Accelerated test is conducted in exceptional conditions. Creative Biolabs can simulate the transient supernormal conditions that may be encountered during drug transportation and storage, so as to investigate the stability of drugs under these supernormal conditions. The test can preliminarily predict the long-term stability of the sample under the specified storage conditions.
- The accelerated test includes the trial of six months in one environment.
- Three batches of samples are taken for the accelerated test. It is recommended to carry out the accelerated test at a temperature at least 15 °C higher than that of the long-term test. The experiment can be carried out under the conditions of 40 °C±2 °C and RH75% ± 5% for 6 months.
- Long-term test. The long-term test is carried out under the storage conditions stipulated by the drug. The experiment can assist customers to investigate the stability of the drug in the process of transportation, storage and use. It can directly reflect the stability characteristics of the drug and is the ultimate basis for determining the period of validity and storage conditions.
- Long-term test includes the trial of thirty-six months in one environment.
- Three batches of samples are tested at 25 °C ±2 °C and RH60% ± 10%. The sampling time point is generally once every 3 months in the first year, once every 6 months in the second year, and once every year thereafter.
References
- ICH, Q1E. Evaluation for Stability Data. February, 2003.
- FDA Guidance for Industry: Q1D bracketing and matrixing designs for stability testing of new drug substances and products. January, 2003.
*For Research Use Only. Not for use in diagnostic procedures.