Mohsen, K., H. M. E. Azzazy, N. K. Allam, and E. B. Basalious, "Intranasal lipid nanocapsules for systemic delivery of nimodipine into the brain: In vitro optimization and in vivo pharmacokinetic study", Material Science and Engineering, vol. c116, pp. 111236, 2020.
Shaeer, O., A. A. Raheem, H. Elfeky, A. Seif, T. M. Abdel-Raheem, A. Elsegeiny, M. S. Soliman, E. B. Basalious, and K. Shaeer, "Urethral instillation of chlorhexidine gel is an effective method of sterilisation", Arab journal of Urology, vol. 19, issue 3, pp. 419-422, 2021.
Ramadan, A., E. Basalious, and M. Abdallah, "Industrial application of QbD and NIR chemometric models in quality improvement of Immediate release tablets", Saudi Pharmaceutical Journal , vol. 29, issue 6, pp. 516-526, 2021.
Mazayen, Z. M., A. M. Ghoneim, R. S. Elbatanony, E. B. Basalious, and E. R. Bendas, "Pharmaceutical nanotechnology: from the bench to the market", Future Journal of Pharmaceutical Sciences , vol. 8, issue 1, pp. 1-11, 2022.
Hamdy, N. M., A. A. Bosaila, A. Ramadan, and E. B. Basalious, "Iron Oxide Nanoparticles-Plant Insignia Synthesis with Favorable Biomedical Activities and Less Toxicity, in the “Era of the-Green”: a Systematic Review", Pharmaceutics , vol. 14, issue 4, pp. 844, 2022.
Farrah, A. Y., A. M. Al-mahallawi, E. B. Basalious, and D. I. Nesseem, "Investigating the potential of phosphatidylcholine-based nano-sized carriers in boosting the oto-topical delivery of caroverine: In vitro characterization, stability assessment and ex vivo transport studies", International Journal of Nanomedicine, vol. 15, pp. 8921-8931, 2020. Abstract

© 2020 Farrah et al. Purpose: Drug delivery into the inner ear across the intact tympanic membrane (TM) has been a challenge in the treatment of inner ear disorders. In this study, nano-sized carriers were formulated for improving the non-invasive oto-topical delivery of caroverine for the treatment of tinnitus. Methods: Caroverine was loaded into two types of phospholipid-containing systems, namely, nano elastic vesicles (EVs) and phosphatidylcholine-based liquid crystalline nanoparticles (PC-LCNPs). The prepared formulations were characterized for their drug loading, particle size, polydispersity index, zeta potential, morphological features by transmission electron microscopy (TEM), and physicochemical stability. In addition, comparative ex vivo transport study was carried out using rabbits’ TM for both types of formulations. Results: The findings show a significant superiority of PC-LCNPs over the EVs formulations in the drug payload (1% and 0.25%, respectively), physical stability and the efficiency of permeation across rabbits’ TM. The results showed a more than twofold increase in the cumulative drug flux values of PC-LCNPs (699.58 ± 100 µg/cm2) compared to the EVs (250 ± 45 µg/cm2) across the TM. Conclusion: The current study revealed the smart physicochemical properties of PC-LCNPs demonstrating the potential of this carrier as a new attractive candidate for improving the non-invasive oto-topical delivery of caroverine.

Yousry, C., P. M. Zikry, E. B. Basalious, and O. N. El-Gazayerly, "Self-nanoemulsifying system optimization for higher terconazole solubilization and non-irritant ocular administration", Advanced Pharmaceutical Bulletin, vol. 10, pp. 389-398, 2020. Abstract

© 2020 The Author (s). This is an Open Access article distributed under the terms of the Creative Commons Attribution (CC BY), which permits unrestricted use, distribution, and reproduction in any medium, as long as the original authors and source are cited. No permission is required from the authors or the publishers. Purpose: Eye drops' formulations of poorly water-soluble drugs, offer the advantage of crossing the lipophilic cornea, but their limited aqueous solubility may lead to low ocular bioavailability limiting their therapeutic uses. Terconazole (TZ) is an antifungal drug with low aqueous solubility, restricting its application in ocular fungal infection. Thus, the aim of the work in this study is to enhance TZ solubilization, permitting better ocular permeation and higher bioavailability. To achieve this goal, different self-nanoemulsifying systems (SNESs) were prepared using different oils, surfactants and co-surfactants. Methods: Ternary phase diagrams were constructed to identify self nano-emulsification regions for each oil system examined; either Labrafil® M2125CS or Capryol™ 90. TZ saturated solubility in the different formulated systems were measured and systems showing highest potential for TZ solubilization were selected. The optimized systems were chosen based on their globule size, polydispersity index, self-emulsification characteristics. Finally, TZ release as well as the irritation effect via Hen's Egg test-chorioallantoic membrane (HET-CAM test) of the optimized system was observed in vitro. Results: The optimized system was formulated using 20% w/w Labrafil® M2125 CS, 50% w/w Tween® 80 and 30% w/w Transcutol® HP. Oil globules showed size range of 15.13 nm and self-emulsification time of 12.80 seconds. The system released 100% of the drug within half an hour compared to 2 hours in case of TZ-suspension. Finally, HET-CAM test showed non-irritating response and normal vascularization of the chorioallantoic membrane. Conclusion: The formulated SNES could be a promising approach to enhance ocular efficacy of TZ.

Yousry, C., P. M. Zikry, H. M. Salem, E. B. Basalious, and O. N. El-Gazayerly, "Integrated nanovesicular/self-nanoemulsifying system (INV/SNES) for enhanced dual ocular drug delivery: statistical optimization, in vitro and in vivo evaluation", Drug Delivery and Translational Research, vol. 10, pp. 801-814, 2020. Abstract

© 2020, Controlled Release Society. Ocular drug administration is usually problematic and suffers low bioavailability due to several physiological and biological factors that hinder their effective treatment. Terconazole (TZ) is considered as one of the effective ocular antifungal agents that is usually administrated intravitreally for higher efficacy. The aim of the work in this study is to formulate a TZ-loaded ocular drug delivery system with high efficiency and good tolerability. First, TZ-loaded bile-based nanovesicles (BBNV) were prepared and the formulation variables (namely, Span 60, cholesterol, and sodium deoxycholate levels) were optimized based on the results of the entrapment efficiency (EE%), particle size (PS), and zeta potential (ZP) using Box-Behnken statistical design. The optimized system was formulated using 73.59 mg Span 60, 1.28 mg cholesterol, and 3.11 mg sodium deoxycholate. The formulated system showed vesicles with PS of 526 nm, − 42.2 mV ZP, and 93.86% EE%. TZ release, cellular uptake, and cytotoxicity of the optimized system were evaluated in vitro. In addition, in vivo assessment of its safety was conducted histopathologically and via ocular irritation test to ensure the ocular tolerance of the system. Afterwards, the optimized TZ-loaded BBNV was integrated into a self-nanoemulsifying system (SNES) to allow faster TZ release for immediate antifungal effect, enhanced ocular residence, and improved ocular permeation. TZ release study revealed more than 2 folds increment in drug release rate from the integrated system compared to BBNV alone. Finally, this integrated system was assessed for its antifungal activity in vivo where it demonstrated higher antifungal activity against induced Candida albicans infection. [Figure not available: see fulltext.].

Ibrahim, M. M., E. B. Basalious, and M. A. E. - Nabarawi, "Consolidated bile-based vesicles/self-nanoemulsifying system (CBBVs/SNES) as a solution for limitations of oral delivery of vesicular dispersions: In-vitro optimization and elucidation of ex-vivo intestinal transport mechanisms", Journal of Drug Delivery Science and Technology, vol. 56, 2020. Abstract

© 2020 Elsevier B.V. The oral delivery of bile-based vesicles (BBVs) has been limited by their poor physical stability, low drug load and slow absorption rate. The novel consolidated bile-based vesicles/self-nanoemulsifying system (CBBVs/SNES) combines the advantages of vesicular and self-nanoemulsifying systems (SNES). This work aimed to prepare physically stable CBBVs/SNES loaded with the full dose of amlodipine besylate (AB) as model drug. AB-loaded BBVs dispersion was optimized using Box-Behnken design and evaluated for particle size distribution, encapsulation efficiency and solubilization efficiency. AB-loaded CBBVs/SNES was prepared by mixing the vesicles of the optimized BBV with Labrafil-based SNES that gave the highest drug solubility. AB-loaded CBBVs/SNES was evaluated for particle size, Polydispersity index (PDI) and in vitro release. When diluted in GIT fluids, consolidated system spontaneously emulsifies forming nanosized oil droplets and in-situ formed mixed micelles. The formation of nanosized mixed micelles (<100 nm) was confirmed by transmission electron microscopy and particle size analysis (PS; 106.8 ± 17.60 nm and PDI; 0.20 ± 0.01). The developed CBBVs/SNES showed enhanced physical stability when stored for 3 months at 2–8 °C. The ex-vivo transport study confirmed that the developed CBBVs/SNES improved the drug transport about 3.8 folds in comparison to the reconstituted vesicular dispersion through offering three pathways of transport (in-situ formed mixed micelles uptake, nanoemulsion droplet uptake and vesicular uptake). The various offered transport pathways and the improvement of drug load and physical stability propose that CBBVs/SNES administered via the oral route could therefore be promising in oral delivery of vesicular systems. In-vivo studies is presently investigated.

Abdel-Salam, F. S., S. A. Elkheshen, A. A. Mahmoud, E. B. Basalious, M. Samer, A. A. Mostafa, and N. A. ElKasabgy, "In-situ forming chitosan implant-loaded with raloxifene hydrochloride and bioactive glass nanoparticles for treatment of bone injuries: Formulation and biological evaluation in animal model", International Journal of Pharmaceutics, vol. 580, 2020. Abstract

© 2020 Elsevier B.V. In-situ forming implants receive great attention for repairing serious bone injuries. The aim of the present study was to prepare novel chitosan in-situ forming implants (CIFI) loaded with bioactive glass nanoparticles and/or raloxifene hydrochloride (RLX). Incorporating raloxifene hydrochloride (RLX) as a selective estrogen receptor modulator was essential to make use of its anti-resorptive properties. The prepared formulae were tested for their in-vitro gelation time, drug release, injectability, rheological properties, erosion rate and morphological properties. Results revealed that the formulation composed of 1% (w/v) chitosan with 2% (w/v) NaHCO3 and 1% (w/v) bioactive glass nanoparticles (CIFI-BG) possessed the most sustained drug release profile which extended over four months with low burst release effect compared to the same formulation lacking bioactive glass nanoparticles (CIFI). Selected formulations were tested for their ability to enhance bone regeneration in induced puncture in rate tibia. Results declared that these formulations were able to enhance bone regeneration after 12 weeks in comparison to the untreated tibial punctures and that containing bioactive glass could be considered as novel approach for treatment of serious bone injuries which require long term treatment and internal mechanical bone support during healing.

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