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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Wed Apr 01 2020
Journal Name
Saudi Pharmaceutical Journal
Pharmacist role to enhance the prescribing of hospital discharge medications for patients after heart attack
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Publication Date
Sun Mar 02 2008
Journal Name
Baghdad Science Journal
A study of analysis and comparison to the low nutrient density foods that more normality for children age (3 –5 years)
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Through the early childhood and after the ablactating the child learns acquired food habbits that might studying with him throughout his life. Here the parents role arises: teaching the child the sound food habits and hygienic styles and whatever beneficial to the health and with the sufficient quantities for the body. In this way the experiences the child learns at home will be of great help in his future life in choosing the suitable food after becoming more dependent in making his decisions and choices away from his parents. The results in this study showed that the averages of the children’s consumption of the high energy foods in comparison with the other highest consumption average , after that comes the con sumption of soft drills

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Publication Date
Wed Feb 01 2017
Journal Name
Journal Of Economics And Administrative Sciences
A comparison between the logistic regression model and Linear Discriminant analysis using Principal Component unemployment data for the province of Baghdad
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     The objective of the study is to demonstrate the predictive ability is better between the logistic regression model and Linear Discriminant function using the original data first and then the Home vehicles to reduce the dimensions of the variables for data and socio-economic survey of the family to the province of Baghdad in 2012 and included a sample of 615 observation with 13 variable, 12 of them is an explanatory variable and the depended variable is number of workers and the unemployed.

     Was conducted to compare the two methods above and it became clear by comparing the  logistic regression model best of a Linear Discriminant  function written

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Publication Date
Fri Mar 01 2019
Journal Name
Al-khwarizmi Engineering Journal
Comparison of Practical Investigations for CO Emissions Emitted From Single Cylinder S. I. Engine Fueled With Different Kinds of Hydrocarbon Fuels and Hydrogen
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Liquefied petroleum gas (LPG), Natural gas (NG) and hydrogen were all used to operate spark ignition internal combustion engine Ricardo E6. A comparison of CO emissions emitted from each case, with emissions emitted from engine fueled with gasoline as a fuel is conducted.

The study was accomplished when engine operated at HUCR for gasoline n(8:1), was compared with its operation at HUCR for each fuel. Compression ratio, equivalence ratio and spark timing were studied at constant speed 1500 rpm.

CO concentrations were little at lean ratios; it appeared to be effected a little with equivalence ratio in this side, at rich side its values became higher, and it appeared to be effected by equivalence ratio highly, the results s

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Publication Date
Fri Jun 19 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Evaluation of the effectiveness of coenzyme Q10 gel in management of patients with chronic periodontitis (I intra group comparison)
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Background: Periodontal pathogens can induce free radicals over-formation and thus may cause collagen and periodontal destruction. Anti-oxidants are used as supplements to counteract the over production of free radicals in periodontal disease, that can reduce of collagen destruction. Coenzyme Q10 serves as an endogenous antioxidant, regenerates other antioxidants, stimulates cell growth, and inhibits cell death. Because it is an antioxidant, coenzyme Q10 has received much research attention associated with periodontal diseases. Perio Q gel may possibly be effective as a topical agent and as an adjunct to scaling& root planing in treatment of gingivitis and chronic periodontitis. Aim of study:Determine the periodontal health status in a foll

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Publication Date
Fri Jun 15 2018
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison of certain radiomorphometric facial indices in different facial types of Iraqi adults using Cone Beam Computed Tomography
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Background: The human face has its special characteristics. It may be categorized into essentially three kinds in horizontal and vertical directions: short or brachyfacial, medium or mesofacial and long or dolichofacial. The aim of this study was to describe several orofacial indices and proportions of adults, according to gender in Iraqi subjects by using cone beam computed tomography . materials and methods: This prospective study included 100 Iraqi patients (males and females) ranging from 20 to 40 years. All subjects attended the Oral and Maxillofacial Radiology Department of Health Specialist Center for Dentistry in AL Sadr city in Baghdad taking cone beam computed tomography scan for different diagnostic purposes from October 2016 to

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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)
Evaluation the Effect of Phytosterol Fraction of Chenopodium Murale in Comparison with Tacrolimus on Mice Induced Atopic Dermatitis
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Atopic dermatitis (atopic eczema), is a common familial chronic inflammatory skin disease, determined by xerosis, itching, scaly and erythematous skin lesions, and high serum levels of IgE. Between 10 to 20% of children and 1 to 3% of adults worldwide affected by it and has negative medical and social effect on patients and their families. To evaluate the effectiveness of Phytosterol Fraction of Chenopodium Murale on induced atopic dermatitis (AD) of mice; Forty mice were included in the study, divided in to four groups (10 mice/group): apparently healthy, induced AD without treatment, induced AD treated with Tacrolimus 0.1% ointment, and induced AD treated with Phytosterol Fraction of Chenopodium Murale cream 3% topica

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Publication Date
Sun Jan 01 2023
Journal Name
Al-bayan Journal For Medical And Health Sciences
Effect of Nd:YAG Laser Surface Treatment on Wettability of Thermoplastic Acrylic in Comparison with Heat-Cure Acrylic resin
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Aim of the study: This study's goal was to determine how laser surface alteration affected wettability of injectable thermoplastic acrylic and heat cure acrylic denture base materials. Materials and methods: Injectable thermoplastic acrylic resin (Deflex) and heat cure acrylic (Procryla) were used in this study to produce forty-disc shaped specimens, 20 specimens for each material type. The control group was made up of ten samples of each type of plastic denture base material. The other ten samples were treated with a nano-pulse fiber-optic lens Nd:YAG laser. The results were looked at with the Kruskal-Wallis test and the unpaired t-test (a=.05). Results: Compared to the control groups, the laser-treated groups were more likely to sti

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Publication Date
Wed Mar 11 2020
Journal Name
Journal Of Cardiovascular Disease Research
Resistive Index is an Early Indicator for Flow Deterioration in Comparison with Intima Media Thickness for Patients with Hypertension and Diabetes in Relation to Age
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Background: Atherosclerosis is well known related to age and certain cardiovascular diseases. Aging is one reason of arteries function deterioration which can cause loss of compliance and plaque accumulation, this effect increases by the presence of certain diseases such as hypertension and diabetes disease. Aim: To investigate the reduction of blood supply to the brain in patients with diabetes and hypertension with age and the role of resistive index in the diagnosis of reduced blood flow. Method: Patients with both diseases diabetic and hypertension were classified according to their age to identify the progression of the disease and factors influencing the carotid artery blood flow. By using ultrasound and standard Doppler techniq

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Publication Date
Sun Jun 07 2015
Journal Name
Baghdad Science Journal
Optimum conditions for Inulinase production by Aspergillus niger using solid state fermentation
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Thirty local fungal isolates according to Aspergillus niger were screened for Inulinase production on synthetic solid medium depending on inulin hydrolysis appear as clear zone around fungal colony. Semi-quantitative screening was performed to select the most efficient isolate for inulinase production. the most efficient isolate was AN20. The optimum condition for enzyme production from A. niger isolate was determined by busing a medium composed of sugar cane moisten with corn steep liquor 5;5 (v/w) at initial pH 5.0 for 96 hours at 30 0C . Enzyme productivity was tested for each of the yeast Kluyveromyces marxianus, the fungus A. niger AN20 and for a mixed culture of A. niger and K. marxianus. The productivity of A. niger gave the highest

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