What You Need to Know About Stability Studies

Types of blister packaging

When new pharmaceutical products are being developed, they have to undergo a lot of testing. One important part of the process is the stability studies that they have to undergo before they can be sold to the public. When the clinical trials are being conducted, it is also important to make sure any placebo that is being used looks exactly like the real medication. This can be achieved through the use of the right pharmaceutical blister packaging.

What is the value of stability studies?

Pharmaceutical companies use stability studies to evaluate and examine the physical characteristics such as color, hardness, etc of a new medication. They also examine the new pharmaceutical product’s purity, potency and appearance. Stability studies are also used to evaluate the shelf life of a new pharmaceutical product. When a product is repackaged or altered in any way, these studies are critical for maintaining the quality of the product. When the pharmaceutical and medical packaging is set, stability studies are used to make sure the product’s quality is not impacted by the packaging. It is important to develop the medical packaging techniques for the product before the clinical trials are conducted on the product. The same packaging that is used for the clinical trials needs to be what is used when the product is sold to the public. The importance of the packaging really cannot be overstated. It can have a direct impact on the quality of the product.

How are stabilities studies conducted?

There are several ways pharmaceutical companies conduct stability studies on their new products. They conduct studies in real time and on an accelerated time frame.

The first kind of tests are the real time stability studies. The real time tests look at how the medication fares under the normal conditions that are recommended by the manufacturer. They look at how long it takes for the new product to start to fail. The monitoring for these stability tests generally happens at several intervals. Companies test the drug at the outset, at three months, six months, nine months and then a year. After the drug has survived at least one year, the testing is repeated every six months for the second year. After the new pharmaceutical product has been able to last for two years, the testing drops down to once every 12 months.

The second kind of stability studies are the accelerated tests. When pharmaceutical companies conduct these stability studies they subject their product to more stressful conditions. They change the humidity levels and the temperature at which the new product is stored. These tests are done immediately, then at the three month and six month marks. The degradation rate is noted and compared to the conditions the medication was subjected to.

Stability studies need to be conducted in tandem with clinical trials.

When pharmaceutical companies are planning clinical trials for new medications, they need to factor in the costs of stability studies on those medications. It is important to know what the shelf life of a new product is before it is given to actual people. The responsibility of determining the shelf life and the proper storage conditions for a pharmaceutical product are the responsibility of the developer of the new product. Many regulatory agencies across the planet require companies to conduct their stability studies on their new products at the same time as they are working on the clinical trials of those products. Should any new information about the medication and its shelf life be discovered, that has to be reported to the agencies that regulate the clinical trials and approval of any new pharmaceutical products.

When a pharmaceutical company is developing a new product, there are a lot of tests that need to be conducted on it to determine how effective and safe it is. The clinical trials process is long and complicated and there are significant rules and regulations that govern it. The same thing can be said of stability studies that help a company understand how well the medication can hold up to normal and harsh conditions that it may experience after it has been sold to patients. It is important to take the process of conducting stability studies as seriously as any other part of the drug development process.




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