IN VITRO MODELING FOR THE EVALUATION OF BIOPHARMACEUTICAL PARAMETERS OF PHASE INVERSION-BASED DENTAL IN SITU IMPLANTS

Abstract

Abstract. Postoperative therapy is one of the least developed areas of modern dentistry in terms of the breadth of the segment of dosage forms used. Dental in situ implants are an innovative dosage form proposed for use in post-resection therapy, which eliminates a number of disadvantages inherent in existing pharmaceuticals. Phase inversion-based in situ implants are of the greatest interest in the study, since they have the properties necessary for dental implantation and advantages over alternative in situ systems. However, the development of such innovative delivery systems is complicated by the lack of available, verified and biorelevant methods for evaluating the biopharmaceutical parameters of the dosage form at the screening stage. To solve this problem, it is possible to use in vitro modeling. The aim of this study was to determine the applicability of using an in vitro agar gingiva model to evaluate a dosage form qualitatively and quantitatively for a number of critical parameters with the intention of improving formulation, adjusting active ingredient release kinetics under near real conditions, and predicting in vivo behavior. The maximum in vitro/in vivo correlation was achieved due to the presence of a standard identical to the real tooth socket in anatomical shape and volume and the correspondence of the created model to the actual physiological parameters. For a more accurate evaluation, in addition to the agar model, a 3D-gingiva model was also used as part of the in vitro simulation. The data obtained in in vitro studies made it possible to assess the compliance of the dosage form with the specified requirements, and also, in cases of discrepancy, correct its composition at the early stages of development.