Biopharmaceutical study of berberine bisulphate dental gel

The lack of uniform design requirements for the pharmaceutical development of dental gels - especially in terms of common biorelevant approaches to assessing the release of an active ingredient in vitro - complicates the harmonization of international research results with each other and slows down the entry of new effective drugs into the market. Aim. To conduct approbation of a complex of biopharmaceutical tests - diffusion into an agar layer and biodegradation in a biological fluid using a sample of berberine bisulfate dental gel. Materials and methods. In the experiment, samples of dental gels of berberine bisulfate obtained in previous studies, based on hydroxyethyl cellulose and a combination of poloxamers, were compared. Diffusion was carried out in a layer of sterile agar gel, when 1.0 g of the gel was placed in a well with a diameter of 10.0 mm, according to the size of the diameter of the colored zone with thermostating (37 °C) for 60 minutes. Biodegradation in the oral cavity was studied on the "Dissolution" ERWEKA DT-800 tester, "Rotating paddle" apparatus (rotation speed 50 rpm) in a potassium-phosphate buffer solution pH 7.0 at 37 ± 0.1 C for 1.0 g of gel in 60 minutes. Results. In the course of the studies, the advantage of using a combined gel base of poloxamers over hydroxyethyl cellulose and its effect on the rate of release of berberine bisulfate was shown. An experimental sample of a gel based on poloxamers underwent biodegradation within an hour, which, together with high rates of mucoadhesion, makes it possible to assume a long exposure of the drug when used in vivo. Conclusion. For the analyzed compositions of dental gels of berberine bisulfate, made on the basis of a combination of poloxamers and hydroxyethyl cellulose, a difference in the kinetics and completeness of release by the method of diffusion into agar was shown. Biodegradation of the dental gel of berberine bisulfate based on the combination of poloxamers was evaluated within 60 minutes and was complete. It should also be noted that the sample remained adhesive to the substrate during the first half of the test and practically did not undergo degradation.