STUDI BIOEKIVALENSI AMSTUDI BIOEKIVALENSI AMOKSISILIN GENERIK DAN DAGANG MENGGUNAKAN MATRIKS URINOKSISILIN GENERIK DAN DAGANG MENGGUNAKAN MATRIKS URIN
Abstrak: Bioequivalence
studies of amoxicillin which derived from generic drugs (OGB) had been done as
a product test with branded amoxicillin as a comparison using urine matrix. The
purpose of this study is to measure the bioavailability parameters based on 24
hours urine, so it is known as
bioequivalent or bioinequivalent.
Based on approach to cheap and quality generic drugs, and referring to
the BPOM RI guidelines for bioequivalence, so this study using 12 healthy
people aged 18 -21 years as a subject. The study design is the design crossed
two-way (2 way) for 2 periods of treatment in two drug products, according to
the selection of 24-hour urine matrix and determination of amoxicillin level by
spectrophotometry UV Vis at wavelength of 273 nm, whereas the bioavailability
parameters determined by using the cumulative profile of amoxicillin in the 24
hours urine and the rate of excretion. The results of the geometric mean
and ratio CI 90% based on cumulative
levels of amoxicillin were 104.67% and 117.65%, while based on the rate of
amoxicillin excretion in 24 hours urine is 105.23% and 118.29%. All within the
range 80-125% as a drug with a broad therapeutic index. Means that amoxicillin
generic product (OGB) which had been studied is bioequivalet with the product
branded amoxicillin.
KATA KUNCI: Bioequivalence.,
Amoxicillin., urine
Penulis: Dwi Leboe, Elly
Wahyudin, Tadjuddin Naid
Kode Jurnal: jpfarmasidd140543
