Pharmaceutical Stability Studies: what they are and why they are essential

Stability studies are used to define how long a medicine can be safely used and under what environmental conditions. These studies directly influence fundamental choices such as the type of packaging, transport and logistics management.

A stability study is an essential scientific investigation to assess how a drug behaves over time, as a function of environmental factors such as temperature, humidity and light. These tests are essential to establish the shelf life of a medicine and the optimal storage conditions, so as to ensure its efficacy and safety throughout its life cycle, from marketing to end of use.

They are performed on both the active ingredient and the finished product, packaged or not, and are based on strict protocols established by international guidelines (ICH). The results obtained make it possible to determine not only when a drug can be used, but also how it should be stored, transported and distributed along the supply chain.

There are different types of stability studies, each designed to address specific needs related to the storage, distribution and safety of the drug. The most common are long-term studies, accelerated studies, studies for particular climates, photostability tests and on-going studies.

Long-term studies are the basis for determining the validity of the medicine over time. They are conducted in stable and controlled environmental conditions, generally at 25°C with a relative humidity of 60%, or at 5°C for products to be stored in refrigeration. They can extend up to five years and realistically reproduce the conditions under which the drug will be stored and used.

Studies under accelerated conditions, on the other hand, simulate the aging of the drug in a shorter time, subjecting it to higher temperatures (such as 40°C) and high humidity (up to 75%). These tests, which last six months, allow for rapid observation of any degradation phenomena and useful data to be collected, for example in the event of changes in packaging or formulation.

For products intended for markets with extreme climatic conditions, such as tropical or desert areas, specific studies are performed to evaluate stability in high temperature environments and persistent humidity. This type of analysis is particularly important in a global context, where drugs travel and are distributed in very different territories.

Another relevant category is that of photostability studies, which evaluate the effect of light exposure on drug quality. These tests take place in special chambers equipped with lamps that simulate solar radiation, and help to understand if the product needs protection from light through specific packaging.

Finally, there are on-going studies, i.e. tests conducted during the marketing of the drug. In this case, samples from at least one batch of each medicinal product are stored under the conditions provided and analysed periodically, for the duration of validity. This approach ensures that the drug maintains its chemical-physical characteristics over time, thus confirming the reliability of the information on the label.

Stability studies are conducted in controlled climatic chambers, capable of reproducing the environmental conditions required by international protocols, such as those of the ICH guidelines. Temperature and humidity are kept stable and monitored over time to assess the drug’s behavior in realistic or extreme settings.

For photostability studies, sun boxes are used, specific chambers equipped with high-intensity lamps that simulate sunlight, in order to verify any photoinduced alterations.

During the entire observation period, the samples are subjected to in-depth analysis: not only the amount of active ingredient is evaluated, but also the presence of degradation products, microbiological stability and technological characteristics, such as disintegration or dissolution.

The goal is to ensure that the drug maintains integrity, efficacy and safety over time, through a rigorous methodological process and advanced analytical tools.

Stability studies are not just a scientific control tool: they represent a key element for the entire logistical management of the drug. Without reliable data on stability, it would be impossible to properly plan packaging, identify  suitable means of transport or ensure compliance during storage in the various logistics nodes. The studies therefore provide a solid basis for building tailor-made logistics solutions, especially for drugs that require special conditions, such as the cold chain or light protection.

In addition, in the case of international distribution, stability studies allow logistics to be adapted to different climatic zones, ensuring that the drug reaches the end patient in optimal conditions, regardless of the country of destination.

Logistic Company supports companies in the pharmaceutical sector by offering specialized, safe logistics solutions that comply with the most rigorous standards. Thanks to controlled structures and advanced monitoring systems, we guarantee compliance with the environmental conditions that emerged from stability studies, from storage to transport.

We collaborate with producers, laboratories and stakeholders in the supply chain to ensure a precise, traceable and compliant service.

With Logistic Company, every drug travels in total safety, in full respect of its integrity and quality.