Principaux facteurs de test de stabilité à prendre en compte

Stability testing is an essential part of the drug development process—maintaining the quality of active pharmaceutical ingredients (APIs) and drug products, while providing accurate shelf life. Stability testing enables pharmaceutical companies to determine the most suitable packaging and/or container closure systems for drug product storage and distribution.

"Stability storage and testing play an important role in drug development from discovery to commercialization and beyond," said Scott Jedrey, Director of Quality Operations at Alcami. “With testing at each stage, whether physical or chemical, data can be collected, trended and reviewed. Based on this data, a decision is made whether to move on to the next stage, which includes more testing and more patients for clinical trials "Products must have purity, potency and safety at every stage of the drug development process in order to receive very important agency approvals."

There are several important factors to consider when designing and conducting stability studies, with safety, quality and product efficacy being the most important. Drug development companies have the ability to identify and trend shelf life and its impact on efficacy by exposing samples to various temperatures, humidity levels, and light over time.

Analytical methods for valid Stability Chamber testing vary by drug product. The design of a stability study must consider product form, container type, and packaging. For example, commercially released products have been tested to study the effect of conditions on the drug product and packaging container on degradation.

In the case of a multi-dose product, in-use stability testing can be used. The purpose of an in-use stability study is to simulate the use of the product in practice, taking into account the fill level of the container, any dilution/reconstitution prior to use, holding time prior to use, and various diluents that may be used. for management.

Degradation factors, including physical, chemical, and microbial causes, are important to study. Physical factors include changes in the physical properties of the drug, such as appearance, properties, hardness, friability, and particle size found in tablets, capsules, and semisolids.

From a chemical point of view, scientists want to separate compounds into elements, simpler compounds, or change the chemical properties of drugs through hydrolysis, oxidation, isomerization, polymerization, or photodegradation.

Understanding all the ways in which a finished product or API may be affected by degradation is critical to successful stability testing. For example, Stability Lab studies aim to simulate climate impacts. These studies are based on a variety of product factors, such as expected mode of transport, environmental temperature and humidity test chamber exposure to light and atmosphere, and distribution location. From these studies, scientists are better able to determine the shelf life of drugs, decide the best way to store them, and ultimately help keep consumers safe.

Finally, microbial contamination of the product, depending on the type of microorganism and its level of toxicity, may also play a role in the design and function of these studies.

"Alcami has a wide range of capabilities to support the needs of our customers," Jedrey said. “If unique conditions are required and chambers are readily available, Alcami has the in-house resources and expertise to revalidate existing chambers to meet customer needs. Working with validation, stability management, instrument services, metrology and quality departments can be very Chambers are certified and released for use as needed in a timely manner.”

Summarize
The quality of APIs and pharmaceutical products can be safeguarded by determining appropriate storage, shelf life and distribution methods. Stability Chamber Manufacturer Thchamber possède une vaste expérience dans la mise en place de programmes de stabilité à toutes les étapes du cycle de vie du médicament, depuis les premières étapes jusqu'à la nécessité de tests de stabilité des médicaments.