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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Fri Jun 16 2023
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Role of Fasting Mimicking Diet in Farnesoid x Receptor for Suppressing Epithelial-to-Mesenchymal Transition, Cell Cycle Progression, and Viability of Prostate Cancer Cells
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The systemic and resistant nature of metastatic castration-resistant prostate cancers (mCRPC) renders it largely incurable even after intensive multimodal therapy. Proliferation, survival, and epithelial-mesenchymal transition (EMT) are three fundamental events that are deeply linked to carcinogenesis.  Hence, it is necessary to find a new combination of several therapies, targeting those vital mechanisms without causing side effects. Significant research works have shown differential low expression of the metabolic Farnesoid X receptor (FXR) in primary and metastatic prostate cancer suggesting their importance in prostate pathogenesis. Obticholic acid (INT 747), a potent FXR agonist is widely used in primary biliary chola

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Publication Date
Thu Jun 23 2022
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Flow Injection Spectrophotometric Technique for Determining of Genistein in Pure and Supplements Formulations Through Diazotization Coupling Reaction
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Genistein (GEN) is The major isoflavone found in soybeans, has a number of cardiovascular health benefits, Postmenopausal syndrome and osteoporosis. A direct flow injection analysis method for estimation of (GEN) in pure and supplements formulation . This system is based on diazotization coupling reactions between procaine penciline (PR) and genistein in basic medium, they formed yellow dyes have maximum absorption at 416 nm. Calibration curve were constructed over different GEN concentrations, linearity for GEN was 10-100 µg.mL-1 and detection limits of 1.51 ?g/mL. In the FIA technique, all analytical factors were analyzed and optimized. The established method was successfully used to determine GEN in the formulations of its supplement

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Publication Date
Tue May 01 2018
Journal Name
Journal Of Physics: Conference Series
Strong Convergence of Iteration Processes for Infinite Family of General Extended Mappings
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Publication Date
Sat Apr 13 2024
Journal Name
Journal Of Optics
Analysis of laser induced breakdown spectra for distinguish between healthy and carious teeth
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Dielectric barrier discharges (DBD) can be described as the presence of contact with the discharge of one or more insulating layers located between two cylindrical or flat electrodes connected to an AC/pulse dc power supply. In this work, the properties of the plasma generated by dielectric barrier discharge (DBD) system without and with a glass insulator were studied. The plasma was generated at a constant voltage of 4 kV and fixed distance between the electrodes of 5 mm, and with a variable flow rate of argon gas (0.5, 1, 1.5, 2 and 2.5) L/min. The emission spectra of the DBD plasmas at different flow rates of argon gas have been recorded. Boltzmann plot method was used to calculate the plasma electron temperature (Te), and Stark broadeni

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Publication Date
Thu Jan 30 2014
Journal Name
Al-kindy College Medical Journal
Normal bowel habites in a sample of healthy Iraqi population
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Background: Clinicians and investigators consider the normal range of bowel habit and frequency as between 3 to 21 motions per week . Stool frequency out side the normal range may be unusual but may not be abnormal in the sense of a disease . And according to the consistency, the normal stool ranges from porridge like to hard and pellety .Objectives: To establish a basic data about the bowel habits (consistency and frequency) in a sample of healthy Iraqi population; in addition to learn about their definition of constipation and diarrhea.Methods: Prospective study from Jan 2000- Jun 2000 at Al-Yarmouk teaching hospital, Baghdad. Questionnaires were distributed to 950 healthy persons of different age group .The questionnaire included: Det

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Publication Date
Mon Jun 30 2014
Journal Name
Al-kindy College Medical Journal
Normal bowel habits in a sample of healthy Iraqi population
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Clinicians and investigators consider the normal range of bowel habit and frequency as between 3 to 21 motions per week. Stool frequency outside the normal range may be unusual but may not be abnormal in the sense of a disease, and according to the consistency, the normal stool ranges from porridge like to hard and pellety.
Objectives: To establish a basic data about the bowel habits (consistency and frequency) in a sample of healthy Iraqi population; in addition to learn about their definition of constipation and diarrhea.
Methods: Prospective study from Jan 2000- Jun 2000 at Al-Yarmouk teaching hospital, Baghdad. Questionnaires were distributed to 950 healthy persons of different age group .The questionnaire included: Detailed hi

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Publication Date
Tue Jul 01 2025
Journal Name
Egyptian Journal Of Medical Microbiology
Assessment of Ochratoxin A among Healthy Individuals in Baghdad, Iraq
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Background: Mycotoxins have a significant impact on population health worldwide. Ochratoxin is a common mycotoxin that can be detected in the serum of healthy people due to its prevalence in food. Researches on ochratoxin and its metabolites in biological fluids can help us better understand the toxin's biological impacts. Objective: The aim of this study was to investigate whether individuals in Baghdad, Iraq, were exposed to ochratoxin A. Methodology: Serum samples were obtained from 90 healthy persons (ages 14–40 years) and evaluated for ochratoxin A using the human Ochratoxin A ELISA Kit, an accurate, quantitative, and sensitive technique (limit of detection 0.34 ng/ml). Results: We detected Ochratoxin A in all serum samples, with a m

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Publication Date
Mon Apr 01 2024
Journal Name
The Egyptian Journal Of Hospital Medicine
Prevalence of Subclinical Cases of HBsAg and IgM-HCV Positivity among Healthy Iraqi Individuals
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Publication Date
Thu Jun 29 2017
Journal Name
College Of Islamic Sciences
Opinions of Abu Bakr Muhammad bin Al-Fadl Al-Bukhari Al-Hanafi (d. 381 AH): In acts of worship: the books of fasting and Hajj
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In The Name of Allah Most Gracious Most Merciful

Scholars, past and present, have paid attention to the books of Fasting and Hajj, and they have compiled literature on that, and they have written treatises and researches. The best days, and as for the pilgrimage, it is one of the great pillars of Islam, which God Almighty has distinguished by making its rituals in the best of places, which is the Sacred House of God.

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Publication Date
Fri Jul 03 2026
Journal Name
Journal Of Baghdad College Of Dentistry
The effect of tooth shape ratio on mandibular incisors arrangement in Iraqi adult subjects
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Background: This study aimed to assess the effect of tooth shape ratio on mandibular incisor arrangement. Materials and methods: The sample included dental casts of some dental students and orthodontic patients having Class I dental and skeletal patterns with normal occlusion and severe crowding. The sample was divided into two groups according to the severity of crowding into: group I had Class I normal occlusion with mild or no crowded mandibular dentition and group II had Class I malocclusion with severe crowded mandibular dentition. Each group comprising of 40 subjects (20 males and 20 females). The mesio-distal and facio-lingual crown diameters were measured manually for each cast using modified vernier caliper gauge. Descriptive sta

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