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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Mar 26 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Evaluation of Poisoning Cases in the Poisoning Consultation Center and Forensic Medicine Institute within Baghdad area
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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

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Publication Date
Mon Mar 25 2019
Journal Name
Al-academy
Body Language in the Works of Sculptors George Segal and Duane Hanson: قصي زين العابدين طعمة
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The means of communication in the accepted human contexts depend on several modes, beginning with the oldest of which in history, represented by the sign language, the sign and the symbol and ending with it, until countless of them became icons that are circulating between the societies themselves or with their neighbors. These icons are often implied in formations that represent a visual discourse which the sender uses as a means and as a message at the same time to express a certain phenomenon in society or in his human self, and thus the sender or performer or artist, in the end, adopted a visual intermediary in order to position his speech in its entirety and perhaps in a specific part of it, to carry the content of that speech and c

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Publication Date
Thu Aug 01 2024
Journal Name
Journal Of Taibah University Medical Sciences
Cytotoxic properties of Pelargonium graveolens leaf extract and its green-synthesized gold nanoparticles (in vitro study)
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Publication Date
Fri Dec 01 2023
Journal Name
Baghdad Science Journal
Fabrication of PVC Enrofloxacin-Selective Electrodes for Estimating Enrofloxacin in Pure Form and as Preparation Formula:
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This study explored the development and qualities of the response of electrochemical properties of enrofloxacin-selective electrodes using precipitation based on producing phosphotungstic, after utilizing a matrix of polyvinyl chloride (PVC) and dibutyl phthalate or dibutyl phosphate as a plasticizer. The resulting membrane sensors were an enrofloxacin-phosphotungstic electrode (sensors 1) and an ENR-DOP-PTA electrode (sensors 2). Linear responses of (ENR-DBPH-PTA) and (ENR-DOP-PTA) within the concentration ranges of 2.1×10-6-10-1 and 3.0×10-6-10-2 mol. L-1, respectively, for both sensors were observed. Slopes of 51.61±0.24 and 39.40± 0.16 mV/decade and pH ranges equal to 2.5-8.5

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Publication Date
Sun Jan 03 2016
Journal Name
Journal Of The Faculty Of Medicine Baghdad
The Impact of Body Mass Index and Some Trace Elements in Iraqi Women with Breast Cancer
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Background: Breast cancer is a highly heterogeneous disease globally. Trace elements such as copper and zinc have a role in many biochemical reactions as micro source, their metabolism is profoundly altered in neoplastic diseases especially breast cancer which is ranked as the first of female cancersObjective: The aim of the present study is to study the impact of body mass index and some trace elements in Iraqi women with breast cancer.Patients and methods: The group of the study consisted of 25 breast cancer patients; their age range was (25–65) years recruited from the Al-Kadhimia Teaching Hospital and 25 apparently healthy women age matched, over a period of 6 months from January 2015 until June 2015. After the diagnosis was m

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Publication Date
Sun Jun 01 2014
Journal Name
Baghdad Science Journal
Study of growth curve and morphological change for Trichomonas vaginalis parasite in the tow culture media
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The objective of this study was shed light for cultivation and maintenance of Trichomonas vaginalis parasite growth after isolated it by vaginal swaps from females suffering vaginitis and abnormal vaginal discharges in these media CPLM and TAB media to detect growth curve, morphological changes and viability of parasite in the two culture media, together with effect of sheep and bovine serum on the growth of it. The results of this studies were showed there was abtaine differences between the two types of media , The maximum growth of parasite was in TAB medium after 72 hours incubation with use of bovine serum, while such growth was maximized after 144 hours incubation with the use of sheep serum. In CPLM medium, a maximum gro

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Publication Date
Sun Feb 10 2019
Journal Name
Drug Invention Today
Design, characterization, and in vitro evaluation of zaltoprofen solid dispersion as a hollow-type rectal suppository
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Aim: The present study aims to improve the poor water solubility of zaltoprofen which is a non-steroidal anti-inflammatory drug (NSAIDs) with a potent analgesic effect using solid dispersion then formulate it as a hollow type suppository to be more convenient for geriatric patients. Materials and Method: Zaltoprofen solid dispersions were prepared by solvent evaporation technique in different zaltoprofen: Soluplus® ratios. Results: Among the formulations tested, zaltoprofen solid dispersion preparation using 1:5 (zaltoprofen: Soluplus®) ratio showed the highest solubility and selected for further investigation. Solid dispersion characterization was evaluated by differential scanning calorimetry (DSC), X-ray diffraction study (XRD) and Fou

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Publication Date
Tue Dec 01 2015
Journal Name
Journal Of Economics And Administrative Sciences
Leadership Skills and their Impact on Strategic Planning: Applied Research in the Iraqi Ministry of Planning
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The present search addressed the " leadership skills and their impact on strategic planning " Where has the objective of leadership skills and strategic planning of increasing importance at the present time , for being fairly modern topics ,which have a tremendous impact on the success of organizations..                                                                        &n

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Publication Date
Mon Oct 31 2022
Journal Name
Journal Of Sustainability Science And Management
THE MEDIATING ROLE OF SUSTAINABLE DEVELOPMENT IN THE RELATIONSHIP BETWEEN PRODUCER COST EXPECTATIONS AND CUSTOMER DESIRES
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In this paper, customers’ expectations are continually shifting due to the business environment’s growing competition and substantial changes. As a result, organisations no longer viewed it as a static objective but as an ever-evolving aim. From this vantage point, the research has explored the accounting literature in search of novel approaches to addressing the strategic dimensions of quality, cost and time. Getting them to respond positively to the customer’s requests also requires recognising their needs and controlling their impact on these dimensions. With the removal of operations that do not contribute any value to the product’s value chain and a reduction in manufacturing costs through continuous improvement, the ou

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Publication Date
Fri May 12 2023
Journal Name
Journal Of Population Therapeutics And Clinical Pharmacology
Effect of Maternal Variables on some Physiological and Immunological Biomarkers in Iraqi Women Undergoing Caesarean Section
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Pregnancy and childbirth are physiological states characterized by sudden hormonal and immunologically described changes. The current study aimed to investigate the influence of maternal variables (age, previous abortion, placental position, and fetal position) on some physiological biomarkers, such as oxytocin (OT), prolactin (PRL), cortisol, and insulin growth factor 2 (IGF -2) and some immune biomarkers such as programmed cell death protein 1 (PD-1), programmed cell death ligand 1 (PD-L1) and interleukin 6 (IL-6) in Iraqi women undergoing caesarean section (CS). Blood samples were collected from 48 pregnant women in the age range (16-43 years) and serum was obtained to determine the levels of the above biomarkers. The effect of

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