Formulasi dan Uji Stabilitas Nanosuspensi Ketoprofen dengan Natrium Alginat sebagai Penstabil

Abstract

Background: Ketoprofen is a class of non-steroidal anti-inflammatory drugs (NSAID) with analgesic and antipyretic effects. However, ketoprofen has low solubility and significant gastrointestinal effects, Nanosuspension has been known to increase the solubility and stability of the drug. Sodium alginate as a natural polymer is used to stabilize ketoprofen nanosuspension. Objective: Formulate ketoprofen nanosuspension using sodium alginate as a stabilizer, and evaluate the physical stability, dissolution and microbiological stability of the nanosuspension. Method: Ketoprofen nanosuspension was formulated using the evaporative precipitation method with varying concentrations of sodium alginate. Characterization of the preparation included organoleptic tests, determination of particle size, zeta potential and polydispersity index used a Particle Size Analyzer, pH measurements, evaluation of the physical stability of the preparation during 3 months storage at room temperature included organoleptic, particle size, zeta potential, polydispersity index and pH, microbiological stability test consisting of ALT and AKK tests. Calculation of ketoprofen levels in nanosuspension preparations, and dissolution testing of the preparation used the paddle method. Results: Ketoprofen nanosuspension produce a liquid form, clear appearance, characteristic odor and no sedimentation, ketoprofen nanosuspension particle size with variations of sodium alginate polymer with concentrations of 1%, 0.5% and 0.25%. Respectively had a particle size of 17 ± 0.1 nm; 16.41±0.35 nm; 13.34±0.03 nm, zeta potential value -37.15 mV; -15.49mV; -15.55 mV, and the polydispersity index value is 0.2991±0.03; 0.3460±0.03; 0.2624 ± 0.01. Ketoprofen nanosuspension has a pH in the range of 4.5-5.0, specific gravity >1 g/mL. Ketoprofen nanosuspension preparation with sodium alginate polymer with concentrations of 1%, 0.5% and 0.25%. showed that the preparation was stable in storage for 3 months at room temperature (25℃) and in the microbiological stability test for 3 months at the three concentrations no growth of microorganisms and mold were found. Conclusion: Ketoprofen nanosuspension preparation with sodium alginate polymer with concentrations of 1%, 0.5% and 0.25%. It showed that the preparation was stable in storage for 3 months at room temperature (25℃) and in the microbiological stability test for 3 months at the three concentrations no growth of microorganisms and mold was obtained. All ketoprofen nanosuspension formula showed a faster dissolution rate compared to ketoprofen suspension.