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Comparison of dissolution profiles of theophylline extended-release dosage forms

Daniel Wolny ,  Arkadiusz R. Gruchlik ,  Ewa Chodurek ,  Magdalena Szara ,  Zofia Dzierżewicz 

Department of Biopharmacy, Medical University of Silesia, Narcyzów 1, Sosnowiec 41-200, Poland


Dissolution testing has emerged in the pharmaceutical field as a very important tool to characterize drug product performance, for example, to demonstrate similarity between different formulations. Because the rate of release of theophylline could differ between the products, the patient health may be endangered, especially that this drug has a narrow therapeutic range.

The investigation of theophylline release from tablets was performed by the basket apparatus type DT700 (Erweka). The f1 (difference factor) and f2 (similarity factor), calculated according to FDA guidelines, were used to compare the obtained dissolution profiles, using Euphyllin long 300 as a reference product.

Obtained values showed that dissolution profiles of investigated formulations were not equivalent to each other. The tablets differed by the mechanism of drug release also. Therefore, these formulations should not be used alternatively, especially that theophylline has a narrow therapeutic range.


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Related papers

Presentation: Poster at VIII Multidyscyplinarna Konferencja Nauki o Leku, by Daniel Wolny
See On-line Journal of VIII Multidyscyplinarna Konferencja Nauki o Leku

Submitted: 2012-03-12 08:16
Revised:   2012-03-12 08:16