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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Tue Sep 01 2020
Journal Name
Rawal Medical Journal
HOMA-IR and TyG Index as acute phase reactants in obese and lean subjects
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Objective: To evaluate biomarkers of insulin resistance and acute phase reactants in obese, overweight and lean subjects and investigate the associations among those biomarkers. Methodology: This cross sectional study included 158 subjects who were stratified into three groups. Group1 comprised 53 obese patients (BMI≥ 30 kg/m2); group 2 were 54 overweight subjects, and group 3 had 51 healthy lean (BMI

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Publication Date
Sun Jun 21 2020
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Preparation, in vitro and ex-vivo Evaluation of Mirtazapine Nanosuspension and Nanoparticles Incorporated in Orodispersible Tablets
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          The objective of the present investigation was to enhance the solubility of practically insoluble mirtazapine by preparing nanosuspension, prepared by using solvent anti solvent technology. Mirtazapine is practically insoluble in water which act as antidepressant .It was prepared as nano particles in order to improve its solubility and dissolution rate. Twenty formulas were prepared and different stabilizing agents were used with different concentrations such as poly vinyl pyrrolidone (PVPK-90), poly vinyl alcohol (PVA), poloxamer 188 and poloxamer 407. The ratios of drug to stabilizers used to prepare the nanoparticles were 1: 1 and 1:2. The prepared nanoparticles were evaluated for

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Publication Date
Sat Jan 06 2018
Journal Name
International Journal Of Applied Pharmaceutics
PREPARATION, RELEASE, RHEOLOGY AND STABILITY OF PIROXICAM EMULGEL
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Objective: The purpose of this work was to develop and optimize the emulgel formulation of piroxicam with two types of gelling agent chitosan and xanthan gum. The release profiles of prepared formulas were investigated. In addition, the rheology and stability of the best formula were investigated.Methods: Emulsified piroxicam was prepared to use oleic acid, tween 80 and PG with a ratio (3:10:10). In xanthan based emulgel, the xanthan gum (1% and 1.5%) was spread as powder on emulsified piroxicam with stirring until emulgel was formed. In chitosan-based emgels, Chitosan gel was added to emulsified piroxicam and stirring until the Emulgel was constructed. Chitosan gels were prepared by incorporating different concentration, 2%, 3%, 6%

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Publication Date
Tue Sep 01 2020
Journal Name
Meta Gene
Genetic polymorphisms frequency of vitamin D receptor gene rs7975232 and rs731236 in Iraqi thalassemic patients and healthy controls compared to Arabian healthy populations
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Publication Date
Tue Mar 28 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Formulation and Optimization of Oral Fast Dissolving Prochloperazine Maleate Tablets
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Prochloperazine maleate (PCM) is one of the most prescribed phenothiazine. The purpose of the present research was to develop fast dissolving tablets of PCM with β-cyclodextrin inclusion complex. Tablets prepared  by wet granulation with sublimation and by using  different superdisintegrants type [ low-hydroxypropylcellulose LH21 (L-HPC LH21), carboxymethylcellulose calcium (ECG505), crospovidone (CP)], and different type of subliming agents (urea and ammonium bicarbonate (AB)). Tablets evaluated for its % friability, disintegration time, wetting time, hardness, content uniformity, weight variation, in vitro dissolution studies. For further enhancement of disintegration and dissolution, PCM orodispersible tablet were formula

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Publication Date
Sun Jul 09 2023
Journal Name
Journal Of Engineering
Analysis and Control of PWM Buck-Boost AC Chopper Fed Single-Phase Capacitor Run Induction Motor
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Single phase capacitor-run induction motors (IMs) are used in various applications such as home appliances and machine tools; they are affected by the sags or swells and any fault that can lead to disturb the supply and make it produce rms voltage below or above the rated motor voltage, which is 220V. A control system is designed to regulate the output voltage of the converter irrespective to the variation of the load and within a specific range of supply voltage variation. The steady-state equivalent circuit of the Buck-Boost chopper type AC voltage regulator, as well as the analysis of this circuit are presented in this paper. Switching device for the regulator is an IGBT Module. The proposed chopper uses pulse width modulation (PWM) c

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Publication Date
Sat Aug 20 2022
Journal Name
International Journal Of Health Sciences
Study the efficacy of intralesional pentoxifylline versus triamcinolone acetonide in keloid scars patients
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Keloids are prevalent fibro-proliferative tumors, and treating them is still a challenge although intralesional injections of triamcinolone acetonide (TAC) are effective, they have frequently linked adverse effects. Pentoxifylline (PTX) is an anti-fibrotic and anti-inflammatory, and vasodilator. It has not yet been tested for intralesional injection in keloids. The aim of the study is to study the efficacy of intralesional pentoxifylline versus triamcinolone acetonide in keloid scars of 40 patients. In this study, 40 patients with keloid scars regardless of the cause of keloid born, 20 patients have injected with intralesional triamcinolone acetonide, and 20 patients with intralesional pentoxifylline every two weeks until the lesi

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Publication Date
Sun Mar 02 2008
Journal Name
Baghdad Science Journal
Spectrophotometric determination of Procaine penicillin in pure and pharmaceutical formulations using metol
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A simple, accurate and sensitive spectrophotometric method for the determination of Procaine penicillin (PP) is described. The method is based on charge-transfer reaction of PP with metol (N-methyl-p-hydroxy aniline) in the presence of ferric sulphate to form a purple-water soluble complex ,which is stable and has a maximum absorption at 510 nm .A graph of absorbance versus concentration shows that Beer’s low is obeyed over the concentration range of 3-80 µg /ml of PP (i.e.,3-80 ppm) with a molar absorbativity of 4.945 ×103 L.mol-1.cm-1 ,Sandell sensitivity of 0.1190 µg cm-2 ,a relative error of (-1.57)-2.79 % and a standard deviation of less than 0.59 depending on the concentration of PP.The optimum conditions for full co

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Publication Date
Thu Feb 01 2024
Journal Name
Journal Of Engineering
Performance Evaluation of Two Stages Parallel Flow Indirect Evaporative Cooling with Aspen Pads in Baghdad Climate Conditions
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This study delves into the realm of advanced cooling techniques by examining the performance of a two-stage parallel flow indirect evaporative cooling system enhanced with aspen pads in the challenging climate of Baghdad. The objective was to achieve average air dry bulb temperatures (43 oC) below the ambient wet bulb temperatures (24.95 oC) with an average relative humidity of 23%, aiming for unparalleled cooling efficiency. The research experiment was carried out in the urban environment of Baghdad, characterized by high temperature conditions. The investigation focused on the potential of the two-stage parallel flow setup, combined with the cooling capability of aspen pads, to surpass the limitat

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Publication Date
Sun Dec 22 2019
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Formulation and Evaluation of Sustained Release Sumatriptan Mucoadhesive Intranasal in-Situ Gel
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Sumatriptan(ST) is a selective agonist at serotonin 5-HTI receptors, as well as 5-HT1B/1D subtypes. It is effective for acute migraine attacks, but has a short half  life (about 2 hours) and low oral bioavailability (15%). The purpose of this study was to develop and optimize nasal mucoadhesive in-situ gel(IG) of ST to enhance nasal residence time for migraine management. Cold method was used to prepare different formulas of  ST nasal IG, using thermosensitive polymers (poloxamer 407  alone or with poloxamer 188) with a mucoadhesive polymer hyaluronic acid (HA) which were examined for gelation temperature and gelation time, pH, drug content, gel strength, spreadability, muc

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