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Bioequivalence and Pharmacokinetics Comparison of Two Formulations of Extended-Release Pentoxifylline Tablets in Healthy Subjects after Fasting and Fed Conditions
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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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-Â¥, Cmax/AUC0-Â¥, Tmax, lZ & 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-Â¥ were also statistically analyzed by ANOVA & CI tests using the corresponding Ln-transformed values. The mean values  Cmax,  AUC0-t , AUC0-Â¥ , Cmax/AUC0-Â¥ , Tmax, lZ & T0.5 for the test formula obtained from the fasting study  were; 144.4 ng/ml,  845.4 ng.hr/ml, 868.4 ng.hr/ml, 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 ng.hr/ml, 893.7 ng.hr/ml, 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 ng.hr/ml, 853.8 ng.hr/ml, 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 ng.hr/ml, 894.8 ng.hr/ml, 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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Publication Date
Sun Sep 01 2019
Journal Name
Baghdad Science Journal
Kinetic- spectrophotometric Method for the Determination of Naringenin in Pure and Supplements Formulations
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          Simple, cheap, sensitive, and accurate kinetic- spectrophotometric method has been developed for the determination of naringenin in pure and supplements formulations. The method is based on the formation of Prussian blue. The product dye exhibits a maximum absorbance at 707 nm. The calibration graph of naringenin was linear over the range 0.3 to 10 µg ml-1 for the fixed time method (at 15 min) with a correlation coefficient (r) and percentage linearity (r2%) were of 0.9995 and 99.90 %, respectively, while the limit of detection LOD was 0.041 µg ml-1. The method was successfully applied for the determination of naringenin in supplements with satisfac

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Publication Date
Fri Jan 01 2021
Journal Name
Annals Of Tropical Medicine And Public Health
SPECTROPHOTOMETRIC DETERMINATION OF DIPHENHYDRAMINE HCL IN PURE AND PHARMACEUTICAL FORMULATIONS USING THYMOL BLUE
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This approach was developed to achieve an accurate, fast, economic and sensitivity to estimation of diphenhydramine Hydrochloride. The dye that produced via reaction between diphenhydramine HCl with thymol blue in acidic medium pH ≈ 4.0. The ion pair method include an optimization study to formed yellowcolored that extraction by liquid – liquid method. The product separated of complexes by using by chloroform solution measured spectrophotometry at 400 nm. The analysis data at optimum conditions showed that linearity concentration in a range of calibration curve 1.0 – 50 μg /mL, limit of detectionand limit of quantification 0.0786 and 0.2358 μg/mL respectively. The molar absorptivity and Sandell’s sensitivity were 1.8 × 10 -4 L/mo

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Publication Date
Sat Jan 20 2024
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
Comparison of the Optical Efficiency of Two Designs of the Maksutov–Cassegrain Telescope
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The research aims to develop the best possible design for the widely used Cassegrain telescope. The system consists of two models of different designs: (a) the telescope consists of a Maksutov lens, a spherical primary mirror, and a secondary mirror attached to the lens; (b) it consists of a Maksutov lens and a spherical primary mirror, plus a non-lens attached secondary mirror located between the lens and the primary mirror. The image was evaluated and analyzed using the analysis tools in Zemax software. The results of the two designs showed that the telescope whose secondary mirrors are not adjacent to the Maksutov lens produces high quality image that is almost free from aberration, and then comes the telescope whose secondary mirrors

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Publication Date
Fri Mar 01 2019
Journal Name
2019 9th International Ieee/embs Conference On Neural Engineering (ner)
Differences in EMG Feature Space between Able-Bodied and Amputee Subjects for Myoelectric Control
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Publication Date
Wed Oct 17 2018
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Two of (Turnbull) and (Generalization Turnbulls)non-parametric methods in estimating conditional survival function (applied study on breast cancer patients)
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   This research includes the application of non-parametric methods in estimating the conditional survival function represented in a method (Turnbull) and (Generalization Turnbull's) using data for Interval censored of breast cancer and two types of treatment, Chemotherapy and radiation therapy and age is continuous variable, The algorithm of estimators was applied through using (MATLAB) and then the use average Mean Square Error (MSE) as amusement  to the estimates and the results showed (generalization of Turnbull's) In estimating the conditional survival function and for both treatments ,The estimated survival of the patients does not show very large differences

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Publication Date
Tue Mar 15 2022
Journal Name
Malaysian Journal Of Medicine And Health Sciences
Detection of Extended Spectrum β-lactamases and Metallo β-lactamases in Pseudomonas Aeruginosa isolated from Burns
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P. aeruginosa is one of the complex targets for antimicrobial chemotherapy. Also, it is intrinsically resistant to several antibiotics. It produces β-lactamases enzymes that are responsible for the widespread β-lactam antimicrobial resistance. There are three major groups of β-lactamase enzymes, MBLs and ESBLs forming Pseudomonas is a major issue for the treatment of burns victims. Methods: A total of 28 clinical isolates related to P. aeruginosa have been obtained from the burns specimens from patients attending to AL-Imam hospital/Baghdad-Iraq, through the period from October 2015 to March 2016. Also, all isolates have been recognized as P. aeruginosa via utilizing bacteriological assay and confirmed by Vitek 2. In addition, the suscep

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Publication Date
Mon May 20 2019
Journal Name
The Journal Of Engineering
Experimental comparison of two linear machines developed for the free piston engine
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: In this study, a linear synchronous machine is compared with a linear transverse flux machine. Both machines have been designed and built with the intention of being used as the power take off in a free piston engine. As both topologies are cylindrical, it is not possible to construct either using just flat laminations and so alternative methods are described and demonstrated. Despite the difference in topology and specification, the machines are compared on a common base in terms of rated force and suitability for use as a generator. Experience gained during the manufacture of two prototypes is described.

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Publication Date
Mon May 20 2019
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
Convergence Comparison of two Schemes for Common Fixed Points with an Application
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      Some cases of common fixed point theory for classes of generalized nonexpansive maps are studied. Also, we show that the Picard-Mann scheme can be employed to approximate the unique solution of a mixed-type Volterra-Fredholm functional nonlinear integral equation.

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Publication Date
Fri Dec 23 2022
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Preparation and Evaluation of Oroslippery Tablets Contain Irbesartan and Hydrochlorothiazide Combination for Dysphagia Patients
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Oro slippery tablets (OSTs) is a technique used to improve swallowing of tablets for patients with dysphagia. The aim of this study was to formulate irbesartan and hydrochlorothiazide as Oroslippery tablets (OST) containing 150 mg irbesartan and 25 mg hydrochlorothiazide for dysphagia patients. A simple and rapid method of analysis was developed and validated according to the ICH guideline using HPLC with UV detector. Tablets were prepared by direct compression and then coated with the slippery coat of three different concentrations of the slippering substance “xanthan gum’ (2%, 3% and 4%) in Opadry Colorcone® and evaluated according to USP. Slipperiness test was performed using Albino rabbits. Results showed that 2% xanthan gum gav

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Publication Date
Wed Mar 29 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Evaluation of Stability of Cefamandol and Ceftazidime with Clavulanic Acid Against Extended Spectrum ?- Lactamase
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The aim of this study is to evaluate in-vitro activity of Cefamandol (Cfm) and Ceftazidime (Cfz), in combination with Clavulanic acid (CA) against ten complicated multiresistant uropathogenic E.coli .One hundred clinical strains were isolated from patients with chronic urinary tract infections (UTIs), these isolates were identified by the Api identification systems. The antimicrobial susceptibility tests were determined by Kirby-Bauer method, all of them were sensitive to Imipenem (Imp). Ten strains were chosen for the present study, they were resistant to Ampicillin (Amp), Amoxicillin (Amo), Carbenicillin (Cb), Ticarcillin (Tic), Azlocillin (Azl), Amoxicillin\ Potassium Clavulanate {Augmentin(Amc)}, (Amo\CA), Ticarcillin\ Potas

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