DEVELOPMENT AND IN VITRO EVALUATION OF SELEGILINE HYDROCHLORIDE BUCCAL FILM FORMULATIONS FOR PARKINSON TREATMENT
Project no. 22759 · Status: Kapanmış · 2021
Summary
<p>Parkinson's disease (PD), the second most common neurogenerative disease after Alzheimer's, is a disease that affects nerve cells in the brain that control movement. According to the data of the PH Association, it is predicted that there are 150,000 patients diagnosed with PH in our country and 10 million in the world, and that the number of patients in the world will reach 30 million in the 2030s. In the treatment of PD, selegiline hydrochloride (SH), a monoamine oxidase type B inhibitor, is used in the early stages as monotherapy or in addition to levodopa at advanced levels. SH mainly undergoes first-pass metabolism in the liver by microsomal P-450 enzymes, and therefore, the amount of active substance that enters the systemic circulation is considerably reduced. It is a widely accepted view that the efficacy of oral treatments, which are used for symptom control and with a high frequency of use, will decrease over time as PH progresses. Studies show that these problems can be solved effectively only with non-oral treatments. Oral mucosal tissue with intense blood flow; It is a preferred application area due to its high permeability, rapid recovery, easy administration and removal of the dosage form, overcoming the first pass effect of the applied active substance and the pre-elimination process in the gastrointestinal tract. In our project, it is aimed to prepare bioadhesive buccal film formulations containing SH in order to extend the residence time of the dosage form, reduce the daily dosing frequency, increase the bioavailability of the drug by localization in the target area and increase the patient's compliance with the treatment. Detailed in vitro characterization studies of all prepared formulations will be made. The toxicity of the formulations determined as optimum on mucosal cells will be examined by cell culture studies. Finally, the possible efficacy of the formulations in the treatment will be evaluated through the expressions of intracellular PH-related proteins in the neuroplastoma cell line for which a PH model has been created.</p>