Optimization of taste-masked dapoxetine oral thin films using factorial design: <i>in vitro</i> and <i>in vivo</i> evaluation

El-Said, Ibrahim A; Aboelwafa, Ahmed A.; El‐Gazayerly, Omaima N.

doi:10.1080/10837450.2021.1894445

Cited by 4 publications

(2 citation statements)

References 41 publications

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“…Of particular interest, pullulan is a natural, biocompatible, biodegradable, non-ionic, water-soluble material obtained from the black yeast Aureobasidium pullulan [ 23 , 24 ]. Pullulan has been used in film formulations of various drugs and has been found to be a safe and non-toxic material [ 25 , 26 ]. Accordingly, in this study pullulan was employed as a polymer in the formulation of i-ODFs.…”

Section: Introductionmentioning

confidence: 99%

Development and Characterization of Pullulan-Based Orodispersible Films of Iron

Gupta

Kumar

Reddy³

et al. 2023

Pharmaceutics

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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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Section: Introductionmentioning

confidence: 99%

Development and Characterization of Pullulan-Based Orodispersible Films of Iron

Gupta

Kumar

Reddy³

et al. 2023

Pharmaceutics

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“…Furthermore, drug complexes with ion-exchange resins are stable, easily manufactured, and cost-effective [ 20 ]. In addition, since the release pattern of the complex depends on the chemical process of ion exchange, these drugs are suitable for controlling drug release [ 21 ]. However, few studies have been conducted on the use of controlled release according to various physicochemical properties, such as particle size.…”

Section: Introductionmentioning

confidence: 99%

Paliperidone–Cation Exchange Resin Complexes of Different Particle Sizes for Controlled Release

et al. 2023

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This study aimed to develop electrolyte complexes of paliperidone (PPD) with various particle sizes using cation-exchange resins (CERs) to enable controlled release (both immediate and sustained release). CERs of specific particle size ranges were obtained by sieving commercial products. PPD–CER complexes (PCCs) were prepared in an acidic solution of pH 1.2 and demonstrated a high binding efficiency (>99.0%). PCCs were prepared with CERs of various particle sizes (on average, 100, 150, and 400 μm) at the weight ratio of PPD to CER (1:2 and 1:4). Physicochemical characterization studies such as Fourier-transform infrared spectroscopy, differential scanning calorimetry, powder X-ray diffraction, and scanning electron microscopy between PCCs (1:4) and physical mixtures confirmed PCC formation. In the drug release test, PPD alone experienced a complete drug release from PCC of >85% within 60 min and 120 min in pH 1.2 and pH 6.8 buffer solutions, respectively. Alternatively, PCC (1:4) prepared with CER (150 μm) formed spherical particles and showed an almost negligible release of PPD in pH 1.2 buffer (<10%, 2 h) while controlling the release in pH 6.8 buffer (>75%, 24 h). The release rate of PPD from PCCs was reduced with the increase in CER particle size and CER ratio. The PCCs explored in this study could be a promising technology for controlling the release of PPD in a variety of methods.

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