To accurately characterize how an oral form of a solid dosage performs, dissolution testing is a primary tool used in today’s world of science and medicine. The core value of this tool reveals that the effectiveness of a drug is based on its initial release from within the actual product and how timely it dissolves within the person’s gastrointestinal fluids before the bloodstream can absorb it.
Why Quality Control Depends on Dissolution Testing
The standard dissolution test is part of the routine procedure assed by quality control teams that want to focus on consistent and efficient production as well as the justification of post-approval modifications and scale-up recommendations during the manufacturing stage. During the initial stages of drug development, this type of testing plays a key role in the optimization of the drug delivery process as well as the overall formulation design.
The Need for Preparation Before Testing
As is the case with any scientific procedure or test, dissolution media preparation is a vital step that must be taken before this testing can be conducted and assessed. Various preparation systems can be used to cautiously yet efficiently remove any trace of dissolved gases before the dissolution testing begins.
Using a combined collection of circulation, vacuum, dispensing and heating, these systems process many vessels simultaneously. Standard tank sizes for this preparation process are typically either 8 or 15 L. If necessary, the addition of proper volumes of buffer, acid or even surfactant are also included.
The Danger of Dissolved Gases
Why is it so important to ensure that dissolved gases are removed before the actual dissolution testing begins? The presence of dissolved gases or even air bubbles during tablet testing can create inaccurate absorbance readings during the actual dissolution testing. It is also necessary to enforce degassing regulations and procedures regarding proper dosing to comply with FDA and USP stipulations.
Why is Dissolution Testing Conducted?
Below is a list of the main reasons why dissolution testing is conducted and carefully examined:
It provides an accurate assessment of the stability (or instability) of a product
It can be used to efficiently monitor gradual modifications that may occur within the formulation of a product.
Dissolution testing helps to create in-vitro-in-vivo correlations.
As highlighted in the third point referenced above, this tool has also been effectively used as a surrogate test for in-vivo performance predictions.
One of the biggest risks encountered through conducting unnecessary or excessive human studies is that the quality of basic drug products can become compromised. As a result, in the overall decision-making process, dissolution media preparation and testing play key roles from within are gulatory perspective – especially when it comes to developing and approving basic dosage forms.