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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jul 01 2022
Journal Name
Aip Conf. Proc. 2450, 020031 (2022)
The study of the identification and association of adiponectin and Interleukin-6 and some variables. Biochemical parameters in the Iraqi cord blood of newborns
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t. The current study was conducted on the umbilical cord blood of newborns in the Banks Hospital in Baghdad, Diyala, and Khalis in Diyala, where the study included 90 samples of blood, and samples were collected for the period from the 1st of October;2020 to The first of February;2021 AD, where the study included measuring levels of interleukin-6;Adiponectin,glucose and bilirubin in the blood, comparison study between the study variables with the child's weight (greater than 3 kg),(less or equal 3 kg),the mother's age (greater than 25 years, less or equal to 25 years),the sex of the child (male, female).The results of our study showed that there were no significant differences between the variables of the current study between the two sex

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Publication Date
Wed May 01 2019
Journal Name
The Iraqi Journal For Information And Documentation Studies
The role and importance of scientific research in creating new knowledge and its impact on developing the cognitive capabilities of information and librarians and their Employees
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The research aims at identifying the importance of scientific research for researchers and in creating new knowledge، development and utilization of mental and cognitive energies and developed them with the ability to research، extrapolation، meditation and then conclusion. The information was collected by interviewing the Secretary-General of the Central Library and by distributing questionnaire forms to the (33) teaching staff of the College of Higher Education. The responses of the society were analyzed the result and the recommendations were the most important 1. Information specialist and all employees of the administrators and technicians in the centers of information sources (libraries) and in the field are considered scientific r

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Publication Date
Thu Oct 01 2020
Journal Name
Biochemical & Cellular Archives
EXTRACTING PECTIN FROM TOMATOES AND BEET PEELS AND USING IT IN THE MANUFACTURE OF YOGURT AND COMPARING THEM
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Pectin is available in many plants and in this study, the peels of tomatoes and beet were used to be an economical source of pectin production instead of dumping it with waste or using it as animal feed. The pectin extracted from the peels using different solutions, namely citric acid (2 M), oxalic acid (2%) and hydrochloric acid (0.5 M) the outcome of the extraction methods, 7. 1%, 6% and 11% respectively for tomatoes peels, while the pectin of beet peels were 8%, 6.5%, and 8.3%, and the highest percentage obtained in the manner of hydrochloric acid adopted in the manufacture of yogurt.Yogurt was manufactured with four treatments, in the first treatment standard pectin was added and the second treatment in addition to the pectin extracted

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Publication Date
Wed Mar 10 2021
Journal Name
Baghdad Science Journal
Role of single and mixed culture of Pseudomonas aeruginosa and Serratia ficaria in utilization of petroleum wastes of Dora- refineries.
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The ability of single and mixed bacterial culture to utilize Dora-refineries petroleum wastes was compared. Pseudomonas aeruginosa and Serratia ficaria mixed culture consumed the wastes better than the single bacterial cultures. The highest log. number of viable cells in mixed culture was 6.842 , while in single bacterial cultures it was 6.683 and 5.631, respectively. after 3 days in API medium containing the refinery wastes. The effect of some environmental conditions on the degradation of petroleum wastes was studied included aeration , NaCl concentration , pH and temperature. The growth of bacteria in the agitated culture was higher than stagnant culture the log. of cell no. was 6.021 in the first culture. The h

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Publication Date
Tue Mar 19 2019
Journal Name
Tikrit Journal For Agricultural Sciences
Dependence and Phenotypic and Molecular Labels in Estimations of Genetic of Variance of Some Genotypes of Corn (Zea mays L.)
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Afield experiment was conducted in the college of Agriculture labs Sulaimanya University in 2014 to estimate the genetic variance between 12 genotypes of maize. (SSR) technology was used depending on (PCR) technology. Twenty primers were used for the genetic variance analysis between the studied genotypes and 15 primers showed polymorphic results in repeated experiment caused to experinse 52 alleles which gave 307 bands of range 3.1 by different molecular sizes ranged between 80-1000 pair base the value of PIC reached to phi069 gave high value (0.8785), the range of genetic diversity for studied genotypes reached to (0.625) gave primers pairs phi069 hig value for genetic diversity (0.888). The value of total allele replication ranged at pri

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Publication Date
Sun Jun 01 2008
Journal Name
Baghdad Science Journal
Effect of physical form and washing of treated and untreated rice straw with sodium hydroxide upon chemical composition and in vitro digestibility
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Hydroxide upon the chemical composition and dry matter(DM) and organic matter(OM) digestibility . Rice straw was treated with 4% sodium hydroxide using 30% of DM basis moisture, and incubated at 40 ºC for 40 days., DM digestibility (DMD) was significantly affected (P<0.01) by the treatment , where DMD increased The objective of this experiment was to study the effect of physical form (long ,chopped and ground ) and washing rice straw treated with sodium from 42.32 to 45.41% , OM digestibility (OMD) and total digestible nutrient (TDN) increased(P<0.05) from 47.38 and 49.33 to 49.67 and 52.83% ,respectively. While hemicellulose content increased (P<0.05 ) from 261.71 to 268.17 gm/kg DM ,and metabolizable energy (ME) from 7.11 to 7.48 MJ/

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Publication Date
Mon Jan 26 2026
Journal Name
Journal Of Sport Sciences
The school system and its relationship to the evolution of some indicators of physical and functional skills in a lesson and basketball
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Publication Date
Wed Jan 03 2024
Journal Name
Al-rafidain Journal Of Medical Sciences ( Issn 2789-3219 )
Proficiency and Knowledge of Community Pharmacists in the Use of Liraglutide and Semaglutide as Weight Reduction Agents
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Background: In recent years, the prevalence of obesity has climbed sharply. Still, only a few safe and effective medications are approved as weight-loss drugs. Objective: This study aims to assess the knowledge and practice of community pharmacists in Iraq regarding the use of Liraglutide and Semaglutide as weight-loss medications. Method: A cross-sectional survey was implemented using a validated questionnaire and a convenient sample of Iraqi community pharmacists from different governorates. The questionnaire was created after conducting a literature review of the most important articles about liraglutide and semaglutide. The questionnaire consists of three sections. The first part was used to collect demographic information. The

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Publication Date
Tue Sep 14 2021
Journal Name
Research Journal Of Pharmacy And Technology
The Effect of Pseudoephedrine (Sudafed) on Kinetic activity and histology of Livers and Kidneys in Albino Mice
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Pseudoephedrine (PSE) or (Sudafed) is one of the sympathomimetic group of drugs (ephedrine, PSE and amphetamines) which effects cardiovascular system, respiratory system, and gastrointestinal tract. However, only little researches had supported its effect on solid abdominal organs. This study aims to investigate the effects of different doses of Sudafed in the liver and kidney of albino mice. The current study included 18 albino mice grouped into 2 groups: control (3 mice), and acute group (15 mice). The acute group was further subdivided into 5 subgroups, each subgroup of 3mice wasgiven a lonely intaperitonial injection of 0.3ml of the following conc. (500mg/kg, 250mg/kg, 125mg/kg, 62.52mg/kg, and 31.24mg/kg) for 24hrs. After the m

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Publication Date
Tue Aug 01 2023
Journal Name
Iop Conference Series: Earth And Environmental Science
Effect of Light Source and Adenine Sulfate on the Multiplication and Rooting of Kalanchoe blossfeldiana in Vitro
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Abstract<p>This study was conducted in the Tissue Culture laboratory of the Horticultural Department of the Faculty of Agriculture at Karbala University to investigate the effects of a light source (Florescent, LED) and adenine sulfate (Ads) a 0, 40, 80, and 120 mg l-1 on the multiplication and rooting of <italic>Kalanchoe blossfeldiana</italic>. Results showed there are which achieved a 100% response percentage for multiplication and rooting when the addition of adenine sulfate (Ads) under LED light especially a concentration of 120 mg l-1 significantly increased the Shoot height, Shoot number, Number of leaves, Chlorophyll content and fresh, Dry weight. The results showed that they h</p> ... Show More
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