In vitro comparative dissolution kinetics test (in vitro equivalence dissolution test) is a study of solid dosage forms, which includes a comparison of the release profiles of the active ingredient from the studied drug and the comparison drug in different dissolution media. For regulatory purposes (registration), pharmacopoeial buffer solutions with pH 1.2; 4.5 and 6.8 are generally used, as well as in quality control media. In the early stages of development all kinds of additional media can be used.
1) Complementary to bioequivalence studies, including informed series selection;
2) Bioweaver procedure step of supplemental dosing;
3) Stage of bioequivalence procedure based on BCS;
4) Substitution of bioequivalence studies when the formulation is changed;
5) Confirmation of equivalence when making changes in production technology, when scaling up production;
6) Prognostic tool at early stages of drug development.
The lab has three dissolution testers: the Erweka DT 820, the Sotax AT Xtend, and the Pharma Test WS 100D, which allow you to work on "Paddle Stirrer" and "Rotating Basket" dissolution machines. Also available are fine weave baskets for CDKT of finely dispersed drug forms, as well as sinkers for flotation drugs. Analysis of samples obtained by these means is performed on Shimadzu UV1800 and Spectramax M5 spectrophotometers, Waters Acquity I-class HPLC systems, Agilent Infinity 1260 and UV, diode matrix, refractometric, fluorescence detectors. The laboratory has an arsenal of a variety of chromatographic columns, which is especially useful for development, validation, and transfer of HPLC techniques.
Our staff has over 10 years of experience in comparative drug dissolution kinetics testing. During this time we have investigated a wide variety of drugs: both widely known all over the world and innovative ones; modified-release drugs, enteric-insoluble drugs. We worked with substances of all classes and subclasses according to biopharmaceutical classification system. We have wide experience in development of dissolution methods from scratch, transfer and adaptation of ready-made dissolution methods for CDKT, validation, application of bio-relevant media and development of original dissolution media, researches within BioWeaver procedure. We own different ways of statistical processing of results, their scientific and regulatory interpretation. The laboratory is able to perform both works in strict regulatory frameworks and exploratory-creative works. We are ready to accompany the research in the process of submission to the Ministry of Health, we respond to inquiries, give comments and explanations if necessary.
Our employees have academic degrees, regularly speak at conferences with reports and attend refresher courses. Exact Labs successfully passes annual audits from customers and authorized organizations, which, among other things, affect studies under the CDKT.