PENGARUH KOMPLEKSASI INKLUSI ATORVASTATIN DENGAN β-SIKLODEKSTRIN TERHADAP FORMULASI DAN EVALUASI FAST DISINTEGRATING TABLETS (FDT) ATORVASTATIN

Authors

  • Dilal Adlin Fadil Departmen Farmasetik dan Teknologi Farmasi Fakultas Farmasi Universitas Padjadjaran
  • Taofik Rusdiana Departmen Farmasetik dan Teknologi Farmasi Fakultas Farmasi Universitas Padjadjaran
  • Muchtaridi Muchtaridi Departmen Analisis Farmasi dan Kimia Medisinal Fakultas Farmasi Universitas Padjadjaran

DOI:

https://doi.org/10.12928/mf.v13i2.7768

Abstract

Atorvastatin merupakan salah satu zat aktif penurun kolesterol darah golongan statin atau inhibitor HMG-CoA reductase. Atorvastatin memiliki karaktersitik biofarmasetik kelarutan dalam air yang buruk tetapi  permeabilitas dalam membran usus yang tinggi (BCS kelas II), sehingga untuk memperbaiki bioavailabilitasnya dapat diupayakan dengan cara memperbaiki tingkat kelarutannya dalam air. Penelitian ini bertujuan untuk mengetahui pengaruh kompleksasi inklusi atorvastatin dengan β-siklodekstrin terhadap kelarutan dan disolusinya serta terhadap proses formulasi sediaan Fast Disintegrating Tablets (FDT). Kompleks inklusi dibuat dengan cara kneading method dengan perbandingan molar atorvastatin dengan β-siklodkestrin; 1:1, 1:2, dan 1:3. Studi ketetapan kesetimbangan kompleks didapat 502,087 M-1. Hasil uji disolusi dalam medium buffer fosfat pH 6,8 menunjukkan peningkatan laju disolusi atorvastatin dalam kompleks inklusi atorvastatin-β-siklodkestrin (KIAS) masing-masing sekitar 5,76% (1:1); 8,89% (1:2); dan 7,73% (1:3). Hasil karakterisasi KIAS dengan metode X-ray difraction (X-RD), spektroskopi inframerah, dan differential scaning calorimetry (DSC) menunjukkan adanya pembentukan kompleks inklusi. Formulasi FDT dibuat dengan menggunakan metode kempa langsung terhadap 6 formula (3 formula menggunakan KIAS dan 3 formula tanpa KIAS), superdisintegrat yang digunakan adalah Kyron T 314 dengan variasi penggunaannya masing-masing sebanyak 2, 4, dan 6% dan variasi kekerasan tablet sebesar 4 dan 6 N. Hasil evaluasi FDT menunjukan bahwa FDT dengan KIAS lebih baik dibandingkan dengan FDT tanpa KIAS. Hasil uji disolusi FDT dalam medium buffer fosfat pH 6,8 diketahui terjadi peningkatan laju disolusi atorvastatin dalam FDT KIAS. Dengan demikian, dapat disimpulkan bahwa kompleksasi inklusi atorvastatin dengan β-siklodkestrin dapat meningkatkan laju disolusi atorvastatin secara signifikan.

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Issue

Vol. 13 No. 2: September 2016

Section

Pharmaceutical & Technology

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