A COMPARATIVE QUALITY CONTROL STUDY OF CETIRIZINE HYDROCHLORIDE 10MG TABLETS ON THE ALBANIAN PHARMACEUTICAL MARKET

Authors

  • Delina Xhafaj University of Medicine Tirana
  • Ledjan Malaj University of Medicine Tirana
  • Migena Mileti University of Medicine Tirana

Keywords:

Cetirizine hydrochloride, Quality control, Pharmaceutical equivalents

Abstract

Objective: The aim of this study was to carry out a quality control test on a range of different production of cetirizine hydrochloride 10mg tablets and to compare the generic productions with the reference one in order to evaluate if there are any outstanding differences in terms of quality and price.

Methods: Various pharmacopeias tests were carried out: weight variation test, disintegration test, dissolution test, as well as other tests such as: setting the diameter, thickness, tensile strength, friability and hardness test. The pharmaceutical equivalents were compared to the reference product in terms of similar dissolution factor (f2) of dissolution profiles and the evaluation of dissolution efficiency (DE). Tablet dissolution was carried out in a multi bath (n=6) dissolution test system (Varian Dissolution Apparatus 2) (50rpm, 37.0±0.5 ºC, bi distillated water 900 ml, pH 7.0). An UV-Vis spectrophotometer (Cary 100, Varian) was used to determine cetirizine concentration at wavelength 230.1 nm. Varian Hardness VK200, Guoming CS-2 friability apparatus and Guoming BJ-2 disintegration apparatus are used for the specific tests.

Results: The study showed that all the products met with the standards of pharmacopoeia and that dissolution profiles were significantly the same but, however, there is also a remarkable difference in price.

Conclusion: All the productions met the requirements and are within the limits of pharmacopoeia for the presented tests. Cetirizine reference product still sells well on the open pharmaceutical market even though it costs more and regardless of the fact that other generics have practically the same qualities.

 

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Author Biography

Delina Xhafaj, University of Medicine Tirana

Department of pharmaceutical Technology and biopharmacy

References

U S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System; Guidance for Industry, U. S. Government Printing Office: Washington, DC, August; 2000.

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Bettiol F. Manuale delle preparazioni galeniche, terza edizione; 2010. p. 239.

The United States Pharmacopeial Convention, Disintegration, Revision Bulletin Official; 2008

Anderson NH1. An evaluation of fit factors and dissolution efficiency for the comparison of in vitro dissolution profiles. J Pharm Biomed Anal 1998;17(4-5):811-22.

Costa P1, Sousa Lobo JM. Modeling and comparison of dissolution profiles. Eur J Pharm Sci 2001;13(2):123-33.

Published

01-01-2015

How to Cite

Xhafaj, D., L. Malaj, and M. Mileti. “A COMPARATIVE QUALITY CONTROL STUDY OF CETIRIZINE HYDROCHLORIDE 10MG TABLETS ON THE ALBANIAN PHARMACEUTICAL MARKET”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 7, no. 1, Jan. 2015, pp. 504-7, https://www.innovareacademics.in/journals/index.php/ijpps/article/view/3118.

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Section

Original Article(s)