National Organization of Drug Control and Research

Al Jīzah, Egypt

National Organization of Drug Control and Research

Al Jīzah, Egypt

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Eissa S.,Ain Shams University | Shabayek M.I.,National Organization of Drug Control and Research | Ismail M.F.,Cairo University | El-Allawy R.M.,National Organization of Drug Control and Research | Hamdy M.A.,Cairo University
IUBMB Life | Year: 2010

Bladder carcinoma is an important worldwide health problem. Both cystoscopy and urine cytology used in detecting bladder cancer suffer from drawbacks where cystoscopy is an invasive method and urine cytology shows low sensitivity in low-grade tumors. This study validates easier and less time-consuming techniques for the estimation of survivin and TIMP-2 in urine of bladder cancer patients to evaluate them in comparison with cytology. This study includes malignant (bladder cancer patients, n = 42), benign (patients with bilharzial cystitis, n = 22) and healthy (n = 21) groups. The studied groups were subjected to cystoscopic examination, detection of bilharzial antibodies, urine cytology, and estimation of urinary survivin by qualitative RT-nested PCR and TIMP-2 by ELISA. Significantly higher positivity rates of urinary survivin and TIMP-2 were observed in the malignant group compared with benign and healthy groups. On associating the two urinary markers with different clinicopathological factors, only TIMP-2 exerted significantly higher positivity rate in invasive stage (100%) than superficial stage (82.3%). Survivin showed 78.6% sensitivity, 95.3% specificity, 94.3% PPV, 82% NPV, and 87% accuracy. When combined with urine cytology, the sensitivity increased to 83.3%. While on applying the cutoff value of urinary TIMP-2 (<639.5 pg/mg protein), it showed 93% sensitivity, 83.7% specificity, 85% PPV, 92.3% NPV, and 88.2% accuracy. When combined with urine cytology, the TIMP-2 sensitivity remained 93%. On combining cytology with both urinary survivin and TIMP-2, the highest sensitivity was reached (98%). Survivin and TIMP-2 can be considered as potentially useful urine markers in early detection of bladder cancer. © 2010 IUBMB.


Hegazy M.A.E.-M.,Cairo University | Eissa M.S.,Egyptian Russian University | Abd El-Sattar O.I.,National Organization of Drug Control and Research | Abd El-Kawy M.,Cairo University
Spectrochimica Acta - Part A: Molecular and Biomolecular Spectroscopy | Year: 2014

Linezolid (LIN) is determined in the presence of its alkaline (ALK) and oxidative (OXD) degradation products without preliminary separation based on ultraviolet spectrophotometry using two-way chemometric methods; principal component regression (PCR) and partial least-squares (PLS), and three-way chemometric methods; parallel factor analysis (PARAFAC) and multi-way partial least squares (N-PLS). A training set of mixtures containing LIN, ALK and OXD; was prepared in the concentration ranges of 12-18, 2.4-3.6 and 1.2-1.8 μg mL-1, respectively according to a multilevel multifactor experimental design. The multivariate calibrations were obtained by measuring the zero-order absorbance from 220 to 320 nm using the training set. The validation of the multivariate methods was realized by analyzing their synthetic mixtures. The capabilities of the chemometric analysis methods for the analysis of real samples were evaluated by determination of LIN in its pharmaceutical preparation with satisfactory results. The accuracy of the methods, evaluated through the root mean square error of prediction (RMSEP), was 0.058, 0.026, 0.101 and 0.026 for LIN using PCR, PLS, PARAFAC and N-PLS, respectively. Protolytic equilibria of LIN and its degradation products were evaluated using the corresponding absorption spectra-pH data obtained with PARAFAC. The obtained pKa values of LIN, ALK and OXD are 5.70, 8.90 and 6.15, respectively. The results obtained were statistically compared to that of a reported HPLC method, and there was no significant difference between the proposed methods and the reported method regarding both accuracy and precision. © 2014 Elsevier Ltd. All rights reserved.


Hegazy M.A.-M.,Cairo University | Eissa M.S.,Egyptian Russian University | Abd El-Sattar O.I.,National Organization of Drug Control and Research | Abd El-Kawy M.M.,Cairo University
Journal of Pharmaceutical Analysis | Year: 2014

Simple, accurate, sensitive and validated UV spectrophotometric and chemometric methods were developed for the determination of imidapril hydrochloride (IMD) in the presence of both its alkaline (AKN) and oxidative (OXI) degradation products and in its pharmaceutical formulation. Method A is the fourth derivative spectra (D4) which allows the determination of IMD in the presence of both AKN and OXD, in pure form and in tablets by measuring the peak amplitude at 243.0 nm. Methods B, C and D, manipulating ratio spectra, were also developed. Method B is the double divisor-ratio difference spectrophotometric one (DD-RD) by computing the difference between the amplitudes of IMD ratio spectra at 232 and 256.3 nm. Method C is the double divisor-first derivative of ratio spectra method (DD-DR1) at 243.2 nm, while method D is the mean centering of ratio spectra (MCR) at 288.0 nm. Methods A, B, C and D could successfully determine IMD in a concentration range of 4.0-32.0 μg/mL. Methods E and F are principal component regression (PCR) and partial least-squares (PLS), respectively, for the simultaneous determination of IMD in the presence of both AKN and OXI, in pure form and in its tablets. The developed methods have the advantage of simultaneous determination of the cited components without any pre-treatment. The accuracy, precision and linearity ranges of the developed methods were determined. The results obtained were statistically compared with those of a reported HPLC method, and there was no significant difference between the proposed methods and the reported method regarding both accuracy and precision. © 2013 Xi'an Jiaotong University.


El-Ries M.A.,National Organization of Drug Control and Research | Khaled E.,National Research Center of Egypt | Zidane F.I.,Al - Azhar University of Egypt | Ibrahim S.A.,National Organization of Drug Control and Research | Abd-Elmonem M.S.,National Organization of Drug Control and Research
Drug Testing and Analysis | Year: 2012

The catalytic effect of iodide on the oxidation of four dyes: viz. variamine blue (VB), methylene blue (MB), rhodamine B (RB), and malachite green (MG) with different oxidizing agents was investigated for the kinetic spectrophotometric determination of iodide. The above catalyzed reactions were monitored spectrophotometrically by following the change in dye absorbances at 544, 558, 660, or 617 nm for the VB, RB, MB, or MG catalyzed reactions, respectively. Under optimum conditions, iodide can be determined within the concentration levels 0.064-1.27 μg mL -1 for VB method, 3.20-9.54 μg mL -1 for RB method, 5.00-19.00 μg mL -1 for the MB method, and 6.4-19.0 μg mL -1 for the MG one, with detection limit reaching 0.004 μg mL -1 iodide. The reported methods were highly sensitive, selective, and free from most interference. Applying the proposed procedures, trace amounts of iodide in pharmaceutical and edible salt samples were successfully determined without separation or pretreatment steps. © 2011 John Wiley & Sons, Ltd.


El-Gazayerly O.N.,Cairo University | Makhlouf A.I.A.,Cairo University | Soelm A.M.A.,National Organization of Drug Control and Research | Mohmoud M.A.,National Organization of Drug Control and Research
Journal of Microencapsulation | Year: 2014

Milk thistle extract is a well-known hepatoprotectant with low bioavailability (20-50%). The objective of the present study is to prepare and characterize silymarin phytosomes and to test the hepatoprotective effect of the phytosomes in CCl4 induced liver injury in rats compared to milk thistle extract. Phytosomes were prepared using lecithin from soybeans and from egg yolk. The prepared phytosomes were examined using scanning electron microscopy, transmission electron microscopy, differential scanning calorimetry, Fourier transform infrared spectroscopy and proton nuclear magnetic resonance spectroscopy (H1NMR). The loading efficiency was >85% in all phytosomal formulations. Formula P2 (with the molar ratio of soybean lecithin to silybin 1:1) and P4 (with the molar ratio of egg-yolk lecithin to silybin 0.25:1) exhibited significantly (p<0.05) faster release than milk thistle extract. The in vivo study revealed that phytosomes significantly (p<0.05) decreased glutamic pyruvic transaminase and super oxide dismutase activities compared to milk thistle extract. © 2014 Informa UK Ltd.


Mahmoud D.B.,National Organization of Drug Control and Research | Shukr M.H.,National Organization of Drug Control and Research | Bendas E.R.,Cairo University
International Journal of Pharmaceutics | Year: 2014

The current investigation was aimed to improve the solubility of poorly soluble drug, cilostazol (CLZ). Self-nanoemulsifying drug delivery system (SNEDDS) composed of oil, surfactant and co-surfactant for both oral and parenteral administration of CLZ was formulated. The components for SNEDDS were identified by solubility studies, and pseudo-ternary phase diagrams were plotted to identify the efficient self-emulsification regions. The optimum formula, composed of Capryol 90 as an oil phase, Cremophor EL as a surfactant, and Transcutol HP as a co-surfactant in a ratio of 19.8:30.5:49.7 by weight, was able to solubilize CLZ 2000 times higher than its solubility in water. This formula was able to form grade "A" nanoemulsion when diluted with water, resulted in emulsification time of 50 ± 1.1 s, particle size of 14.3 nm, PDI of 0.5 and % transmittance was 97.40% ± 0.65. It showed excellent in vitro dissolution of 93.1% and 81.5% after 5 min in 0.3% sodium lauryl sulphate solution and phosphate buffer pH 6.4, respectively when compared with the marketed tablet formulation and drug suspension as the tablets showed only 44.3% and 9.9% while CLZ suspension showed 33.9% and 8.8% in 0.3% sodium lauryl sulphate solution and phosphate buffer pH 6.4, respectively. It was found to be robust to dilution, thermodynamically stable with low viscosity values of 14.20 ± 0.35 cP. In vivo study revealed significant increase in bioavailability of CLZ in rabbits to 3.94 fold compared with the marketed tablet formulation after oral administration. This formula could be sterilized by autoclaving and did not cause significant hemolysis to human blood which indicates its safety for intravenous administration with a 1.12 fold increase in bioavailability compared with its oral administration. Our study illustrated the potential use of SNEDDS of poorly soluble CLZ orally, and its successful administration of parenterally when required in acute cases of myocardial and cerebral infarction. © 2014 Elsevier B.V. All rights reserved.


Ksiksi T.,United Arab Emirates University | Hamza A.A.,United Arab Emirates University | Hamza A.A.,National Organization of Drug Control and Research
Molecules | Year: 2012

Acridocarpus orientalis (AO) is a traditional medicinal plant used for treatment of inflammatory diseases that may have potential in cancer treatment. In the present study, the aqueous ethanolic crude extract of Acridocarpus aerial parts obtained from Al Ain and Oman were evaluated for their antioxidant capability, polyphenolic content, anti-lipoxygenase and anti-histone deacetylase (HDAC) properties. The total antioxidant capacity was estimated by the FRAP, DPPH, ABTS and β-carotene bleaching assays. Acridocarpus-Al Ain exhibited the highest polyphenol content (184.24 mg gallic acid/g) and the best antioxidant activity (1.1, 1.04, 1.14 mmol ascorbic acid equivalent/g in the FRAP, ABTS and DPPH assays, respectively). Additionally, the same extract showed significant anti-inflammatory properties via lipoxygenase (LOX) inhibitory activity (IC 50 = 50.58 μg/mL). Acridocarpus-Al Ain also showed the strongest histone deacetylase (HDACs) inhibitory activity (IC 50 = 93.28 μg/mL). The results reported here suggest that there was a significant influence of location and the plant may be considered a good source of compounds with antioxidant, anti-LOX and HDAC properties for therapeutic, nutraceutical and functional food applications. © 2012 by the authors.


Hamza A.A.,United Arab Emirates University | Hamza A.A.,National Organization of Drug Control and Research
Food and Chemical Toxicology | Year: 2010

This study was carried out to evaluate the effect of Moringa oleifera Lam (Moringa) seed extract on liver fibrosis. Liver fibrosis was induced by the oral administration of 20% carbon tetrachloride (CCl4), twice weekly and for 8 weeks. Simultaneously, M. oleifera Lam seed extract (1 g/kg) was orally administered daily. The biochemical and histological results showed that Moringa reduced liver damage as well as symptoms of liver fibrosis. The administration of Moringa seed extract decreased the CCl4-induced elevation of serum aminotransferase activities and globulin level. The elevations of hepatic hydroxyproline content and myeloperoxidase activity were also reduced by Moringa treatment. Furthermore, the immunohistochemical study showed that Moringa markedly reduced the numbers of smooth muscle α-actin-positive cells and the accumulation of collagens I and III in liver. Moringa seed extract showed significant inhibitory effect on 1,1-diphenyl-2-picrylhydrazyl free radical, as well as strong reducing antioxidant power. The activity of superoxide dismutase as well as the content of both malondialdehyde and protein carbonyl, which are oxidative stress markers, were reversed after treatment with Moringa. Finally, these results suggested that Moringa seed extract can act against CCl4-induced liver injury and fibrosis in rats by a mechanism related to its antioxidant properties, anti-inflammatory effect and its ability to attenuate the hepatic stellate cells activation. © 2009 Elsevier Ltd. All rights reserved.


Mohamed N.G.,National Organization of Drug Control and Research | Mohamed M.S.,National Organization of Drug Control and Research
Journal of the Chilean Chemical Society | Year: 2010

Spectrophotometric procedures are presented for the determination of the antiparkinsonism drug entacapone. The first method based on the formation of a coloured complex of entacapone with ferric chloride in ethanolic solutions. The coloured product is quantified spectrophotometrically at 665nm. The other Spectrophotometric method determine entacapone in presence of levodopa and carbidopa (which formulated with entacapone in stalevo tablets) by measuring the UV absorbance of entacapone either in zero order at 391nm or in the first order by measuring the amplitude between 360nm and 402nm without any interference from levodopa and carbidopa. HPLC method is described for the separation and determination of entacapone, levodopa and carbidopa on Luna CN 150 × 4.6 column with UV detection at 390nm for entacapone and at 280nm for both levodopa and carbidopa. © 2010.


El-Houssieny B.M.,National Organization of Drug Control and Research | El-Dein E.Z.,National Organization of Drug Control and Research | El-Messiry H.M.,National Organization of Drug Control and Research
Drug discoveries & therapeutics | Year: 2014

Dexibuprofen, is a practically water-insoluble nonsterodial anti-inflammatory drug which has a better anti-inflammatory effect than ibuprofen. A mixed hydrotropic solubilization technique was applied in order to improve the aqueous solubility and dissolution rate of dexibuprofen. Nine formulae were prepared using different concentrations of hydrotropic agents (sodium citrate dihydrate and urea). The prepared formulae were inspected visually for color and odor. Hygroscopicity, micromeretic properties, solubility, and pH for 1% aqueous solutions were determined. In-vitro dissolution studies of the different prepared formulae were performed adopting the USP XXII dissolution method type I basket apparatus method. The prepared formulae were characterized by infrared (IR) spectroscopy and differential scanning calorimetry (DSC). The prepared formulae were a white color, odorless, slightly hygroscopic and exhibited good flow properties. Formulae containing higher amounts of hydrotropic agents exhibited an increase in the pH, solubility, rate and amount of dexibuprofen released from the dissolution medium. The highest dissolution rate was achieved from the F9 formula at drug:sodium citrate dihydrate:urea ratio (1:3:7.5). IR and DSC thermograph of dexibuprofen, hydrotropic agents and prepared formulae indicated the presence of intermolecular interaction between drug and hydrotropic agents which increased solubility and dissolution rate of drug, also, there is no chemical interaction confirming the stability of the drug with hydrotropic agents.

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