Formulation, Microencapsulation, and Evaluation of Taste-Masked Ibuprofen Chewable Soft Gelatin Capsules for Improved Patient Compliance

AbstractIbuprofen, a widely used non-steroidal anti-inflammatory drug, presents formulation challenges in pediatricand geriatric patients owing to its intensely bitter taste and the swallowing difficulties associated withconventional tablets and capsules. The present study aimed to develop taste-masked ibuprofenmicrocapsules and incorporate them into chewable soft gelatin capsules to improve palatability and patientcompliance. Ibuprofen was characterized by melting point, solubility, partition coefficient, UVspectrophotometry, FT-IR spectroscopy, and differential scanning calorimetry (DSC), and its compatibilitywith ethyl cellulose, polyvinyl alcohol, gelatin, and glycerin was confirmed by FT-IR and DSC.Microcapsules were prepared by a solvent evaporation technique at five drug-to-ethyl cellulose ratios (1:0.5to 1:1.5, F1–F5) and evaluated for percentage yield, particle size, surface morphology, entrapmentefficiency, in-vitro drug release, and taste-masking efficiency by electronic tongue and human sensorypanel. Formulation F3 (1:1 drug:polymer ratio) gave the best overall performance, with 91.62 ± 1.48%yield, a mean particle size of 245 ± 18 µm, 88.42 ± 2.15% entrapment efficiency, Korsmeyer–Peppasrelease kinetics (n = 0.55), and 78.1% taste-masking efficiency by electronic tongue (bitterness score 1.2 ±0.3/5 by sensory panel). F3 microcapsules were incorporated into chewable soft gelatin capsules preparedby rotary die encapsulation using a gelatin/glycerin/sorbitol/starch shell. The final capsules showed uniformweight (744.2 ± 8.5 mg), acceptable hardness (3.2 ± 0.4 kg/cm²) and friability (0.42%), rapid disintegration(8.5 ± 1.2 min), 99.75 ± 1.15% drug content uniformity, more than 85% in-vitro drug release within 45minutes, and high overall taste acceptability (4.6 ± 0.3/5) with no reported aftertaste or grittiness.Accelerated (40°C/75% RH) and long-term (25°C/60% RH) stability studies over three months showeddrug content retention exceeding 98.8% and 99.3%, respectively, with no significant change in appearanceor dissolution profile. These results demonstrate that ethyl cellulose microencapsulation combined with achewable soft gelatin capsule matrix is a feasible, stable, and patient-friendly strategy for delivering bittertasting drugs such as ibuprofen, particularly for pediatric and geriatric populations.