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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Tue Jan 01 2019
Journal Name
Indian Journal Of Public Health Research & Development
Comparison of the Cyclic Fatigue of Protaper Next, 2Shape and Hyflex EDM Using Glyde
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Publication Date
Fri Sep 01 2023
Journal Name
Iraqi Journal Of Physics
Employment of Silicon Nitride Films Prepared by DC Reactive Sputtering Technique for Ion Release Applications
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In this work, silicon nitride (Si3N4) thin films were deposited on metallic substrates (aluminium and titanium sheets) by the DC reactive sputtering technique using two different silicon targets (n-type and p-type Si wafers) as well as two Ar:N2 gas mixing ratios (50:50 and 70:30). The electrical conductivity of the metallic (aluminium and titanium) substrates was measured before and after the deposition of silicon nitride thin films on both surfaces of the substrates. The results obtained from this work showed that the deposited films, in general, reduced the electrical conductivity of the substrates, and the thin films prepared from n-type silicon targets using a 50:50 mixing ratio and deposited on both

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Publication Date
Thu Apr 25 2019
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
BIOLOGICAL ACTIVITY OF THE CAROTENOIDS WHICH ARE PRODUCED FROM LOCAL ISOLATE Rhodotorula mucilaginosa AND DETRERMINATION THE CONDITIONS AFFECTING THEIR STABILITY: BIOLOGICAL ACTIVITY OF THE CAROTENOIDS WHICH ARE PRODUCED FROM LOCAL ISOLATE Rhodotorula mucilaginosa AND DETRERMINATION THE CONDITIONS AFFECTING THEIR STABILITY
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Biological activity of the carotenoids which are produced fromchemically-mutaed local isolate of Rhodotorula mucilaginosawas studied. The results showed variation of inhibition activity of caritenoids against different types of pathogenic bacteria include, Staph aureus, E. coli, B. subtilis and Salmo. typh., the number declined from 2×107cell/ml to 2×104, 5×104, 2×105, 9×105 cell/ml respectively after 24hour. The produced carotenoids from alocal mutant Rhodotorula mucilaginosa revealed an antioxidant activity as free radical removal of 85.6%. Carotinoides revealed a highest stability in petroleum ether solvent for 30 days at room temperature. It found that the pigment was more stability in sesame oil compared with sun flower and coc

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Publication Date
Sun Dec 30 2007
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
The Effect of Time and Corrosion Products Formation on Corrosion Rate of Carbon Steel Pipe Under Turbulent Flow Conditions
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The effect of time (or corrosion products formation) on corrosion rates of carbon steel pipe in aerated 0.1N NaCl
solution under turbulent flow conditions is investigated. Tests are conducted using electrochemical polarization
technique by determining the limiting current density of oxygen reduction in Reynolds number range of 15000 to 110000
and temperature range of 30 to 60oC. The effect of corrosion products formation on the friction factor is studied and
discussed. Corrosion process is analyzed as a mass transfer operation and the mass transfer theory is employed to
express the corrosion rate. The results are compared with many proposed models particularly those based on the
concept of analogy among momentum, heat,

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Publication Date
Mon Apr 03 2023
Journal Name
Journal Of Genetic And Environmental Resources Conservation, 2023, 11(1):53-59.
Comparative histomorphological and immunohistochemical study of parathyroid gland in two Iraqi mammals (Weasel, Herpestes javanicus and long-ear hedgehog, Hemiechinus auritus)
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The present study aimed to investigate the anatomy, histology, and immunohistochemistry of parathyroid gland in two Iraqi mammals (Weasel, Herpestes javanicus and Long-ear hedgehog, Hemiechinus auritus) as a comparative study. A total of (20) animal for each species were used in the present study. Animals collected were immediately anesthesia and dissected to get the parathyroid gland. Methods of Humason and Bancroft and Stevens were employed for histological techniques. Different stains were used (Hematoxylin- Eosin stain-(H & E), Periodic Acid Schiff stain-(PAS), Azan stain, and Methyl Blue stain-(MB)) for staining the histological sections. Anti-calcitonin, code140778 marker used for immune-histochemical study. Results of the present stu

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Publication Date
Fri Mar 15 2019
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison between diode laser and scalpel for lip lengthening in patients with gummy smile
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Background: lip lengthening procedure is one of the surgical options for the correction of gummy smile in patients with short upper lip. Methods: A comparative clinical study was conducted on 15 patients requiring lip lengthening procedure for the esthetic correction of excessive gingival exposure with gummy smile. Scalpel was used in seven patients and diode laser in the remaining eight patients. Under infiltration anesthesia, about one cm strip of mucosa was excised at the vestibular depth and the mucosa of the lip was sutured to the alveolar mucosa. Results: The diode laser group demonstrated less postoperative pain and swelling. Regarding postoperative ecchymosis, three patients in the scalpel group developed ecchymosis and no cases

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Publication Date
Mon Dec 10 2018
Journal Name
Day 3 Wed, December 12, 2018
Experimental Comparison between WASP and LSASF in Bartlesville Sandstone Reservoir Cores Bearing Heavy Oil
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Low salinity (LS) water flooding is a promising EOR method which has been examined by many experimental studies and field pilots for a variety of reservoirs and oils. This paper investigates applying LS flooding to a heavy oil. Increasing the LS water temperature improves heavy oil recovery by achieving higher sweep efficiency and improving oil mobility by lowering its viscosity. Steam flooding projects have reported many problems such as steam gravity override, but override can be lessened if the steam is is alternated with hot LS water. In this study, a series of reservoir sandstone cores were obtained from Bartlesville Sandstone (in Eastern Kansas) and aged with heavy crude oil (from the same reservoir) at 95°C for 45 days. Five reservo

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Publication Date
Sun Jun 01 2014
Journal Name
Baghdad Science Journal
Preparation and diagnosis of new types of Schiff bases one-and two- claw and complexes to study the effectiveness of chemical
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In this research we prepared shiff bases unilateral claw( benzyl imine aniline ) and Bilateral claw ( benzayal-2-imine phenol ) in high purity reach to 98% , which it's prepared from aromatic amine with aldehydes, it's solid,thermosetting, not dissolved in water in general. Diagnosed prepared article by using infra red spectroscopy (IR) which shows azomethen grop at 1640cm-1 At this diagnosis we suggest tetra headral mechanism in this Circumstances For a reaction.

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Publication Date
Fri Nov 09 2018
Journal Name
Iraqi National Journal Of Nursing Specialties
Evaluation of Anemia among Lactating Mothers and their Children Under Two Years of Age
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Objective: The aim of this study is to evaluate anemia among lactating women and their children less than 2 years of
age.
Methodology: The study was done on (148) lactating mothers and their children under 2 years of age in the primary
health care center at AL-Salam Quarter/Baghdad from l/10/2009 to 15/10/2010.
Result: This study recommends that there is a significant relationship between anemic mothers and their children. The
study also revealed that there is (77.8%) from nursing mothers in the age groups (25-29) who suffered from anemia,
while (23.1%) for the age group (20-24) did not have anemia
Recommendation: We encourage the use of breast milk or iron-fortified infant formula only for any milk-based part
of

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Publication Date
Wed Jun 18 2025
Journal Name
Journal Of Baghdad College Of Dentistry
Effect of canal dryness and flaring on the accuracy of two electronic apex locators
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Background: This in vitro study evaluated the effect of canal dryness and flaring on the accuracy of two electronic apex locators for working length (WL) determination. Materials and methods: Sixty extracted teeth were used, after access opening was done, the occlusal surface was flattened to create stable reference point. The teeth were randomly divided into two equal main groups of flared and unflared group each one of 30 teeth. The flaring was done with Gates Glidden drills. The two main groups were further subdivided into two subgroups: dry canal and wet canal using 5.25% sodium hypochlorite groups, Electronic WL of each sample was determined using both Root ZX and i-Root apex locator. Consequently, histologic WL was determined by shav

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