PEMBUATAN S-SNEDDS (Solid-Self Nanoemulsifying Drug Delivery System) KETOPROFEN MENGGUNAKAN MINYAK NABATI

KARINNA ASRI YULIETYANI ZEIN, Dr.rer.nat. Ronny Martien, M.Si.

2014 | Skripsi | FARMASI

osteoartritis yang memiliki nilai pKa rendah (± 4,00) sehingga sukar larut dalam cairan lambung. Pada penelitian ini S-SNEDDS ketoprofen dibuat dengan VCO (Virgin Coconut Oil), Tween 80, PEG 400, serta aerosil sebagai alternatif baru penggunaan per oral. Tween 80 dan PEG 400 dioptimasi dengan SLD menggunakan perangkat lunak Design Expert 7.1.5.Evaluasi kejernihan, emulsification time dalam AGF dan AIF, serta stabilitas nanoemulsi dalam AGFdan AIF dilakukan untuk mengetahui sifat SNEDDS yang dihasilkan. Formula optimum SNEDDS dievaluasi ukuran tetesan yang dihasilkan serta dibuat menjadi S-SNEDDS dengan aerosil menggunakan metode spray drying dan adaptasi fluidbed granulator. Formula optimum SNEDDS ketoprofen dengan komposisi 0,833 ml VCO, 3,565 ml Tween 80, 0,605 ml PEG 400, dan 50 mg ketoprofen/ml SNEDDS mempunyai karakteristik emulsification time< 5 menit yaitu 44,43 ± 0,232 detik dalam AGF dan 46,57 ± 0,193 detik dalam AIF. Nanoemulsi yang dihasilkan stabil selama 1 minggu dalam AGF dan AIF. Ukuran tetesan nanoemulsi formula SNEDDS ketoprofen optimum sebesar 2,8 ± 0,7 nm dengan nilai PI sebesar 0,402. Penggunaan aerosil pada pembuatan S-SNEDDS mampu menghasilkan nanoemulsi yang jernih dengan nilai transmitan 93,23 ± 1,36 % pada metode adaptasi fluid bed granulator.

Ketoprofen is one of most commonly used drug in Indonesia as an antiinflammatory drug for rheumatoid arthritis and osteoarthritis treatment. Ketoprofen has low solubility in gastric fluid provide by low pKa (±4.00). In which dissolution of the drug is the rate limiting step of absorption, ketoprofen was formulated to nanoemulsion by SNEDDS (Self-Nanoemulsifying Drug Delivery System) method. As drug delivery system, SNEDDS has some limitations such as high production cost and too hard to manufacture. So that, SSNEDDS (Solid Self-Nanoemulsifying Drug delivery System) was developed as the one of promising solution. This aim of study is to formulate SNEDDS by VCO (Virgin Coconut Oil) as oil phase, Tween 80 as surfactant, PEG 400 as cosurfactant, and Aerosil as solidifying agent. Ketoprofen nanoemulsion with 0.833 ml VCO, 3.565 ml Tween 80, 0.605 ml PEG 400, and 50 mg/ml ketoprofen gave the best result as selected formula. Droplet size of nanoemulsion is 2.7 ± 0.8 nm with PI (Polidispersity Index) 0.402. Nanoemulsion ketoprofen gave emulsification time 44.43 ± 0.232 s in artificial gastric fluid (AGF) and 46.57 ± 0.193 s in artificial intestinal fluid at 37°C. Result of stabilization study claimed that ketoprofen nanoemulsion could stand within a week in 2 media (AGF and AIF). S-SNEDDS ketoprofen was formulated by spray drying and modification of fluid bed granulator methods with aerosol and clarity of nanoemulsion was obtained by ultraviolet spectrophotometry at 650 nm. Spray drying method could formulate ketoprofen nanoemulsion with 69.23 ± 0.115 % clarity and 48.956 % drug content. Beside, modification of fluid bed granulator gave the best result, 93.23 ± 1.361 % in clarity and 49.981% in drug content.

Kata Kunci : ketoprofen, nanoemulsi, SNEDDS, S-SNEDDS