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Stability testing is essential for maintaining the integrity and quality of biopharmaceuticals and for assessing an accurate shelf-life. It is an important aspect of quality control and is an important step in evaluating product safety and efficacy. It is also important for examining how critical quality attributes (CQAs) of a drug substance vary with time under different environmental factors.
Determining the right packaging
Through stability testing, pharmaceutical companies can ensure the most suitable packaging and/or container closure for the storage and distribution of biopharameutical products. With the right storage, appropriate shelf life determined, and distribution methods in place, the quality of active pharmaceutical ingredient (API) and drug products is safeguarded.
Designing Stability Tests
There are several important factors to consider when designing and conducting stability studies.
Safety, quality, and product efficacy work together in stability studies of APIs and finished drug products. Through stability testing, pharmaceutical companies have the ability to identify and trend shelf life and their effects on efficacy as samples are exposed to time, light, and temperature.
Degradation factors that are fundamental to consider for the efficacy and shelf life of APIs/finished drug products include physical, chemical, and microbiological factors. 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 or simpler compounds or a change in the drug’s chemical nature via hydrolysis, oxidation, isomerization, polymerization, or photodegradation.
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 the studies.
Strategy in stability testing
Knowing all the ways a finished product or API could be affected by degradation is crucial in performing successful stability tests. For instance, stability studies are executed to simulate climatic effects. The studies are based on where the products are going to be sold. From those studies, scientists are able to better establish a shelf life of the medicine, determine the best way to store the medicine, and ultimately help ensure the safety of the consumer.
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, commercial drug product testing would include studying the degradation effects from the conditions on both the drug product and the container it is sold in.
There are many variables but it ultimately depends on the client and their interests as well as requirements for the climate zone they intend to sell their product.
In-use stability testing
In the case of multi-dose product types, in-use stability testing can be used. 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.
1. ICH, Q1 (A-F) Stability, Step 5 version (ICH, 2003).
2. ICH, Q5C Quality of Biotechnological Products, Stability Testing of Biotechnological/Biologic Products, Step 4 version (ICH, 1995).
3. EMA, Note for Guidance on In-Use Stability Testing of Human Medicinal Products (EMA, September 2001).
Volume 31, Number 1
When referring to this article, please cite as F. Mirasol, “Stability Testing Ensures Proper Packaging for Drug Storage,” BioPharm International 31 (1) 2018.
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