Formulation Design and Development of Orodispersible Tablets of Bisoprolol Fumarate by Using Natural Superdisintegrants
Year: 2026
Type: article
Abstract: The present study aimed to develop orally dispersible tablets (ODTs) of Bisoprolol Fumarate, a cardioselective β1-blocker used in hypertension, angina pectoris and heart failure, to improve patient compliance in geriatric, pediatric and dysphagic patients. Fenugreek seed mucilage (FSM), a plant-derived natural superdisintegrant, was compared with the synthetic and semi-synthetic superdisintegrants croscarmellose sodium, crospovidone and sodium starch glycolate, each at 8, 16 and 24 mg per tablet. Twelve formulations (F1–F12) were prepared by direct compression and evaluated for post-compression parameters: hardness, weight variation, friability, drug content, wetting time, in vitro disintegration time and in vitro drug release. Hardness ranged from 3.2 to 4.1 kg/cm², friability was below 0.5% and drug content was between 97.60% and 99.92% for all batches. Disintegration time ranged from 18 to 55 seconds and wetting time from 17 to 64 seconds. Formulation F3, containing 24 mg FSM, showed the shortest disintegration time (18 s), the shortest wetting time (17 s), the highest drug content (99.92%) and the highest drug release (96.3% in 30 minutes), and was selected as the optimized formulation. Stability studies of F3 for 3 months under ambient and accelerated conditions (40 °C/75% RH) showed only marginal changes in disintegration time (18 to 22 s and 27 s, respectively), drug release and drug content, which stayed within acceptable limits. Fenugreek seed mucilage can therefore act as an effective, economical and biocompatible natural alternative to synthetic superdisintegrants in stable Bisoprolol Fumarate orally dispersible tablets. Keywords: Bisoprolol Fumarate; Orally dispersible tablets; Fenugreek seed mucilage; Natural superdisintegrant; Direct compression; Disintegration time; Wetting time; In vitro drug release.
Language: English
Subfield: Pharmaceutical Science
Domain: Life Sciences
Open Access status: diamond
OpenAlex ID: W7223141710