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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Thu Jan 30 2020
Journal Name
Al-kindy College Medical Journal
A Comparison between High Ablative Versus Usual Dosages of Iodine-131 in Inducing Hypothyroidism After One Year of Therapy in Hyperthyroid Patients
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Background: Radioactive iodine-131 therapy is highly effective in treating patients with hyperthyroidism. An ablative dose is preferred by a number of endocrinologists, and, a fixed dose protocol seems to be better than a calculated dose in real practice.

Objective: To check for hypothyroidism in hyperthyroid patients one year after RAI therapy, comparing between the results of high ablative versus usual dosages of RAI-131.

 Methods:  This study included 174 hyperthyroid patients, 101 males and 73 females, divided into 2 groups, the first consisted of 162 patients given a usual fixed dose of RAI while the second consisted of 12 patients given a high fixed ablati

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Publication Date
Sat Oct 28 2023
Journal Name
Baghdad Science Journal
Indirect Flow Injection Spectrophotometric and Chromatographic Methods for the Determination of Mebendazole in Pharmaceutical Formulations
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Chromatographic and spectrophotometric methods for the estimation of mebendazole in
pharmaceutical products were developed. The flow injection method was based on the oxidation of
mebendazole by a known excess of sodium hypochlorite at pH=9.5. The excess sodium hypochlorite is then
reacted with chloranilic acid (CAA) to bleach out its color. The absorbance of the excess CAA was recorded
at 530 nm. The method is fast, simple, selective, and sensitive. The chromatographic method was carried out
on a Varian C18 column. The mobile phase was a mixture of acetonitrile (ACN), methanol (MeOH), water
and triethylamine (TEA), (56% ACN, 20% MeOH, 23.5% H2O, 0.5% TEA, v/v), adjusted to pH = 3.0 with
1.0 M hy

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Publication Date
Tue Sep 08 2020
Journal Name
Baghdad Science Journal
A Comparison Between Two Shape Parameters Estimators for (Burr-XII) Distribution
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This paper deals with defining Burr-XII, and how to obtain its p.d.f., and CDF, since this distribution is one of failure distribution which is compound distribution from two failure models which are Gamma model and weibull model. Some equipment may have many important parts and the probability distributions representing which may be of different types, so found that Burr by its different compound formulas is the best model to be studied, and estimated its parameter to compute the mean time to failure rate. Here Burr-XII rather than other models is consider  because it is used to model a wide variety of phenomena including crop prices, household income, option market price distributions, risk and travel time. It has two shape-parame

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Publication Date
Tue Jan 01 2019
Journal Name
Indian Journal Of Public Health Research & Development
Spectrophotometric Determination of Nifedipine in Pharmaceutical Tablets Using Batch and Flow Injection Method Via Diazotization Coupling Reaction
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Publication Date
Fri Sep 15 2017
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison of Shear Bond Strength of Sapphire Bracket Bonded to Zirconium Surface after Using Different Surface Conditioning Methods (In Vitro Study)
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Background: The present study was carried out to compare shear bond strength of sapphire bracket bonded to zirconium surface after using different methods of surface conditioning and assessment of the adhesive remnant index. Materials and methods: The sample composed of 40 zirconium specimens divided into four groups; the first group was the control, the second group was conditioned by sandblast with aluminum oxide particle 50 μm, the third and fourth group was treated by (Nd: YAG) laser (1064nm)(0.888 Watt for 5 seconds) for the 1st laser group and (0.444 Watt for 10 seconds) for the 2nd laser group. All samples were coated by z-prime plus primer. A central incisor sapphire bracket was bonded to all samples with light cure adhesive res

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Publication Date
Wed Jan 26 2022
Journal Name
International Journal Of Agricultural And Statistical Sciences
EFFECT OF CONTINUOUS AND DISCONTINUOUS LEACHING OF CALCIUM AND MAGNESIUM RELEASE FROM SOME CALCAREOUS SOIL
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Publication Date
Thu Jan 01 2015
Journal Name
Chemical And Process Engineering Research
Synthesis and Characterization of Gelatin-G-Poly (Acryloyl Amide) Proflavine and Controlled Release Study
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Gelatin-grafted N- proflavine acryl amide was synthesized through two steps; firstly the Gelatin was grafted with acrylic acid free radically using Ammonium per-sulfate at 60℃, Then it was modified to its corresponding acyl chloride derivation, second step included the substitution with amino group of proflavine, in this research Gelatin was used as a natural nontoxic, water soluble polymer as a drug carrier. The prepared pro drug polymer was characterized by FTIR and 1H-NMR spectroscopies, Controlled drug release was studied in different pH values at 37℃. Many advantages were obtained comparing with other known methods.

Publication Date
Sat Oct 01 2016
Journal Name
Journal Of Economics And Administrative Sciences
ORGANIZATIONAL VALUES AND ITS IMPACT ON STRATEGIC PERFORMANCE A field study a comparison between Two Universities of Baghdad & Al-Nahrain
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ABSTRACT

     The researcher seeks to shed light on the relationship analysis and the impact between organizational values in all its dimensions (Administration Management, Mission, relationship management, environmental management) and strategic performance (financial perspective, customer perspective, the perspective of internal processes, learning and development) in the presidency of Two Universities of Baghdad & Al-Nahrain, it has been formulating three hypotheses for this purpose.

      The main research problem has been the following question: Is there a relationship and the impact of bet

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Publication Date
Tue Aug 15 2023
Journal Name
Al-academy
The aesthetics of the sculptural formulations of swords in the Al-Kafeel Museum of Treasures and Manuscripts
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The research included (the aesthetics of the sculptural formulations of swords in the Al-Kafeel Museum) four chapters. Al-Kafeel Museum.)
Within the time period: (1240 AH / (1824 and 1825) AD - 1312 AH / (1894 and 1895) AD). The second: the types of Islamic swords. The third chapter included (research procedures), and the analysis of samples from the sample (3) as a model according to the descriptive approach, and the fourth chapter dealt with (results, conclusions, recommendations, and proposals). As well as recommendations, proposals and sources.

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Publication Date
Thu Apr 20 2023
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
A Comparative Biochemical Study Between Patient’s Obese and Healthy
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Objectives: Obesity rates have increased globally with increase in the incidence of comorbidities especially type 2 diabetes mellitus. A cross-sectional study was conducted on healthy obese adults to estimate: (i) comparisons of anthropometric indicators, lipid profile, and glycemic profile in obese compared with non-obese, and (ii) the association of anthropometrics and lipid profile with glycemic profile in obese adults. Methods: The study includes 120 individual with aged ranged (25 – 55) years were enrolled in this study. They were divided into two groups: group one (G1) consist of 90 patients with a body mass index (BMI) of more than 25 kg/m2. Group two (G2) of 30 healthy adults as a co

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