Preparation and Assessment of Oral Floating Beads of a NSAID Drug, Tramadol Hydrochloride

Rapid GI transit can prevent complete drug release in the absorption zone and reduce the efficacy of the administered dose since most drugs are absorbed in the stomach or the upper part of the small intestine. Floating bead formulations are designed to stay buoyant in gastric fluids, allowing the drug to be released over an extended period in the stomach. Some common methods for preparing floating beads are- 1. Ionotropic Gelation Method 2. Emulsion Gelation Method 3. Spray-Drying Method 4. Freeze-Drying (Lyophilization) Method 5. Coacervation Method. 6. Emulsion Solvent Evaporation Method 7. Solvent Evaporation Method 8. Extrusion Method 9. Melt dispersion method. In this formulation, Floating beads were fabricated using a modified ionotropic gelation technique using various natural and synthetic polymers in different proportions. The drug used was Tramadol Hydrochloride. Here, the Bonferroni method was applied to the dissolution study to check if there was a significant difference or non-significant difference in the release of drugs in formulated formulations. In the formulated batches BT1 to BT11 did not give in vitro release for 12 hours. In the formulated batch, BT 12 (Sodium alginate 6%: Carbopol 940 1.2 %) shows In vitro release for 12 hours (100.26 ± 0.66%). It also gave floating lag time and floating time immediate, and a floating duration of more than 12 hours. In kinetic model fitting it follows Korsemeyers Peppas equation. Also, it was found stable in 6 months of accelerated stability study. From all the formulation and evaluation studies of oral floating beads of Tramadol Hydrochloride, it was concluded that: Among all different polymer ratios Sodium Alginate 6% and CaCl2 3% (2:1 ratio) give formulation of beads. The use of acetic acid in CaCl2 gives floating of beads for 12 hours. Among different polymers Carbopol 940 gives retarded release for 12 hours. The optimized batch was found to be stable for 6 Months in accelerated stability studies. It was concluded that the use of acetic acid in CaCl2 gives floating of beads for 12 hours. Moreover, among different polymers, Carbopol 940 gives retarded release for 12 hours and the optimized batch was found to be stable for 6 Months in accelerated stability studies.