The stability of drugsis a basic attribute of drugs and one of the important factors for evaluating drug quality. The instability of drugs can lead to increased impurities, decreased bioavailability, decreased safety, increased toxicity, increased side effects and adverse reactions. Therefore, it is necessary to carry out drug stability tests when developing drugs.
In order to investigate the law of changes in raw materials or pharmaceutical preparations over time under the influence of temperature, humidity, and light, provide scientific basis for the production, packaging, storage, and transportation conditions of drugs, and establish the validity period of drugs through experiments, it is necessary to develop drug stability test. Influencing factor tests, accelerated tests, and long-term tests are all drug stability test methods. Today, let’s take a brief look at long-term tests.
The samples for drug stability test should be representative. According to online data reports, long-term tests usually use 3 batches of samples, placed in the same or similar packaging containers of commercial production products, at a temperature of 25±2 and a relative humidity. Put it for 12 months under the condition of 60%±10%, or put it for 12 months under the condition of temperature 30±2 and relative humidity 65%±5%. This is based on the difference between the climate of southern and northern China. As for the above The choice of the two conditions is determined by the researcher. Sampling is carried out every 3 months, and samples are taken at 0, 3, 6, 9 and 12 months according to the key stability inspection items for testing. After 12 months, it is still necessary to continue the inspection, and take samples for testing at 18, 24, and 36 months. Compare the results with 0 months to determine the expiration date of the drug.
The registration stability test of APIs and preparations should usually be carried out with samples of at least pilot scale batches. The synthesis route, prescription and production process should be consistent with the commercialized product or the key process steps of the commercialized product. The quality of the sample should be consistent with the quality of the commercial production product; the packaging container should be the same or similar to the commercial production product. Drug stability test can provide basis for drug production, transportation and storage, etc., to ensure the effectiveness and safety of drug to the greatest extent. Medicilon provides drug stability testing services, which can provide customers with research on the stability of global drug registration, experimental/exploratory stability (pre-test) and drug stability after approval.
The purpose of long-term trials is to confirm the results of influencing factor trials and accelerated trials, to clarify the changes in drug stability, and to clarify the validity period of drugs. For example, in order to investigate the stability of salbutamol sulfate inhalation aerosols, some researchers used the properties of salbutamol sulfate inhalation aerosols and the properties of salbutamol sulfate inhalation aerosols according to the “Guidelines for the Stability Test of Raw Materials and Preparations” and the quality standards of salbutamol sulfate inhalation aerosols. Amine ketones, related substances, uniformity of delivered dose, fine particle dose, content determination, and microbial limit were investigated as indicators. Influencing factor tests, accelerated tests and long-term tests were carried out respectively, and the stability of the preparation was evaluated by observing changes in each index. Establish the expiry date of the drug through experiments [1].
Results Three batches of salbutamol sulfate inhalation aerosol were simulated on the market. After influencing factor tests, accelerated tests and long-term tests, there was no significant change in various indicators, which met the requirements of quality standards. The predicted validity period of the 3 batches of salbutamol sulfate inhalation aerosol samples is greater than 60 months. The study found that the various indicators of the salbutamol sulfate inhalation aerosol met the requirements within the observation period, and the validity period was tentatively set to 24 months.
In short, conducting drug stability tests to predict the expiration date of drugs and provide technical support for the drug stability period for subsequent phases of research and development is of vital importance to drug development.
[1] Study on the stability of salbutamol sulfate inhalation aerosol [J].
Analysis of the Role of Differential Scanning Calorimetry in the Study of Drug Stability
Analysis of the Role of Plasma Stability Determination in Drug Development
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