Mefenamic acid as pain relief drug belongs to the biopharmaceutics classification system (BCS) class II which is practically insoluble in water causing extremely low dissolution in gastrointestinal tract. The self nanoemulsifying drug delivery system (SNEDDS) is a new innovation pharmaceutical dosage form that has effectively known to increase solubilization of hydrophobic drug in polar solvent. In this study the capryol-90 was selected as oil phase in SNEDDS as it showed maximal solubility of mefenamic acid (20 mg/mL). Combination of polysorbate-80 and PEG-400 as a generally regarded as safe (GRAS) excipient were used as surfactant and co-surfactant in SNEDDS due to its high HLB property that can increase mefenamic acid solubility in water. The ternary phase diagram of capryol-90, polysorbate-80, and PEG-400 was constructed in advance to obtain the component concentration of spontaneous nanoemulsion region. Model simplex-lattice-design cooperated in Design-Expert®10 was used to define SNEDDS mefenamic acid formula. Optimized mefenamic acid SNEDDS formula consisted of 20% capryol-90, 31.62% polysorbate-80, and 48.38% PEG-400. Characterization study of Optimized mefenamic acid SNEDDS formula showed improvement of drug content (102.820 ± 4.950)%, emulsification time (421.015 ± 1.290) second, and viscosity (0.927 ± 0.017) mm2/s 30oC. One way ANOVA statistical analysis result of optimal formula SNEDDS (105.210 ± 4.425)% of drug content, commercial generic caplet (0.917 ± 0.094)%, and mefenamic acid powder capsule (10.446 ± 0,333)% gave significant value (sig*) below than 0.05. Optimal formula proved that SNEDDS can significantly increase mefenamic acid dissolution of pH 7.4 (ileum fluid). The optimal formula of mefenamic acid SNEDDS successfully formed an uniformity droplet size (PDI 0.18) with mean size 241.9 nm and the surface charge has a value of -16.5 mV respectively.
Glibenclamide has the biopharmaceutics classification system (BCS) class II which has high permeability and low solubility. The solubility of glibenclamide can be enhanced by forming solid lipid nanoparticles (SLN). This research has the aim to prepare and characterize SLN loading glibenclamide. The glibenclamide SLN formula was composed by using the liquid lipid as virgin coconut oil (VCO), PEG 6000 as a solid matrix, tween 80 with various concentrations as a stabilizer, and PEG 400 as co-surfactant. Characterization was conducted by determining the encapsulation efficiency (%EE), size measurement, particle size distribution, and zeta potential of SLN glibenclamide. SLN formation was also tested for its physical stability based on the heating-cooling cycle method. The optimum formula was obtained at the concentration of tween-80 of 1 mg/mL yielding the %EE value of 60.6194%, and pH 6.01. The results of particles diameter analysis were 175.5 ± 10.07 nm with a polydispersity index (PDI) of 0.1270, and zeta potential of +5.9 mV respectively. Stability testing by the heating-cooling cycle method has shown the instability of the SLN glibenclamide form under extreme temperatures and mechanics. It could be concluded that the results of characterization of glibenclamide SLN showed appropriate physical properties for nanoparticulate formulation.
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