EVALUATION OF QUALITATIVE AND QUANTITATIVE STABILITY
PARAMETERS OF A NEW TABLET FORMULATION CONTAINING
BISOPROLOL FUMARATE
ALINA DIANA PANAINTE 1, GRATIELA POPA 2*, MADALINA VIERIU 1, NELA BIBIRE 1, GLADIOLA ȚANTARU 1, ANDREEA CRETEANU 2, MIHAI APOSTU 1
1“Grigore T. Popa” University of Medicine and Pharmacy, Faculty of Pharmacy, Department of Analytical Chemistry, 15
Universității Street, 700115, Iași, Romania
2“Grigore T. Popa” University of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical
Technology, 15 Universității Street, 700115, Iași, Romania
*corresponding author: gratielapopa@yahoo.com
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Abstract:
Formulations that are able to modulate drug release have become an integral part of the pharmaceutical industry. The stability
of the newly developed formulations depends on the physico-chemical properties of the associated substances and on various
other external factors. The stability of a drug implies that its properties may change within controlled and acceptable limits.
The main objective of the present study was to evaluate the qualitative and quantitative parameters of modified release tablets
of bisoprolol fumarate (BF) formulated using hydroxypropyl methylcellulose and Precirol ATO5 excipients. 20 mg BF
tablets were prepared through melt granulation technique using Precirol ATO5 as binder. The results of storage-stability tests
showed that the obtained tablets were stable under stress condition (40 ± 2°C, RH 75 ± 5%) for at least 6 months and did not
show any significant changes regarding their appearance and drug content.

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