Sistem Penghantar Obat Self Microemulsion Cair Simvastatin dan Y-Oryzanol

Jannah, Afifatul (2023) Sistem Penghantar Obat Self Microemulsion Cair Simvastatin dan Y-Oryzanol. Masters thesis, Institut Teknologi Sepuluh Nopember.

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Abstract

Hiperkolesterolemia adalah kondisi dimana konsentrasi low density lipoprotein (LDL) dalam darah ≥190mg/dL. Tingginya kadar LDL dalam darah dapat diatasi dengan mengkonsumsi obat dari jenis statin, khususnya simvastatin. Namun simvastatin diketahui memiliki kelarutan dalam air dan bioavailibilitas yang rendah, hal ini akan meningkatkan dosis konsumsi. Untuk menghindari efek samping ketergantungan obat, diperlukan bahan alami lain yang memiliki sifat yang sama dengan simvastatin. γ-Oryzanol diketahui memiliki sifat anti-hiperkolesterolemia, merupakan bahan bioaktif dalam minyak dedak padi. Sehingga γ-oryzanol dapat dimanfaatkan sebagai alternatif penurun kolesterol alami, namun γ-oryzanol juga tidak larut dalam air. Sistem penghantar obat berbasis lipid telah berkembang pesat, khususnya mikroemulsi. Mikroemulsi telah menunjukkan adanya peningkatan kelarutan simvastatin dan γ-oryzanol, namun portabilitas dan stabilitas terhadap suhu masih rendah. Sistem self-microemulfying cair (SMEDDS) dapat memberikan stabilitas suhu yang lebih baik dibandingkan mikroemulsi sehingga dapat meningkatkan kelarutan dan bioavailibilitas simvastatin dan γ-oryzanol. SMEDDS tersusun atas minyak, surfaktan, dan kosurfaktan yang dicampur dan akan membentuk mikroemulsi saat terlarut dalam air atau cairan lambung dan usus. Dalam penelitian ini, hasil uji kelarutan diperlukan untuk menyusun diagram fasa terner. Kelarutan tertinggi simvastatin dalam minyak, surfaktan dan kosurfaktan berturut-turut dalam Capryol 90 7,55 mg/mL; Labrasol 6.42 mg/mL; dan Transcutol HP 8,04 mg/mL. Sedangkan kelarutan tertinggi γ-oryzanol dalam minyak, surfaktan dan kosurfaktan berturut-turut dalam Lauroglycol 90 5,14 mg/mL; Tween 80 3.95 mg/mL; dan Transcutol HP 7,68 mg/mL. Untuk mendekati pelarut alami γ-oryzanol, fasa minyak terbaik (Capryol 90) ditambah dengan rice bran oil (RBO) dalam penyusunan diagram fasa pseudoterner. Setelah dilakukan uji stabilitas, analisa ukuran droplet, dan indeks polidispersitas pada formulasi SMEDDS, didapatkan hasil terbaik adalah F12 yang mengandung 13,33% Capryol 90, 6,67% RBO, 64% Tween 80, dan 16% Transcutol HP memberikan drug load terbesar untuk muatan tunggal simvastatin dan γ-oryzanol, masing-masing 6,869 dan 7,757 mg/mL. Pada muatan gabungan simvastatin dan γ-oryzanol dengan rasio massa 2:8 memberikan karakteristik yang terbaik dengan kelarutan total tertinggi.
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Hypercholesterolemia is a condition where the concentration of low-density lipoprotein (LDL) in the blood is ≥190 mg/dL. High levels of LDL in the blood can be overcome by taking statin drugs, especially simvastatin. However, simvastatin is known to have low water solubility and bioavailability, this will increase the consumption dose. To avoid side effects of drug dependence, other natural ingredients are needed that have the same properties as simvastatin. γ-Oryzanol is known to have anti-hypercholesterolemic properties and is a bioactive ingredient in rice bran oil. So that γ-oryzanol can be used as an alternative to natural cholesterol lowering, γ-oryzanol is also not soluble in water. Lipid-based drug delivery systems have developed rapidly, especially microemulsions. Microemulsions have shown an increase in the solubility of simvastatin and γ-oryzanol, but portability and stability to temperature are still low. Liquid self-microemulfying systems (SMEDDS) can provide better temperature stability than microemulsions so that they can increase the solubility and bioavailability of simvastatin and γ-oryzanol. SMEDDS is composed of oil, surfactants, and cosurfactants which are mixed and will form microemulsions when dissolved in water or gastric and intestinal fluids. In this study, the solubility test results are needed to construct a ternary phase diagram. The highest solubility of simvastatin in oil, surfactant, and cosurfactant were in Capryol 90 7.55 mg/mL; Labrasol 6.42 mg/mL; and Transcutol HP 8.04 mg/mL. While the highest solubility of γ-oryzanol in oil, surfactant, and cosurfactant were in Lauroglycol 90 5.14 mg/mL; Tween 80 3.95 mg/mL; and Transcutol HP 7.68 mg/mL. To approach the natural solvent γ-oryzanol, the best oil phase (Capryol 90) was added with rice bran oil (RBO) in preparing the pseudo-ternary phase diagram. After stability testing, droplet size analysis, and polydispersity index on the SMEDDS formulation, the best result was F12 containing 13.33% Capryol 90, 6.67% RBO, 64% Tween 80, and 16% Transcutol HP giving the most considerable solubility. for single loadings of simvastatin and γ-oryzanol, 6.869 and 7.757 mg/mL, respectively. The combined charge of simvastatin and γ-oryzanol with a mass ratio of 2:8 gives the best characteristics with highest total solubility

Item Type:	Thesis (Masters)
Subjects:	R Medicine > RS Pharmacy and materia medica T Technology > TP Chemical technology > TP669 Oils, fats, and waxes
Divisions:	Faculty of Industrial Technology > Chemical Engineering > 24101-(S2) Master Thesis
Depositing User:	Afifatul Jannah
Date Deposited:	09 Feb 2023 06:23
Last Modified:	09 Feb 2023 06:23
URI:	http://repository.its.ac.id/id/eprint/96555

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