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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sat Mar 25 2023
Journal Name
International Journal Of Drug Delivery Technology
Improvement of Entrapment and Ocular Permeability of Ganciclovir Nanostructured Lipid Carriers Using Various Conditions of Preparations
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Ganciclovir (GCV) is a drug included in BCS-Class III, having high solubility and low permeability. It is a synthetic acyclic nucleoside analog of 2′-deoxyguanosine, considered a potent inhibitor of herpes viruses and cytomegalovirus (CMV) infection. Herpes simplex virus (HSV) infections are very common and are also considered a major cause of corneal blindness. This study intended to advance a pioneering nanostructured lipid carriers (NLCs) system for improving the ocular permeability of GCV. Several procedures were used for the preparation. Cold homogenization, solvent injection, and emulsifi cationultrasonication methods. A mixture of palmitic acid (PA) and oleic acid (OA) as a lipid matrix, cremophore EL, and transcutol HP wer

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Publication Date
Sat Jan 13 2018
Journal Name
Journal Of Engineering
Comparison Between ESP and Gas Lift in Buzurgan Oil field/Iraq
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Buzurgan oil Field which is located in south of Iraq has been producing oil for five decades that caused production to drop in many oil wells. This paper provides a technical and economical comparison between the ESP and gas lift in one oil well (Bu-16) to help enhancing production and maximize revenue. Prosper software was used to build, match and design the artificial lift method for the selected well, also to predict the well behavior at different water cut values and its effect on artificial lift method efficiency. The validity of software model was confirmed by matching, where the error difference value between actual and calculated data was (-1.77%).

The ESP results showed the durability of ESP regarding th

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Publication Date
Mon Apr 01 2024
Journal Name
Academic Science Journal
Comparison between MDDV and VADD routing protocols in VANET (Case Study)
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Routing is the process of delivering a packet from a source to a destination in the network using a routing algorithm that tries to create an efficient path. The path should be created with minimum overhead and bandwidth consumption. In literature, routing protocols in VANET were categorized in many ways, according to different aspects. In the present study, we prefer the classification based on the number of hops to reach the destination node. In literature, these are single-hop and multi-hops protocols. We first discuss the two types and then compare the MDDV (multi-hops protocol) with VADD (single-hop protocol). The comparison is theoretically and experimentally implemented by providing a network environment consisting of SUMO, VIENS and

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Publication Date
Thu Dec 30 2021
Journal Name
Al-kindy College Medical Journal
The Impact of COVID-19 on Healthy Related Issues, A structured Review
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Coronavirus: (COVID-19) is a recently discovered viral disease caused by a new strain of coronavirus.

The majority of patients with corona-virus infections will have a mild-moderate respiratory disease that recovers without special care. Most often, the elderly, and others with chronic medical conditions such as asthma, coronary disease, respiratory illness, and malignancy are seriously ill.

    COVID-19 is spread mostly by salivary droplets or nasal secretions when an infected person coughs or sneezes.

    COVID-19 causes severe acute respiratory illness (SARS-COV-2). The first incidence was recorded in Wuhan, China, in 2019.  Since then it spreads leading to a pandemic.

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Publication Date
Wed Jan 01 2014
Journal Name
Journal Of The College Of Languages (jcl)
A comparison between Objective and subjective tests
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This paper aims at presenting a comparison between objective and subjective tests . This paper attemptsto shed light on these two aspects of tests and make do a compression by using suitable techniques for objective and subjective tests .

     The paper compares between the two techniques used by the objective and subjective tests respectively, the time and efforts required by each type, the extent to which each type can be reliable, and the skills each type is suitable to measure.

     The paper shows that objective tests, on the contrary of the subjective ones, encourages guess> Objective tests are used to test specific areas of langua

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Publication Date
Tue Apr 19 2022
Journal Name
Chemistryselect
A Continuous Flow Injection/Indirect Photometric Method for the Detection of Fosetyl Aluminum in Commercial Pesticide Formulations
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Abstract<p>Because of their Physico‐chemical characteristics and its composition, the development of new specific analytical methodologies to determine some highly polar pesticides are required. The reported methods demand long analysis time, expensive instruments and prior extraction of pesticide for detection. The current work presents a new flow injection analysis method combined with indirect photometric detection for the determination of Fosetyl‐Aluminum (Fosetyl‐Al) in commercial formulations, with rapid and highly accurate determination involving only construction of manifold system combined with photometric detector without need some of the pre‐treatments to the sample before the analysis such a</p> ... Show More
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Publication Date
Wed Feb 01 2023
Journal Name
Journal Of Engineering
Comparison of Groundwater Quality and Quantity between Al-Rahbah and Al-Haydariyah Regions
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This study focused on two areas in AL-Najaf city, AL-Ruhbah and Al-Haydariyah regions because of the importance and widespread use of groundwater in these areas. The two areas were compared quantitatively and qualitatively. For the quantitative approach, the GMS software was used in conjunction with the GIS software to simulate the groundwater flow behavior. The solid model for both areas was created, the geological formation was determined, and the hydraulic properties were identified using GMS software. To test the quantity of groundwater in both areas, the wells have been redistributed to a distance of 2000 m between them, and a period of 1000 days was chosen. When a discharge of 10 l/s and operation times of 4, 8, an

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Publication Date
Thu Mar 20 2025
Journal Name
Osol Journal Of Medical Sciences (ojms)
Thyroid Function Variations in Critically Ill Neonates A Comparative Study with Healthy Controls
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Normal thyroid function is essential for neonatal growth and brain development. In a newborn infant with severe disease, endocrine regulation of hormones can be affected by abnormal metabolism. The assessment of thyroid parameters results in the recognition of a dysfunction and its association with disease severity

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Publication Date
Sun Mar 02 2025
Journal Name
Osol Journal Of Medical Sciences (ojms)
Thyroid Function Variations in Critically Ill Neonates: A Comparative Study with Healthy Controls
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Background: Normal thyroid function is essential for neonatal growth and brain development. In a newborn infant with severe disease, endocrine regulation of hormones can be affected by abnormal metabolism. The assessment of thyroid parameters results in the recognition of a dysfunction and its association with disease severity. Objective: This study aimed to assess thyroid function profiles in critically ill neonates in the neonatal intensive care unit (NICU) compared with healthy controls. Additionally, we aimed to detect the presence of TD and its possible association with critical illness. Methods: A case-control study was performed in 100 neonates, comprising 50 sick neonates and 50 healthy controls. We measured thyroid functio

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Publication Date
Sun Jul 02 2017
Journal Name
Journal Of Educational And Psychological Researches
Prevalence of Posttraumatic Stress Symptomatology and Distribution of Attachment Patterns 1 and 5 Months after a Terrorist Attack
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As a consequence of a terrorist attack, people may experience posttraumatic stress disorder (PTSD) and lack of feeling secure in relationships. This longitudinal study aimed to examine the prevalence of PTSD symptoms over time, the relationship between adult attachment styles and PTSD, as well as their association with degree of exposure, and finally to consider the distribution and the trajectory of attachment styles. The sample consisted of 235 students (M=125, F=110) who were exposed to different levels of trauma intensity in response to a bombing attack. Participants were recruited and assessed approximately 1 month and 5 months after the attack using a battery of questionnaires. Findings revealed, as expected, that 79.5% of the part

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