Omeprazole (OME) is employed for treating ulcer in children, but is unstable and exhibits\nfirst pass metabolism via the oral route. This study aimed to stabilize OME within mucoadhesive\nmetolose (MET) films by combining cyclodextrins (CD) and L-arginine (L-arg) as stabilizing excipients\nand functionally characterizing for potential delivery via the buccal mucosa of paediatric patients.\nPolymeric solutions at a concentration of 1% w/w were obtained by dispersing the required weight of\nmetolose in 20% v/v ethanol as solvent at a temperature of 40 ââ??¦C using polyethylene glycol (PEG 400)\n(0.5% w/w) as plasticizer. The films were obtained by drying the resulting polymer solutions at in an\noven at 40 ââ??¦C. Textural (tensile and mucoadhesion) properties, physical form (differential scanning\ncalorimetry (DSC), X-ray diffraction (XRD) and Fourier transform infrared (FTIR) spectroscopy),\nresidual moisture content (thermogravimetric analysis (TGA)) and surface morphology (scanning\nelectron microscopy (SEM)) were investigated. Optimized formulations containing OME, CDs (Ã?² or\nÃ?³) and L-arg (1:1:1) were selected to investigate the stabilization of the drug. The DSC, XRD, and\nFTIR showed possible molecular dispersion of OME in metolose film matrix. Plasticized MET films\ncontaining OME:Ã?²CD:L-arg 1:1:1 were optimum in terms of transparency and ease of handling and\ntherefore further functionally characterized (hydration, mucoadhesion, in vitro drug dissolution\nand long term stability studies). The optimized formulation showed sustained drug release that\nwas modelled by Korsmeyerââ?¬â??Peppas equation, while the OME showed stability under ambient\ntemperature conditions for 28 days. The optimized OME loaded MET films stabilized with Ã?²CD\nand L-arg have potential for use as paediatric mucoadhesive buccal delivery system, which avoids\ndegradation in the stomach acid as well as first pass metabolism in the liver.
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