Farag, M. M., W. El-Sebaie, E. B. Basalious, and O. N. El-Gazayerly, "Self-Nanoemulsifying/ Self-Assembled Cubic Nanoparticles Lyophilized Tablet: A Novel Biphasic Release Approach to Enhance the Bioavailability of a Lipophilic Drug.", AAPS PharmSciTech, vol. 25, issue 8, pp. 250, 2024. Abstract
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This study aimed to prepare a combined self-nanoemulsifying and self-assembled cubic nanoparticles (SNE/SAC) lyophilized tablet eliciting biphasic release pattern escorted with enhanced bioavailability for drugs hampered with slow dissolution and poor absorption. The antimuscarinic Darifenacin hydrobromide (DRF) was selected as a model drug used to treat overactive bladder-associated nocturia. The DRF-SNE/SAC lyophilized tablet was prepared so that upon reconstitution a mixture of DRF-loaded cubic nanoparticles and nanoemulsion dispersion is obtained. The nanoemulsion portion is responsible for the fast release followed by controlled release of the remaining dose loaded in cubic nanoparticles. A comparative pharmacokinetic study adopting randomized crossover design in male albino rabbits versus marketed product Frequefenacine® tablet was performed. Half of the dose (52.05% ± 4.21%) was rapidly released in the first 4 h followed by sustained release of the remaining drug where (90.16% ± 8.85%) was released in 24 h. The tested system showed 2.45 folds higher % relative bioavailability and 1.57 folds higher C with 1.62 longer residence time relative to reference product. The results endow the ability of the developed DRF-SNE/SAC lyophilized tablet to be considered as a propitious approach for the treatment of overactive bladder-associated nocturia without midnight dose administration.

Abdel-ghaffar, H. M., H. M. Abdel-Bar, A. M. Al-mahallawi, and O. N. E. Gazayerly, "SKIN CANCER ADVANCED TOPICAL TREATMENT WITH IMIQUIMOD LOADED NANOCARRIERS: AN IN-DEPTH REVIEW", Bull. Pharm. Sci., Assiut University, vol. 47, issue 1, pp. 119-140, 2024.
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MANNAA, I. M., O. E. N. Gazayerly, A. A. Abdelbary, S. S. Saleh, and D. a Mostafa, "Validated green spectroscopic manipulation of area under the curve (AUC) for estimation of Simvastatin: Application to nano-structured lipid carriers and niosomal systems", Journal of Research in Pharmacy, vol. 27, issue 1, pp. 30-42, 2023.
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Mabrouk, A. A., N. S. El-Mezayen, A. K. Awaad, M. I. Tadros, O. N. El-Gazayerly, and W. M. El-Refaie, "Novel celecoxib-loaded chitosan-fucoidan nanoparticles as potential immunotherapy for oral squamous cell carcinoma: Mechanistic insights", Journal of Drug Delivery Science and Technology, vol. 81, pp. 104228, 2023.
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Mabrouk, A. A., N. S. El-Mezayen, M. I. Tadros, O. N. El-Gazayerly, and W. M. El-Refaie, "Novel mucoadhesive celecoxib-loaded cubosomal sponges: Anticancer potential and regulation of myeloid-derived suppressor cells in oral squamous cell carcinoma.", European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V, vol. 182, pp. 62-80, 2023. Abstract
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Oral squamous-cell carcinoma (OSCC) is a widespread health problem. Myeloid-derived suppressor cells (MDSCs) are major tumor microenvironment (TME) population that govern many carcinogenesis aspects by establishing immunosuppressive milieu favoring tumor aggressiveness and treatment resistance. Cyclooxygenase-2 (COX-2) regulates MDSCs activity, hence, COX-2-selective inhibition by celecoxib (CXB) showed good anticancer effect at relatively high doses with possible subsequent cardiovascular complications. Therefore, targeted CXB delivery to MDSCs may represent a promising OSCC treatment strategy. Novel mucoadhesive-cubosomal buccal sponges were prepared for MDSCs targeting and were evaluated for their in-vitro quality attributes, ex-vivo mucoadhesion using buccal chicken-mucosa. Optimally-selected formulation showed considerable uptake by CD33/11bMDSCs in human OSCC cell-line (SCC-4) when quantitatively analyzed by flow-cytometry and examined using confocal-laser microscope. Optimum formulations loaded with low CXB doses (12 mg) were promoted to in-vivo studies via local application, using 4-nitroquinoline-1-oxide-induced OSCC in rats, and compared to their corresponding CXB gels. SP16 revealed the highest ability to decrease MDSC activation, recruitment and TME-immunosuppression in the isolated tumors. Consequently, SP16 exerted the greatest capacity to reduce histologic tumor grade, the OSCC-specific serum tumor markers levels, cancer hallmarks and stemness markers. CXB-loaded cubosomal sponges preferentially target MDSCs with noticeable anticancer potential and may exemplify novel mucoadhesive nanocarriers for OSCC treatment.

Fathi, H. A., C. Yousry, M. Elsabahy, Mahmoud El-Badry, and O. N. Elgazayerly, "Effective loading of incompatible drugs into nanosized vesicles: a strategy to allow concurrent administration of furosemide and midazolam in simulated clinical settings.", International journal of pharmaceutics, vol. 636, pp. 122852, 2023. Abstract
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The current study aims to assess the use of nanocarriers to limit drug incompatibilities in clinical settings, and thus eliminating serious clinical consequences (e.g., catheter obstruction and embolism), and enhancing in vivo bioavailability and efficacy. As a proof-of-concept, the impact of loading well-documented physically incompatible drugs (i.e., furosemide and midazolam) into nanosized vesicles on in vitro stability and in vivo bioavailability of the two drugs was investigated. Furosemide and midazolam were loaded into nanosized spherical vesicles at high entrapment efficiency (ca. 62-69%). The drug-loaded vesicles demonstrated a sustained drug release patterns, high physical stability and negligible hemolytic activity. Physical incompatibility was assessed by exploiting microscopic technique coupled with image processing and analysis, dynamic light scattering and laser Doppler anemometry. Incorporation of drugs separately inside the nanosized vesicles dramatically decreased size and number of the precipitated particles. In vivo, the niosomal drug mixture demonstrated a significant improvement in pharmacokinetic profiles of furosemide and midazolam compared to the mixed free drug solutions, as evidenced by their longer circulation half-lives and higher area under the plasma-concentration time curves of both drugs. Nanocarriers could provide an auspicious strategy for circumventing drug incompatibilities, thus reducing adverse reactions, hospitalization period and improving therapeutic outcomes.

Farag, M. M., W. El-Sebaie, E. B. Basalious, and O. N. El-Gazayerly, "Darifenacin Self-assembled Liquid Crystal Cubic Nanoparticles: a Sustained Release Approach for an Overnight Control of Overactive Bladder.", AAPS PharmSciTech, vol. 24, issue 5, pp. 120, 2023. Abstract
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The current study is regarding the development and characterization of Darifenacin-loaded self-assembled liquid crystal cubic nanoparticles (LCCN). An anhydrous approach was used for the preparation of these cubic nanoparticles using a hydrotropic agent (propylene glycol), with minimal energy input. Upon dispersion in aqueous medium, the system was successfully transformed to cubosomal nanoparticles counterpart as depicted by transmission electron micrographs. A Box-Behnken design was used to optimize formulation variables, namely A: amount of GMO, B: amount of Pluronic F127, C: amount of PG, and D: amount of HPMC. The design has generated 29 formulae which were tested regarding drug content uniformity, dispersibility in water, particle size, zeta potential, polydispersity index, and in vitro release behavior. The numerical optimization algorithms have generated an optimized formula with high desirability ≈ 1. The optimized formula displayed small particle size, good homogeneity, and zeta potential along with controlled in vitro release profile and ex vivo permeation through rabbit intestine. Thus, self-assembled LCCN might offer an alternative anhydrous approach for the preparation of cubosomal nanoparticles with controlled release profile for a possibly better control of overactive bladder syndrome which tremendously affect the overall life quality.

Abdallah, M., D. I. Nesseem, and A. A. Abdelbary, "TOPICAL DELIVERY OF QUERCETIN LOADED TRANSFERSOMES FOR WOUND TREATMENT: IN VITRO AND IN VIVO EVALUATION", International Journal of Applied Pharmaceutics, vol. 13, issue 5, pp. 189-197, 2021.
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El-Dahmya, R. M., A. H. Elshafeey, N. A. A. E. Gawad, and I. Elsayed, "Statistical optimization of nanostructured gels for enhancement of vinpocetine transnasal and transdermal permeation", Journal of Drug Delivery Science and Technology, vol. 66, pp. 102871, 2021.
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