Title : Formulation and characterization of buccal films based on Sodium Alginate and Chitosan for using in Parkinson's disease
Abstract:
Parkinson's disease is the second most common neurodegenerative disease in the world, 16-20 thousand people suffer from this disease in Hungary and more than 10 million people worldwide. The symptoms can be various, both non-motor and motor symptoms can appear. The biggest problem in the treatment of the disease is the difficulty in swallowing for the patients. The aim of our experimental work was to produce and test a buccal polymer film containing pramipexole dihydrochloride as an active pharmaceutical agent. With this pharmaceutical form, due to the difficulty in swallowing in patients with who suffer in Parkinson's disease, the inappropriate application of the drug can be eliminated and thereby improve the success of the therapy. The biggest advantage of buccal films is that the patients do not have to swallow the dosage form, therefore the active substance is absorbed directly from the buccal mucosa into the systemic circulation. For the preparation of polymer films, sodium alginate and chitosan were used as film-forming agent and pramipexole dihydrochloride was used as the active pharmaceutical ingredient. The physical properties of the prepared polymer films were examined, as well as the chemical interactions between components of films, using various methods such as FT-IR and RAMAN spectroscopy. Dissolution of the pramipexole from the polymer film was also investigated, as well as the permeation of the active ingredient through the cells of the TR 146 buccal cell line. Finally, the biocompatibility of the prepared polymer films was also tested on a buccal cell line. Based on the results, it can be said that by increasing the concentration of glycerol, the tensile strength of the films increased in the case of both types of film-forming agent, but at the same time, glycerol reduced the in vitro mucoadhesive force values. Based on the results of Raman mapping, the active ingredient (pramipexole) was distributed homogeneously in the polymer films, and interactions were observed between the components of films, which were also confirmed by the FT-IR tests. All formulations were biocompatible.
