Text

EVALUASI MUTU FISIK SEDIAAN TABLET KETOCONAZOLE GENERIK DAN BERMERK

---

ABSTRAK
Tablet ketoconazole merupakan suatu antifungi oral golongan azol yang
disetujui oleh Food and Drug Administration (FDA) sejak tahun 1981. Obat ini
beredar di pasaran dalam berbagai sediaan generik dan bermerek, sehingga
memungkinkan adanya perbedaan formulasi dan metode fabrifikasi. Mutu suatu
obat dijadikan sebagai acuan terkait dengan kebenaran khasiat dan keamanan
obat. Penelitian ini bertujuan untuk membandingkan mutu fisik sediaan tablet
ketoconazole generik dan bermerek berdasarkan persyaratan standar fisik tablet.
Penelitian yang dilakukan meliputi uji keseragaman bobot, keseragaman ukuran,
kekerasan, waktu hancur, kerapuhan, disolusi, dan kadar zat aktif obat. Hasil
penelitian dianalisis secara statistik menggunakan program SPSS (Statistical
Product and Service Solution), data diolah dengan metode Analysis of Variance
(ANOVA) satu jalan (one way). Hasil penelitian menunjukkan bahwa mutu fisik
sediaan ketoconazole generik dan bermerk memenuhi persyaratan dalam
Farmakope Indonesia Edisi V. Hasil analisis SPSS terhadap mutu fisik sediaan
tablet ketoconazole generik dan bermerk menunjukkan bahwa sediaan tablet
ketoconazole generik maupun bermerk memiliki nilai kehancuran, kerapuhan,
disolusi, dan kadar zat aktif yang sama baiknya, tetapi terdapat perbedaan yang
signifikan pada nilai keseragaman bobot, kekerasan, dan keseragaman ukuran
tablet dengan nilai p value sebesar 0,000; 0,002; dan 0,000 yang menunjukkan
adanya perbedaan.
Kata kunci : Tablet ketoconazole, generik, bermerk, mutu fisikviii
ABSTRACT
Ketoconazole tablets are an azole oral antifungal that has been approved
by the Food and Drug Administration (FDA) since 1981. This drug is available in
the market in various generic and branded, thus allowing for different
formulations and fabrication methods. The quality of a drug is used as a reference
related to the truth of the efficacy and safety of the drug. This study aims to
compare the physical quality of generic and branded ketoconazole tablets based
on the requirements of tablet physical standards. The research includes tests for
weight uniformity, size uniformity, hardness, disintegration time, friability,
dissolution, and levels of active drug substances. The results of the study were
statistically analyzed using the SPSS (Statistical Product and Service Solution)
program, the data were processed using the one-way Analysis of Variance
(ANOVA) method. The results showed that the physical quality of generic and
branded ketoconazole tablets complied with the requirements of the Indonesian
Pharmacopoeia Fifth Edition. The results of the SPSS analysis on the physical
quality of generic and branded ketoconazole tablets showed that both generic and
branded ketoconazole tablets had the value of destruction, friability, dissolution,
and concentration. the active substances were equally good, but there were
significant differences in the value of weight uniformity, hardness, and uniformity
of tablet size with a p value of 0,000; 0,002; and 0,000 which indicated a
difference.
Key words: Ketoconazole tablets, generic, branded, physical quality.

---

Ketersediaan

Informasi Detail

Judul Seri

-

No. Panggil

118

Penerbit

Mataram : Farmasi FK Unram., 2021

Deskripsi Fisik

-

Bahasa

Indonesia

ISBN/ISSN

-

Klasifikasi

DTS 610 Nik e F.2021

Tipe Isi

-

Tipe Media

-

Tipe Pembawa

-

Edisi

-

Subjek

SKRIPSI

Info Detail Spesifik

-

Pernyataan Tanggungjawab

-

Versi lain/terkait

Lampiran Berkas

Komentar

---

Anda harus masuk sebelum memberikan komentar