Abstract
Background Tablets and capsules are difficult to swallow for children. Therefore, liquid formulations are preferred for administration to children. Most of the drugs have bitter taste and children do not support oral administration. Aim The aim of this study was to prepare a palatable paediatric dry syrup with ofloxacin and ornidazole as targeted released formulation using natural polymer and to mask the bitter taste of the drugs with suitable natural polymers. Materials and methods Extraction of the mucilaginous substances was carried out as per the method of extraction of pectin, followed by phytochemical examination, and physicochemical characterization was carried out. Lethal dose, 50% of the extracted natural polymer was determined as per OECD/OCDE guidelines 423. Compatibility study of natural polymer with formulation excipient was carried out. Preparation, characterization and evaluation of microspheres were carried out, including drug-release study in simulated gastric fluid and intestinal fluid, followed by preparation of dry syrup using suitable sweetening and flavouring agents. Results The release study states that the polymers released the drugs at the intestine (site of action) only and not (or little) at the stomach. Drug release from the optimum formulation F5 (Dillenia indica) was 99.97% for ofloxacin and 99.12% for ornidazole after 2.5?h in simulated intestinal fluid as compared with 8.3% for ofloxacin and 8.46% for ornidazole after 8?h in simulated gastric fluid. Microspheres of optimum formulation F5 D. indica were used for preparation of dry syrup. Statistical methods were utilized to analyse the results of different tests performed throughout the investigation. Conclusion Palatable dry syrup containing ofloxacin and ornidazole using natural polysaccharides was successfully prepared without any stability problem. It is expected to be effective/suitable for the paediatric patients with high compliance.
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