Spectrophotometric method in comparative in vitro dissolution test of branded and generic ibuprofen tablets
Abstract
Dissolution test is a simple and important in vitro method for assessing bioequivalence of drugs. It implies the use of proper analytical method, and high-performance liquid chromatography (HPLC) is widely used. Spectrophotometry could be a significant substitute, through clear 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 dissolution test for solid dosage forms. The ibuprofen content and the amount of ibuprofen released in the dissolution test were determined using a simple and accurate 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 could be used for bioequivalence screening in conditions where rapid and simple assessment is required or where HPLC is not available.
References
2. Swarbrick J, Boylan JC. Encyclopedia of pharmaceutical technology, second edition. Marcel Dekker, 2002; 156-75.
3. Pokrajac M. Farmakokinetika. Beograd, Grafolik, 2002.
4. Parojčić J, Ibrić S, Đurić Z. Farmaceutska tehnologija sa biofarmacijom, priručnik za praktičnu nastavu. Beograd, 2006.
5. Dunne S, Shannon B, Dunne C, et al. 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 Pharmacol Toxicol 2013; 14(1):1.
6. Swarbrick J. Encyclopedia of pharmaceutical technology, third edition. Informa Healthcare, New York London, 2007; 1891-6.
7. Jakovljević MB, Janković SM. Studije bioekvivalencije. Acta Med Median 2006; 45(4):50-5.
8. 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), July 2002.
9. Committee For Medicinal Products For Human Use: European Medicines Agency website, Guideline on the Investigation of Bioequivalence, European Medicines Agency, 2010.
10. European Pharmacopoeia. Strasbourg: Council of Europe, 2016.
11. Jugoslovenska farmakopeja 2000, peto izdanje. Savezni zavod za zaštitu i unapređenje zdravlja, Savremena administracija, Beograd, 2000.
12. Mazaleuskaya LL, Theken KN, Gong L, et al. PharmGKB summary: ibuprofen pathways. Pharmacogenet Genom 2015; 25(2):96-106.
13. Davies NM. Clinical pharmacokinetics of ibuprofen. Clin Pharmacokinet 1998; 34(2):101-54.
14. Sweetman SC. Martindale: the complete drug reference 36th ed. London; Chicago: Pharmaceutical Press, 2009; 64-6.
15. Dressman JB, Reppas C. In vitro-in vivo correlations for lipophilic, poorly water-soluble drugs. Eur J Pharm Sci 2000; 11:S73-80.
16. Dhingra G, Sreelesh B, Nagpal M, et al. In-vitro dissolution testing of ibuprofen using compendial and biorelevant dissolution media. Res J Pharm Technol 2010; 3(3):931-3.
17. Agencija za lekove i medicinska sredstva, https://www.alims.gov.rs.
18. Bosanquet AG, Betteridge RF. Comparison of dissolution rates of ibuprofen tablets. Int J Pharm Pract 1993; 2(2):114-6.
19. Romero AJ, Grady LT, Rhodes CT. Dissolution testing of ibuprofen tablets. Drug Dev Ind Pharm 1988; 14(11):1549-86.
