A COMPARATIVE STUDY ON THE QUALITY OF DIFFERENT OLMESARTAN TABLETS AVAILABLE IN THE ALBANIAN MARKET
Objective: Olmesartan (OLM) is the latest molecule of registered and marketed in Albania for the treatment of arterial hypertension. This study aims
to carry out a quality control (QC) test on all the alternatives available in the Albanian market and evaluate if there are any outstanding differences
terms of quality as it is in terms of price.
Methods: There were carried out various QC pharmacopeias tests on a range of different productions of OLM 20 mg tablets. There have been carried
out weight variation test, setting the diameter, thickness, friability, hardness, disintegration, and dissolution test. The pharmaceutical equivalents were
compared to the reference product in terms of similar dissolution factor (f
) of dissolution profiles and the dissolution efficiency. The dissolution test was
carried out using Varian dissolution apparatus 2 (50 rpm, 37Â±0.5Â°C); Varian Prostar high-performance liquid chromatography was used to determine the
OLM concentration at wavelength 250 nm; Varian hardness VK 200, Guoming BJ-2 disintegration apparatus were used for the respective tests.
Results: The study showed that although there is a consistent difference in market price, their quality is comparable. The dissolution profiles were
very similar. All formulations met the standards of the United States Pharmacopoeia.
Conclusion: All tablets were within the pharmacopoeia limits. The present study confirmed that the difference in price not always represents a
difference in terms of quality.
Keywords: Olmesartan medoxomil, Quality control, Pharmacopoeia standards.
1. Burazeri G, Bregu A, Qirjako G, Roshi E, Petrela K, Bukli M,
et al. National Health Report: The Health Situation of the Albanian
Population. Tirana: Public Health Institution; 2014. p. 118-20, 121-122.
2. Whitworth JA; World Health Organization, International Society of
Hypertension Writing Group 2003 World Health Organization (WHO)/
International Society of Hypertension (ISH) statement on management
of hypertension. J Hypertens 2003;21(11):1983-92.
3. Xianhai H, Aslanian RG. Case studies in modern drug discovery
and development, prodrug of olmesartan: The way to olmesartan
medoxomil. p. 52. Available from: http://www.pubchem.ncbi.nlm.nih.
4. The United States Pharmacopeial Convention, Uniformity of dosage
unÄ±ts; Stage 6, Harmonization Official Bulletin; 2011.
5. USP. Pharmacopeial Forum, Tablet Breaking Force; USP 32 - NF 27.
Vol. 31. Rockville: USP; 2009; p. 726, 1695.
6. General Notices and Requirements; Applying to Standards, Tests, Assays
and Other Specifications of the United States Pharmacopeia. p. 32.
7. The United States Pharmacopeial Convention, DÄ±sÄ±ntegratÄ±on, Revision
Bulletin Official; 2008.
8. The United States Pharmacopeial Convention, Dissolution, Stage 6
Harmonization Official; 2011.
9. Prior PF, Correa CP. Comparison of dissolution profiles. Int J Drug
10. Bettiol F. Manuale Preparazioni Galeniche. 3rd ed. 2010. p. 239.