Romanian Society of Pharmaceutical Sciences
 

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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

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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.