Nicotine (NCT), administered in the form of a fast dissolving oral delivery system, can be a potential alternative to nicotine replacement therapy. NCT was extracted by maceration and acid-base extraction methods from Burley tobacco leaves with different stalk positions and extraction yield and NCT content were further determined. The extract with the highest nicotine content was selected for incorporation into a fast dissolving film formulation. The optimized film was evaluated for its physical and mechanical properties, in vitro disintegration, and drug release profile. The results demonstrated that the extract from the upper part of tobacco leaves using the acid-base extraction method had the highest amount of NCT. NCT fast dissolving film consisting of this extract as the active ingredient and HPMC E15 as a film polymer resulted in a homogeneous translucent film with a light brown color. The addition of NCT significantly affected the film properties in terms of weight, disintegration time, tensile strength, percentage elongation at break, and Young’s modulus values. The drug release of NCT fast dissolving film showed a rapid initial release of 80% within three minutes, and its kinetics followed the Higuchi matrix model. The results suggest that these NCT films can be employed in the development of NCT fast dissolving films for clinical use.

Burst release of carbamide peroxide (CP) from traditional hydrogels causes severe inflammation to periodontal tissues. The present study explores the development of a novel CP nanoemulgel (CP-NG), an oil-in-water nanoemulsion-based gel in which CP was loaded with a view to controlling CP release. CP solid dispersions were prepared, using white soft paraffin or polyvinylpyrrolidone-white soft paraffin mixture as a carrier, prior to formulating nanoemulsions. It was found that carrier type and the ratio of CP to carrier affected drug crystallinity. Nanoemulsions formulated from the optimized CP solid dispersions were used to prepare CP-NG. It was found that the ratio of drug to carrier in CP solid dispersions affected the particle size and zeta potential of the nanoemulsions as well as drug release behavior and tooth bleaching efficacy of CP-NG. Drug release from CP-NG followed a first-order kinetic reaction and the release mechanism was an anomalous transport. Drug release rate decreased with an increase in solid dispersion carriers. CP-NG obtained from the solid dispersion with a 1:1 ratio of CP to the polymer mixture is suitable for sustaining drug release with high tooth bleaching efficacy and without reduction of enamel microhardness. The developed CP-NG is a promising potential tooth bleaching formulation.

Carbamide peroxide (CP) possesses a strong tooth bleaching activity, however, its clinical application is limited because of its instability in aqueous formulations. This study explores the improvement of CP stability and bleaching activity by loading CP in electrospun nanofibrous film (ENF). Polyvinylalcohol, polyvinylpyrrolidone, and silica were used as components for core-based nanofibers of ENF. Electrospinning feed aqueous solutions (EFASs) were developed for preparing CP loaded ENF (CP-ENF). Stability of CP in EFASs is significantly higher than in pure water. The highest stability of CP is found in PPS-CP3, composed of 0.5% CP, 5.5% polyvinylalcohol, 3% polyvinylpyrrolidone, and 1% silica. The results from X-ray diffraction indicate that CP is dispersed as a non-crystalline form in CP-ENFs. CP and the compositions of EFASs play a major role on characteristics and bleaching efficiency of CP-ENFs. Drug release of CP-ENFs is the first order kinetics. CP-ENF obtained from PPS-CP3 shows the highest drug entrapment efficiency, high adhesion, and suitable sustained release. Drug release mechanism is along with anomalous transport according to Korsmeyer–Peppas model. In an ex vivo study using human teeth, it shows the highest bleaching efficiency among the others. Therefore, CP-ENF obtained from PPS-CP3 is a promising ENF for clinical use.

Carbamide peroxide (CP), a tooth whitening agent, is chemically unstable. The present study explores stability enhancement of CP by loading in a nanofibrous film (CP-F) composed of polyvinyl alcohol/polyvinylpyrrolidone/silica mixture, using an electrospinning technique. Kept at a temperature range of 60–80 °C for 6 h, CP in CP-F showed significantly higher stability than that in a polymer solution and in water, respectively. Degradation of CP in CP-F could be described by the first order kinetics with the predicted half-life by the Arrhenius equation of approximately 6.52 years. Physicochemical properties of CP-F after long-term storage for 12 months at different temperatures and relative humidity (RH) were investigated using scanning electron microscopy, X-ray diffractometry, differential scanning calorimetry, and Fourier transform infrared spectroscopy. It was found that high temperature and high humidity (45 °C/75% RH) could enhance water absorption and destruction of the nanofibrous structure of CP-F. Interestingly, kept at 25 °C/30% RH, the nanofibrous structure of CP-F was not damaged, and exhibited no water absorption. Moreover, the remaining CP, the mechanical properties, and the adhesive properties of CP-F were not significantly changed in this storage condition. It is concluded that the developed CP-F and a suitable storage condition can significantly improve CP stability.