| Abstract [eng] |
The aim of work: modeling, Optimization of Composition of Hydroxypropyl methylcellulose and Polyethylene Oxide Blend Films, Physical, Mechanical Properties and Biopharmaceutical Evaluation. Research object: hydroxypropyl methylcellulose and polyethylene oxide blend oral film. Relevance: the development of polymeric oral films as an alternative pharmaceutical form would address the psychological fears or physiological disorders of the target patient group through the use of conventional solid oral pharmaceutical forms. Methods: experimental planning and optimization of film compositions; manufacture of polymeric films by solvent casting method; evaluation of physical (uniformity of mass and thickness, pH, moisture content, dissolution time) and mechanical (strength, elasticity and stickiness) properties; uniformity of dexpanthenol content in films; in vitro release of dexpanthenol; quantitative analysis of dexpanthenol by ultra-high performance liquid chromatography method. Results: the optimal composition of the film, which consists of hydroxypropyl methylcellulose – 0.3 g, polyethylene oxide – 0.1 g, propylene glycol – 2.8 g, was obtained during the study. The physical properties of the film (thickness 290 (5) µm, moisture content 7.2 (0.6)%, pH 7.1, dissolution time 26.4 (2.6) minutes) and mechanical properties (strength 4.7 (0.1) N, elasticity 13.6 (0.5) mm, stickiness 0.248 (0.041) N) were assessed. Insertion of dexpanthenol significantly increased film thickness (43.1%), moisture content (36.1%), stickiness (32.7%), but decreased film strength (40.4%) and elasticity (24.3%). Modification of the optimal composition by the combination of 200 kDa and 600 kDa polyethylene oxide with hydroxypropyl methylcellulose significantly increased the film strength (28.6%), elasticity (19.4%) and a dissolution time (25.5 (0.8) min) similar to the optimal composition of the film without the active substance was maintained. Between 56.2% and 66.1% of the inserted dexpanthenol content was released from the experimental film. Conclusions: the applied experimental planning method allowed the appropriate polymer films composition to be modeled. The obtained significant mathematical models and the equations describing them allowed to reliably predict the optimal composition of the film. The evaluation of the physical and mechanical properties of the films showed the compliance of the modified composition film containing dexpanthenol with the requirements of its quality parameters and suitability for use in the oral cavity. The oral dosage form based on selected polymeric materials is suitable for the release of the active ingredient. |
