FORMULATION AND CHARACTERIZATION OF PARACETAMOL GRANULES UTILIZING BOMBAX CEIBA MUCILAGE AND CORN STARCH CO-PROCESSED WITH BOMBAX CEIBA MUCILAGE

Abstract

Abstract 
This study evaluates the binding properties of mucilage extracted from the calyx of Bombax ceiba and its co-processed form with corn starch, comparing their performance to corn starch in paracetamol granules formulation. The mucilage was extracted using hot-water extraction, characterized for physicochemical and phytochemical properties, and combined at varying ratios (90/10, 80/20, 70/30, 60/40, 50/50, 100/0, 0/100) with corn starch through co-fusion to produce a co-processed binder. Granules were formulated via wet granulation and assessed for flow indices, density parameters, hydration capacity, and moisture sorption, particle size 
analysis and dissolution. Results showed that Bombax ceiba mucilage possesses high swelling capacity (583%), high hydration capacity (999%), and moderate flowability, indicating strong binding potential. The co-processed binders demonstrated improved flow, reduced cohesiveness, and balanced hydration compared to the crude mucilage. The particle size analysis revealed that CS 100% had the most uniform particles, while 100% BCM granules had the largest size variation due to the high binding solution of Bombax ceiba mucilage. The USP (2005) sets standards for uniformity of content, requiring:  ≥9/10 units within 85-115% of label claim, no units outside 75-125% of label claim and RSD ≤6.0% and this study found that all batches had RSD <6%, meeting the USP standards. 100% CS granules had the fastest release (100% in 45 minutes) due to low swelling capacity and moderate water-binding ability. 100% BCM granules had the slowest release (90% in 45 minutes) due to high swelling and mucilage-forming properties. Blended formulations (BCM + CS) had intermediate release rates, with higher BCM proportions slowing down dissolution. All formulations met pharmacopeial standards for immediate-release granules. This study concludes that Bombax ceiba mucilage is a promising natural binder, while co-processing with corn starch significantly optimizes its performance, which potentially provide a cost-effective, locally sourced multifunctional excipient for granule formulation.