Continuous development is the key to managing disease in the modern lifestyle. This doctoral thesis, in which we have systematically presented the field of buccal films and dealt with their formulation, also represents a small piece of this development. Buccal films are mucoadhesive pharmaceutical forms intended for systemic or local drug delivery. They are characterized by the fact that they adhere to the mucous membranes in the mouth and release the active ingredient there. The production of such formulations requires additional knowledge acquired in the development of buccal films.
We approached the development of the films in different ways. First, we searched for suitable drugs for buccal administration. We focused on drugs with low bioavailability and low dosage. We determined the advantages of films containing these drugs over conventional drugs. We systematically developed the films using statistical methods. We used experimental design approaches to determine the most suitable process parameters and the optimal quantitative composition of the film. We presented and tested different methods for the evaluation of thin films, confirming consistent observations with other researchers about the specificity of such dosage forms. There are few methods for their evaluation that would provide applicable results. We have addressed the challenge of drug release from buccal films by developing our own innovative cell for release of films (ICRF) release method. We evaluated this method in detail and compared it with other systems. We confirmed that two-sided release of films is more suitable than one-sided release as it is more comparable to in vivo conditions. We addressed the formulation of films with valasartan and metoclopramide. We prepared films with the drug in amorphous and crystalline form and evaluated their properties. During the development of the formulations, we realized how important it is to observe the appearance of the films, as this contains a lot of information about their quality. A particular challenge is the evaluation of abstract phenomena such as the cracking of the film during drying, the phenomenon of drug crystallization and the evaluation of the homogeneity of the film. The evaluation of these properties was approached using machine image analysis with a neural network. This opened up new possibilities for the examination and quantitative evaluation of buccal films. The field of buccal films is one of the neglected areas of research, as the selection of suitable drugs is limited. Nevertheless, this direction of pharmaceutical development continues to attract the interest of researchers due to the many advantages of this delivery system.
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