| Summary: | 碩士 === 國立臺灣海洋大學 === 食品科學系 === 103 === In dental therapy, local anesthetic administration not only can improve therapeutic outcome, but also relieves psychological tension from patients, consequently enhancing comfort during the procedure. This study aims to reformulate the traditional injection form into oral dissolving film (ODF), which allows painless surgical procedure and can overcome the problem of slow onset from that of other dosage forms. In this study, a combination of lidocaine and different polymers, fillers, plasticizers, coloring agents and flavoring agents is used to formulate ODF. Then, the product of lidocaine ODF is formulated and evaluated in aspects of smoothness, permeation, tensility and adhesiveness. On the other hand, to compare the dissolution rate of lidocaine under same pH, ODF and commercial products are separately placed in the vessels of dissolution apparatus with different solvents, including 0.1 N HCl, pH 4.5 phosphoric acid, pH 6.8 phosphoric acid and water. Dissolved samples are collected to analyze lidocaine at 3, 6, 9, 12, 15, 30, 45, and 60 min. In addition to the dissolution test, another apparatus used in this study is the Transdermal Franz Diffusion Cell, in which ODF and commercial products are placed on the artificial skin of the receptor with donor filled with 37.0 ± 0.5℃ of solvents to simulate the physiological environment of the oral cavity. The diffused lidocaine from each cell is collected at 5, 10, 15, 20, 30, and 60 min and determined. The results show that ODF can release 90% of lidocaine within 6 min, while the commercial product requires 30 min to release 90% of the pharmaceutical ingredient lidocaine. On the other hand, the permeation test show a significant different between the permeation rate of the ODF and commercial product. The ratio of the permeation rate of ODF and commercial product is 2:1 within 30 min. Therefore, the ODF releases the pharmaceutical ingredient lidocaine in a short time to exert pharmacological action. The ODF formulated in this study shows the potential of being applied clinically and to serve as an alternative to the traditional injection form of local anesthetic.
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