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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jul 12 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Formulation and Evaluation of Optimized Zaltoprofen Lyophilized Tablets by Zydis Technique
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“Orodispersible Tablet” a tablet that is to be placed in oral cavity where it disperses rapidly by saliva with no need for water before swallowing. Zaltoprofen (ZLP) is one of NSAIDs which is used in the treatment of rheumatoid arthritis and osteoarthritis as well as to relieve inflammation and pain after surgery, injury and tooth extraction. The present study was aimed to prepare rapidly dissolved lyophilized Zaltoprofen tablet with different pharmaceutical excipients and studying the factors affecting pharmaceutical properties like (solubility, disintegration time DT, dissolution, etc.) of tablets. The lyophilized disintegrating tablets (LDTs) were prepared using Zydis technique by lyophilization an aqueous

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Publication Date
Tue Mar 15 2022
Journal Name
Malaysian Journal Of Medicine And Health Sciences
Detection of Extended Spectrum β-lactamases and Metallo β-lactamases in Pseudomonas Aeruginosa isolated from Burns
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P. aeruginosa is one of the complex targets for antimicrobial chemotherapy. Also, it is intrinsically resistant to several antibiotics. It produces β-lactamases enzymes that are responsible for the widespread β-lactam antimicrobial resistance. There are three major groups of β-lactamase enzymes, MBLs and ESBLs forming Pseudomonas is a major issue for the treatment of burns victims. Methods: A total of 28 clinical isolates related to P. aeruginosa have been obtained from the burns specimens from patients attending to AL-Imam hospital/Baghdad-Iraq, through the period from October 2015 to March 2016. Also, all isolates have been recognized as P. aeruginosa via utilizing bacteriological assay and confirmed by Vitek 2. In addition, the suscep

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Publication Date
Sat Feb 27 2021
Journal Name
Journal Of Engineering
Design and Simulation of a controller for Double Fed Induction Generator turbine Utilized Solar Up Draft Tower
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This paper introduces a complete design and simulation of a controller for the double fed induction generator (DFIG) turbine. The work also included the solar updraft tower (SUT) design to supply Al-Mahmoudia hospital in Baghdad/Iraq. The design includes the daily average load estimation, annual solar irradiance and, temperature monitoring, and logging.

According to the data obtained from the Ministry of Science and Technology, Baghdad has low wind speed. Therefore, the (SUT) has been designed to generate electrical power depending on the difference between the external and internal air temperature. The temperature difference will generate a suitable airspeed to drive the wind turbine, connected to the proposed (DFIG) generators

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Publication Date
Wed Aug 11 2021
Journal Name
Biochem. Cell. Arch
Diagnostic study of candidiasis in the mouth, urine and vagina of diabetic and healthy people
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A study that collected 240 samples and divided into two groups: the first 120 samples were for diabetics and the second 120 samples were for healthy people, and each group included (90, 20.10) samples from the mouth, urine and vagina respectively, The results showed positive (28.67, 4.00, 1.67) isolates of Candida. In the mouth, urine and vagina, respectively, of diabetic patients compared to (9.33, 2.33, 5.00) positive isolates in the mouth, urine and vagina, respectively, in the healthy. The rate of positive isolates in women was high in women with diabetes and healthy, and it reached 25.33 and 9.00 isolates, respectively, compared with the rate of isolates in men with Candida disease for diabetic patients and healthy people 14.67 and 2.0

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Publication Date
Sat Jun 07 2025
Journal Name
Sciences Journal Of Physical Education
Comparison of maximum strength and peak electrical activity (EMG) of the muscles of the two legs among bodybuilding players and Weightlifting
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Publication Date
Wed Dec 27 2023
Journal Name
Journal Of Planner And Development
Effective indicators of healthy cities in facing natural disasters (epidemics and diseases)
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The excessive and rapid urban growth witnessed by most cities in the world can be a cause of diseases and epidemics, especially those problems related to population, which include problems of transportation and increase in density in the centers, in addition to the lack of interest in planning and designing those cities to take into account the health aspect of the city and obtain The health well-being of the population, and each of these problems has negative effects on health in general and on human health in particular through its prevalence. Therefore, many concepts that serve as a tool for achieving public health and the physical health of the population have emerged, including the concept of city health, which is defined as cities

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Publication Date
Wed Mar 29 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Preparation and Evaluation of Oral Disintegrating Tablets of Ketoprofen by Dirct Compression
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Ketoprofen is a non-steroidal anti-inflammatory (NSAID) drug with analgesic, anti-inflammatory, and antipyretic effects. It is widely used in the treatment of inflammation and pain associated with rheumatic disorders such as rheumatoid arthritis, osteoarthritis, and in soft tissue injury. The purpose of this study was to prepare an  oral disintegrating tablets of ketoprofen by simple method. The tablets were prepared by direct compression method and different ratios of various subliming agents or superdisintegrants were incorporated. Then these tablets were evaluated for hardness, friability, weight variation, water absorption ratio, disintegrating time and dissolution time. The results showed that Formula F11 batch had short disint

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Publication Date
Wed Mar 29 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Evaluation of Stability of Cefamandol and Ceftazidime with Clavulanic Acid Against Extended Spectrum ?- Lactamase
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The aim of this study is to evaluate in-vitro activity of Cefamandol (Cfm) and Ceftazidime (Cfz), in combination with Clavulanic acid (CA) against ten complicated multiresistant uropathogenic E.coli .One hundred clinical strains were isolated from patients with chronic urinary tract infections (UTIs), these isolates were identified by the Api identification systems. The antimicrobial susceptibility tests were determined by Kirby-Bauer method, all of them were sensitive to Imipenem (Imp). Ten strains were chosen for the present study, they were resistant to Ampicillin (Amp), Amoxicillin (Amo), Carbenicillin (Cb), Ticarcillin (Tic), Azlocillin (Azl), Amoxicillin\ Potassium Clavulanate {Augmentin(Amc)}, (Amo\CA), Ticarcillin\ Potas

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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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Publication Date
Wed Jun 29 2022
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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