Formulasi Orally Disintegrating Tablet (Odt) Domperidon Menggunakan Superdisintegran Krospovidon Dan Primogel Dengan Metode Sublimasi

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.
Kata kunci: Orally Disintegrating Tablet, Domperidon, Krospovidon, Primogel,
Camphora

vi

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.
Keywords:

Orally Disintegrating
Primogel, Camphor

Tablet,

vii

Domperidone,

Crosspovidone,