Journal of International Research in Medical and Pharmaceutical Sciences

Aims: To formulate oral medicated jellies of fluoxetine hydrochloride using different gelling agents (agar, guar gum, gelatin, xanthan gum and gellan gum) and evaluate the prepared jellies for their pharmaceutical parameters in order to identify the optimum formulation for patients with dysphagia and medication-related fear.

Study Design: Experimental formulation and in-vitro evaluation study.

Place and Duration of Study: Department of Pharmaceutics, Adhiparasakthi College of Pharmacy, Melmaruvathur, Tamil Nadu, India, during the academic year 2025–2026.

Methodology: Six oral jelly formulations (F1–F6), each containing 20 mg of fluoxetine hydrochloride, were prepared by the heating and congealing method using varying concentrations of agar, guar gum, gelatin, xanthan gum and gellan gum as gelling agents, together with sucrose, citric acid, sodium citrate, propylene glycol, methyl paraben, propyl paraben and colouring/flavouring agents. Pre-formulation studies (solubility, melting point, UV λmax and calibration curve) and drug–excipient compatibility (FT-IR) were carried out prior to formulation. The prepared jellies were evaluated for physical appearance, weight variation, pH, stickiness/grittiness, viscosity, drug content uniformity, in-vitro dissolution and short-term stability (60 days at 25 ± 5 °C and 2–8 °C).

Results: Fluoxetine hydrochloride showed a melting point of 160.3 °C and a λmax of 226 nm in pH 6.8 phosphate buffer, with a linear calibration curve (R² = 0.999) over the 2–10 µg/ml range. FT-IR spectra of the drug–excipient mixtures showed no shifts in characteristic peaks, indicating compatibility. All six formulations were opaque with a smooth texture and differed only in colour according to the colourant used. Weight variation ranged from 3.824 ± 0.05 g to 5.634 ± 0.06 g, while pH ranged from 6.62 to 7.06; both were reported to be within acceptable pharmacopoeial limits. Except for F3, none of the formulations showed stickiness or grittiness on physical evaluation. Drug content ranged from 71.79 ± 1% to 97.43 ± 1%, and cumulative in-vitro drug release at 30 minutes ranged from 74.40% to 88.42%. Formulation F4 (containing agar, gelatin and gellan gum) showed the highest drug content (97.43 ± 1%) and the fastest drug release (88.42% in 30 minutes). No syneresis was observed in any formulation, and all formulations remained physically and chemically stable, with insignificant changes in pH and appearance over the 60-day storage period at both temperatures.

Conclusion: Oral medicated jelly is a patient-friendly, palatable and easy-to-swallow alternative dosage form for fluoxetine hydrochloride, particularly for paediatric, geriatric and psychiatric patients who have difficulty swallowing tablets or are apprehensive about conventional medication. Among the six formulations evaluated, F4 was identified as the optimum formulation based on its drug content, dissolution rate, physical characteristics and stability.