National Organization of Drug Control and Research NODCAR

Al Jīzah, Egypt

National Organization of Drug Control and Research NODCAR

Al Jīzah, Egypt
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PubMed | Damanhour University, Egyptian Russian University and National Organization of Drug Control and Research NODCAR
Type: | Journal: Journal of chromatography. B, Analytical technologies in the biomedical and life sciences | Year: 2016

Fast and sensitive HPLC method was developed, optimized and validated for quantification of linezolid (LNZ) in human plasma using guaifenesin as an internal standard (IS). Analyte and IS were extracted from plasma by simple protein precipitation extraction technique using methanol as the precipitating solvent. The pretreated samples were injected in a mobile phase formed of acetonitrile:water:methanol (20:70:10v/v/v) in an isocratic mode at a flow rate of 1.5mL/min with UV detection at 251nm. Separation was done using Aglient ODS C


Sanad R.A.,National Organization of Drug Control and Research NODCAR | Malak N.S.A.,Cairo University | El-Bayoomy T.S.,National Organization of Drug Control and Research NODCAR | Badawi A.A.,Cairo University
Drug Discoveries and Therapeutics | Year: 2010

The objective of the current study was to formulate solid lipid nanoparticles of oxybenzone to enhance its sunscreening efficacy while reducing its side effects. Solid lipid nanoparticles (SLNs) of oxybenzone were prepared by the solvent diffusion method. A complete 24 factorial design was used to optimize preparations. The study design involves the investigation of four independent variables, namely lipid type (Glyceryl monostearate, GMS; and Witepsol E85, WE85), lipid concentration (5 and 10%), polyvinyl alcohol (PVA) concentration (1 and 2%), and ethanol/acetone ratios (1:1 and 3:1, v/v), in terms of their effect on the particle size and entrapment efficiency. GMS was found to significantly increase the p.s. and EE%. SLNs prepared using 10% lipid had slower drug release compared to those prepared using 5%. The candidate oxybenzone-loaded SLN formula (SLN2) consisting of 0.5% oxybenzone, 10% GMS, 1% PVA, and ethanol/acetone (1:1, v/v) was then formulated into a gel and compared to the corresponding free oxybenzone nanosuspension and placebo SLN. The formulations were evaluated for skin irritation, in vitro sun protection factor, and ultraviolet A protection factors. The incorporation of oxybenzone into solid lipid nanoparticles greatly increased the SPF and UVA protection factor of oxybenzone more than five-fold while providing the advantage of overcoming skin irritancy problems.


Mohareb R.M.,Cairo University | Wardakhan W.W.,National Organization of Drug Control and Research NODCAR | Elmegeed G.A.,National Research Center of Egypt | Ashour R.M.S.,Cairo University
Steroids | Year: 2012

Pregnenolone (1) was used as a template to develop new anticancer compounds. Ring D modification of 1 through its reaction with 4-phenyl-3-thiosemicarbazide gave the thiosemicarbazone derivative 3. The latter compound underwent heterocyclization reactions to give the thiazolyl hydrazonoandrostane and pyrazolyl semicarbazidoandrostane derivatives 5a-d, and 9a-d, respectively. On the other hand compound 1 reacted with either malononitrile or ethyl cyanoacetate to give the Knoevenagel condensated products 11a and 11b, respectively. Compounds 11a,b afforded the thiophenyl pregnane derivatives 12a and 12b, respectively, their reactivity toward some chemical reagents was studied. The cytotoxicity of the newly synthesized heterocyclic steroids against three human tumor cell lines namely breast adenocarcinoma (MCF-7), non-small cell lung cancer (NCI-H460) and CNS cancer (SF-268) were studied. Some of tested compounds were found to exhibit much higher inhibitory effects toward the three tumor cell lines than the reference drug, doxorubicin. © 2012 Elsevier Inc. All rights reserved.


Georgy G.S.,National Organization of Drug Control and Research NODCAR | Nassar N.N.,Cairo University | Mansour H.A.,National Organization of Drug Control and Research NODCAR | Abdallah D.M.,Cairo University
PLoS ONE | Year: 2013

Cerebrolysin (CBL), a mixture of several active peptide fragments and neurotrophic factors including brain-derived neurotrophic factor (BDNF), is currently used in the management of cognitive alterations in patients with dementia. Since Cognitive decline as well as increased dementia are strongly associated with diabetes and previous studies addressed the protective effect of BDNF in metabolic syndrome and type 2 diabetes; hence this work aimed to evaluate the potential neuroprotective effect of CBL in modulating the complications of hyperglycaemia experimentally induced by streptozotocin (STZ) on the rat brain hippocampus. To this end, male adult Sprague Dawley rats were divided into (i) vehicle- (ii) CBL- and (iii) STZ diabetic-control as well as (iv) STZ+CBL groups. Diabetes was confirmed by hyperglycemia and elevated glycated haemoglobin (HbA1c%), which were associated by weight loss, elevated tumor necrosis factor (TNF)-α and decreased insulin growth factor (IGF)-1β in the serum. Uncontrolled hyperglycemia caused learning and memory impairments that corroborated degenerative changes, neuronal loss and expression of caspase (Casp)-3 in the hippocampal area of STZ-diabetic rats. Behavioral deficits were associated by decreased hippocampal glutamate (GLU), glycine, serotonin (5-HT) and dopamine. Moreover, diabetic rats showed an increase in hippocampal nitric oxide and thiobarbituric acid reactive substances versus decreased non-protein sulfhydryls. Though CBL did not affect STZ-induced hyperglycemia, it partly improved body weight as well as HbA1c%. Such effects were associated by enhancement in both learning and memory as well as apparent normal cellularity in CA1and CA3 areas and reduced Casp-3 expression. CBL improved serum TNF-α and IGF-1β, GLU and 5-HT as well as hampering oxidative biomarkers. In conclusion, CBL possesses neuroprotection against diabetes-associated cerebral neurodegeneration and cognitive decline via anti-inflammatory, antioxidant and antiapototic effects. © 2013 Georgy et al.


PubMed | October 6 University, Cairo University and National Organization of Drug Control and Research NODCAR
Type: | Journal: AAPS PharmSciTech | Year: 2016

The aim of this study was to develop a novel double-layer bi-medicated prolonged release mucoadhesive buccal film (MBF) containing lidocaine hydrochloride (LC) and diclofenac potassium (DK). The ultimate goal of the prepared system is the treatment of radiation-induced oral mucositis pain with improved patient acceptance. MBFs were prepared using 32


Abo Enin H.A.,Taif University | Abo Enin H.A.,National Organization of Drug Control and Research NODCAR
Drug Development and Industrial Pharmacy | Year: 2015

Aim: The aim is improving the antihyperlipidemic activity of Rosuvastatin Calcium (Rs) through improving its solubility using self-nanoemulsifying drug delivery system (SNEDDS) containing natural oil full of unsaturated fatty acid and omega 3. Methods: A 7 × 32 full factorial design was adopted for optimization of oil ratio, Surfactant: Co-surfactant (S:CoS) ratio and oil:S/CoS ratio. Ternary phase diagrams were constructed for optimizing the system with drug loading (10 and 20%). The optimized SNEDD systems were evaluated according to their physical evaluation and drug release. Furthermore, the anti-hyperlipidemia efficacy was compared with commercially marketed product on rates followed by clinical study. Results: The system containing Tween 80:PEG 400 (3:1) and olive oil:garlic oil (1:1) as an oily phase has droplet size less than 100 nm, ZP (+23.43 ± 2.58 mV), PDI (<0.02) and cloud point (>90 °C). In vitro drug release studies showed remarkable enhancement of the Rs release from Rs-SNEDDS. The antihyperlipidemic effect of Rs-SNEDDS is greater than that of the commercial tablets and the pure drug on rates and in hyperlipidemic patients. Conclusion: Rs-SNEDDS is a promising drug delivery system for improving the drug solubility and antihyperlipidemic effect using natural oils as (olive oil and garlic oil). © 2014 Informa Healthcare USA, Inc. All rights reserved: reproduction in whole or part not permitted.


Sanad R.A.B.,National Organization of Drug Control and Research NODCAR | Mabrouk M.I.,National Organization of Drug Control and Research NODCAR
Drug Development and Industrial Pharmacy | Year: 2016

Context: Garlic oil and Eruca oil have been reported to have excellent antimicrobial activity. However, the exact knowledge of their required hydrophilic–lipophilic balance (rHLB) values to facilitate their emulsification are still not reported in the literature. Objective: The objective of this study is to determine rHLB values of Garlic and Eruca oils to formulate an elegant stable cream formulation enriched with both oils. Materials and methods: Emulsions of both oils were prepared by the bottle method using water, Tween 80 and Span 80. Formulated emulsions were evaluated for creaming index (CI), droplet size, and turbidity to determine rHLB. Utilizing determined rHLB, creams were formulated using a combination of two surfactants, Span 60:Brij 58 (1:2.333) at three different concentrations (2, 4, and 6%). Results: rHLB of Garlic oil and Eruca oil was determined to be 7.92 ± 0.27 and 9.76 ± 0.32, respectively. Stable cream (F1) developed with 2% surfactant blend showed elegant rheological properties, the best antimicrobial activity against Staphyococcus aureus ATCC29737, Escherichia coli ATCC25299 S. aureus (MRSA), Malassezia fufur AUMC No. 5173 with no skin irritation. In addition, its texture parameters and pH were found to be consistent over 12 months at 25 ± 1ºC and 60% relative humidity. Discussion: The lowest CI, smallest droplet size, and highest turbidity were obtained at the optimum surfactant concentration in the prepared emulsions. Increasing surfactant blend concentration in cream formulations leads to increasing viscosity and consequently decreasing antimicrobial activity. Conclusion: Determination of the rHLB of Garlic and Eruca oils allows the ease of preparation of stable, consistent, and non-irritant cream. © 2015 Taylor & Francis.


Hanaa-Mansour A.,National Organization of Drug Control and Research NODCAR | Hassan W.A.,National Organization of Drug Control and Research NODCAR | Georgy G.S.,National Organization of Drug Control and Research NODCAR
Brain Research | Year: 2016

Systemic bacterial infection results in systemic inflammatory response syndrome due to the release of lipopolysaccharide (LPS) in blood that can lead to multiple organ failure, shock, and potentially death. Other impact, LPS exposure produces robust increase in anxiety-like behavior, suppression of locomotor, exploratory activity, and reduced social behavior. The therapeutic use of glucocorticoids in septic shock remains one of the first-aid approaches for their anti-inflammatory properties. The aim of this study was to evaluate the possible protective effect of dexamethazone (DEX), the most commonly used corticosteroid, against Escherichia coli (E. coli) immunohistochemical changes and neurobehavioral dysfunction. To this end, male Sprague-Dawley rats were divided into four groups; (1) Control group (2) E. coli infected group, where animals received 0.2 ml of 24 h growth of E. coli suspension in nutrient broth containing approximately 1.8×108 cfu/ml i.p for once, 48 h before sacrificing (3) DEX (20 mg/kg, i.p, 3 days) treated group (4) DEX and E. coli treated group. The results revealed that DEX significantly protected animals against most E. coli-induced behavioral deficits, reduced signs of cognitive impairment. DEX also reduced the LPS-evoked rise in C-reactive protein (CRP), Interferon gamma (IFγ), as well as, expression of Caspase-3. In conclusion, DEX provides neuroprotection against E. coli-associated neurobehavioral and immunological changes via its anti-inflammatory and immunomodulatory effects. © 2015 Elsevier B.V.


PubMed | National Organization of Drug Control and Research NODCAR
Type: Journal Article | Journal: PloS one | Year: 2016

Cerebrolysin (CBL), a mixture of several active peptide fragments and neurotrophic factors including brain-derived neurotrophic factor (BDNF), is currently used in the management of cognitive alterations in patients with dementia. Since Cognitive decline as well as increased dementia are strongly associated with diabetes and previous studies addressed the protective effect of BDNF in metabolic syndrome and type 2 diabetes; hence this work aimed to evaluate the potential neuroprotective effect of CBL in modulating the complications of hyperglycaemia experimentally induced by streptozotocin (STZ) on the rat brain hippocampus. To this end, male adult Sprague Dawley rats were divided into (i) vehicle- (ii) CBL- and (iii) STZ diabetic-control as well as (iv) STZ+CBL groups. Diabetes was confirmed by hyperglycemia and elevated glycated haemoglobin (HbA1c%), which were associated by weight loss, elevated tumor necrosis factor (TNF)- and decreased insulin growth factor (IGF)-1 in the serum. Uncontrolled hyperglycemia caused learning and memory impairments that corroborated degenerative changes, neuronal loss and expression of caspase (Casp)-3 in the hippocampal area of STZ-diabetic rats. Behavioral deficits were associated by decreased hippocampal glutamate (GLU), glycine, serotonin (5-HT) and dopamine. Moreover, diabetic rats showed an increase in hippocampal nitric oxide and thiobarbituric acid reactive substances versus decreased non-protein sulfhydryls. Though CBL did not affect STZ-induced hyperglycemia, it partly improved body weight as well as HbA1c%. Such effects were associated by enhancement in both learning and memory as well as apparent normal cellularity in CA1and CA3 areas and reduced Casp-3 expression. CBL improved serum TNF- and IGF-1, GLU and 5-HT as well as hampering oxidative biomarkers. In conclusion, CBL possesses neuroprotection against diabetes-associated cerebral neurodegeneration and cognitive decline via anti-inflammatory, antioxidant and antiapototic effects.


PubMed | National Organization of Drug Control and Research NODCAR
Type: Journal Article | Journal: Expert opinion on drug delivery | Year: 2016

This study aims to illustrate the applicability of solid supersaturated self-nanoemulsifying drug delivery system (sat-SNEDDS) for the improvement of rosuvastatin calcium (RC) oral bioavailability.Different sat-SNEDDS were prepared by incorporating different ratios of RC into SNEDDS using tween80/PEG400 (77.2%) as surfactant/cosurfactant mixture and garlic /olive oil (22.8%) as oil phase. The prepared systems were characterized viz; size, zeta potential, TEM and stability. Various hydrophilic and hydrophobic carriers were employed to solidify the optimized RC sat-SNEDDS. The influence of the carrier was investigated by SEM, XRPD, DSC, flow properties, in vitro precipitation, drug release and oral bioavailability study.The adsorption of the stable positively charged nanocarrier RC sat-SNEDDS onto solid carriers provided free flowing amorphous powder. The carrier could amend the morphological architecture and in vitro release of the RC solid sat-SNEDDS. Hydrophobic carriers as microcrystalline cellulose 102 (MCC) showed superior physical characters and higher dissolution rate over hydrophilic carriers as maltodextrin with respective TSolid MCC-sat-SNEDDS combined dual benefits of sat-SNEDDS and solid dosage form was successfully optimized to improve RC oral bioavailability.

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