STRUCTURE OF CHEMICAL COMPOUNDS,
METHODS OF ANALYSIS AND PROCESS CONTROL
COMPARATIVE DISSOLUTION KINETICS OF IBUPROFEN 200-MG
CAPSULES (MEDISORB CO., RUSSIA) AND IBUPROFEN
200-MG COATED TABLETS (BIOSYNTHESIS CO., RUSSIA)
N. A. Prozorova,
G. P. Vdovina,
and A. V. Bobrov
Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 52, No. 3, pp. 50 – 53, March, 2018.
Original article submitted November 29, 2014.
Experimental data on the comparative dissolution kinetics of two ibuprofen preparations from different manu
facturers are presented. The study was performed in three buffer solutions at pH 1.2, 4.5, and 6.8 according to
requirements of the Scientific Center for Expert Evaluation of Medicinal Products of the Russian Federation.
A fourth dissolution medium was buffer solution at pH 7.2, which is included in a draft regulation. The test
used a Erweka DT-720 rotating-basket device.
Keywords: ibuprofen, bioavailability, dissolution, in vitro.
Generics account for 78 – 88% of finished drugs on the
current Russian pharmaceutical market . Generic prepara-
tions from various manufacturers often have the same quality
and quantity of active pharmaceutical ingredients (APIs) and
the same dosage form as the original drug but different effi
cacy and safety .
The main reasons for this are the manufacturing technol
ogy of the drug substance and preparation, the type and
amount of excipients, preparation packaging, and storage
and transportation conditions. The efficacy of generic prepa
rations and the severity of their side effects can vary greatly
due to these factors .
Therefore, ensuring high-quality generics is an important
Bioequivalence is investigated to evaluate the efficacy
and safety of generic drugs. According to Methodical In
structions (MI) of the Ministry of Health and Social Devel
opment (MHSD) of the RF “Drug Bioequivalence Evalua
tion,” two preparations are considered bioequivalent if they
have the same bioavailability of the API .
Bioequivalence is determined from pharmacokinetic
studies on healthy volunteers and is a lengthy and costly
stage. Studies of comparative dissolution kinetics in vitro are
less labor-intensive than pharmacokinetic studies for evaluat
ing the bioequivalence of generics. In Russia, this study is
used in addition to in vivo bioequivalence studies . Thus,
studies of comparative dissolution kinetics of drugs in vitro
are a critical problem and defined the goal and tasks of the
The goals of the present investigation were to study the
comparative dissolution kinetics of ibuprofen in vitro from
preparations from different manufacturers (with statistical
processing of the results) and to evaluate the equivalence of
the comparative dissolution kinetic profiles.
Dissolution kinetics were studied in media at pH 1.2
(HCl buffer), 4.5 (acetate buffer), and 6.8 (phosphate buffer)
and in a buffer solution at pH 7.2, which was used according
to the regulations for Ibuprofen 200-mg capsules in the Dis
solution test. Buffer solutions were prepared according to the
USA USP 29.
Comparative dissolution kinetics were studied consider
ing requirements of the MI of the RF MHSD “Drug Bioequi
valence Evaluation” (Appendix 4).
Pharmaceutical Chemistry Journal, Vol. 52, No. 3, June, 2018 (Russian Original Vol. 52, No. 3, March, 2018)
0091-150X/18/5203-0245 © 2018 Springer Science+Business Media, LLC
E. A. Wagner Perm State Medical University, 26 Petropavlovskaya St.,
Perm, 614000 Russia.
Medisorb Co., 6 Gal’perina St., Perm, 614113 Russia.
e-mail: prosorova firstname.lastname@example.org