| Abstract [eng] |
The aim of work: modeling and optimization of the composition of hydroxyethylcellulose and sodium carboxymethylcellulose bend films, evaluation of their physical, and mechanical properties as well as biopharmaceutical evaluation. Research object: hydroxyethylcellulose and sodium carboxymethylcellulose bend experimental films with an active substance of dexpanthenol. Actuality: the development of polymeric films as an alternative to other oral pharmaceutical forms for people with swallowing disorders and for ease of use improvement. Research methods: modeling of the composition of experimental films by using experimental planning; film production by using solvent casting method; evaluation of physical, and mechanical properties (uniformity of mass and thickness, pH, dissolution time, humidity amount, stickiness, strength, and elasticity); uniformity of dexpanthenol content; evaluation of in vitro release of dexpanthenol; ultra-efficient liquid chromatographic method. Research results: dexpanthenol was inserted to the optimal composition (HEC 0,4 g, SCMC 0,1 g. PEG 400 2,0 g) of the film. After evaluation of physical-mechanical properties and biopharmaceutical evaluation, the optimal composition of the film was modified in two ways: by reducing PEG 400 amount from 2,0 to 1,8 g and by changing SCMC to PVP K90. Thickness of experimental films with dexpanthenol was 425–458 µm, pH 6,3–6,4, dissolution time 5,21–7,48 min, humidity amount 4,3–6,3 %, stickiness 0,168–0,284 N, strength 6,1–6,7 N, elasticity 7,7–13,1 mm. Insertion of dexpanthenol to the optimal composition of film decreased the strength of the film by 1,6 times, the amount reduction of PEG 400 from 2,0 to 1,8 g, decreased the stickiness of the film by 1,5 times, the change of SCMC to PVP K90, decreased the elasticity of the film by 1,8 times. In the first 15 minutes, the largest amount of dexpanthenol was released from the optimal composition film and the film with reduced PEG 400 amount, in 30 minutes the largest amount of dexpanthenol was released from the film with PVP K90. After 120 minutes the amount of released dexpanthenol from the experimental films with this active substance was 54,1–58,6 %. Conclusions: the selected criteria (maximum stickiness, maximum thickness) and their mathematical equations allowed to select the optimal composition of film. Experimental films conformed to the quality parameters and are suitable for releasing dexpanthenol. |
