FORMULATION OF “KUCAI”(ALLIUM CHINENSE G. DON) BULB EXTRACT ENTERIC COATED PELLET

• Main Author: Putu Ayu Dewi Wijayanti, Ni
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/45688
• Institution: Institut Teknologi Bandung

“Kucai”(Allium chinense G. Don) bulbs extract has been widely used by the Indonesians as an antihypertensive agent. Characteristics physics of bulbs extract is viscous, sticky, caramel brown color, sweet tasty, smell slightly sharp like onions and hygroscopic. The physical properties must be overcame, so that no interfere during the manufacturing process and while administered by community. Solid dosage form developed was pellets. The objective of this research was to formulate “kucai”bulbs extract become enteric pellet using etermanan as an enteric coat materia. The pellet was produced by extrusion-spheronization process, using Avicel PH 101 as filler, and developed using two factorial experimental design with design expert 8.0.4 program. There were 4 critical parameters influencing the production process, i.e. amount of water (mL), rate of extruder (rpm), rate of spheronizer (rpm) and time of spheronization (second). The pellet produced was evaluated in terms of its physical characteristic, which includes particle size, moisture content, yield of pellet, yield of pellet in size of 710-1250 µm, bulk, tapped density and porosity. The best pellet formula which have particle size of 710-1250 µm were coated with 2 types of coating agent, namely etermanan and Eudragit L 30 D-55 using fluidized bed dryer type top sprayer with operating condition spray rate 1 mL/min, spray pressure 2 bar, inlet air temperature 30-40 0 C, and inlet air rate 4-7 m 3 /min until the weight of pellet are 1, 3 and 5 % respectively. Dissolution test was then performed in HCl medium for 2 hours at pH 1.2, followed in phosphate buffer medium for 45 minutes at pH 6,8. Analysis using ANOVA test showed that the production of pellet were significantly influenced by the four parameters studied (p < 0.05). By using two factorial experimental design, the best pellet formula and the estimated of the evaluation results can be obtained. Pellet coating using etermanan 3 % and Eudragit L 30 D-55 5 % showed the best release profile of tetramethyloxamide in acidic medium of 9.42 % and 9.76 % respectively; while in phosphate buffer pH 6.8 medium of 57.41 % and 59.08 % respectively. The conclusion this reseacrh show that optimum formula was obtained under this technical requirements ratio of extract: Avicel PH 101 (1 : 1); amount of water, 15 mL, rate of extruder, 100 rpm, rate of spheronizer, 1000 rpm and time of spheronization 180 seconds. Pellet coated using etermanan 3 % have comparable strength enteric coat with Eudragit L 30 D-55 5 %.