Stability studies in the pharmaceutical sector are an essential component in the development and manufacturing of medicines

Stability studies are performed to assess how the properties of a drug vary over time under the influence of various environmental factors such as temperature, humidity and light. Their main objective is to ensure that the drug maintains its safety, efficacy and quality throughout its shelf life.

Significance of these studies

Stability studies are carefully designed to obtain accurate and reliable data on how a drug behaves under specific conditions. Key aspects to consider include:

  • Quality assurance: stability studies ensure that a drug maintains its integrity and functionality through its expiration date.
  • Regulation and compliance: regulatory authorities, such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe, require stability studies for the approval of new drugs.
  • Patient safety: ensuring drug stability protects patients from adverse effects that could arise from product degradation.
  • Storage optimization: These studies help determine optimal storage and transportation conditions to maintain product quality.

In these studies, accelerated storage conditions use higher temperatures and humidity levels to speed up the degradation process and obtain results more quickly. While in long-term storage conditions, normal storage conditions are reflected, providing data on the stability of the drug over its projected shelf life.

The duration of the study is usually up to five years, although the exact duration depends on the type of product and applicable regulations. Sampling frequency is scheduled at defined intervals, at 0, 3, 6, 9, 12, 18, 24, 36, 48 and 60 months, to perform periodic analysis of the drug.

In these, the parameters evaluated include physical appearance, which considers the color, shape and general appearance of the medicine; chemical purity, which measures the amount of active ingredient and degradation products; potency, which evaluates the ability of the medicine to produce the desired effect; and dissolution and release, which analyzes the speed and extent with which the active ingredient is released from the product.

Types of stability studies

  • Accelerated stability: performed at elevated temperatures and humidity levels to predict the long-term stability of the drug in a shorter time. They are usually carried out at 40°C and 75% relative humidity for six months.
  • Long-term stability: assesses the stability of the drug under normal storage conditions, typically at 25°C and 60% relative humidity. These studies provide data on the stability of the product over its expected shelf life.
  • Intermediate stability: performed at storage conditions that are less extreme than accelerated but more stringent than long-term conditions, typically at 30°C and 65% relative humidity.
  • In-use stability studies: assess the stability of the drug once opened or after reconstitution, which is crucial for products that must be mixed with a solvent before administration.
  • Photostability studies: determine the stability of the drug when exposed to light, which is important for products that may be sensitive to light.

The process followed in these studies involves several stages. In sampling and testing, samples of the drug are taken at defined intervals and subjected to analytical tests to assess stability parameters. Then, in data analysis, the test results are analysed to identify any degradation trends and predict the shelf life of the drug.

Finally, in documentation and reporting, the data obtained are documented in detailed reports that are submitted to regulatory authorities as part of the drug approval process.

Contact our team of experts to request more information about this type of studies. Stability studies are essential in the pharmaceutical sector to ensure that medicines are safe and effective throughout their shelf life.