The Dissolution Test is mandatory for all oral solid dosage forms as per pharmaceutical pharmacopoeias. This test must be conducted throughout all stages of product development and stability studies and is one of the most critical indicators for assessing the quality of oral solid drug products. It is also a key test used to detect physical changes in the Active Pharmaceutical Ingredient (API) and in the formulated product.

Drug dissolution assessment is also used to evaluate quality, drug release profiles, and the similarity of developed generic drugs to the originator’s branded drug. Similarity testing is performed in two ways: In-vivo and In-vitro. In the in-vivo state, the plasma concentration of the drug within a living organism is evaluated. In the in-vitro state, the drug’s dissolution and release profile is assessed through the Dissolution test. Subsequently, In-vivo/In-vitro Correlation (IVIVC) is evaluated to predict the drug’s behavior in the living body using the in-vitro data.

At our company, In-Vitro studies and the assessment of the similarity of generic drugs to the branded reference product are conducted in accordance with ICH and USP protocols, as well as the sponsor’s specific proprietary protocol.

In the final in-vitro study report provided by our company, the obtained results, test method, protocol used, equipment and chemical reagents employed, as well as the statistical calculations performed, are all clearly described. Furthermore, all chromatograms, spectra, and other instrumental reports are attached to the final report.

We are proud to have provided high-quality, timely, accurate, and customized services in this field to a large number of pharmaceutical companies in the country. This is just one of the many specialized services we can offer our clients in the pharmaceutical domain