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FORMULASI ORALLY DISINTEGRATING TABLET (ODT) DOMPERIDON MENGGUNAKAN SUPERDISINTEGRAN KROSPOVIDON DAN PRIMOGEL DENGAN METODE SUBLIMASI
ABSTRAK
Latar Belakang: Metode sublimasi adalah salah satu teknik pembuatan Orally Disintegrating Tablet yang berdasarkan prinsip untuk meningkatkan porositas dan/atau penambahan superdisintegran dan bahan tambahan yang larut dalam air kedalam tablet. Oleh karena itu, perlu dikembangkan suatu formulasi Orally Disintegrating Tablet (ODT) yang memenuhi persyaratan.
Tujuan dari penelitian ini adalah untuk mengetahui pengaruh camphora terhadap waktu hancur dan disolusi Orally Disintegrating Tablet yang mengandung domperidon sebagai bahan obat.
Metode: Pada penelitian ini dibuat Orally Disintegrating Tablet dengan metode sublimasi yang mengandung domperidon sebagai bahan obat dengan superdisintegran krospovidon dan primogel dengan bahan volatil camphora. Konsentrasi camphora yang diformulasi yaitu 5, 10, dan 15%. Orally Disintegrating Tablet yang telah diformulasi diuji yaitu uji preformulasi meliputi waktu alir, sudut diam, dan indeks tap; dan uji evaluasi meliputi kekerasan, friabilitas, waktu hancur, waktu pembasahan, absorbsi air, penetapan kadar, keseragaman kandungan, dan disolusi.
Hasil: Dari hasil penelitian menunjukkan bahwa Orally Disintegrating Tablet domperidon memenuhi persyaratan British Pharmacopoeia untuk uji waktu hancur. Uji waktu hancur dan uji disolusi menunjukkan adanya perbedaan yang signifikan antara semua formula Orally Disintegrating Tablet domperidon yang diuji (p < 0,05). Waktu hancur formula 1 (18,68 detik), formula 2 (17,11 detik), formula 3 (15,31 detik), formula 4 (14,13 detik), formula 5 (14,93 detik), formula 6 (13,09 detik), formula 7 (12,22 detik), formula 8 (16,13 detik), formula 9 (14,37 detik), dan formula 10 (13,83 detik). Hasil uji disolusi pada menit ke-3 memiliki persen kumulatif: formula 1 (18,77%), formula 2 (20,62%), formula 3 (20,70%), formula 4 (23,40%), formula 5 (35,71%), formula 6 (26,23%), formula 7 (29,36%), formula 8 (26,68%), formula 9 (24,26%), dan formula 10 (22,40%). Kesimpulan: Hasil penelitian ini menunjukkan bahwa camphora mempercepat waktu hancur tetapi tidak mempercepat disolusi dari Orally Disintegrating Tablet domperidon.
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FORMULATION ORALLY DISINTEGRATING TABLET (ODT) OF DOMPERIDONE USING SUPERDISINTEGRANT CROSSPOVIDONE
AND PRIMOGEL WITH SUBLIMATION METHOD
ABSTRACT
Background: Sublimation method is one of techniques for preparing Orally Disintegrating Tablet that based on principle can increase porous structure in the tablets and/or adding superdisintegrant and other water soluble ingredients into tablets. Hence, it is necessary to develop a formulation of Orally Disintegrating Tablet that fulfilled the requirement.
Purpose: The aim of this study was to evaluate the effect of Camphor to disintegrating time and dissolution of Orally Disintegrating Tablet containing domperidone as drug.
Methods: In this study, Orally Disintegrating Tablets were formulated by sublimation method with domperidone as drug using superdisintegrant crosspovidone and primogel and camphor as sublimating agent. In this formulation, camphor (5, 10, and 15%) was used as sublimating agent. The prepared formulations were evaluated by preformulation test for flow time, angle of repose, and tapped index; and physical characteristic for hardness, friability, disintegration time, wetting time, water absorption, drug content, uniformity of content, and dissolution.
Results: The result showed that Orally Disintegrating Tablet domperidone suitable to characteristic British Pharmacopoeia to disintegration time. Disintegration time test and dissolution test showed a significant differences between all the formulas Orally Disintegrating Tablet domperidone characterized by values (p < 0.05). Disintegration time for formula 1 (18.68 second), formula 2 (17.11 second), formula 3 (15.31 second), formula 4 (14.13 second), formula 5 (14.93 second), formula 6 (13.09 second), formula 7 (12.22 second), formula 8 (16.13 second), formula 9 (14.37 second), and formula 10 (13.83 second). The results of dissolution test in the third minute to have a cumulative percent: formula 1 (18.77%), formula 2 (20.62%), formula 3 (20.70%), formula 4 (23.40%), formula 5 (35.71%), formula 6 (26.23%), formula 7 (29.36%), formula 8 (26.68%), formula 9 (24.26%), and formula 10 (22.40%).
Conclusion: The results of this study show that camphor can accelerate disintegrating time, but not the dissolution of Orally Disintegrating Tablet (ODT) domperidone.
