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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sat Feb 09 2019
Journal Name
Journal Of The College Of Education For Women
The Foreign Investment in Oil Sector in Iraq after 2003
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Iraq has the distinction of being a great potential of non-renewable natural resources,
especially crude oil and natural gas. Since the discovery of crude oil at the beginning of the
twentieth century in Iraq. Although the different of investment types, it contributed to the oil
sector in the provision of financial resources to the state treasury , since that date until the
present time.
Search has been marked by division ((The foreign investment in the oil sector in Iraq after
2003)) into three sections. The first section included a brief history of the development of
Iraq's oil potential in terms of oil reserves, and oil fields, and the quantities of production and
export. The second section reviewed the investm

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Publication Date
Wed Jul 22 2015
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
Studying the Optimal Conditions for Extraction of Local Basil Seeds Gum.: Studying the Optimal Conditions for Extraction of Local Basil Seeds Gum.
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This study aimed to determine the optimal conditions for extracting basil seed gum in addition to determine the chemical components of basil seeds. Additionally, the study aimed to investigate the effect of the mixing ratio of gum to ethanol when deposited on the basis of the gum yield which was1:1, 1:2, 1:3 (v/v) respectively. The best mixing ratio was one size of gum to two sizes of ethanol, which recorded the highest yield. Based on the earlier, the optimal conditions for extracting basil seed gum in different levels which included pH, temperature, mixing ratio seeds: water and the soaking duration were studied. The optimal conditions were: pH 8, temperature of 60°C, mixing ratio seeds: water 1:65 (w/v) and soaking duration of 30 min

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Publication Date
Thu Dec 10 2009
Journal Name
Iraqi Journal Of Laser
Immuno-hematological and biochemical changes in diabetic retinopathy patient`s blood after treatment by Nd-YAG laser
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Diabetic retinopathy is one of most important complications of diabetes mellitus that can be treated by Nd:YAG laser. Laser is used in ophthalmic practice for photocoagulation and photodisruption. The purpose of this study is to evaluate changes in immunological ,hematological and biochemical values after treatment of diabetic retinopathy by laser. Blood samples from 10 patients suffering from diabetic retinopathy were taken before and after laser treatment to coagulate retina to prevent leakage and hemorraghe to avoid deterioration of vision.In group one (4 patients = 40%), blood tests were done one day after treatment. In group two (6 patients =60%) tests were done 7 days after treatment with laser. The study showed no clear changes in

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Publication Date
Fri Dec 15 2023
Journal Name
Journal Of Baghdad College Of Dentistry
Color stability of nano resin-modified glass Ionomer restorative cement after acidic and basic medications challenge
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Background: Color stability of glass ionomers (GIs) could be affected by many factors such as pH and consumption of liquid medications like antibiotics. Most common antibiotics used during childhood are amoxicillin suspension (AM.S) and azithromycin suspension (AZ.S) which have acidic and basic pH respectively. Aim: to evaluate and compare the effect of AM.S and AZ.S on color stability of nano resin-modified GI. Methods: Thirty disc of nano resin-modified glass ionomer (2mm height x 4mm diameter) were divided into three groups (n=10 for each) and independently exposed to AM.S, AZ.S, and artificial saliva (A.S.). Color stability was evaluated in triplicate by VITA Easyshade® before and after three immersion protocols, repeated over

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Publication Date
Fri Dec 15 2023
Journal Name
Journal Of Baghdad College Of Dentistry
Color stability of nano resin-modified glass Ionomer restorative cement after acidic and basic medications challenge
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Background: Color stability of glass ionomers (GIs) could be affected by many factors such as pH and consumption of liquid medications like antibiotics. Most common antibiotics used during childhood are amoxicillin suspension (AM.S) and azithromycin suspension (AZ.S) which have acidic and basic pH respectively. Aim: to evaluate and compare the effect of AM.S and AZ.S on color stability of nano resin-modified GI. Methods: Thirty disc of nano resin-modified glass ionomer (2mm height x 4mm diameter) were divided into three groups (n=10 for each) and independently exposed to AM.S, AZ.S, and artificial saliva (A.S.). Color stability was evaluated in triplicate by VITA Easyshade® before and after three immersion protocols, repeated over a thr

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Publication Date
Wed Aug 19 2026
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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Publication Date
Mon Jan 01 2024
Journal Name
Aip Conference Proceedings
The dynamical behavior of AIDS and HCV infection model with two modes of transmission
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The aim of this paper is to describe an epidemic model when two SI-Type of diseases are transmitted vertically as well as horizontally through one population. The population contains two subclasses: susceptible and infectious, while the infectious are divided into three subgroups: Those infected by AIDS disease, HCV disease, and by both diseases. A nonlinear mathematical model for AIDS and HCV diseases is Suggested and analyzed. Both local and global stability for each feasible equilibrium point are determined theoretically by using the stability theory of differential equations, Routh-Hurwitz and Gershgorin theorem. Moreover, the numerical simulation was carried out on the model parameters in order to determine their impact on the disease

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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
Thu Nov 01 2018
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Multistage and Numerical Discretization Methods for Estimating Parameters in Nonlinear Linear Ordinary Differential Equations Models.
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Many of the dynamic processes in different sciences are described by models of differential equations. These models explain the change in the behavior of the studied process over time by linking the behavior of the process under study with its derivatives. These models often contain constant and time-varying parameters that vary according to the nature of the process under study in this We will estimate the constant and time-varying parameters in a sequential method in several stages. In the first stage, the state variables and their derivatives are estimated in the method of penalized splines(p- splines) . In the second stage we use pseudo lest square to estimate constant parameters, For the third stage, the rem

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Publication Date
Tue Jan 01 2019
Journal Name
Malaysian Journal Of Biochemistry And Molecular Biology
Efficiency of primer design tools in evaluation of two molecular methods to detect two single nucleotide polymorphisms related with atherosclerosis
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