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AZZA AHMED MOHAMED MAHMOUD

Basic information

Name : AZZA AHMED MOHAMED MAHMOUD
Title: Professor
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Personal Info: Dr. Azza Ahmed Mahmoud; Professor of Pharmaceutical Technology at Pharmaceutics and Pharmaceutical Technology Department. She holds MSc and PhD degrees in Pharmaceutics from Faculty of Pharmacy, Cairo University (Egypt) as well as Associate Professor degree from the National Research Center (Egypt). Azza received the Scientific Engorgement Award in Science of Pharmacy from the National Research Center for 2011 and got a certificate of appreciation for excellence in research output for 2011 from the National Research Center. Azza’s research is focused on the development of advanced drug delivery systems, such as biodegradable nanoparticles, transfersome, liposomes, chitosan nanoparticles, solid-lipid nanoparticles, liquid crystal nanoparticles, nanoemulsion and self-nanoemulsifying drug delivery systems. She co-authored 20 articles published in international journals and her work has been presented in more than 12 international conferences and workshops. She has guided 4 MSc students successfully and 7 candidates are registered under her supervision. View More...

Education

Certificate Major University Year
PhD Pharmaceutics Cairo University 2008
Masters Pharmaceutics Cairo University 2006
Bachelor Faculty of Pharmacy Cairo University 2002

Teaching Experience

Name of Organization Position From Date To Date
Department of Pharmaceutical Technology, National Research Center Research Staff Member 01/01/2003 06/05/2014

Researches /Publications

Long Lasting in-situ forming implant loaded with raloxifene HCl: An injectable delivery system for treatment of bone injuries - 01/1

AZZA AHMED MOHAMED MAHMOUD

Nermeen A. Elkasabgy, Fatma S. Abdel-Salam, Emad B. Basalious, Mohammed S. Amer, Amany A. Mostafa

01/11/2019

Bone injury is very serious in elder people or osteoporotic patients. In-situ forming implants (IFI) for bone rebuilding are usually poly-lactic-co-glycolic acid (PLGA)-based, which have a burst release effect. This study aimed to prepare novel liquid lipid-based PLGA-IFI loaded with raloxifene hydrochloride for prolonged non-surgical treatment of bone injuries by applying solvent-induced phase inversion technique. Labrasol® and Maisine® were added to the selected IFI forming long lasting lipid-based IFI (LLL-IFI). The formulations were characterized by analysing their in-vitro drug release, solidification time, injectability, rheological properties, and DSC in addition to their morphological properties. Results revealed that the LLL-IFI composed of 10%w/v PLGA with a lactide to glycolide ratio of 75:25 with ester terminal and 10% Maisine® possessed the most sustained drug release and lowest burst effect, as well as delayed pore formation compared to its counterpart lacking Maisine®. The selected LLL-IFI and PLGA-IFI formulations were tested for their capability to enhance bone regeneration in bone injuries induced in rats. Both formulations succeeded in healing the bones completely with the superiority of LLL-IFI in the formation of well-organized bone structures lacking fibrous tissues. The results suggest that LLL-IFI and PLGA-IFI are innovative approaches for treating critical and non-critical sized bone injuries.

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Fabrication Strategies of Scaffolds for Delivering Active Ingredients for Tissue Engineering - 01/1

AZZA AHMED MOHAMED MAHMOUD

Nermeen A. Elkasabgy

01/10/2019

Designing scaffolds with optimum properties is an essential factor for tissue engineering success. They can be seeded with isolated cells or loaded with drugs to stimulate the body ability to repair or regenerate the injured tissues by acting as centers for new tissue formation. Recently, scaffolds gained a significant interest as principal candidates for tissue engineering due to overcoming the autograft or allograft’s associated problems. The advancement of the tissue engineering field relies mainly on the introduction of new biomaterials for scaffolds’ fabrication. This review presents and criticizes different scaffolds’ fabrication techniques with particular emphasis on the fibrous, injectable in situ forming, foam, 3D freeze-dried, 3D printed, and 4D scaffolds. This article highlights on scaffolds’ composition which would be beneficial for developing scaffolds that could potentially help to meet the demand for both drug delivery and tissue regeneration.

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Design and evaluation of novel inhalable sildenafil citrate spray-dried microparticles for pulmonary arterial hypertension - 01/0

AZZA AHMED MOHAMED MAHMOUD

Bhavani Prasad Vinjamuri, Rehab N. Shamma, Mahmoud M. Ghorab, Mahavir Bhupal Chougule,Lipika Chablani

01/05/2019

Pulmonary delivery of vasodilators is a promising alternative for the intravenous and oral treatment of pulmonary arterial hypertension (PAH). The aim of this study was to design and evaluate hydrogel microparticles as a carrier for sustained pulmonary delivery of sildenafil citrate. Spray dried hydrogel microparticles containing biodegradable sodium carboxymethyl cellulose, sodium alginate, and sodium hyaluronate polymers at variable concentrations were prepared. A design of experiment using the “Extreme Vertices Mixture” design was executed. The design was used to study the influence of polymer concentration and their interactions on the physicochemical properties of the formulations in terms of particle size, particle size distribution, product yield, entrapment efficiency, and in-vitro drug release. Selected formulations were also evaluated for swelling, biodegradation, moisture content, in-vitro aerodynamic performance, and cytotoxicity. In addition, a lung deposition and pharmacokinetic study was conducted in rats to study drug accumulation in lungs and blood after intratracheal administration of the spray dried inhalable hydrogel microparticles in comparison to orally administered Viagra®. The results demonstrated that formulated microparticles had a mean geometric particle size between 2 and 5 μm, entrapment efficiency of >80%, and yield ranging between 47 and 66% w/w. The in-vitro drug release profiles showed a sustained drug release of sildenafil citrate for over 24 h. The statistical design showed a significant influence of the microparticulate composition on the physicochemical properties. Furthermore, selected formulations were evaluated for their aerodynamic properties. The aerodynamic properties included fine particle fraction ranging between 24 and 30%, dose recovery percent of 68–8 5%, and average mass median aerodynamic diameter of 4.6–4.8 μm. The in-vivo pharmacokinetic study showed that inhaled spray dried hydrogel microparticles (M6) formulation had significantly higher lung/blood Cmax, AUC, extended half-life, and mean residence time in comparison to orally administered sildenafil citrate of the same dose. In conclusion, the formulated drug-loaded spray dried hydrogel microparticles showed promising in-vitro and in-vivo results for the pulmonary delivery of sildenafil citrate. The spray dried hydrogel microparticles formulation can be considered as a potential alternative of oral sildenafil citrate for treatment of PAH.

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Flexible nano-sized lipid vesicles for the transdermal delivery of colchicine; in vitro/in vivo investigation - 01/0

AZZA AHMED MOHAMED MAHMOUD

Gina S. El-Feky, Mona M. El-Naa

01/02/2019

Colchicine (CL) is the most effective treatment of acute gout, however, it is associated with side effects in 80% of the patients at therapeutic doses, in addition, it's a water-soluble strong base (pKa ∼12.8) which ionizes at physiological gastrointestinal pH resulting in low oral bioavailability of 44%. This work employed enhancing the bioavailability and reducing the side effects of CL through combining the benefits of the transdermal route together with those of elastic lipid nano-vesicles. Transfersomes (TRs) have been studied as vehicles for transdermal drug delivery, however, poor encapsulation of drugs and drug leaking of the vesicles required complexation of CL with β-cyclodextrin (β-CD) before formulation. The composition of the designed CL-β-CD-TR was studied to balance the flexibility of the vesicles to their entrapment ability. CL-β-CD-TR were characterized for their shape, size, entrapment efficiency, elasticity, release profile, ex vivo skin permeation, pharmacological efficacy, and histopathological effect. Encapsulation efficiency of CL-β-CD complex in the vesicular formulations ranged from 42.3% to 93.8%. Particle size ranged from 70.6 nm to 138.5 nm and zeta potential ranged from 16.1 mV to 23.4 mV. The in vitro release of CL from the selected CL-β-CD-TR formulation (F3) showed a controlled, biphasic profile. Ex vivo study reported the great potential of F3 (CL-β-CD-TR) for skin permeation. In vivo experiment demonstrated that F3 (CL-β-CD-TR) possessed high biological efficacy with reduced skin irritation.

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Bioavailability Enhancement of Aripiprazole Via Silicosan Particles: Preparation, Characterization and In vivo Evaluation - 01/0

AZZA AHMED MOHAMED MAHMOUD

Alaa H. Salama, Rehab N. Shamma, Faten Farouk

01/09/2018

The aim of this study was to design a novel carrier for enhancing the bioavailability of the poorly water-soluble drug, aripiprazole (ARP). Silicosan, the applied carrier, was obtained by chemical interaction between tetraethyl orthosilicate (TEOS) and chitosan HCl. Different ARP-loaded silicosan particles were successfully prepared in absence and presence of one of the following surfactants; Tween 80, Poloxamer 407 and cetyltrimethylammonium bromide (CTAB). The prepared ARP-loaded silicosan particles were thoroughly investigated for their structures using FTIR, XRD, and DSC analysis as well as their particle size, zeta potential, flowability, drug content, and in vitro drug release efficiencies. The prepared ARP-loaded silicosan particles were characterized by amorphous structure, high drug entrapment efficiency and a remarkable improvement in the release of aripiprazole in simulated gastric fluid. SEM and EDX revealed that the morphology and silica atom content in the prepared ARP-loaded silicosan particles were affected by the used surfactant in their formulations. The selected ARP-loaded silicosan particles were subjected to in vivo study using rabbits. The obtained pharmacokinetic results showed that the relative bioavailability for orally administered ARP-loaded silicosan particles (SC-2-CTAB) was 66% higher relative to the oral suspension (AUC0-10h was 16.38 ± 3.21 and 27.23 ± 2.35 ng.h/mL for drug powder and SC-2-CTAB formulation, respectively). The obtained results suggested the unique-structured silicosan particles to be used as successful vehicle for ARP

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Design and characterization of emulsified spray dried alginate microparticles as a carrier for the dually acting drug roflumilast. - 01/0

AZZA AHMED MOHAMED MAHMOUD

Nermeen A.Elkasabgy

01/09/2018

Roflumilast is a selective inhibitor of phosphodiesterase-4 isoenzyme in lung cells. Having psychiatric adverse reactions when administered orally affects negatively the patients' adherence to the drug. This work aimed to prepare emulsified spray dried alginate microparticles for the pulmonary delivery of roflumilast. Sodium alginate was used as microparticle-forming material, isopropyl myristate as an oil, Tween®80 as surfactant and calcium beta-glycerophosphate as cross-linking agent to enhance the mechanical properties of the particles. The prepared particles were evaluated for their encapsulation efficiency, particle size and in-vitro drug release. From the studied carriers, beta-cyclodextrin (CD) was the best regarding giving formulation with smaller particle size and more sustained drug release. The inhalation profile of CD-based microparticles was investigated using Anderson cascade impactor. The aerosolization profile of CD-based microparticles suggested their efficiency to deliver the drug deep in the lung. The CD-based microparticles possessed more inhibitory effects on the viability of A549 cells and on the pro-inflammatory cytokines (TNF-α, IL-6 and IL-10) compared to the pure drug. Hence, CD-based microparticles could regulate the tumorigenesis besides tumor-associated inflammation. Finally, CD-based microparticles showed more sustained bronchodilatation properties in healthy human volunteers when compared to Ventolin®HFA. CD-based microparticles proved to be a promising carrier for inhaled roflumilast in human.

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Lamotrigine loaded poly-ɛ-(d, l-lactide-co-caprolactone) nanoparticles as brain delivery system - 01/0

AZZA AHMED MOHAMED MAHMOUD

Mahmoud M. Ghorab, Iman M. Higazy

01/03/2018

Management of epilepsy requires brain delivery therapy, therefore, this study was aimed to prepare lamotrigine loaded poly-ɛ-(d,l-lactide-co-caprolactone) (PLCL) nanoparticles using spontaneous emulsification solvent diffusion method. Nanoparticles for brain delivery required to have a particle size <200 nm, polydispesity index <0.2 and a sustained drug release properties. For such aim different factors were considered in preparing the nanoparticles as PLCL monomers' ratio, type of organic solvent used to prepare the nanoparticles, amount of PLCL and Pluronic®F127 in the nanoparticles. Prepared nanoparticles were characterized for their shape, particle size, polydispersity index, zeta potential, encapsulation efficiency, drug loading capacity, process yield and in-vitro drug release pattern. The in-vivo investigation for brain delivery of selected nanoparticles delivered by intravenous route was investigated in rats and compared to that for oral tablet. The obtained nanoparticles were spherical in shape. The amount of surfactant and PLCL affected the properties of the obtained nanoparticles. Using a mixture of organic solvent in preparing the nanoparticles improved its properties. The nanoparticles prepared using PLCL with monomers' ratio of 25:75, had particle size value of 125 nm, polydispersity index value of 0.184, zeta potential value of −39 mV and encapsulation efficiency value of 99%, was selected to study their efficacy to deliver the drug to the brain. The tested nanoparticles showed higher values of Tmax, Cmax, AUC, and MRT in homogenized rat brain, compared to oral lamotrigine tablet, while the bioavailability of the oral tablet was higher in rat plasma compared to that for the nanoparticles. This reflects that brain was the main distribution site for tested nanoparticles, and plasma was the main distribution site for oral tablets. This confirms the goal of the selected formulation as brain delivery nanoparticles.

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Determination of cytocompatibility and osteogenesis properties of in situ forming collagen-based scaffolds loaded with bone synthesizing drug for bone tissue engineering. - 01/0

AZZA AHMED MOHAMED MAHMOUD

Nermeen Adel Elkasabgy, Rehab Nabil Shamma

01/05/2017

Bone tissue engineering using in situ forming 3D scaffolds can be an alternative to surgically treated scaffolds. This work aimed to develop in situ forming scaffolds using poly (lactic-co-glycolic acid) and a bone synthesizing drug (risedronate) with or without the porogenic agent (collagen). Hybrid scaffolds were formed through solvent-induced phase inversion technique and were morphologically evaluated using scanning electron microscopy (SEM). The effect of scaffolds on Saos-2 cell line viability using 3-(4,5-dimethyl-2-thiazolyl)-2,5-diphenyl-2H-tetrazolium bromide test besides their effect on cell growth using fluorescence microscope was assessed. Furthermore, alkaline phosphatase (ALP) activity as well as Ca2+ deposition on the scaffolds was evaluated. SEM images revealed the porous structure for collagen-based scaffolds. Saos-2 cell proliferation was significantly enhanced with risedronate-loaded scaffolds compared to those lacking the drug. Porous collagen-based scaffolds were more favorable for both the cell growth and the promotion of ALP activity. Furthermore, collagen-based scaffolds promoted the Ca2+ deposition compared to their counterparts without collagen. Such results suggest that collagen-based scaffolds offer excellent biocompatibility for bone regeneration, where this biocompatible nature of scaffold leads to the proliferation of cells that lead to the deposition of mineral on the scaffold. Such in situ forming 3D scaffolds provide a promising noninvasive approach for bone tissue engineering.

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Etodolac transdermal cubosomes for the treatment of rheumatoid arthritis: ex vivo permeation and in vivo pharmacokinetic studies. - 01/0

AZZA AHMED MOHAMED MAHMOUD

Salwa saleh, Amany O.Kamel

01/05/2017

In this study, transdermal etodolac-loaded cubosomes were developed in order to relieve patient pain and joints stiffness by providing stable etodolac concentration at the targeting sites through controlled drug delivery via the noninvasive skin route with more sustaining and less frequent dosing. Different ratios and percentages of poloxamer 407 and monoolein were used to formulate the cubosomes using emulsification and homogenization processes. The etodolac-loaded cubosomes showed particle size values ranging from 135.95 to 288.35 nm and zeta potential values ranging from −18.40 to −36.10 mV. All the cubosomes offered an encapsulation efficiency value of about 100% and showed drug loading capacity ranging from 1.28 to 6.09%. The in vitro drug release studies revealed a controlled drug release profile with a drug release rate up to 15.08%/h. Increasing poloxamer concentration in etodolac-loaded cubosomes resulted in nanoparticles with less particle size and faster drug release. The particles exhibited cubic and hexagonal shapes. The DSC and X-ray analysis demonstrated that the drug was encapsulated in the cubosomes bicontinuous structures in amorphous form. In addition, investigated cubosomes exhibited fast drug penetration through excited mice skin followed by slower drug penetration for up to 24 h. The pharmacokinetic study in human volunteers showed that the selected etodolac-loaded cubosomes enhanced the bioavailability of etodolac as compared to the oral capsules (266.11%) with evidence of longer half-life and higher MRT that reached 18.86 and 29.55 h, respectively. The etodolac-loaded cubosomes propose a promising system for treatment of arthritis simply through skin application.

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Design of novel injectable in-situ forming scaffolds for non-surgical treatment of periapical lesions: In-vitro and in-vivo evaluation. - 01/0

AZZA AHMED MOHAMED MAHMOUD

Rehab N.Shamma,Nermeen A.Elkasabgy,Shaimaa I.Gawdat,Mohamed M.Kataia,Mohamed A.Abdel Hamid

01/04/2017

Periapical lesions are considered one of the common pathological conditions affecting alveolar bone. The primary focus of this study was to investigate the effectiveness of formulating an injectable in-situ forming scaffold-loaded with risedronate (bone resorption inhibitor) and with lornoxicam (anti-inflammatory drug) for the non-surgical treatment of periapical lesions. The scaffolds were prepared using solvent-induced phase inversion technique. Two insoluble copolymers were investigated namely; PLGA (ester-terminal) and PLGA-A (acid-terminal), additionally, SAIB was added as a high viscosity water-insoluble carrier. The addition of porogenic agents like hydrolyzed collagen was also investigated. The prepared scaffolds were characterized by analyzing their in-vitro release, DSC and rheological properties, besides their morphological properties. The results showed that the scaffolds prepared using 30% (w/v) PLGA or combined PLGA: SAIB (1:1, w/w) with total polymer concentration of 30% (w/v) possessed the most sustained drug release profile. Selected scaffolds were tested for their therapeutic effect to study the effect of porogenic agent, anti-inflammatory drug and risedronate in periapical lesions induced in dogs’ teeth. Results declared that the selected scaffolds succeeded in improving the inflammation and enhancing the formation of new bony regions confirming the success of the prepared scaffolds as an innovative approach in the treatment of bone defects.

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PLGA Nanoparticles as subconjunctival injection for management of glaucoma. - 01/0

AZZA AHMED MOHAMED MAHMOUD

Hamed A. Salama, Mahmoud Ghorab, Mayssa Abdel Hady

01/02/2017

Nanoparticles fabricated from the biodegradable and biocompatible polymer, polylactic-co-glycolic acid (PLGA), could be a promising system for targeting ocular drug delivery. The objective of this work was to investigate the possibility of encapsulating brinzolamide in PLGA nanoparticles in order to be applied as a subconjunctival injection that could represent a starting point for developing new therapeutic strategies against increase in ocular pressure. The brinzolamide-loaded PLGA nanoparticles were fabricated using emulsion-diffusion-evaporation method with varying concentrations of Tween 80 or poloxamer 188 (Plx) in aqueous and organic phases. The nanoparticles were characterized in terms of particle size and size distribution, entrapment efficiency and in-vitro drug release pattern as well as DSC and X-ray analysis. Nanoparticles prepared using Tween 80 in the aqueous phase showed higher encapsulation efficiency and smaller particle size-values compared to those prepared using Plx. Furthermore, the addition of Plx 188 or Brij 97 to the organic phase in the formulation containing Tween 80 in the aqueous phase led to an increase in the particle diameter-values of the obtained nanoparticles. The nanoparticles had the capacity to release the brinzolamide in a biphasic release profile. The nanoparticles were spherical in shape and the drug was entraped in the nanoparticles in an amorphous form. Selected nanoparticles, injected subconjunctivally in normotensive Albino rabbits, were able to reduce the IOP for up to 10 days. Nanoparticles loaded with brinzolamide with lower particle size were able to reduce the IOP for longer period compared to those with higher particle size. Histopathological studies for the anterior cross sections of the rabbits’ eyes revealed that the tested nanoparticles were compatible with the ocular tissue. The overall results support that PLGA nanoparticles, applied as subconjunctival injection, can be considered as a promising carrier for ocular brinzolamide delivery with targeting delivery of the drug to the eye tissues.

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Antiinflammatory sunscreen nanostructured lipid carrier formulations. - 01/0

AZZA AHMED MOHAMED MAHMOUD

Fatma S.Abdel-Salam

01/02/2017

Discoid lupus erythematosus is a condition of chronic inflammation of the skin which requires protection from ultraviolet radiations and prolonged treatment with topical corticosteroids. The aim of this study was to prepare semisolid nanostructured lipid carrier (NLC) formulations containing diflucortolone valerate (DFV) as a model corticosteroid drug and titanium dioxide (TiO2) as an inorganic UV-filter in the same formulation. The NLC formulations were prepared by applying high shear homogenization and ultrasonication techniques using Precriol®ATO5 or Tristearin® as the solid lipids, Capryol™ or isopropyl myristate as the liquid lipids, Poloxamer® 407 as a surfactant and Labrafil® M1944CS as a lipid based surfactant. The incorporation of TiO2 in the NLCs in concentration of 5% w/w was found to be the optimum concentration which enhances the intrinsic sun protection factor (SPF) of this carrier system and resulted in suitable sun protection values ranged from 4.94 to 21.27 with an acceptable spreadable consistency for the NLC formulation. Semi-solid NLC formulations were characterized by small particle size ranged from 180.8 to 255.1 nm before the addition of TiO2 and the particle size reached 540.1 nm after addition of 5% TiO2. Incorporation of TiO2 in NLC formulations leads to a synergistic photoprotection and increase patient compliance.

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Nanostructured lipid carriers as semisolid topical delivery formulations for diflucortolone valerate. - 01/0

AZZA AHMED MOHAMED MAHMOUD

Fatma S. Abdel-Salam

01/01/2017

Context: Topical treatment of skin disease needs to be strategic to ensure high drug concentration in the skin with minimum systemic absorption. Objective: The aim of this study was to produce semisolid nanostructured lipid carrier (NLC) formulations, for topical delivery of the corticosteroid drug, diflucortolone valerate (DFV), with minimum systemic absorption. Method: NLC formulations were developed using a high shear homogenization combined with sonication, using Precirol® ATO5 or Tristearin® as the solid lipid, Capryol™ or isopropyl myristate as the liquid lipid and Poloxamer® 407 as surfactant. The present study addresses the influence of different formulations composition as solid lipid, liquid lipid types and concentrations on the physicochemical properties and drug release profile from NLCs. Results and discussion: DFV-loaded NLC formulations possessed average particle size ranging from 160.40 nm to 743.7 nm with narrow polydispersity index. The encapsulation efficiency was improved by adding the lipid-based surfactants (Labrasol® and Labrafil® M1944CS) to reach 68%. The drug release from the investigated NLC formulations showed a prolonged release up to 12 h. The dermatopharmacokinetic study revealed an improvement in drug deposition in the skin with the optimized DFV-loaded NLC formulation, in contrast to a commercial formulation. Conclusion: NLC provides a promising nanocarrier system that work as reservoir for targeting topical delivery of DFV.

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Bioactive/natural polymeric scaffolds loaded with ciprofloxacin for treatment of osteomyelitis. - 01/0

AZZA AHMED MOHAMED MAHMOUD

Amany A. Mostafa , Mayyada M. H. El-Sayed, Amira M. Gamal-Eldeen

01/01/2017

Local delivery of antibiotic into injured bone is a demand. In this work, different scaffolds of chitosan (C) with or without bioactive glass (G) were prepared using the freeze-drying technique in 2:1, 1:1, and 1:2 weight ratios. Chitosan scaffolds and selected formulas of chitosan to bioglass were loaded with ciprofloxacin in 5%, 10%, and 20% w/w. Scaffold morphology showed an interconnected porous structure, where the glass particles were homogeneously dispersed in the chitosan matrix. The kinetic study confirmed that the scaffold containing 1:2 weight ratio of chitosan to glass (CG12) showed optimal bioactivity with good compromise between Ca and P uptake capacities and Si release rate. Chitosan/bioactive glass scaffolds showed larger t 50 values indicating less burst drug release followed by a sustained drug release profile compared to that of chitosan scaffolds. The cell growth, migration, adhesion, and invasion were enhanced onto CG12 scaffold surfaces. Samples of CG12 scaffolds with or without 5% drug induced vascular endothelial growth factor (VEGF), while those containing 10% drug diminished VEGF level. Only CG12 induced the cell differentiation (alkaline phosphatase activity). In conclusion, CG12 containing 5% drug can be considered a biocompatible carrier which would help in the localized osteomyelitis treatment.

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Design and in vitro/in vivo evaluation of ultra-thin mucoadhesive buccal film containing fluticasone propionate. - 01/0

AZZA AHMED MOHAMED MAHMOUD

Mahmoud M. Ghorab,

01/01/2017

Fluticasone propionate is a synthetic corticosteroid drug distinguished by its potent anti-inflammatory action with low systemic side effects in comparison to other corticosteroids making it a potential drug for local buccal delivery. The aim of the present study was to design mucoadhesive buccal film containing fluticasone that is aesthetically acceptable and could maintain local drug release for a sustained period to manage the sign and symptoms of severe erosive mouth lesions. Solvent casting technique was used in film preparation. Different polymeric blends were used either alone or in combination with mucoadhesive polymers, sodium carboxymethyl cellulose (SCMC), or Carbopol 971P at different concentrations. The physicochemical properties, in vitro mucoadhesion time as well as the drug release properties for all prepared formulations were determined. Selected formulations with adequate properties were further examined by differential scanning calorimetry (DSC) and X-ray diffraction (XRD) and subjected to in vivo evaluation. Films containing hydroxypropyl methylcellulose (HPMC)/ethyl cellulose (EC) showed acceptable physicochemical properties, homogenous drug distribution, convenient mucoadhesion time, moderate swelling as well as sustained drug release up to 12 h. The biological performance of these formulations was assessed on healthy human volunteers and compared with a prepared mouthwash which showed enhanced pharmacokinetic parameters for the selected films in comparison to the mouthwash. The results revealed that the optimized formulation containing HPMC/EC and 10% SCMC could successfully achieve sustained drug release for 10 h which is considered promising for local treatment of severe mouth lesions.

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Formulation of risperidone in floating microparticles to alleviate its extrapyramidal side effects - 01/1

AZZA AHMED MOHAMED MAHMOUD

Mahmoud M. Ghorab, Shereen H. Noshi

01/12/2016

Risperidone is effective in the treatment of positive as well as negative symptoms of schizophrenia. But, there is a strong correlation between plasma levels of risperidone and its adverse effects. Objective This study aimed to develop risperidone in floating microparticles to overcome its extrapyramidal side effects. Methods Floating microparticles were prepared using Eudragit S100, hydroxypropylmethyl cellulose (HPMC), Gelucires (Gelucire 43/01 pellets, Gelucire 44/14 and Gelucire 50/13), Geleol mono and diglyceride NF, glyceryl monostearate, Compritol 888 ATO, methyl-betacyclodextrin (MβCD) and hydroxypropyl-betacyclodextrin (HPβCD), by emulsion solvent diffusion technique. In-vitro experiments were conducted to optimize formulation parameters regarding floating ability, yield value, drug loading and in-vitro release properties. The best formula was investigated for its in-vivo floating ability and for its pharmacokinetics as well as its extrapyramidal side effects in human volunteers. Results The optimized floating microparticles showed promising in-vitro experiment performance with floating ability up to 95.93% for 12 h. Also, this floating ability was confirmed using in-vivo x-ray studies. Pharmacokinetics studies revealed significant (p < 0.05) lower Cmax, longer Tmax and higher AUC values for the optimized formula compared to the marketed oral product (Risperidal® 4 mg tablets) indicating gradually release properties which lead to high treatment efficacy of the drug with obvious reduced extrapyramidal side effects. Conclusion These results proved that formulating risperidone as floating microparticles is a suitable dosage form for overcoming risperidone side effects.

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Formulation of risperidone in floating microparticles to alleviate its extrapyramidal side effects - 01/1

AZZA AHMED MOHAMED MAHMOUD

Ghorab, M. M, Noshi, S.H.

01/12/2016

Abstract Risperidone is effective in the treatment of positive as well as negative symptoms of schizophrenia. But, there is a strong correlation between plasma levels of risperidone and its adverse effects. Objective This study aimed to develop risperidone in floating microparticles to overcome its extrapyramidal side effects. Methods Floating microparticles were prepared using Eudragit S100, hydroxypropylmethyl cellulose (HPMC), Gelucires (Gelucire 43/01 pellets, Gelucire 44/14 and Gelucire 50/13), Geleol mono and diglyceride NF, glyceryl monostearate, Compritol 888 ATO, methyl-betacyclodextrin (MβCD) and hydroxypropyl-betacyclodextrin (HPβCD), by emulsion solvent diffusion technique. In-vitro experiments were conducted to optimize formulation parameters regarding floating ability, yield value, drug loading and in-vitro release properties. The best formula was investigated for its in-vivo floating ability and for its pharmacokinetics as well as its extrapyramidal side effects in human volunteers. Results The optimized floating microparticles showed promising in-vitro experiment performance with floating ability up to 95.93% for 12 h. Also, this floating ability was confirmed using in-vivo x-ray studies. Pharmacokinetics studies revealed significant (p < 0.05) lower Cmax, longer Tmax and higher AUC values for the optimized formula compared to the marketed oral product (Risperidal® 4 mg tablets) indicating gradually release properties which lead to high treatment efficacy of the drug with obvious reduced extrapyramidal side effects. Conclusion These results proved that formulating risperidone as floating microparticles is a suitable dosage form for overcoming risperidone side effects.

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Brinzolamide loaded-polymeric nanoparticles - 01/0

AZZA AHMED MOHAMED MAHMOUD

Hamed A. Salama, M. Ghorab, Azza A. Mahmoud and Mayssa Abdel Hady

01/06/2016

The objective of the present study was to investigate the ability to formulate brinzolamide in the form of polylactic-co-glycolic acid (PLGA) nanoparticles. In this study brinzolamide-loaded nanoparticles were formulated according to the emulsification/solvent evaporation technique using the biodegradable PLGA. The effect of surfactant type and its percentage in the preparation were investigated. The investigated PLGA polymer with lactide: glycolide monomers’ ratio of 75:25 was able to develop PLGA vesicular system using the investigated surfactants. Brinzolamide-loaded nanoparticles prepared using PLGA with Pluronic acid F68 in the aqueous phase and 1 % Brij 97 in the organic phase showed the smallest particle size value (441.80 ± 72.97 nm). Brinzolamide-loaded nanoparticles prepared using PLGA with Pluronic acid F68 in aqueous phase and 2 % polysorbate 80 in organic phase had the largest encapsulation efficiency and drug loading values (47.86 ± 0.97 % and 38.76 %, respectively).

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Nano spray drying technique as a novel approach to formulate stable econazole nitrate nanosuspension formulations for ocular use - 01/0

AZZA AHMED MOHAMED MAHMOUD

Maged, A., Mahmoud, A.A., Ghorab, M.M.

01/03/2016

The effect of using methyl-β-cyclodextrin and hydroxypropyl-β-cyclodextrin as carriers for econazole nitrate nanoparticles prepared by nano spray dryer was explored in this work. Stabilizers, namely, poly(ethylene oxide), polyvinylpyrrolidone k30, poloxamer 407, Tween 80, and Cremophor EL, were used. The nano spray dried formulations revealed almost spherical particles with an average particle size values ranging from 121 to 1565 nm and zeta potential values ranging from −0.8 to −2.5 mV. The yield values for the obtained formulations reached 80%. The presence of the drug in the amorphous state within the nanosuspension matrix system significantly improved drug release compared to that for pure drug. Combination of hydroxypropyl-β-cyclodextrin with Tween 80 achieved an important role for preserving the econazole nanosuspension from aggregation during storage for one year at room temperature as well as improving drug release from the nanosuspension. This selected formulation was suspended in chitosan HCl to increase drug release and bioavailability. The in vivo evaluation on albino rabbit’s eyes demonstrated distinctly superior bioavailability of the selected formulation suspended in chitosan compared to its counterpart formulation suspended in buffer and crude drug suspension due to its mucoadhesive properties and nanosize. The nano spray dryer could serve as a one step technique toward formulating stable and effective nanosuspensions.

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Bioactive/natural polymeric scaffolds loaded with ciprofloxacin for treatment of osteomyelitis - 01/0

AZZA AHMED MOHAMED MAHMOUD

Amany A. Mostafa, Mayyada M.H. El-Sayed, Azza A. Mahmoud, Amira M. Gamal-Eldeen

01/02/2016

Local delivery of antibiotic into injured bone is a demand. In this work, different scaffolds of chitosan (C) with or without bioactive glass (G) were prepared using the freeze-drying technique in 2:1, 1:1 and 1:2 weight ratios. Chitosan scaffolds and selected formulas of chitosan/bioglass were loaded with ciprofloxacin in 5, 10 and 20% w/w. Scaffold morphology showed an interconnected porous structure, where the glass particles were homogeneously dispersed in the chitosan matrix. The kinetic study confirmed that the scaffold containing 1:2 weight ratio of chitosan:glass (CG12) showed optimal bioactivity with good compromise between Ca and P uptake capacities and Si release rate. Chitosan / bioactive glass scaffolds showed larger t50 values indicating less burst drug release followed by a sustained drug release profile compared to those of chitosan scaffolds. The cell growth, migration, adhesion, and invasion were enhanced onto CG12 scaffold surfaces. Samples of CG12 scaffolds with or without 5% drug induced vascular endothelial growth factor (VEGF), while those containing 10% drug diminished VEGF level. Only CG12 induced the cell differentiation (alkaline phosphatase activity). In conclusion, CG12 containing 5% drug can be considered a biocompatible carrier which would help in the localized osteomyelitis treatment.

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Design and in-vitro/in-vivo evaluation of ultra-thin mucoadhesive buccal film containing fluticasone propionate - 01/0

AZZA AHMED MOHAMED MAHMOUD

Ammar, H.O., Ghorab, M. and Mahmoud, A.A., Shahein, H.

01/02/2016

Fluticasone propionate is a synthetic corticosteroid drug distinguished by its potent anti-inflammatory action with low systemic side effects in comparison to other corticosteroids making it a potential drug for local buccal delivery. The aim of the present study was to design mucoadhesive buccal film containing fluticasone that is aesthetically acceptable and could maintain local drug release for a sustained period to manage the sign and symptoms of severe erosive mouth lesions. Solvent casting technique was used in film preparation. Different polymeric blends were used either alone or in combination with mucoadhesive polymers, sodium carboxymethyl cellulose (SCMC), or Carbopol 971P at different concentrations. The physicochemical properties, in vitro mucoadhesion time as well as the drug release properties for all prepared formulations were determined. Selected formulations with adequate properties were further examined by differential scanning calorimetry (DSC) and X-ray diffraction (XRD) and subjected to in vivo evaluation. Films containing hydroxypropyl methylcellulose (HPMC)/ethyl cellulose (EC) showed acceptable physicochemical properties, homogenous drug distribution, convenient mucoadhesion time, moderate swelling as well as sustained drug release up to 12 h. The biological performance of these formulations was assessed on healthy human volunteers and compared with a prepared mouthwash which showed enhanced pharmacokinetic parameters for the selected films in comparison to the mouthwash. The results revealed that the optimized formulation containing HPMC/EC and 10% SCMC could successfully achieve sustained drug release for 10 h which is considered promising for local treatment of severe mouth lesions.

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Nanostructured lipid carriers as semisolid topical delivery formulations for diflucortolone valerate - 01/0

AZZA AHMED MOHAMED MAHMOUD

Abdel-Salam, F. S., Mahmoud, A. A., Ammar, H. O. and Elkheshen, S. A.

01/01/2016

Context: Topical treatment of skin disease needs to be strategic to ensure high drug concentration in the skin with minimum systemic absorption. Objective: The aim of this study was to produce semisolid nanostructured lipid carrier (NLC) formulations, for topical delivery of the corticosteroid drug, diflucortolone valerate (DFV), with minimum systemic absorption. Method: NLC formulations were developed using a high shear homogenization combined with sonication, using Precirol ATO5 or Tristearin as the solid lipid, CapryolTM or isopropyl myristate as the liquid lipid and Poloxamer 407 as surfactant. The present study addresses the influence of different formulations composition as solid lipid, liquid lipid types and concentrations on the physicochemical properties and drug release profile from NLCs. Results and discussion: DFV-loaded NLC formulations possessed average particle size ranging from 160.40 nm to 743.7nm with narrow polydispersity index. The encapsulation efficiency was improved by adding the lipid-based surfactants (Labrasol and Labrafil M1944CS) to reach 68%. The drug release from the investigated NLC formulations showed a prolonged release up to 12 h. The dermatopharmacokinetic study revealed an improvement in drug deposition in the skin with the optimized DFV-loaded NLC formulation, in contrast to a commercial formulation. Conclusion: NLC provides a promising nanocarrier system that work as reservoir for targeting topical delivery of DFV.

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Norfloxacin-loaded collagen/chitosan scaffolds for skin reconstruction: Preparation, evaluation and in-vivo wound healing assessment - 01/1

AZZA AHMED MOHAMED MAHMOUD

Mahmoud, A.A., Salama, A.H.

01/12/2015

Biomaterial scaffolds are versatile tools as drug carrier for treatment of wounds. A series of norfloxacin-loaded scaffolds were synthesized for treatment of wounds by combining collagen with two different types of chitosan using freeze-drying technique. Subsequently, scaffolds were screened in terms of morphology, water absorption and retention capacity, biodegradation, ex-vivo bioadhesive strength, in-vitro drug release biological compatibility, X-ray diffractometry, differential scanning calorimetry as well as in-vivo evaluation. The results indicate that the scaffold mechanical strength is dependent on the type of used chitosan. The prepared scaffolds contained interconnected porous architecture. The scaffolds had high water uptake and retention capacity with extended biodegradation rate. Scaffolds prepared with chitosan HCl showed superior bioadhesive strength compared to those prepared with low molecular weight chitosan. All scaffolds showed almost 100% drug release within 24 h. As identified by the terahertz pulsed imaging measurements, there is single scaffold area with the same concentration. After 28 days of wound dressing with selected norfoloxacin-loaded or unloaded collagen/chitosan scaffolds in Albino rats, it was found that the tissue regeneration time was fast compared to non-treated wounds. Furthermore, the drug-loaded scaffolds showed normal structure of an intact epidermal layer as well as the underlying dermis as revealed by histopathological studies. The obtained results suggest that the investigated norfloxacin-loaded collagen/chitosan scaffold is a potential candidate for skin regeneration application.

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A novel method for preparing surface-modified fluocinolone acetonide loaded PLGA nanoparticles for ocular use: in vitro and in vivo evaluations - 01/1

AZZA AHMED MOHAMED MAHMOUD

Alaa H. Salama, Rabab Kamel

01/11/2015

Our objective was to prepare nanoparticulate system using a simple yet attractive innovated method as an ophthalmic delivery system for fluocinolone acetonide to improve its ocular bioavailability. Poly(lactic-co-glycolic acid) (PLGA) nanoparticles were prepared by adopting thin film hydration method using PLGA/poloxamer 407 in weight ratios of 1:5 and 1:10. PLGA was used in 75/25 and 50/50 copolymer molar ratio of DL-lactide/glycolide. Results revealed that using PLGA with lower glycolic acid monomer ratio exhibited high particle size (PS), zeta potential (ZP) and drug encapsulation efficiency (EE) values with slow drug release pattern. Also, doubling the drug concentration during nanoparticles preparation ameliorated its EE to reach almost 100%. Furthermore, studies for separating the un-entrapped drug in nanoparticles using centrifugation method at 20,000 rpm for 30 min showed that the separated clear supernatant contained nanoparticles encapsulating an important drug amount. Therefore, separation of un-entrapped drug was carried out by filtrating the preparation using 20–25 μm pore size filter paper to avoid drug loss. Aiming to increase the PLGA nanoparticles mucoadhesion ability, surface modification of selected formulation was done using different amount of stearylamine and chitosan HCl. Nanoparticles coated with 0.1% w/v chitosan HCl attained most suitable results of PS, ZP and EE values as well as high drug release properties. Transmission electron microphotographs illustrated the deposition of chitosan molecules on the nanoparticles surfaces. Pharmacokinetic studies on Albino rabbit’s eyes using HPLC indicated that the prepared novel chitosan-coated PLGA nanoparticles subjected to separation by filtration showed rapid and extended drug delivery to the eye.

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A novel method for preparing surface-modified fluocinolone acetonide loaded PLGA nanoparticles for ocular use: in vitro and in vivo evaluations - 01/0

AZZA AHMED MOHAMED MAHMOUD

Salama, A.H., Mahmoud, A.A., Kamel, R.

01/01/2015

Our objective was to prepare nanoparticulate system using a simple yet attractive innovated method as an ophthalmic delivery system for fluocinolone acetonide to improve its ocular bioavailability. Poly(lactic-co-glycolic acid) (PLGA) nanoparticles were prepared by adopting thin film hydration method using PLGA/poloxamer 407 in weight ratios of 1:5 and 1:10. PLGA was used in 75/25 and 50/50 copolymer molar ratio of DL-lactide/glycolide. Results revealed that using PLGA with lower glycolic acid monomer ratio exhibited high particle size (PS), zeta potential (ZP) and drug encapsulation efficiency (EE) values with slow drug release pattern. Also, doubling the drug concentration during nanoparticles preparation ameliorated its EE to reach almost 100%. Furthermore, studies for separating the un-entrapped drug in nanoparticles using centrifugation method at 20,000 rpm for 30 min showed that the separated clear supernatant contained nanoparticles encapsulating an important drug amount. Therefore, separation of un-entrapped drug was carried out by filtrating the preparation using 20-25 μm pore size filter paper to avoid drug loss. Aiming to increase the PLGA nanoparticles mucoadhesion ability, surface modification of selected formulation was done using different amount of stearylamine and chitosan HCl. Nanoparticles coated with 0.1% w/v chitosan HCl attained most suitable results of PS, ZP and EE values as well as high drug release properties. Transmission electron microphotographs illustrated the deposition of chitosan molecules on the nanoparticles surfaces. Pharmacokinetic studies on Albino rabbit's eyes using HPLC indicated that the prepared novel chitosan-coated PLGA nanoparticles subjected to separation by filtration showed rapid and extended drug delivery to the eye

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Diflucortolone valerate loaded solid lipid nanoparticles as a semisolid topical delivery system - 01/0

AZZA AHMED MOHAMED MAHMOUD

Abdel-Salam, F. S., Ammar, H. O., Elkheshen, S. A. and Mahmoud, A. A.

01/01/2015

Solid lipid nanoparticles (SLNs) are promising delivery carriers that have been utilized for formulation and delivery of various drugs. For topical administration, they are usually incorporated into gel or cream to increase their residence time, which is time-consuming process and could affect their stability and characteristics. Preparation of solid lipid nanoparticles (SLNs)-based semisolid formulations could have potential pharmaceutical applications. The aim of this study was to formulate the corticosteroidal drug, diflucortolone valerate (DFV) into topical semisolid SLN formulations using a rapid cheap one-step process. SLN formulations were developed using a high-shear homogenization combined with sonication, using different types of solid lipids (e.g., Geleol®, Preciriol® ATO5, Tristearin® and Compritol® 888ATO) and Poloxamer® 407 as a surfactant. Selection of the lipids and using high lipid concentration were the key elements to get semisolid formulation immediately after sonication without incorporating the nanoparticles into a gel or a cream base. DFV SLN formulations possessed average particle size ranging from 203.71 ± 5.61 to 1421.00 ± 16.32 nm with a narrow size distribution and possessed shear thinning behavior. Incorporation of lipid based surfactants (Labrasol® or Labrafil®) was found to significantly increase DFV encapsulation efficiency (up to 45.79 ± 4.40%). Semisolid DFV-loaded SLN with high drug encapsulation efficiency and acceptable rheological behavior for topical preparation could be prepared in a one-step process.

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Awards

Award Donor Date
Certificate of appreciation for excellence in research output for 2011 from the National Center for Research National Research Center 2011
Scientific Engorgement Award in Science of Pharmacy from the National Research Center for 2011. National Research Center 2011

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