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Abstract
Abstract Ascorbyl palmitate is a derivative of ascorbic acid which has a more lipophilic propertis. Ascorbic acid as a hydrophilic compound in topical formulation has low penetration through the skin. Ascorbyl palmitate has better penetration through the skin than that of ascorbic acid. Problem of ascorbic acid and its derivatives that it has a low stability in topical formulation. Microemulsion may increase stability of drugs and have better penetration through the skin. Microemulsion has high surfactant concentration in the formula which followed irritation. The aim of this research was to evaluate stability and primary irritation ascorbyl palmitate microemulsion. Ascorbyl palmitate microemulsion was made by low energy process. Physical stability of microemulsion was examined for viscosity, phase separation and homogeneities. Stress testing was also performed to the drug for hydrolisis (0.1 N HCl, water and 0.1 N NaOH) and oxidation (3% H2O2). Primary irritation test conducted with techniques on rabbits skin patch test. Rabbits were divided into 2 groups on the incision (n = 5) and not in the incision (n=5). Each group consisted of distilled water control, base control and treatment groups with dose variations 0.25 ml / inch, 0.50 ml / inch, 1 ml / inch and 2 ml / inch. Ascorbyl palmitate microemulsion change in colour, viscosity and pH values during storage at temperature of 25°C and of 40°C. The stability of microemulsion, ascorbyl palmitate underwent degradation by route of hydrolysis and by oxidation. Primary irritation index values obtained respectively 1.275, 1.825, 1.875 and 1.350. Ascorbyl palmitate microemulsion produce irritation index slightly irritating.
Keyword: Ascorbil palmitate, mikroemulsion, stability, surfactan,skin irritation
Intisari Vitamin C memiliki beberapa turunan, antara lain berupa askorbil palmitat yang memiliki kepolaran yang rendah, salah satu kendala dalam membuat sediaan vitamin C topikal adalah rendahnya stabilitas dan penetrasi ke dalam kulit. Mikroemulsi memiliki keunggulan antara lain mempunyai kestabilan yang baik, serta dapat meningkatkan penetrasi obat ke dalam kulit. Penelitian ini bertujuan mengetahui kestabilan mikroemulsi askorbil palmitat dan tingkat toksisitas dengan mengukur indeks iritasi pada kulit kelinci. Mikroemulsi askorbil palmitat dibuat dengan teknik low energy, dilakukan uji stabilitas fisik meliputi pH, visikositas, pemisahan fase dan homogenitasnya. Uji stabilitas kimia dilakukan dengan prosedur uji hidrolisis (0,1 N HCl, air dan 0,1 N NaOH) dan oksidasi (H2O2 3%). Uji iritasi primer dilakukan dengan teknik uji tempel pada kulit kelinci yang terbagi menjadi 2 kelompok yang di insisi (n=5) dan tidak di insisi (n=5). Tiap kelompok terdiri dari kontrol akuades, kontrol basis dan perlakuan dengan variasi dosis pengolesan 0,25ml/inci, 0,50 ml/inci, 1 ml/inci dan 2 ml/inci. Hasil stabilitas fisik dari mikroemulsi mengalami perubahan pH, visikositas, warna dan homogenitas. Stabilitas kimia menunjukan askorbil palmitat mengalami degradasi secara hidrolisis dan secara oksidasi. Bedasarkan uji iritasi primer skor eritma dan edema pada kulit yang di insisi lebih besar daripada kulit yang tidak diinsisi, sedangkan berdasarkan dosis pengolesan didapatkan nilai indeks iritasi primer berturut-turut 1,275; 1,825; 1,875 dan 1,350 sehingga dapat disimpulkan sediaan tersebut memiliki indeks iritasi dengan kategori sedikit mengiritasi.
Kata kunci : Askorbil palmitat, mikroemulsi, stabilitas, surfaktan, iritasi kulit
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