Abstract [eng] |
The aim of work: modeling and optimization quality-compliant polyvinyl alcohol and carboxymethylcellulose sodium salt blend films with lidocaine hydrochloride and perform biopharmaceutical assessment. Main tasks: modeling and optimization polyvinyl alcohol and carboxymethylcellulose sodium salt blend films based on the selected parameters; to evaluate the physical-chemical and mechanical properties of selected films; to evaluate the physico-chemical and mechanical properties of polyvinyl alcohol and carboxymethylcellulose sodium salt blend films; to evaluate release of lidocaine hydrochloride from of polyvinyl alcohol and carboxymethylcellulose sodium salt blend films. Research object: polyvinyl alcohol and carboxymethylcellulose sodium salt blend films. Actuality: polymeric films are a solution of patient discomfort or psychological fears and deficiencies of dermatological products. Methods: experimental films composition optimization; films production for solvent casting method; evaluation of physico-chemical properties (uniformity of mass and thickness, pH, time of dissolution, determination of humidity) and mechanical properties (determination of tensile force and stickiness); uniformity of lidocaine hydrochloride in films; in vitro release of lidocaine hydrochloride; ultra-high performance liquid chromatography method. Results: to selected composition films (carboxymethylcellulose sodium salt and polyvinyl alcohol ratio 3:1 and 1 2-propanediol quantity 2,0 g or 2,5 g) were to inserted lidocaine hydrochloride. The physico-chemical properties of these films were: pH value from 6.4 to 6.5, the moisture content ranges from 5 to 6.2 % and time of dissolution from 35 to 43 min. The mechanical properties of these films were: tensile force from 6 to 9 N, distance to rupture point from 6 to 9 mm ant stickiness from 0,308 to 0,444 N. The physico-chemical properties of selected composition films inserted lidocaine hydrochloride remained the same but mechanical properties decreased (tensile force, distance to rupture point and stickiness). In vitro studies lidocaine hydrochloride was released from polymer films from 1260 to 1327 μg/cm2. Conclutions: the selected qualitative parameters allowed to model and select the films. In these studies were not get statistic significant mathematical model which to predict physico-chemical and mechanical properties. After evaluating qualitative properties of films were suitable for use on the skin. Polymer films are suitable for lidocaine hydrochloride release. |