×
Home Current Archive Editorial board
News Contact
Research paper

Spectrophotometric method in comparative in vitro dissolution test of branded and generic ibuprofen tablets

By
Ana Marković ,
Ana Marković
Miroslava Spasić ,
Miroslava Spasić
Vesna Savić ,
Vesna Savić
Slavica Sunarić ,
Slavica Sunarić
Marija Tasić-Kostov
Marija Tasić-Kostov

Abstract

The dissolution test is a simple and important in vitro method for assessing the bioequivalence, which aims to compare the bioavailability of generic and branded drugs. It implies the use of a proper apparatus (usually pharmacopoeially defined) in which the dosage form is dissolved, and the dissolution process itself is monitored/quantified using an appropriate analytical method among which high-performance liquid chromatography (HPLC) is widely used. Spectrophotometry could be a significant substitute, through its advantages in terms of simplicity and costs of analysis. In the present study, possible differences in bioavailability between branded and generic ibuprofen coated tablets were predicted using a dissolution test for solid dosage forms. The ibuprofen content and the amount of ibuprofen released in the dissolution test were determined using a simple spectrophotometric method. Based on the obtained results, no significant differences in the dissolution rate of ibuprofen from generic and branded coated tablets were observed. It can be concluded that the spectrophotometric method applied for the dissolution test, among other suitable methods, could be used for bioequivalence screening in conditions where rapid and simple assessment is required or where HPLC method is not available.

References

1.
European Pharmacopoeia. 2016;
2.
Romero AJ, Grady LT, Rhodes CT. Dissolution Testing of Ibuprofen Tablets. Drug Development and Industrial Pharmacy. 1988;14(11):1549–86.
3.
Bosanquet AG, Betteridge RF. Comparison of dissolution rates of ibuprofen tablets. International Journal of Pharmacy Practice. 2011;2(2):114–6.
4.
quarta PJE. Savezni zavod za zdravstvenu zaštitu. 1984;496–7.
5.
Dhingra G, Sreelesh B, Nagpal M. In-vitro dissolution testing of ibuprofen using compendial and biorelevant dissolution media. Res J Pharm Technol. 2010;3(3):931–3.
6.
Dressman JB, Reppas C. In vitro–in vivo correlations for lipophilic, poorly water-soluble drugs. European Journal of Pharmaceutical Sciences. 2000;11:S73–80.
7.
S.C S. Martindale: the complete drug reference 36. 2009.
8.
Davies NM. Clinical Pharmacokinetics of Ibuprofen. Clinical Pharmacokinetics. 1998;34(2):101–54.
9.
Mazaleuskaya LL, Theken KN, Gong L, Thorn CF, FitzGerald GA, Altman RB, et al. PharmGKB summary. Pharmacogenetics and Genomics. 2015;25(2):96–106.
10.
Jugoslovenska farmakopeja 2000, peto izdanje. Savezni zavod za zaštitu i unapređenje zdravlja, Savremena administracija. 2000;
11.
Zakon o lekovima i medicinskim sredstvima ("Sl.
12.
Committee For Medicinal Products For Human Use: European Medicines Agency website, Guideline on the Investigation of Bioequivalence. European Medicines Agency. 2010;
13.
Guidance for industry: Bioavailability and bioequivalence studies for orally administered drug products: General considerations. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER. 2002;
14.
M.B J, S.M J. Studije bioekvivalencije. Acta Med Median. 2006;45(4):50–5.
15.
Swarbrick J. Encyclopedia of pharmaceutical technology. 2007.
16.
Dunne S, Shannon B, Dunne C, Cullen W. A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study. BMC Pharmacology and Toxicology. 2013;14(1).
17.
Parojčić J, Ibrić S, Đurić Z. Farmaceutska tehnologija sa biofarmacijompriručnik za praktičnu nastavu. 2006;7–10.
18.
Pokrajac M. Farmakokinetika. 2002.
19.
Swarbrick J, J.C B. Encyclopedia of pharmaceutical technology. 2002.

Citation

Article metrics

Google scholar: See link

The statements, opinions and data contained in the journal are solely those of the individual authors and contributors and not of the publisher and the editor(s). We stay neutral with regard to jurisdictional claims in published maps and institutional affiliations.