In Quality Control Courses? Learn the Role of Dissolution in the Development of Pharmaceuticals

Pharmaceutical scientists started to recognize the importance of dissolution testing in the 1950s. During that decade, theories about the absorption of drugs like aspirin into the bloodstream were starting to be more widely understood. However, studies involving dissolution began as early as 1897 with Noyes and Whitney.

 

Today, dissolution testing plays an integral role in the development and approval of pharmaceutical products, especially generic oral dosage form drugs. It is an indispensable analytical test for drug regulations, quality control, and quality assurance.

 

Keep reading to learn more about how these tests work throughout the life cycle of pharmaceuticals.

First: In Vivo vs. In Vitro

To understand the role of dissolution testing, you must first understand the difference between in vivo testing and in vitro testing. Dissolution testing is typically done in vitro. What does this mean?

 

In vitro, ‘within the glass’

• Refers to testing done outside of a living organism
• Laboratory method for studying things like bacteria, human or animal cells

In vivo, ‘within the living’

• Method involving living subjects, such as clinical trials with humans

In vitro provides a controlled environment for dissolution testing

Living organisms’ systems are complex, which means that when in vitro testing is done, the controlled environment may not always accurately replicate all conditions. However, this is something that is known, so results from in vitro dissolution testing are scrutinized and interpreted as such.

The Key Issues for Pharmaceutical Quality Assurance

Learning about dissolution testing is an important component of quality control courses and quality assurance in general. For oral dosage form drugs, their effectiveness depends on the way the drug dissolves in the gastrointestinal tract before it is absorbed into the body’s circulatory system.

 

Dissolution testing identifies and measures how the absorption process will happen so that the effectiveness of the drug is optimized. This means dissolution testing makes sure a drug will have the intended and advertised therapeutic effect(s). Dissolution tests must be reproducible and rigorous to ensure quality, and for approval from regulatory organizations.

When it comes to consumer safety and accuracy, dissolution tests are necessary

Additionally, in vitro dissolution testing plays a major role in regulatory organizations’ “efforts to reduce the regulatory burden and unnecessary human studies in generic drug development without sacrificing quality.”

Approval, Batch Consistency, and Scale Up

The results of dissolution testing will contribute to the optimization of the pharmaceutical product’s release rate. The tests will also evaluate the critical process parameters (CPPs) in the process of manufacturing, which will affect the performance of the drug. According to the Scientific Affairs Manager at Agilent Technologies, Bryan Crist:

 

Data from dissolution studies form an essential component in regulatory submissions and all stages of the approval process.

Study quality assurance to get a more in-depth understanding of dissolution testing

 This is why a quality assurance professional with a quality assurance certificate must be able to use dissolution testing to tell the difference between the ways different formulations work. These tests allow QA professionals to detect changes between batches of a pharmaceutical product. If a drug goes from one phase of development to the next, QA professionals will also ensure quality is maintained in the scale up process through dissolution testing, among other processes.

 

Want to learn more about pharmaceutical quality assurance training?

 

Contact the Academy of Applied Pharmaceutical Sciences today!