Stability testing is a fundamental part of the drug development process— upholding the quality of active pharmaceutical ingredients (APIs) and drug products while also providing an accurate shelf life. Through stability testing, pharmaceutical companies are able to determine the most suitable packaging and/or container closure system for the storage and distribution of drug products.
“Stability storage and testing plays a big part in the drug development process from research and development up to commercialization and beyond,” said Alcami Director of Quality Operations, Scott Jedrey. “Testing throughout each phase, whether it is physical or chemical, allows data to be gathered, trended, and reviewed. Based on the data, decisions are made on whether to move forward to the next phase, which includes more testing and more patients in several clinical trials. The product must possess the purity, potency, and safety throughout each phase of the drug development process in order to obtain that very important agency approval.”
There are several important factors to consider when designing and conducting stability studies, with safety, quality, and product efficacy being at the forefront. Drug development companies have the ability to identify and trend shelf life and their effects on efficacy through exposing samples to various temperatures, humidity levels, and light over a set amount of time.
Analytical methods for effective stability testing vary from drug product to drug product. The design of stability studies must take into account the product form, container type, and packaging. For example, commercially released products would have been tested to study the degradation effects from the conditions on both the drug product and the container it is packaged in.
In the case of multi-dose products, in-use stability testing can be utilized. The intent of an in-use stability study is to simulate the use of the product in practice, taking into consideration the filling volume of the container, any dilution/reconstitution before use, the hold-time before use, and various diluents that could be used for administration.
Degradation factors including physical, chemical, and microbiological causes are important to study. Physical factors encompass changes to the physical nature of the drug, such as appearance, properties, hardness, brittleness, and particle size that occur in tablets, capsules, and semisolids.
From a chemical perspective, scientists look for separation of the chemical compound into elements, simpler compounds, or a change in the chemical nature of the drug via hydrolysis, oxidation, isomerization, polymerization, or photodegradation.
Knowing all the ways a finished product or an API could be affected by degradation is crucial in performing successful stability tests. For instance, stability studies are designed to simulate climatic effects. The studies are based on multiple product factors such as expected transportation methods, environmental exposure to light and atmosphere, and distribution locations. From those studies, scientists are able to better establish the shelf life of the medicine, decide the best way to store it, and ultimately help ensure the safety of the consumer.
Finally, microbiological contamination of a product, depending on the type of microbe and its level of toxicity, can also play a role in the design and functions of these studies.
“Alcami has a wide range of capabilities to support the needs of our customers,” said Jedrey. “If a unique condition is needed and a chamber is readily available, Alcami has the in-house resources and expertise to requalify an existing chamber to fit a client's needs. Working collaboratively with Validations, Stability Management, Instrument Services, Metrology, and Quality, chambers can be qualified and released for use as needed in a very timely manner.”
With the appropriate storage, shelf life, and distribution methods determined, the quality of APIs and drug products is safeguarded. Alcami has extensive experience establishing stability programs across all phases of the drug product lifecycle from early phase to annual commercial stability needs.
At Alcami we pledge to prioritize stability studies with every drug formulation, testing,
and manufacturing procedure we conduct to help ensure we are working
in a safe, connected way with our clients and their patients.
Scott Jedrey is the Director of Quality Operations overseeing both oral solid dosage manufacturing and packaging at Alcami. Joining the company in 1989, he has over 30 years of experience in the pharmaceutical industry and over 24 years of experience in solid dose manufacturing, stability, packaging, distribution, and quality management. Scott has a Bachelor of Science degree in Business Management from the University of Mount Olive.