Orodispersible films (ODF) represent an innovative drug delivery system in which active pharmaceutical ingredients for local or system delivery can be incorporated. The active pharmaceutical substance is released into the oral cavity within a few seconds after the application of ODFs, thus achieving a rapid onset of action. A range of doses can be incorporated into ODFs, i.e. adapted for the pediatric population. At the same time, the ODFs represent an alternative to tablets within the geriatric population who have difficulties with swallowing.
Within the master's thesis, ibuprofen-loaded nanocellulose-based ODFs were developed and evaluated. ODFs are based on nanocrystalline cellulose (NCC) from two different manufactures (i.e. powder or gel NCC) in combination with three various natural polymers (low viscosity chitosan, alginate, and pectin) and glycerol. NCC is a natural polymer that does not exceed 100 nm in at least one dimension, while natural polymers do increase crosslinking of the polymer chains and improve the mechanical properties of the hydrogel network. In the first part of the thesis, we focused on the incorporation of ibuprofen as a model for poorly water-soluble active pharmaceutical ingredient into hydrogels. Poor solubility was resolved with pre-incorporation of ibuprofen into the self-microemulsifying system, consisting of surfactant and oil. Hydrogels were rheologically evaluated in terms of natural polymer and integrated active pharmaceutical ingredients influence on the viscosity and values of the elastic/plastic module. ODFs were then produced from hydrogels by the solvent casting method. Films made with natural polymer alginate proved to be the most suitable for production. Total content of the the produced ODFs was determined with the higher ibuprofen content in ODFs based on gel NCC, which indicated a higher ability to bind ibuprofen with gel NCC. As confirmed by DSC method the ibuprofen is present in dissolved form in the ODFs. The disintegration time of the films was determined using two methods: the classical pharmacopeia method and the drop method, a newer approach for determining disintegration time. The longer times in the droplet method are attributed to the fact that ODFs at first slowly swell and then disintegrate. With both methods, the same trend was observed, namely thet gel NCC based ODFs disintegrate faster than their powder NCC based ODFs parallels. The disintegration times are the shortest for pectin, followed by alginate, while ODFs made with chitosan, which is insoluble at neutral pH, do not disintegrate in water.
Based on all the obtained results, we can conclude that ODFs with pectin and alginate are suitable for ibuprofen incorporation, and it would be reasonable to explore the release from these ODFs as well.
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