Abstract
Oral dissolvable films (ODFs) of diclofenac sodium intended for osteoarthritis were prepared using Albizia and Khaya gums as hydrophilic film formers. The physicochemical properties of the gums were characterized and the gums were used to prepare diclofenac sodium ODFs (~50 mg/4 cm2 film) by solvent casting. The two gums showed satisfactory film forming properties. The physicomechanical properties, drug-excipient compatibility, and in vitro drug release of the films in phosphate buffer pH 6.8 were studied. Khaya gum had higher extraction yield, moisture content, insoluble matter and true density while Albizia gum showed greater swelling capacity, solubility, and minerals content. The ODFs were thin, soft, and flexible with smooth glossy surfaces and possessed satisfactory physicomechanical properties. FTIR studies showed that no interaction occurred between the drug and the gums. The ODFs disintegrated in <45 s achieved >75% drug release within 7 min with dissolution efficiencies of ~83–96%. Drug releases from F2, F3, F4, F5, and F6 were similar to F1 (p > 0.05; f1 < 15 and f2 ≥ 50) while F7 differed markedly from F1 (p < 0.001; f1 > 15 and f2 < 50). Drug release followed the Higuchi kinetic model which is indicative of Fickian drug diffusion.
Highlights
Fast dissolving drug delivery systems like oral dissolvable films (ODFs) and fast disintegrating tablets (FDTs) were introduced in the late 1970s as alternative dosage forms for paediatric and geriatric patients who have difficulties in swallowing conventional oral solid dosage forms such as tablets and capsules [1]
Khaya gum gave a higher purification yield, true density, moisture content, and insoluble matter compared to Albizia gum
Albizia gum exhibited higher ash values and greater solubility in four of the solvents tested than Khaya gum
Summary
Fast dissolving drug delivery systems like oral dissolvable films (ODFs) and fast disintegrating tablets (FDTs) were introduced in the late 1970s as alternative dosage forms for paediatric and geriatric patients who have difficulties in swallowing conventional oral solid dosage forms such as tablets and capsules [1]. ODFs emerged from the confectionery and oral care department in the form of breath strips and soon grew into a contemporary and widely accepted dosage form by end users for delivering vitamins and personal care products [1]. They are composed basically of the active pharmaceutical ingredient (API), hydrophilic polymers, plasticizers, sweeteners, flavours, colours, surfactants, saliva stimulating agents, and so forth [4, 5]. Dysphagic, schizophrenic, and dementia patients are able to use ODFs with little or no difficulty [6].
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