Development of the «Dissolution» test method for vaginal suppositories Pimafucin®
https://doi.org/10.33380/2305-2066-2025-14-1-1778
Abstract
Introduction. «Dissolution test» for drugs is one of the key studies of control and, in many ways, is designed to simulate the bioavailability of the active substance under the conditions of use. However, there are several drugs containing active pharmaceutical substances that are poorly soluble under standard conditions. For this substances action is local, so, they are practically not absorbed in the human body, but showed the necessary therapeutic effect. This work discusses the development of conditions for «Dissolution test» in lipophilic-based suppositories containing natamycin, which is an antifungal agent related to tetraene macrolides, poorly soluble in water and, therefore, in standard buffer solutions intended for this test.
Aim. Choose the conditions for conducting «Dissolution test», under which it will be possible to achieve complete release of the active substance from lipophilic-based suppositories on «Pimafucin» and «Primacin».
Materials and methods. The objects of the study are lipophilic-based suppositories containing natamycin. The study was carried out using dissolution testers (Rotating Basket and Flow Cell apparatus) and an HPLC system to define the amount of natamycin released.
Results and discussion. The research objects were analyzed under «Dissolution test». The work shows the possibility of conducting a test with complete release of the active substance by adding surfactants and an organic solvent, which is acceptable for quality control dissolution medias.
Conclusion. Conditions for «Dissolution test» have been developed for suppositories containing natamycin.
About the Authors
A. V. Meleshko
MIREA – Russian Technological University
Russian Federation
Russian Federation
86, prospekt Vernadskogo, Moscow, 119571
A. M. Volkova
MIREA – Russian Technological University
Russian Federation
Russian Federation
86, prospekt Vernadskogo, Moscow, 119571
V. S. Tyukova
MIREA – Russian Technological University; Joint Stock Company "Institute of Pharmaceutical Technologies"
Russian Federation
Russian Federation
86, prospekt Vernadskogo, Moscow, 119571;
21/1, Skolkovskoye highway, Moscow, 121353
A. V. Panov
MIREA – Russian Technological University; Joint Stock Company "Institute of Pharmaceutical Technologies"
Russian Federation
Russian Federation
86, prospekt Vernadskogo, Moscow, 119571;
21/1, Skolkovskoye highway, Moscow, 121353
S. A. Kedik
MIREA – Russian Technological University; Joint Stock Company "Institute of Pharmaceutical Technologies"
Russian Federation
Russian Federation
86, prospekt Vernadskogo, Moscow, 119571;
21/1, Skolkovskoye highway, Moscow, 121353
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For citations:
Meleshko A.V., Volkova A.M., Tyukova V.S., Panov A.V., Kedik S.A. Development of the «Dissolution» test method for vaginal suppositories Pimafucin®. Drug development & registration. 2025;14(1):254-264. (In Russ.) https://doi.org/10.33380/2305-2066-2025-14-1-1778
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