OPTIMASI FORMULA LANSOPRAZOLE DALAM SEDIAAN SELF NANO EMULSIFYING DRUG DELIVERY SYSTEM (SNEDDS) MENGGUNAKAN METODE SIMPLEX-LATTICE-DESIGN
Daftar Isi:
- Lansoprazole is one of proton pump inhibitor (PPI) included in biopharmaceutical classification system class II with poor water solubility it makes the ability of lansoprazole to dissolution so low in gastrointestinal and lower bioavailability. Development into SNEDDS dosage form has effectively known to improve solubilization of hydrophobic drug. Sunflower oil was used as oil phase in SNEDDS as it can dissolved lansoprazole properly (65,65± 1,12 mg/L). Tween-80 and PEG-400 was used as non-ionic surfactant and cosurfactant due to have an high HLB value (>12) in order to increase lansoprazole solubility in water. Determination of ternary phase diagrams conducted to obtain proporsion of combination component formed spontaneous nanoemulsion region. Nanoemulsion region formed on concentration range of sunflower oil 10% – 30%, tween – 80 30 – 80% and PEG – 400 10 – 60%. . Determination of 13 SNEDDS lansoprazole formulas used simplex-lattice-design method in Design-Expert®10 program. Component proportion of SNEDDS lansoprazole optimum formula from optimization process toward 7 characteristics of 13 formulas resulted 10%sunflower oil, 30% tween-80, and PEG-400 60%. Optimum formula resulted characteristics percent of transmittance (74,64 ± 0,005)%, emulsification time (32,33 ± 0,557)second, viscocity (10,0916 ± 0,395) cP, pH (6,13 ± 0,011), robustness to dilution in aquadest, SGF, and SIF ((97,7745 ± 0,115)%; (99,1470 ± 0,453)%; dan (95,4241 ± 0,314)%. Dissolution test showed that SNEDDS can improve lansoprazole dissolution in SIF pH 7.4 compared to pure, and generic capsule lansoprazole with SNEDDS’s DE60 value (7,86 ± 0,22)%, while pure lansoprazole (5,64 ± 0,16)%, and generic capsule (5,94 ± 0,33)%. SNEDDS lansoprazole resulted particle size 353,2 nm, has a good uniformity (PDI 0,486), but has unstable tendency due to surface charge value of 9,4 mV. Based on results in this research, lansoprazole can be prepared into SNEDDS dosage form. Keyword(s): lansoprazole, SNEDDS, sunflower oil, tween-80, PEG-400