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Variation of Comparative Dissolution Test of Atorvastatin: A Review On Biopharmaceutics Study
Variation of Comparative Dissolution Test of Atorvastatin: A Review On Biopharmaceutics Study
Nama
Faculty of Pharmacy, Universitas Padjadjaran
Jl. Raya Bandung Sumedang KM 21, Jatinangor Indonesia
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Abstract
Comparative Dissolution Test is a test that conducted to show the similarity
or different dissolution profiles between test drugs and innovator/comparator drugs.
Comparative Dissolution Test may also be used to ascertain the equivalence and
product properties of a pharmaceutical product. Atorvastatin is one of the most
common synthetic statins in the world. This drug patent runs out in 2011. This drug
is at the top of the list of drugs with the largest sales for many years until 2011. The
purpose of this review is to find out whether different dissolution profile methods
can be applied in conducting comparative dissolution test studies of atorvastatin
and evaluating each method of different calculation methods to obtain dissolution
profile values. Based on the analysis of these methods, it can be concluded that each
method has different characteristics in looking for dissolution profiles. The labeled
atorvastatin inovator and generic samples of tablets meet all the physical
requirements of the tablet, while generic atorvastatin tablets do not meet any of the
tablet's physical requirement.
Table 1. Physical test results of atorvastatin tablet samples criterion (Aini et al., 2015).