Optimasi Fast Disintegrating Tablet Difenhidramin HCl Menggunakan Modifikasi Pati Pisang Kepok Kuning, Crospovidone, dan Microcrystalline Cellulose
DOI:
https://doi.org/10.35814/jifi.v21i2.1406Kata Kunci:
Crospovidone, fast disintegrating tablet, microcristaline cellulose, modifikasi patiAbstrak
Difenhidramin HCl merupakan golongan antihistamin yang tersedia dalam bentuk tablet konvensional. Penelitian ini bertujuan menghasilkan formula optimum fast disintegrating tablet (FDT) difenhidramin HCl menggunakan modifikasi pati, crospovidone, dan MCC yang berkualitas memenuhi syarat fisik tablet dan persen terdisolusi tablet. Modifikasi pati dibuat menggunakan dua tahapan metode yaitu crosslink pati kemudian dilanjutkan coprecipitation silica. FDT dibuat dengan metode kempa langsung. Optimasi dilakukan dengan model simplex lattice design (SLD) menggunakan 3 komponen yaitu: co-process pati crosslink-silica, crospovidone, dan MCC, sehingga didapatkan 14 rancangan formula. Kekerasan, wetting time, waktu hancur dan persen terdisolusi sebagai parameter optimasi. Berdasarkan model SLD didapatkan persamaan untuk masing-masing parameter tersebut, contour plot dan nilai desirability sehingga dapat menentukan formula optimum. Berdasarkan hasil penelitian, didapatkan formula optimum dengan proporsi co-process pati crosslink-silica 56,185 mg, crospovidone 6 mg, dan MCC 45,815 mg yang menghasilkan kekerasan tablet 5 kg, wetting time 51.061 detik, waktu hancur 63,129 detik, dan persen terdisolusi 100,972%. Interaksi ketiga komponen berpengauh menurunkan kekerasan, meningkatkan waktu disintegrasi, meningkatkan wetting time tablet, serta meningkatkan persen terdisolusi.
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