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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jun 29 2017
Journal Name
College Of Islamic Sciences
Imam Yahya bin Saeed Al-Ansari and his jurisprudential views on fasting issues
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In The Name of Allah Most Gracious Most Merciful

 

The reason for choosing this topic was:

 

First: It is my great love for the Prophet Muhammad, may God’s prayers and peace be upon him, his family, his companions, his followers, the followers of their followers, and the scholars after them until the Day of Judgment.

 


Secondly: Showing a great jurisprudential figure who has contributed by speaking about important jurisprudential issues in the life of this nation, and bringing out this immortal book to put it in the hands of scholars, so I chose a figure from the followers (may God be pleased with them all).

 


Third: The study of the jurisprudence of the companions

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Publication Date
Wed Mar 16 2022
Journal Name
Journal Of Educational And Psychological Researches
Internet Addiction: Healthy, Psychological, and Social Implications
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The aim of the current research is to explore the health, psychological, and social implications of Internet addiction. Internet addiction is a new type of addiction, which negatively affects an individual’s life and creates social problems, psychological and nervous disorders. The research is divided into three sections: The first section is devoted to the definition of the research and includes the research problem, its importance in addition to the objectives, and the search terms were defined in it. The second section included the concept of addiction on the Internet and the causes, symptoms of addiction, forms, and previous studies were reviewed. As for the third topic, it deals with the theories explaining Internet addiction and

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Publication Date
Mon May 20 2019
Journal Name
The Journal Of Engineering
Experimental comparison of two linear machines developed for the free piston engine
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: In this study, a linear synchronous machine is compared with a linear transverse flux machine. Both machines have been designed and built with the intention of being used as the power take off in a free piston engine. As both topologies are cylindrical, it is not possible to construct either using just flat laminations and so alternative methods are described and demonstrated. Despite the difference in topology and specification, the machines are compared on a common base in terms of rated force and suitability for use as a generator. Experience gained during the manufacture of two prototypes is described.

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Publication Date
Wed Oct 17 2018
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Two of (Turnbull) and (Generalization Turnbulls)non-parametric methods in estimating conditional survival function (applied study on breast cancer patients)
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   This research includes the application of non-parametric methods in estimating the conditional survival function represented in a method (Turnbull) and (Generalization Turnbull's) using data for Interval censored of breast cancer and two types of treatment, Chemotherapy and radiation therapy and age is continuous variable, The algorithm of estimators was applied through using (MATLAB) and then the use average Mean Square Error (MSE) as amusement  to the estimates and the results showed (generalization of Turnbull's) In estimating the conditional survival function and for both treatments ,The estimated survival of the patients does not show very large differences

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Publication Date
Fri Dec 23 2022
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Preparation and Evaluation of Oroslippery Tablets Contain Irbesartan and Hydrochlorothiazide Combination for Dysphagia Patients
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Oro slippery tablets (OSTs) is a technique used to improve swallowing of tablets for patients with dysphagia. The aim of this study was to formulate irbesartan and hydrochlorothiazide as Oroslippery tablets (OST) containing 150 mg irbesartan and 25 mg hydrochlorothiazide for dysphagia patients. A simple and rapid method of analysis was developed and validated according to the ICH guideline using HPLC with UV detector. Tablets were prepared by direct compression and then coated with the slippery coat of three different concentrations of the slippering substance “xanthan gum’ (2%, 3% and 4%) in Opadry Colorcone® and evaluated according to USP. Slipperiness test was performed using Albino rabbits. Results showed that 2% xanthan gum gav

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Publication Date
Fri Mar 01 2019
Journal Name
2019 9th International Ieee/embs Conference On Neural Engineering (ner)
Differences in EMG Feature Space between Able-Bodied and Amputee Subjects for Myoelectric Control
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Publication Date
Tue Jul 13 2021
Journal Name
Journal Of Craniofacial Surgery
Comparison of Two Botulinum Toxin Injection Methods for Treatment of Excessive Gingival Display
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Background: Hyperfunction of the muscles of the upper lip is considered as the most common cause of excessive gingival display (EGD). The aim of this study was to demonstrate the effectiveness of botulinum toxin (BT) injection as a conservative treatment for EGD due to muscular hyperfunction and to compare the outcome of 2 injection methods. Material and methods: This study included 40 participants who were randomly assigned into 2 groups of 20 each, The first group received 2.5IU BT injection at 1 point per side (2-points group), while the second group received a total of 5 IU of BT at 2 points per side (4-points group). The outcome variables were the reduction in the central and lateral gingival display expressed as the difference between

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Publication Date
Sat Dec 27 2025
Journal Name
Journal Of Baghdad College Of Dentistry
Computed tomographic localization of infraorbital foramen position and correlation with the age and gender of Iraqi subjects
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Background: The Infraorbital foramen is an anatomical structure with an important location in the maxilla, position of foramen in maxillofacial area is necessary in clinical situation requiring regional nerve blocks that are performed in children undergoing facial surgeries to avoid injury to corresponding nerve. The aim of study was to determine the position of the Infraorbital foramen and to correlate Infraorbital foramen position with age and gender using computed tomography. Subjects, Materials, and Methods: The sample consist of prospective study for 50 Iraqi subjects (21 male and 29 female) with age ranged from (5-17) years. The examination was performed on Multi – Slice Spiral Tomography scanner in Al-Karakh General Hospital. Using

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Publication Date
Sun Mar 13 2011
Journal Name
Baghdad Science Journal
Comparison study between two different Environment areas regarding diarrhea causes.
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This study Achieved to search form the infections by Cholera and Diarrhea in two different areas from the side of Cultural, Social, Economical and Environmental field in Baghdad governorate, during a period from 3/10 – 3/12/2007.these were in Obiady city and Palestine street. This study included groups of patients who went to the Kindy Hospital lab. The researcher use a sample of (300) persons of different ages with range (150) persons in each city from the study city, in this study show a great different in the percentage of infection by parasites, helminthes, viruses, bacteria and vibrio cholera in the two city according to age groups, reach upper percentage by infection in age (1-10) years in Obiady city with percent (57.5 %) wh

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Publication Date
Wed Mar 01 2023
Journal Name
Egyptian Journal Of Chemistry
First- and Second-Derivative Spectrophotometry for Simultaneous Determination of lorazepam and clonazepam in pharmaceutical formulations
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The present study describes employing zero-, 1st - and 2nd -order derivative spectrophotometric methods have been developed for determination of lorazepam (LORA) and clonazepam (CLON) in commercially available tablets. LORA was determined by means of 1st (D1), 2nd (D2) derivative spectrophotometric techniques using zero cross, peak height, and Peak area. D1 used for the determination of CLON by using zero cross and peak height while D2 (zero cross) was used for the determination of CLON. The method was established to be linear in concentration containing different ratios of LORA and CLON range of (20-200 mg/L) and (5-35 mg/L) at wavelength range (250 -370 nm), (210-370nm) respectively. The proposed techniques are highly sensitive, precise a

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