Quality control assessment of bisoprolol fumarate scored tablet products available in Saudi Arabia

Abstract

Aim: Bisoprolol fumarate (BF), commonly prescribed for cardiovascular conditions, is usually split to achieve specific doses. This study evaluated the effects of tablet splitting on the quality parameters of scored BF tablets from three different brands marketed in Saudi Arabia.

Methods: The products were evaluated for weight variation, content uniformity, and dissolution for intact and split tablets. A UPLC-sensitive assay was used for drug quantification.

Results: The results showed that all products lost less than 3% of its weight upon splitting, meeting the USP requirements. Content uniformity was between 85% and 115% for all products, complying with pharmacopoeial standards. Dissolution studies showed some variation between intact and split tablets. The f₂ similarity factor was calculated to compare the dissolution profiles of BF from both forms. The f₂ values showed a similar dissolution profile for the innovator product (f₂ was 62.53), but dissimilar profiles for Generic-1 and -2 (f₂ values were 48.90 and 34.43, respectively).

Conclusions: These results should be taken into consideration by healthcare professionals to avoid sub-therapeutic or toxic effects resulting from tablet splitting.

Keywords

bisoprolol fumarate / quality control / scored tablets / content uniformity / dissolution

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