Formulasi dan Evaluasi Fast Disintegrating Tablet (FDT) Loratadin

• Main Author: Christiningtyas E, Mikhania
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/45759
• Institution: Institut Teknologi Bandung

Background : Oraly drug administration is the most chosen route of drug administration with acceptance up to 50 –60 %. Solid dosage forms are popular because of easy to be administrated and accurate dose. Unfortunately, they have limitations for patients that have changes in physiological and neurological (dysphagia, hand tremors, change in taste and smell), children, patients with mental retardation and some conditions which water is not available. Fast Disintegration Tablet (FDT) is solid dosage which rapidly disintegrate in mouth, appropiate for drug absorbed in proximal gastrointestinal tract and has good taste. Purpose : The aim of this study was to formulate fast disintegrating tablet (FDT) loratadine as an antialergy drug which is appropiate for FDT. Methods : FDT was made by direct compression method using granulated mannitol with PVP K30 as diluent or Parteck ® M 200 combined with Avicel ® PH-102. Ac-Di-Sol ® was added in varying concentration to formula and tablet compressed by different hardness. Tablet mass was evaluated including flow properties and compressibility while tablet evaluation included hardness, friability, frictibility, wetting time, and disintegration time. FDT that met the requirements was evaluated including loratadin assay, panelists test, and dissolution testing. The dissolution profiles were then compared to inovator conventional tablets, Claritin ® . Results : Disintegration time of F2, F3 and F4 containing granulated mannitol with hardness of 4 kg were 48-83, 37-86 and 118-205 seconds respectively. Meanwhile the disintegration time of F5, F6, F7 and F8 containing Parteck ® M 200 and Avicel ® PH-102 with hardness of 4 kg were 12-33, 14-18, 16-28 and 12-14 seconds respectively. The result of dissolution test showed that loratadine from F2 and F8 was dissolved faster than Claritin ® tablets with f2 less than 30.60. Meanwhile loratadine was dissolved faster from F8 than F2 with f2 30.90. The hedonic test using 10 panelists showed that the highest response for favorite was obtained by F2 and F8 of 4 and 5 panelists respectively, while panelists did not significantly like conventional tablet. The taste test showed that the highest respon for sweetness was obtained for F2 and F8 of 7 panelists, while conventional tablet gave significantly bitter taste response. Conclusions : F2 and F8 containing 2.5 % Ac-Di-Sol ® with hardness of 4 kg met FDT requirements. Loratadine dissolution rate from F2 and F8 obtained was faster than Claritin ® tablets. The use of saccharin natrium and mannitol in F2 and F8 preparations could mask the bitter taste of loratadine.