Peningkatan Disolusi Tablet Tadalafil Dengan Metode Kompleks Inklusi Betasiklodekstrin dan Variasi Eksipien Penghancur.
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Tadalafil (TDL) merupakan obat yang terbukti secara klinis mengobati disfungsi ereksi, hiperplasia prostat jinak, dan hipertensi paru. TDL diklasifikasikan sebagai obat BCS Kelas II, yaitu obat dengan permeabilitas tinggi namun kelarutan rendah. Peningkatan kelarutan dilakukan melalui metode kompleks inklusi dan diverifikasi dengan uji disolusi. Penelitian ini bertujuan menentukan profil disolusi tablet kompleks inklusi TDL menggunakan metode kompleks inklusi beta-siklodekstrin (βCD) dengan variasi disintegrant. Hasil menunjukkan bahwa kekerasan tablet sebesar: R1 = 6,6 ± 0,5 kgf, R2 = 6,48 ± 1,4 kgf, dan R3 = 6,6 ± 1,3 kgf. Evaluasi waktu hancur menunjukkan: R1 = 4,66 ± 1,08 menit, R2 = 5,08 ± 0,91 menit, dan R3 = 5,1 ± 1,1 menit. Hasil uji kekuatan tarik untuk masing-masing formulasi adalah: R1 = 1,3 MPa, R2 = 1,3 MPa, dan R3 = 1,1 MPa. Rata-rata kadar tablet kompleks inklusi adalah: R1 = 104,11 ± 1%, R2 = 106,23 ± 0,1%, dan R3 = 105,09 ± 1,9%. Profil disolusi tablet kompleks inklusi pada menit ke-30 adalah: R1 = 85,2 ± 4,2%, R2 = 79,7 ± 3,6%, dan R3 = 77,4 ± 5,3%. Variasi pada disintegran secara signifikan memengaruhi profil disolusi pada menit-menit awal, yang berdampak terhadap keseluruhan profil disolusi. Metode kompleks inklusi TDL-βCD berhasil mencapai nilai Q yang sesuai dengan spesifikasi monografi.
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