FORMULASI ORALLY DISINTEGRATING TABLET (ODT) METOKLOPRAMIDA HCl MENGGUNAKAN METODE SUBLIMASI
DENGAN PRIMOGEL SEBAGAI PENGHANCUR
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 ke dalam tablet. Oleh karena itu, perlu dikembangkan suatu formulasi Orally
Disintegrating Tablet (ODT) yang memenuhi persyaratan.
Tujuan: Untuk mengetahui pengaruh menthol terhadap waktu hancur dan disolusi dari Orally Disintegrating Tablet yang mengandung metoklopramida HCl sebagai bahan obat.
Metode: Pada penelitian ini dibuat Orally Disintegrating Tabletdengan metode sublimasi yang mengandung metoklopramida HCl sebanyak 10 mg sebagai bahan obat dengan bahan penghancur primogel dan bahan volatil menthol. Dibuat tujuh formula dengan perbandingan (%) antara primogel dan menthol sebagai berikut: F1 (12,5:0), F2 (0:12,5), F3 (12,5:2,5), F4 (12,5:5), F5 (12,5:7,5), F6 (12,5:10) dan F7 (12,5:12,5). Orally Disintegrating Tabletyang 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: Hasil penelitian menunjukkan adanya perbedaan yang signifikan (p < 0,05) antara semua formula Orally Disintegrating Tabletmetoklopramida HCl saat uji waktu hancur dan uji disolusi. Waktu hancur formula 1 (52,34 detik), formula 2 (28,35 detik), formula 3 (22,25 detik), formula 4 (18,60 detik), formula 5 (16,92 detik), formula 6 (15,79 detik), dan formula 7 (14,48 detik).
Kesimpulan: Hasil penelitian menunjukkan bahwa menthol mempercepat waktu hancurdari Orally Disintegrating Tabletmetoklopramida HCl dan juga meningkatkan persen kumulatif pelepasan metoklopramida HCl tetapi laju pelepasan obat dalam ODT tersebut tetap lebih rendah dibandingkan serbuk metoklopramida HCl.
Kata kunci: Orally Disintegrating Tablet, Metoklopramida HCl, Primogel, Menthol
FORMULATION OF ORALLY DISINTEGRATING TABLET (ODT) OF METOCLOPRAMIDE HCl USING SUBLIMATION METHOD WITH
PRIMOGEL AS DISINTEGRANT
ABSTRACT
Background: Sublimation method is one of techniques for preparing Orally Disintegrating Tablet that based on principle to increase porosity structure in the tablets and/or to add 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 menthol on disintegration time and dissolution of Orally Disintegrating Tablet containing metoclopramide HCl as drug.
Methods: In this study, Orally Disintegrating Tablets were formulated by sublimation method with metoclopramide HCl 10 mg as drug, primogel as disintegrant and menthol as sublimating agent. Seven formulas were created with ratio (%) between primogel and menthol as follows: F1 (12.5:0), F2 (0:12.5), F3 (12.5:2.5), F4 (12.5:5), F5 (12.5:7.5), F6 (12.5:10) dan F7 (12.5:12.5). 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 contents, uniformity of contents, and dissolution.
Results: The result showed that there were significant differences (p < 0.05) among the formulas of Orally Disintegrating Tablet metoclopramide HCl on disintegration time test and dissolution test. Disintegration time for formula 1 (52.34 second), formula 2 (28.35 second), formula 3 (22.25 second), formula 4 (18.60 second), formula 5 (16.92 second), formula 6 (15.79 second), and formula 7 (14.48 second).
Conclusion: The results of this study showed that menthol accelerates disintegration time of Orally Disintegrating Tablet (ODT) metoclopramide HCl and also increased cumulative percentage of ODT metoclopramide HCl however, the release rate of drug in ODT was lower compared to pure metoclopramide HCl powder.
Keywords: Orally Disintegrating Tablet, Metoclopramide HCl, Primogel,
Menthol
