Abstract

Pawan Meghwanshi, Anjali Peter, Purnima Agarwal, Rupesh Soni

ABSTRACT

The present study was undertaken to design, develop, and evaluate pediatric dispersible tablet formulations using crospovidone and sodium starch glycolate as super disintegrants. Eight trial batches (F1–F8) were prepared by direct compression and systematically evaluated for pre compression, post compression, palatability, in?vitro drug release, and stability. The objective was to identify an optimized formulation with rapid disintegration, complete drug release, acceptable mechanical strength, and patient compliance. Pre compression evaluation revealed satisfactory flow properties across all batches, with bulk density (0.41–0.46?g/mL), tapped density (0.49–0.54?g/mL), Carr’s Index (14.5–16.2?%), Hausner ratio (1.16–1.20), and angle of repose (27.8–29.2°) confirming good compressibility and uniform die filling. Post compression parameters demonstrated excellent uniformity: weight variation (299.5–300.8?mg), thickness (4.2–4.6?mm), drug content (98.5–101.2?%), friability (0.32–0.43?%), and disintegration time (85–125?s). All values complied with pharmacopeial limits, ensuring reproducibility and mechanical integrity. Palatability and taste evaluation using a hedonic scale (1–5) confirmed good acceptability, with mean scores of 4.0–4.5. Crospovidone based batches (F1–F4) scored slightly higher due to faster disintegration and smoother mouthfeel, while sodium starch glycolate batches (F5–F8) exhibited mild aftertaste but remained acceptable. In?vitro drug release studies demonstrated rapid dissolution across all batches, with crospovidone formulations showing superior performance. F3 and F4 achieved >98?% release within 50?s, whereas sodium starch glycolate batches reached >90?% release only at 60?s. These findings highlight crospovidone’s wicking and porous mechanism as more effective than the swelling action of sodium starch glycolate. Stability studies conducted on the optimized F4 formulation under accelerated conditions (40?±?2?°C and 75?±?5?%?RH) for 1 and 3?months confirmed excellent physical and chemical stability. Drug content remained within 98.8–99.5?%, and drug release within 97.5–98.2?%, with no significant changes in appearance or mechanical properties. This validates the robustness and shelf life reliability of the optimized formulation. Overall, the study demonstrates that all trial batches met pharmacopeial standards, but F3 and F4 emerged as optimized formulations, combining rapid disintegration, complete drug release, excellent palatability, and stability. The findings confirm the potential of crospovidone based dispersible tablets as a reliable pediatric dosage form, ensuring dose accuracy, patient compliance, and immediate therapeutic action. The methodology adopted here provides a framework for developing similar dispersible formulations for other drugs, contributing to improved pediatric healthcare and pharmaceutical innovation.