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Staff Researches

mina ibrahim tadros

Transdermal delivery of an anti-cancer drug via w/o emulsions based on alkyl polyglycosides and lecithin: design, characterization and in vivo evaluation of the possible irritation potential in rats.

Mina Ibrahim Tadros Ayyad

AAPSPharmSciTech

2011

The purpose of this work was to develop w/o emulsions that could be safely used to promote transdermal delivery of 5-fluorouracil (5-FU). Two pseudo-ternary phase diagrams comprising oleoyl-macrogol glycerides, water and a surfactant/co-surfactant (S/CoS) mixture of lecithin, ethanol and either coco glucoside or decyl glucoside were investigated for their potential to develop promising 5-FU emulsions. Six systems were selected and subjected to thermodynamic stability tests; heat – cool cycles, centrifugation and finally freeze – thaw cycles. All systems passed the challenges and were characterized for transmission electron microscopy, droplet size, rheological behavior, pH and transdermal permeation through newly born mice skin in Franz diffusion cells. The systems had spherical droplets ranging in diameter from 1.81 to 2.97 μm, pH values ranging from 7.50 to 8.49 and possessed Newtonian flow. A significant (P < 0.05) increase in 5-FU permeability parameters as steady-state flux, permeability coefficient was achieved with formula B5 comprising water (5% w/w), S/CoS mixture of lecithin: ethanol: decyl glucoside (14.67: 12.15: 18.18% w/w, respectively) and oleoyl-macrogol glycerides (50% w/w). When applied to shaved rat skin, this system was well tolerated with only moderate skin irritation that was recovered within 12 h. Indeed, minor histopathologic changes were observed after 5-days treatment. Further studies should be carried out, in the future, to investigate the potentiality of this promising system to promote transdermal delivery of 5-FU through human skin.

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Development and in vitro/in vivo evaluation of etodolac controlled porosity osmotic pump tablets

Mina Ibrahim Tadros Ayyad

AAPS PharmSciTech

2011

The aim of the current work was the design and evaluation of etodolac controlled porosity osmotic pump (CPOP) tablets exhibiting zero order release kinetics. Variables influencing the design of (I) core tablets viz., (i) osmogent type (sodium chloride, potassium chloride, mannitol and fructose) and (ii) drug: osmogent ratio (1: 0.25, 1: 0.50 and 1: 0.75)] and (II) CPOP tablets viz., (i) coating solution composition, (ii) weight gain percentage (1 – 5%, w/w) and (iii) pore former concentration (5, 10 and 20%, v/v)] were investigated. Statistical analysis and kinetic modeling of drug release data were estimated. Fructose-containing core tablets showed significantly (P < 0.05) more retarded drug release rates. An inverse correlation was observed between drug: fructose ratio and drug release rate. Coating of the optimum core tablets (F4) with a mixture of cellulose acetate solution (3 %, w/v), diethyl phthalate and polyethylene glycol 400 (85: 10: 5 v/v, respectively) till a 4% w/w weight gain enabled zero order-sustained drug delivery over 24 h. SEM micrographs of coating membrane confirmed pore formation upon contact with dissolution medium. When compared to the commercial immediate release Napilac® capsules, the optimum CPOP tablets (F4 - 34) provided enhanced bioavailability, extended duration of effective etodolac plasma concentration with minimum expected potential for side effects in healthy volunteers.

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Colon-targeted celecoxib-loaded Eudragit(®) S100-coated poly-ϵ-caprolactone microparticles: preparation, characterization and in vivo evaluation in rats.

Mina Ibrahim Tadros Ayyad

journal of Drug Delivery

2011

Context: Celecoxib suffers from low and variable bioavailability following oral administration of solutions or capsules. Recent studies proved that chemoprevention of colorectal cancer is possible with celecoxib. Objective: This work aims to tailor colon-targeted celecoxib-loaded microparticles using time-dependant and pH-dependant coats. Estimation of drug pharmacokinetics following oral administration to fasted rats was another goal. Methods: A 23 factorial design was adopted to develop poly-ε-caprolactone (PCL) celecoxib-loaded microparticles (F1 – F8). To minimize drug-percentages released before colon, another coat of Eudragit® S100 was applied. In vitro characterization of microparticles involved topography, determination of particle size and entrapment efficiency (EE %). Time for 50% drug release (t50%) and drug-percentages released after 2 hours (Q2h) and 4 hours (Q4h) were statistically compared. Estimation of drug pharmacokinetics following oral administration of double-coat microparticles (F10) was studied in rats. Results: PCL-single-coat microparticles were spherical, discrete with a size range of 60.66±4.21 – 277.20±6.10 μm. Direct correlations were observed between surfactant concentration and EE%, Q2h and Q4h. The PCL M.wt. and drug: PCL ratio had positive influences on EE% and negative impacts on Q2h and Q4h. When compared to the best achieved PCL-single-coat microparticles (F2), the double-coat microparticles (F10) showed satisfactory drug protection; Q2h and Q4h were significantly (P < 0.01) decreased from 31.84±1.98% and 54.72±2.10% to 15.92±1.78% and 26.93±2.76%, respectively. When compared to celecoxib powder, F10 microparticles enhanced the bioavailability and extended the duration of drug-plasma concentration in rats. Conclusion: The developed double-coat microparticles could be considered as a promising celecoxib extended-release colon-targeting system.

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Development and in vitro/in vivo evaluation of etodolac controlled porosity osmotic pump tablets

Mina Ibrahim Tadros Ayyad

2011

The aim of the current work was the design and evaluation of etodolac controlled porosity osmotic pump (CPOP) tablets exhibiting zero order release kinetics. Variables influencing the design of (I) core tablets viz., (i) osmogent type (sodium chloride, potassium chloride, mannitol and fructose) and (ii) drug: osmogent ratio (1: 0.25, 1: 0.50 and 1: 0.75)] and (II) CPOP tablets viz., (i) coating solution composition, (ii) weight gain percentage (1 – 5%, w/w) and (iii) pore former concentration (5, 10 and 20%, v/v)] were investigated. Statistical analysis and kinetic modeling of drug release data were estimated. Fructose-containing core tablets showed significantly (P < 0.05) more retarded drug release rates. An inverse correlation was observed between drug: fructose ratio and drug release rate. Coating of the optimum core tablets (F4) with a mixture of cellulose acetate solution (3 %, w/v), diethyl phthalate and polyethylene glycol 400 (85: 10: 5 v/v, respectively) till a 4% w/w weight gain enabled zero order-sustained drug delivery over 24 h. SEM micrographs of coating membrane confirmed pore formation upon contact with dissolution medium. When compared to the commercial immediate release Napilac® capsules, the optimum CPOP tablets (F4 - 34) provided enhanced bioavailability, extended duration of effective etodolac plasma concentration with minimum expected potential for side effects in healthy volunteers.

Download PDF
Transdermal delivery of an anti-cancer drug via w/o emulsions based on alkyl polyglycosides and lecithin: design, characterization and in vivo evaluation of the possible irritation potential in rats

Mina Ibrahim Tadros Ayyad

2011

The purpose of this work was to develop w/o emulsions that could be safely used to promote transdermal delivery of 5-fluorouracil (5-FU). Two pseudo-ternary phase diagrams comprising oleoyl-macrogol glycerides, water and a surfactant/co-surfactant (S/CoS) mixture of lecithin, ethanol and either coco glucoside or decyl glucoside were investigated for their potential to develop promising 5-FU emulsions. Six systems were selected and subjected to thermodynamic stability tests; heat – cool cycles, centrifugation and finally freeze – thaw cycles. All systems passed the challenges and were characterized for transmission electron microscopy, droplet size, rheological behavior, pH and transdermal permeation through newly born mice skin in Franz diffusion cells. The systems had spherical droplets ranging in diameter from 1.81 to 2.97 μm, pH values ranging from 7.50 to 8.49 and possessed Newtonian flow. A significant (P < 0.05) increase in 5-FU permeability parameters as steady-state flux, permeability coefficient was achieved with formula B5 comprising water (5% w/w), S/CoS mixture of lecithin: ethanol: decyl glucoside (14.67: 12.15: 18.18% w/w, respectively) and oleoyl-macrogol glycerides (50% w/w). When applied to shaved rat skin, this system was well tolerated with only moderate skin irritation that was recovered within 12 h. Indeed, minor histopathologic changes were observed after 5-days treatment. Further studies should be carried out, in the future, to investigate the potentiality of this promising system to promote transdermal delivery of 5-FU through human skin.

Download PDF
Colon-targeted celecoxib-loaded Eudragit(®) S100-coated poly-ϵ-caprolactone microparticles: preparation, characterization and in vivo evaluation in rats.

Mina Ibrahim Tadros Ayyad

2011

Context: Celecoxib suffers from low and variable bioavailability following oral administration of solutions or capsules. Recent studies proved that chemoprevention of colorectal cancer is possible with celecoxib. Objective: This work aims to tailor colon-targeted celecoxib-loaded microparticles using time-dependant and pH-dependant coats. Estimation of drug pharmacokinetics following oral administration to fasted rats was another goal. Methods: A 23 factorial design was adopted to develop poly-ε-caprolactone (PCL) celecoxib-loaded microparticles (F1 – F8). To minimize drug-percentages released before colon, another coat of Eudragit® S100 was applied. In vitro characterization of microparticles involved topography, determination of particle size and entrapment efficiency (EE %). Time for 50% drug release (t50%) and drug-percentages released after 2 hours (Q2h) and 4 hours (Q4h) were statistically compared. Estimation of drug pharmacokinetics following oral administration of double-coat microparticles (F10) was studied in rats. Results: PCL-single-coat microparticles were spherical, discrete with a size range of 60.66±4.21 – 277.20±6.10 μm. Direct correlations were observed between surfactant concentration and EE%, Q2h and Q4h. The PCL M.wt. and drug: PCL ratio had positive influences on EE% and negative impacts on Q2h and Q4h. When compared to the best achieved PCL-single-coat microparticles (F2), the double-coat microparticles (F10) showed satisfactory drug protection; Q2h and Q4h were significantly (P < 0.01) decreased from 31.84±1.98% and 54.72±2.10% to 15.92±1.78% and 26.93±2.76%, respectively. When compared to celecoxib powder, F10 microparticles enhanced the bioavailability and extended the duration of drug-plasma concentration in rats. Conclusion: The developed double-coat microparticles could be considered as a promising celecoxib extended-release colon-targeting system.

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13th AARU conference of the Pan Arab Colleges of Pharmacy,

Mina Ibrahim Tadros Ayyad

Misr University for Science and Technology, Cairo, Egypt

2010

Comparative pharmacokinetics of etodolac in healthy human volunteers following oral administration of engineered controlled porosity osmotic pump tablets and immediate release market capsules.

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2nd Scientific Conference of Faculty of Pharmacy,

Mina Ibrahim Tadros Ayyad

Cairo University, Cairo, Egypt

2010

Development and in vivo evaluation of colon-targeted celecoxib-loaded Eudragit(®) S100-coated poly-?-caprolactone microparticles.

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7th world meeting on pharmaceutics, biopharmaceutics and pharmaceutical technology

Mina Ibrahim Tadros Ayyad

Mediterranean Conference center, Valetta, Malta.

2010

Development of controlled porosity osmotic pump tablets of etodolac.

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Controlled-release effervescent floating matrix tablets of ciprofloxacin hydrochloride: Development, optimization and in vitro-in vivo evaluation in healthy human volunteers

Mina Ibrahim Tadros Ayyad

2010

Ciprofloxacin hydrochloride has a short elimination half-life, a narrow absorption window and is mainly absorbed in proximal areas of GIT. The purpose of this study was to develop a gastroretentive controlled release drug delivery system with swelling, floating, and adhesive properties. Ten tablet formulations were designed using hydroxypropylmethylcellulose (HPMC K15M) and/or sodium alginate (Na alginate) as release retarding polymer(s) and sodium bicarbonate (NaHCO3) or calcium carbonate (CaCO3) as a gas former. Swelling ability, floating behaviour, adhesion period and drug release studies were conducted in 0.1 N HCl (pH 1.2) at 37 ± 0.5 ºC. The tablets showed acceptable physicochemical properties. Drug release profiles of all formulae followed non-Fickian diffusion. Statistical analyses of data revealed that tablets containing HPMC K15M (21.42%, w/w), Na alginate (7.14%, w/w) and NaHCO3 (20%, w/w) [formula F7] or CaCO3 (20%, w/w) [formula F10] were promising systems exhibiting excellent floating properties, extended adhesion periods and sustained drug release characteristics. Both formulae were stored at 40 ºC / 75% R.H for 3 months according to ICH guidelines. Formula F10 showed better physical stability. Abdominal X-ray imaging of formula F10, loaded with barium sulfate, in 6 healthy volunteers revealed a mean gastric retention period of 5.50 ± 0.77 h.

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Controlled-release effervescent floating matrix tablets of ciprofloxacin hydrochloride: Development, optimization and in vitro-in vivo evaluation in healthy human volunteers.

Mina Ibrahim Tadros Ayyad

Eur J Pharm Biopharm

2010

Ciprofloxacin hydrochloride has a short elimination half-life, a narrow absorption window and is mainly absorbed in proximal areas of GIT. The purpose of this study was to develop a gastroretentive controlled release drug delivery system with swelling, floating, and adhesive properties. Ten tablet formulations were designed using hydroxypropylmethylcellulose (HPMC K15M) and/or sodium alginate (Na alginate) as release retarding polymer(s) and sodium bicarbonate (NaHCO3) or calcium carbonate (CaCO3) as a gas former. Swelling ability, floating behaviour, adhesion period and drug release studies were conducted in 0.1 N HCl (pH 1.2) at 37 ± 0.5 ºC. The tablets showed acceptable physicochemical properties. Drug release profiles of all formulae followed non-Fickian diffusion. Statistical analyses of data revealed that tablets containing HPMC K15M (21.42%, w/w), Na alginate (7.14%, w/w) and NaHCO3 (20%, w/w) [formula F7] or CaCO3 (20%, w/w) [formula F10] were promising systems exhibiting excellent floating properties, extended adhesion periods and sustained drug release characteristics. Both formulae were stored at 40 ºC / 75% R.H for 3 months according to ICH guidelines. Formula F10 showed better physical stability. Abdominal X-ray imaging of formula F10, loaded with barium sulfate, in 6 healthy volunteers revealed a mean gastric retention period of 5.50 ± 0.77 h.

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Design and in vitro/in vivo evaluation of novel nicorandil extended release matrix tablets based on hydrophilic interpolymer complexes and a hydrophobic waxy polymer.

Mina Ibrahim Tadros Ayyad

Eur J Pharm Biopharm

2008

The purpose of this work was to develop an extended release matrix tablet of nicorandil; a freely water soluble drug used in cardiovascular diseases. Chitosan (CH) / hyaluronate sodium (HA), pectin (PE) or alginate sodium (AL) interpolymer complexes (IPCs) were prepared. The optimum IPCs (CH: HA, 40: 60), (CH: PE, 30: 70) and (CH: AL, 20: 80) were characterized by Fourier transform infrared spectroscopy. The IPCs were based on electrostatic interactions between protonated amine groups of CH and carboxylate groups of HA, PE or AL. Nicorandil matrix tablets were prepared using the optimum IPCs, alone or in combination with Imwitor® 900 K. Evaluations such as weight variation, thickness, content uniformity, friability, disintegration and in vitro release studies were performed. The tablets showed acceptable pharmacotechnical properties and complied with compendial requirements. Results of the dissolution studies revealed that formula F11 (CH: AL, 20: 80) IPC: Imwitor® 900 K, 3: 1) could extend drug release > 8h. Most formulae exhibited non-Fickian diffusion drug release profiles. When compared to the immediate release Ikorel® tablet, the duration of effective nicorandil therapeutic concentration from formula F11, in healthy human volunteers, was significantly (P<0.05) extended from 4 to 8h with expected lowering in side effects potential.

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