Evaluasi Sistem Penghantaran Obat Transdermal Berbasis Microneedle: Tinjauan Karakterisasi, Farmakokinetik, Efikasi, Stabilitas, Dan Keamanan
DOI:
https://doi.org/10.63004/hrji.v4i5.1715Kata Kunci:
microneedle, transdermal, karakterisasi, farmakokinetik, evaluasi keamananAbstrak
Pendahuluan: Microneedle merupakan sistem penghantaran obat transdermal inovatif yang menggunakan jarum berukuran mikro (150–1500 µm) untuk menembus stratum corneum secara minimal invasif. Meskipun teknologi ini telah berkembang sejak akhir 1990-an, panduan terintegrasi mengenai parameter evaluasi yang harus dilakukan dalam pengembangan microneedle masih terbatas, sehingga menyulitkan standardisasi metode dan komparasi hasil antar studi. Tujuan: Review ini bertujuan menyusun kerangka sistematis parameter evaluasi yang perlu dilakukan dalam karakterisasi dan pengembangan sediaan microneedle, yang mencakup enam domain utama: karakterisasi struktur dan sifat fisik, evaluasi sediaan, profil farmakokinetik, efikasi, stabilitas, dan keamanan. Metode: Penelusuran literatur secara naratif-sistematis dilakukan pada basis data PubMed, ScienceDirect, dan Google Scholar terhadap publikasi periode 2018–2025 menggunakan kata kunci microneedle yang dikombinasikan dengan operator Boolean AND/OR. Kriteria inklusi meliputi artikel penelitian asli berbahasa Inggris pada microneedle berbasis polimer yang dimuat zat aktif dan melaporkan minimal satu parameter evaluasi. Hasil: Identifikasi literatur menghasilkan enam domain evaluasi yang harus dilakukan: (1) karakterisasi struktur melalui Scanning Electron Microscopy (SEM), pengukuran kekuatan mekanik (rentang 0,22–32 N), dan ketebalan patch (38 µm–1 mm); (2) evaluasi sediaan melalui insertion test (kedalaman penetrasi 200–600 µm), drug loading (38–99%), uji disolusi (1,5–20 menit), uji difusi Franz cell, dan kadar kelembapan (2,25–3,8%); (3) studi farmakokinetik in vivo yang ditunjukkan pada patch microneedle cannabidiol dengan bioavailabilitas relatif 144,70% dibandingkan injeksi subkutan; (4) evaluasi efikasi yang disesuaikan dengan indikasi terapeutik (antikanker, antidiabetes, antiinflamasi, antihipertensi, antibakterial, dan dermatologi); (5) uji stabilitas mengacu pada pedoman ICH Q1A (R2) dengan kondisi dipercepat, intermediet, dan jangka panjang; serta (6) evaluasi keamanan melalui uji iritasi Draize dengan parameter Primary Irritation Index (PII) yang menunjukkan iritasi ringan dan reversibel. Simpulan: Pengembangan sediaan microneedle yang berkualitas mensyaratkan pelaksanaan keenam domain evaluasi secara terpadu. Kerangka sistematis ini dapat menjadi acuan standar bagi peneliti dan pengembang microneedle di Indonesia, sekaligus mendorong harmonisasi metode evaluasi dengan pedoman internasional untuk memfasilitasi translasi klinis dan registrasi produk domestik.
Unduhan
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