The Possible Cardio-Protective Effects of Ethanolic Artichoke Extract against 5- Fluorouracil Induced Cardiac Toxicity in RatsDesign, Synthesis and Kinetic Study of Coumarin-Based Mutual Prodrug of 5-Fluorouracil and Dichloroacetic acidEstimation of Oxidative Stress and Some Trace Elements in Iraqi Men Patients with Type 2 Diabetes MellitusDetection of Serum Ferritin in Women with Breast Cancer Effect of Metformin Treatment on some Blood Biomarkers in Women with Endometriosis.Gestational Diabetes Mellitus and Hormonal AlterationThe Spectrophotometric Determination of Olanzapine via Coupling with Diazotized p-NitroanilineTrend of Antibiotics Usage in the Intensive Care Unit in the Medical City in BaghdadFormulation and Evaluation of Nystatin Microparticles as a Sustained Release SystemFormulation and Evaluation of Ezetimibe Nanoparticles Evaluation of Poisoning Cases in the Poisoning Consultation Center and Forensic Medicine Institute within Baghdad areaPotentiometric Transducers for the Selective Recognition of Risperidone Based on Molecularly Imprinted PolymerPhytochemical Study of Steroidal Sapogenin “Tigogenin” Present in the Leaves of Agave americana Cultivated in IraqThe Effect of L-Carnitine as an Adjuvant Supplement on Lipid Profile in Iraqi Diabetic PatientsPreparation and Characterization of Montelukast Sodium ( SMLT ) as a Dual Sustained Release Buccal StripsMeasurement of Serum Trace Elements (Zinc, Copper, Magnesium and Iron) Concentrations in Pediatric Patients with Otitis MediaFormulation and Evaluation of Domperidone Nanoemulsions for Oral RoutPhytochemical and Pharmacological Study of Valepotriates in Valeriana officinalis L. F.Valerianeceae Cultivated in IraqStudy the Influence of Captopril on Bone Metabolism in Elderly Hypertensive WomenHypolipidemic Effect of Caffeic Acid Isolated From Arctium Lappa Cultivated In Iraq, in Hyperlipidemic Rat ModelSpectrophotometric Determination of Clonazepam in Pure and Dosage forms using Charge Transfer ReactionPreparation, Characterization and Prophylactic Study of New Microsphere Containing Doxycycline against Diseases of ShrimpIsolation and Characterization of Iridoid Glycoside (Gardenoside) Present in the Leaves of Gardenia jasminoides J.Ellis Cultivated in IraqSynthesis of some Novel Nitrogenous Heterocyclic Compounds with Expected Biological Activity as Antimicrobial and Cytotoxic Agents.Synthesis and Antibacterial Activity of bis Heterocyclic Derivatives of 1,3,4-thiadiazolePhytochemical Investigation and Antioxidant Activity of Iraqi Tribulus terrestrisDesign, Synthesis, Characterization and Preliminary Anticancer Study for Methotrexate Silibinin ConjugatesDesign, Synthesis and Preliminary Antimicrobial Evaluation of New Derivatives of CephalexinPreparation and Evaluation of Cefixime NanocrystalsEvaluation of the Clinical use of Metformin or Pioglitazone in Combination with Meloxicam in Patients with Knee Osteoarthritis; using Knee Injury and Osteoarthritis outcome ScoreIsolation and Characterization of Triterpenoid Saponin Hederacoside C. Present in the Leaves of Hedera helix L. Cultivated in IraqSynthesis of New β-adrenoceptor Blocking Agent Including 1,3,4 Thiadiazole with Expected Adrenoceptor Blocking ActivityLipid Profile and Fasting Blood Sugar Analysis in Patients with CholelithiasisAssociation of Oxidative Stress Markers with CholelithiasisPreparation and Evaluation of Meloxicam Microsponges as Transdermal Delivery SystemSynthesis, Characterization, and Antimicrobial Evaluation of New Ceftriaxone DerivativesEvaluation of Protective Effect of Different Doses of Terminalia arjuna Bark Ethanolic Extract on Cisplatin Induced Oxidative Nephrotoxicity in RatsQuality of Life of Patients with Type II Diabetes Mellitus in Al- Hilla City-IraqSynthesis and Antimicrobial Study of Possible Mutual Prodrugs of Amoxicillin and Metronidazole by Direct and Indirect Coupling through SpacerEvaluation of Rosuvastatin Effect as Adjuvant Therapy to Methotrexate on Lipid Profile and the Possibility of its Cardioprotective Effect in Iraqi Patients with Active Rheumatoid ArthritisMeasurement of some Biochemical Values in Hemodialysis Patients in BaghdadMeasurement of some Biochemical Values in Hemodialysis Patients in BaghdadPreparation and in-Vitro Evaluation of Mucoadhesive Clotrimazole Vaginal HydrogelPhytochemical Investigation of Alkaloids in the Iraqi Echinops heterophyllus (Compositae)Synthesis and Antimicrobial Evaluation of New 6 and7 Substituted Derivatives of CoumarinPreparation, Characterization, and in - vivo Evaluation of Daptomycin Poly(D,L-lactide-co-glycolide) MicrospheresFormulation and Evaluation of Flurbiprofen Oral FilmBioequivalence and Pharmacokinetics of Two Formulations of Amlodipine Tablets in Healthy SubjectsDetection of Helicobacter Pylori IgG and IgA , Serum Biomarkers CA19-9 and CEA in Patients with Gastrointestinal DiseasesGuggulusome - A Novel Vesicular Carriers for Enhanced Transdermal Delivery



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Volume:24 Issue2:-2015

Formulation and Evaluation of Nystatin Microparticles as a Sustained Release System
Sara T.Ismail, Myasar M. Al-Kotaji and Ahlam A. Khayrallah

Nystatin is the drug of choice for treatment of cutaneous fungal infections with main disadvantage that is the need for multiple applications to achieve complete eradication which may reduce patient compliance. Microparticles offer a solution for such issue as they are one of sustained release preparations that achieve slow release of drug over an extended period of time. The objectives of this study were to fabricate nystatin-loaded chitosan microparticles with the ultimate goal of prolonging drug release and to analyze the influence of polymer concentration on various properties of microparticles. Microparticles were prepared by chemical cross-linking method using glutaraldehyde as cross-linking agent. Five formulas, namely N1C1, N1C2, N1C3, N1C4 and N1C5, were prepared and the effect of drug to polymer ratio was studied with respect to drug loading, encapsulation efficiency, particle size and morphology. Furthermore the prepared microparticles were subjected to various physico-chemical studies, such as drug- polymer compatibility by Fourier Transform Infrared Spectroscopy (FTIR) and in-vitro drug release characteristics. Microparticles obtained from N1C1, N1C2 and N1C3 formulas were regular in shape with mean particle size ranging between 1µm and 10µm. N1C5 formula was resulted in particles with irregular shape while N1C4 showed a blend of microparticles and deformed particles. The effect of chitosan concentration on drug loading and entrapment efficiency was studied. The results showed increment in these parameters that was directly proportional to the increment in polymer concentration. Percentage yield showed a significant increment which was related to the increment in the ratio of chitosan used during the study. FTIR results showed no interactions between nystatin and chitosan. DSC studies proved the crystalline nature of nystatin and chitosan. On other hand, the thermogram of loaded microparticles showed the absence of endothermic peak corresponding to nystatin which may indicate the loss of the crystalline nature of the drug presented inside the microparticles. In- vitro release studies resulted in 95.6% release of nystatin for N1C1 after 15 hours. N1C1 appeared to be promising in formulating microparticles that provide nearly complete release of the drug within15 hours. This formula can be selected in future work to be formulated as topical gel that prolongs the release of nystatin.

Keywords: Nystatin, Chitosan, Glutaraldehyde, Chemical cross-linking.

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Formulation and Evaluation of Ezetimibe Nanoparticles
Yasser A.Ali and Shaimaa N. Abd-Alhammid

The aim of this study is to formulate and evaluate ezetimibe nanoparticles using solvent antisolvent technology. Ezetimibe is a practically water-insoluble drug which acts as a lipid lowering drug that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. Ezetimibe prepared as nano particles in order to improve its solubility and dissolution rate. Thirty formulas were prepared and different stabilizing agents were used with different concentrations such as poly vinyl pyrrolidone (PVPK-30), poly vinyl alcohol (PVA), hydroxy propyl methyl cellulose E5 (HPMC), and poloxamer. The ratios of drug to stabilizers used to prepare the nanoparticles were 1: 2, 1:3 and 1:4. The prepared nanoparticles were evaluated for particle size, entrapment efficiency, dissolution study, Fourier transform infrared spectroscopy, differential scanning calorimetry, and atomic force microscopy. The percentage of drug entrapment efficiency of F1-F30 was ranged from 85% ± 1 to 98 % ± 1. On the other hand dissolution rate increasing as the particle surface area is increase due to reduction of particle size to the nano range. The results showed that poly vinyl pyrrolidone (PVPK-30) was found to be the best stabilizer.

Keywords: Ezetimibe, Nanoparticles, Particle Size, poly vinyl alcohol.

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Evaluation of Poisoning Cases in the Poisoning Consultation Center and Forensic Medicine Institute within Baghdad area
Faris H.Maedie , Hasan Alhaddadand Saad A. Hussain

Social factors may affect the available sources of toxic substances and causes of poisoning, and these factors may change over time. Additionally, understanding the characteristics of poisoning cases is important for treating such patients. Therefore, the present study investigated the characteristics of poisoning cases in Baghdad Poisoning Consultation Center (PCC) and Forensic Medicine Institute (FMI). Data on all poisoning cases reported in PCC and FMI during 2013 were retrospectively obtained from medical records. Total of 1131 reports of poisoning cases (1082 from PCC and 49 from FMI) were analyzed according to age, sex, geographical distribution and causes of poisoning according to the type and class of poisoning agent. The results showed that most of the poisoning case are from urban area, and the incidence in male is greater than that in females. In both centers, the higher percent of poisoning occurred within the age range 11-20 years. Regarding the type of poisons, zinc sulphide and carbon monoxide represent the cause of poisoning reported in MFI, while metals (mostly copper) and drugs (mostly CNS depressants) represent the major causes of toxicity reported in PCC. In conclusion, among the elements that are common between the two centers are the age distribution of the cases. Rodenticides and metals represent the major causes of poisoning cases reported in Baghdad during 2013. The study results suggest that it is necessary to continuously collect data of patients admitted to emergency departments with toxic poisoning at multiple centers.

Keywords: Poisoning, Consultation center, Forensic medicine.

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Potentiometric Transducers for the Selective Recognition of Risperidone Based on Molecularly Imprinted Polymer
Najwa I. Abdulla and Hamsa M.Yaseen

Graphite Coated Electrodes (GCE) based on molecularly imprinted polymers were fabricated for the selective potentiometric determination of Risperidone (Ris). The molecularly imprinted (MIP) and nonimprinted (NIP) polymers were synthesized by bulk polymerization using (Ris.) as a template, acrylic acid (AA) and acrylamide (AAm) as monomers, ethylene glycol dimethacrylate (EGDMA) as a cross-linker and benzoyl peroxide (BPO) as an initiator. The imprinted membranes and the non-imprinted membranes were prepared using dioctyl phthalate (DOP) and Dibutylphthalate (DBP) as plasticizers in PVC matrix. The membranes were coated on graphite electrodes. The MIP electrodes using (AA) and (AAm) showed a near nernstian and nernstian response with slopes of 55.2±0.1 and 59.0±0.2 mV/decade, correlation coefficient (r2) 0.9997 and 0.9999, a linear response for a concentration range of (1.0×10-6 - 1.0×10-2) M and (5.0x 10-7 to 1.0 x 10-2) M respectively. The response time of the prepared electrodes was less than 30 seconds. The electrode responses were stable in a pH range (4-8). The electrodes exhibited good selectivity over a wide range of interference. The most effective electrode (Ris-MIP GCE) was used to determine the concentration of (Ris.) in some pharmaceutical formulations. The electrodes could be successfully used within (7and13) weeks respectively without any drift. Keywords: Ion-selective electrodes, Molecularly imprinted polymer, PVC membrane coated graphite electrode, Risperidone.

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Phytochemical Study of Steroidal Sapogenin “Tigogenin” Present in the Leaves of Agave americana Cultivated in Iraq
Ruaa M. Abrahem and Zainab J. Awad

The presence of the most important steroidal sapogenin “Tigogenin” in the leaves of Agave americana cultivated in Iraq was detected. The absence of any study concerning the Tigogenin content of this medicinal plant in Iraq, and the industrial importance of Tigogenin depending on its role as a precursor in the synthesis of some steroidal drugs, acquired this study its value. This search include extraction, isolation, purification and dentification of Tigogenin from the leaves of Agave americana. Extraction of this compound was carried out using two methods. Identification of this compound is carried out by using thin layer chromatography (TLC) where three different mobile phase have been used. Detection is done by using Libermann – Burchard reagent .High performance liquid chromatography (HPLC) is also used for further identification of tigogenin and then this steroidal saponin was isolated and purified. Isolated Tigogenin is identified by using Thin layer chromatography (TLC), melting point (M.P.), Infrared spectroscopy (IR) and High performance liquid chromatography (HPLC) . This study confirms the presence of Tigogenin in the leaves of Agave americana cultivated in Iraq. Also the result of this study showed that the second extraction method is better, because the amount of both tigogenin and extract obtained from method No.2 are more than one extraction method.

Key words : Agave americana , Steroidal saponin , Tigogenin.

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The Effect of L-Carnitine as an Adjuvant Supplement on Lipid Profile in Iraqi Diabetic Patients
Wessam M. Shiblawi and Sajida H.Ismael

Diabetes is a complex set of diseases require continuous medical care, to control blood sugar and prevent complications is .The aim of this research is to determine the effect of administration of L carentin to diabetics on the lipid profile. The research was conducted on sixty diabetic patients were selected from endocrinology and diabetes center / Al-Rusafa, within selected criteria. The patients divided into 3 groups (control group of healthy people and two groups of patients with diabetes who were on metformin and glibenclamide, one group took a L carnitine in a dose of 1000 mg twice daily and a group dealing with a placebo for a period of 3 months continuously). The study found that patients who took Lcarnitine, showed a significant reduction (p <0.05) in the triglyceride level, while no significant changes were observed in the level of cholesterol and HDL and LDL. This study concluded that administration of L carentin improved the lipid profile in type-2diabetic patients.

Key word: Diabetes mellitus (DM), Dyslipidemia, l-carnitine (LC).

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Bioequivalence and Pharmacokinetics Comparison of Two Formulations of Extended-Release Pentoxifylline Tablets in Healthy Subjects after Fasting and Fed Conditions
Jaafar J. Ibraheem Al-Tamimi

The pharmacokinetics and bioequivalence of a newly developed extended-released (ER) tablet containing 400 mg pentoxifylline as a test product was compared with the reference brand product Trental® 400 mg ER tablet produced by Sanofi-Aventis. Two separate studies were conducted simultaneously. The first study was conducted under fasting condition, whereas, the second study was conducted under fed condition; using the same batches of the test and reference products in both studies. In each study, both products were administered to 32 healthy male adult volunteers applying a single-dose, two-treatment, two-period, two-sequence, randomized crossover design with one-week washout period between dosing. Twenty two blood samples were withdrawn from each volunteer over 24 hours period. Pentoxifylline concentrations were determined in plasma by a validated HPLC method according to FDA Bioanalytical Method Validation Guidance using UV detection and chloramphenicol as internal standard. The lower limit of quantitation of the drug in plasma was 5 ng/ml and the upper limit of quantitation was 500 ng/ml. From the plasma concentration-time data of each individual, the pharmacokinetic parameters; Cmax, AUC0-t, AUC0-, Cmax/AUC0-, Tmax, Z & T0.5; were calculated applying non-compartmental analysis. Data of the test and reference products were statistically analyzed to test for bioequivalence of the two products, using criteria of FDA and EMEA Guidance. The pharmacokinetic parameters mentioned above were statistically analyzed by descriptive statistics, ANOVA test and 90% Confidence Interval (CI). ANOVA test involved the calculation of the effects of: treatment, period, sequence and subjects nested in sequence. According to the above guidance, the primary pharmacokinetic parameters used for bioequivalence testing, namely Cmax, AUC0-t and AUC0- were also statistically analyzed by ANOVA & CI tests using the corresponding Ln-transformed values. The mean values Cmax, AUC0-t , AUC0- , Cmax/AUC0- , Tmax, Z & T0.5 for the test formula obtained from the fasting study were; 144.4 ng/ml, 845.4, 868.4, 0.186 hr-1, 3.29 hr, 0.561 hr-1 and 1.65 hr, respectively; and the mean values of these parameters for the reference formula were; 150.0 ng/ml, 871.1, 893.7, 0.177 hr-1, 3.70 hr, 0.558 hr-1 and 1.59 hr, respectively. The mean values of the above mentioned parameters for the test formula obtained from the fed study were; 157.8 ng/ml, 826.5, 853.8, 0.198 hr-1, 5.4 hr, 0.458 hr-1 and 2.06 hr, respectively; and the mean values of these parameters for the reference formula were; 162.1 ng/ml, 869.7, 894.8, 0.196 hr-1, 4.1 hr, 0.525 hr-1 and 1.80 hr, respectively. Based on criteria of FDA and EMEA Guidance on Bioavailability and Bioequivalence, the results of the fasting and fed studies demonstrated bioequivalence of the two products under either condition. Accordingly, it is concluded that the newly developed ER tablet containing 400 mg pentoxifylline is bioequivalent to Trental® 400 mg ER tablet produced by Sanofi-Aventis.

Keywords: Pentoxifylline, Pharmacokinetics, Bioequivalence.

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Preparation and Characterization of Montelukast Sodium ( SMLT ) as a Dual Sustained Release Buccal Strips
Yehia I.Khalil

An oral bi layer sustained release (SR) strips of Sodium Montelukast SMLT , which is selective leukotriene antagonist , used for patients suffered from mid-night asthma , were prepared successfully ,using different polymers, like guar gum , carrageenan , and xanthan gum , by solvent casting method . The results obtained by this study revealed ,that best fast dissolving film of SMLT was loaded in carrageenan polymer 57% w\w (30mg.) , with acceptable physical properties, like film thickness , elastic endurance and surface pH . Besides to that , the disintegration time , and cumulative 80% drug release were estimated 22 seconds and 3.7 minutes , respectively .On the other hand , the sustained release film ( FSR6-7 ) as a second layer , appear to be the most promised layer of SMLT loaded in 50 % w\w (15mg.) PVP K17 , with respect to its film thickness, elastic endurance and , surface pH . Moreover the , the disintegration time of the second layer film was 21seconds , and the time for 50% drug release was 15 minutes extended for 4hours of 100% drug release . Meanwhile , the investigation of possible interference between the drug , and, polymers used revealed no evidence of this effect ,using FTIR , and SEM technique . In an attempt to evaluate the extended release effect of the selected formula , Singulair® plain tablet as a marketed product was used , the result gave more than 4 hours of selected formula , compared with 30 minutes to marketed product Singulair® . The overall results candidates the selected FSR6-7 formula as a promised bi layer buccal fast , as compliance and extended therapy for asthmatic mid- night patients.

Keywords: Montelukast sodium, Dual buccal strips, Guar gum, Xanthan gum, Carrageenan.

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Measurement of Serum Trace Elements (Zinc, Copper, Magnesium and Iron) Concentrations in Pediatric Patients with Otitis Media
Najwan K. Fakree

Otitis media with effusion (OME) is a common disease especially among young children (before school age) and it is one of the common causes of acquired hearing loss in childhood. Pediatric patients with OME are usually undernourished. The purpose of this study is to determine whether the serum levels of trace elements (zinc, copper, magnesium, iron) have a role in the development of OME in children. This study carried out on 55 children and subdivided them into two groups. Group 1 (patient group) consist of 30 children suffering from OME and group 2 (control group) included 25 apparently healthy children. Serum levels of zinc, copper, magnesium and iron were measured for both groups. Comparison the results between the two groups showed that group 1(patients) had significantly lower serum zinc, copper, and iron levels than group2 (P <0.05). Meanwhile the differences between the two groups in terms of serum values of magnesium were not statistically significant (p>0.05). This study postulated that serum levels of zinc, copper, and iron may have a role in the development of OME in children. While, serum magnesium may not have effect on the development of OME in children.

Keyword: Pediatrics, Otitis media, Trace elements.

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Formulation and Evaluation of Domperidone Nanoemulsions for Oral Rout
Mohanad N. Taher and Ahmed A.Hussein

The aim of the present study is to formulate, evaluate and characterize the nanoemulsion of Domperidone a poorly water-soluble anti-emetic drug. Domperidone powder is white or almost white powder, photosensitive, practically insoluble in water, slightly soluble in ethanol and in methanol; soluble in dimethylformamide. It is used as an antiemetic for the short-term treatment of nausea and vomiting of various etiologies. Solubility studies were conducted to select the oil, surfactant and cosurfactant. Phase diagrams were constructed by aqueous phase titration method. Formulations were selected from the phase diagrams. The formulations were characterized for particle size, Polydispersity index (PDI), zeta potential and in vitro drug release. All the formulations were in nanoscale and Formula 1 (which contain anise oil as oil phase ,mixture of Surfactant Tween 80 and cosurfactant (ethanol) at ratio 1:1 in addition to double distilled water as aqueous phase in ratio 1:6:3 respectively ) was the selected formula depending on particle size, PDI, zeta potential and in vitro drug release. The Formula 1 has the best ratio because it gives the smallest nanoemulsion globule size (Particle size Average 20.81nm) and the best homogenicity (lowest PDI 0.266) and highest stability (higher zeta potential -33.9). The selected formula gives accepted physical and chemical properties.

Keywords :Nanoemulsion, Domperidone.

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