Formulasi dan Evaluasi Film Forming Solution Melatonin untuk Terapi Insomnia
DOI:
https://doi.org/10.29313/bcsp.v6i2.24641Keywords:
Melatonin, Film Forming Solution, Sistem Penghantaran Obat TransdermalAbstract
Abstract. This study aimed to formulate and evaluate a melatonin-loaded film-forming solution (FFS) as a transdermal drug delivery system and to determine its permeation profile and sedative effect through a clinical study. The formulations were prepared using different concentrations of polyvinyl alcohol (PVA) and polyethylene glycol (PEG) as the plasticizer. The prepared formulations were evaluated for organoleptic characteristics, pH, viscosity, drying time, tackiness, and stability. Permeation studies were carried out using a Franz diffusion cell with shed snake skin as the diffusion membrane. The sedative effect was evaluated in human subjects using a pre-test–post-test design based on the Insomnia Severity Index (ISI). All formulations met the required physical quality criteria, and Formula F1 was selected as the optimal formulation because it exhibited the most suitable viscosity and drying time. The permeation study indicated that melatonin showed low permeation across the membrane, while the clinical study demonstrated no statistically significant difference between the melatonin-treated group and the placebo group. Therefore, the melatonin-loaded film-forming solution has not yet shown sufficient potential as a non-invasive transdermal therapy for improving sleep quality.
Abstrak. Penelitian ini bertujuan untuk mengembangkan dan mengevaluasi sediaan Film Forming Solution (FFS) yang mengandung melatonin sebagai sistem penghantaran transdermal serta menguji kemampuan permeasi dan aktivitas sedatifnya menggunakan uji klinis. Sediaan diformulasikan dengan variasi konsentrasi polimer PVA dan plastisizer polietilen glikol, kemudian dievaluasi meliputi uji organoleptik, pH, viskositas, waktu pengeringan, kelengketan, dan stabilitas. Uji permeasi dilakukan menggunakan sel difusi Franz dengan membran kulit ular lepas, sedangkan uji aktivitas sedatif dilakukan pada subjek dengan metode pre-test dan post-test menggunakan Insomnia Severity Index (ISI). Hasil penelitian menunjukkan bahwa seluruh formula memenuhi persyaratan mutu fisik, dengan formula F1 sebagai formula optimal berdasarkan viskositas dan waktu pengeringan terbaik. Uji permeasi menunjukkan bahwa melatonin memiliki kemampuan permeabilitas yang rendah, sementara uji klinis menunjukkan tidak adanya perbedaan yang signifikan antara kelompok zat aktif dengan kelompok plasebo. Dengan demikian, sediaan FFS melatonin belum berpotensi sebagai alternatif terapi non-invasif untuk membantu meningkatkan kualitas tidur.
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