Main Article Content
Abstract
Abstract
Background: Mefenamic acid is a non-steroidal anti-inflammatory drug (NSAID) with low solubility in water.
Self-Nanoemulsifying Drug Delivery Systems (SNEDDS) play a role to improve the solubility and bioavailability
of mefenamic acid.
Objective: This study aimed to determine the stability of mefenamic acid in SNEDDS formulation through
various stability studies.
Methods: The stability studies conducted consisted of centrifugation test, heating-cooling cycle test, freezethaw cycle test, robustness to dilution, accelerated storage test, and determination of drug content.
Results: The centrifugation test, heating-cooling cycle test, and freeze-thaw cycle test showed no phase
separation in the samples. The robustness to dilution and accelerated storage test resulted in 2 formulas of
mefenamic acid loaded SNEDDS having good stability with 10% oleic acid, 80% tween 80, 10% PEG 400 and
10% oleic acid, 70% tween 80, 20% PEG 400. The determination of drug content in both of these formulations
showed 98.20 ± 0.04% and 90.98 ± 0.06%.
Conclusion: The SNEDDS formulation of mefenamic acid in this study had good stability.
Keywords: SNEDDS, mefenamic acid, stability study, oleic acid
Intisari
Latar belakang: Asam mefenamat merupakan obat anti inflamasi non steroidal (AINS) dengan kelarutan yang rendah di dalam air. Salah satu cara untuk meningkatkan kelarutan dan bioavailabilitas asam mefenamat membuatnya dalam bentuk sediaan Self Nano-Emulsifying Delivery Drug System (SNEDDS)
Tujuan: Penelitian ini bertujuan untuk menentukan stabilitas SNEDDS asam mefenamat terhadap berbagai studi stabilitas yang dilakukan
Metode: Uji stabilitas dilakukan dengan uji sentrifugasi, uji siklus panas-dingin, uji siklus beku-cair, uji ketahanan, uji penyimpanan dipercepat, dan uji kadar.
Hasil: Hasil dari evaluasi uji sentrifugasi yaitu tidak terjadi pemisahan, pada uji siklus panas-dingin dan uji siklus beku-cair tetap stabil dan tidak terjadi pemisahan fase. Hasil dari uji ketahanan dan uji penyimpanan dipercepat menunjukkan 2 formula SNEDDS asam mefenamat yang memiliki stabilitas yang baik dengan komponen Asam Oleat 10%, Tween 80 80%, PEG 400 10% dan Asam Oleat 10%, Tween 80 70%, PEG 400 20%. Pada uji kadar diperoleh kadar asam mefenamat selama penyimpanan pada formula diatas adalah 98,20 ± 0,04 % dan 90,98 ± 0,06 %.
Kesimpulan: Dapat disimpulkan sediaan SNEDDS asam mefenamat memiliki stabilitas yang baik terhadap berbagai studi stabilitas yang dilakukan.
Kata kunci : SNEDDS, asam mefenamat, studi stabilitas, asam oleat
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