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FORMULASI TABLET IBUPROFEN DENGAN SISTEM DISPERSI PADAT

DIUJI SECARA IN VITRO DAN IN SITU

Abstrak

Tablet merupakan sediaan yang banyak mengalami perkembangan dari segi


formulasi. Pengembangan formulasi ditujukan agar diperoleh sediaan yang cepat
larut dengan sistem dispersi padat. Teknik dispersi padat dibuat dengan tujuan
memperkecil ukuran partikel, meningkatkan laju disolusi dan absorpsi obat yang
tidak larut air. Sistem dispersi padat dalam penelitian ini menggunakan ibuprofen
sebagai bahan aktif yang praktis tidak larut air, merupakan analgesik antiinflamasi
non steroid yang membutuhkan onset kerja yang cepat.
Untuk membuat dispersi padat digunakan ibuprofen sebagai bahan aktif dan
PEG 6000 sebagai pembawa, untuk mempercepat waktu hancur tablet ditambahkan
superdesintegrant natrium kroskarmelosa dan krospovidon. Dispersi padat dibuat
dengan metode peleburan dalam beberapa perbandingan berat antara ibuprofen dan
PEG 6000 yaitu: 1 : 0,25; 1 : 0,5; 1 : 0,75; 1 : 1; 1 : 1,25 dan 1 : 1,5 sebagai
pembanding dibuat campuran fisik dengan perbandingan yang sama. Serbuk dispersi
padat yang terbentuk dikarakterisasi sifat fisiko kimia meliputi : penetapan kadar zat
aktif, pola difraksi sinar –X, SEM, DTA, IR dan uji laju disolusi. Dispersi padat 1 :
0,5 kemudian diformulasi menjadi tablet dengan komposisi superdesintegrant
natrium kroskarmelosa dan krospovidon dengan perbandingan : 3% : 0 (A1); 5% : 0
(A2); 7% : 0 (A3); 0 : 3% (A4); 0 : 5% (A5); 0 : 7% (A6) dan 0 : 0 (A7). Tablet
dikarakterisasi meliputi : kadar zat berkhasiat, kekerasan, kerengasan, waktu hancur,
keseragaman sediaan dan dissolusi. Tablet dispersi padat A2 digunakan untuk
pengujian absorpsi secara in situ teknik perfusi single pass yang dibandingkan
dengan serbuk ibuprofen dan tablet generik.
Hasil penelitian menunjukkan dispersi padat 1 : 0,5 memperlihatkan persen
kumulatif pelepasan obat paling baik yang berbeda signifikan (p<0,05) dengan
formula dispersi padat dan campuran fisik lain. Hasil evaluasi dari tujuh formula
tablet dispersi padat menunjukkan tablet A2 merupakan formula terbaik ditinjau dari
waktu hancur dan persen kumulatif pelepasan obat yang berbeda signifikan (p<0,05)
dari formula tablet yang lain. Pengujian absorpsi secara in situ teknik perfusi single
pass menunjukkan tablet A2 paling banyak diabsorpsi dibandingkan tablet generik
dan bahan baku tetapi tidak berbeda signifikan (p>0,05) pada menit ke 20, 30, 45, 60
dan 90.

Kata kunci : dispersi padat, ibuprofen, PEG 6000, superdisintegrant, perfusi single
pass

Universitas Sumatera Utara


IBUPROFEN TABLET FORMULATION WITH SOLID DISPERSION
SYSTEM TESTED IN VITRO AND IN SITU

Abstract

Tablet is the most developed pharmaceutical dosage form. Formulation


development was purposed to achieve solvable dosage form using solid dispersion
system. Solid dispersion technique is made to reduced the particle size, increased the
dissolution rate, and water-insoluble drug absoption. Solid dispersion system in this
research was using ibuprofen as the active ingredient that practically not solvable in
water, ibuprofen was an on non-steroid antiinflammation analgesic that needed a
rapid on set of action.
Ibuprofen was used as active ingredients while PEG 6000 as an inert vehicle
in making the solid dispersion, sodium crosskarmelose and crosspovidone, two
superdesintegrants added to fasten the dissolution rate. The solid dispersion was
made using melting method at diffrent ratios between ibuprofen and PEG 6000
included: 1 : 0.25; 1: 0.5; 1 : 0.75; 1 : 1; 1 : 1.25 and 1 : 1.5, as comparing, the
physical mixture was made with the same ratio. The solid dispersion powder formed
was characterized for its physicochemical properties included : active ingredient
determination, X-ray diffraction pattern, SEM, DTA, IR, and dissolution rate test.
The ratio 1 : 0.5 of solid dispersion was formulated to tablet with composition of
sodium crosskarmelose superdisintegrant and crosspovidone with ratio of: 3% : 0%
(A1); 5% : 0% (A2); 7% : 0% (A3); 0% : 3% (A4); 0% : 5% (A5); 0% : 7% (A6) and
0% : 0% (A7). The tablet was characterized for: the active ingredient content,
friability, disintegration time, uniformity of dosage unit, and dissolution rate. A2
solid dispersion tablet was used for in situ absorption test using single pass perfusion
technique that compared with ibuprofen standardized materiall and its generic tablet.
The result was ratio 1 : 0.5 of solid dispersion showed the drug release
cumulative percentage which significantly different in statistic calculation (p<0.05)
with solid dispersion formulation and other physical mixture. The evaluation result
showed that of the seven solid dispersion formulation tablets, the A2 tablet was the
best formula assessed from disintegration time and showed the best cumulative
percentage in drug release that significantly different in statistical calculation
(p<0.05) compared to the other tablet formula. The result of in situ absorption test
using single pass perfusion technique, A2 solid dispersion tablet was the most
absorbed compared to generic tablet and standarized material. The result showed that
there was no significant difference in statistic calculation (p<0.05) at 20, 30, 45, 60
and 90 minutes.

Key Words : solid dispersion, ibuprofen, PEG 6000, superdesintegrant, single pass
perfusion.

Universitas Sumatera Utara