Abstract: |
Iron deficiency is the principal cause of nutritional anemia and it constitutes a major health
problem, especially during pregnancy. Despite the availability of various non-invasive traditional
oral dosage forms such as tablets, capsules, and liquid preparations of iron, they are hard to consume
for special populations such as pregnant women, pediatric, and geriatric patients with dysphagia and
vomiting tendency. The objective of the present study was to develop and characterize pullulan-based
iron-loaded orodispersible films (i-ODFs). Microparticles of iron were formulated by a microencapsulation
technique, to mask the bitter taste of iron, and ODFs were fabricated by a modified
solvent casting method. Morphological characteristics of the microparticles were identified by optical
microscopy and the percentage of iron loading was evaluated by inductively coupled plasma optical
emission spectroscopy (ICP-OES). The fabricated i-ODFs were evaluated for their morphology by
scanning electron microscopy. Other parameters including thickness, folding endurance, tensile
strength, weight variation, disintegration time, percentage moisture loss, surface pH, and in vivo
animal safety were evaluated. Lastly, stability studies were carried out at a temperature of 25 C/60%
RH. The results of the study confirmed that pullulan-based i-ODFs had good physicochemical
properties, excellent disintegration time, and optimal stability at specified storage conditions. Most
importantly, the i-ODFs were free from irritation when administered to the tongue as confirmed
by the hamster cheek pouch model and surface pH determination. Collectively, the present study
suggests that the film-forming agent, pullulan, could be successfully employed on a lab scale to
formulate orodispersible films of iron. In addition, i-ODFs can be processed easily on a large scale for
commercial use.
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