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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Oct 01 2016
Journal Name
Journal Of Economics And Administrative Sciences
ORGANIZATIONAL VALUES AND ITS IMPACT ON STRATEGIC PERFORMANCE A field study a comparison between Two Universities of Baghdad & Al-Nahrain
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ABSTRACT

     The researcher seeks to shed light on the relationship analysis and the impact between organizational values in all its dimensions (Administration Management, Mission, relationship management, environmental management) and strategic performance (financial perspective, customer perspective, the perspective of internal processes, learning and development) in the presidency of Two Universities of Baghdad & Al-Nahrain, it has been formulating three hypotheses for this purpose.

      The main research problem has been the following question: Is there a relationship and the impact of bet

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Publication Date
Thu Jan 30 2020
Journal Name
Al-kindy College Medical Journal
A Comparison between High Ablative Versus Usual Dosages of Iodine-131 in Inducing Hypothyroidism After One Year of Therapy in Hyperthyroid Patients
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Background: Radioactive iodine-131 therapy is highly effective in treating patients with hyperthyroidism. An ablative dose is preferred by a number of endocrinologists, and, a fixed dose protocol seems to be better than a calculated dose in real practice.

Objective: To check for hypothyroidism in hyperthyroid patients one year after RAI therapy, comparing between the results of high ablative versus usual dosages of RAI-131.

 Methods:  This study included 174 hyperthyroid patients, 101 males and 73 females, divided into 2 groups, the first consisted of 162 patients given a usual fixed dose of RAI while the second consisted of 12 patients given a high fixed ablati

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Publication Date
Wed Sep 24 2025
Journal Name
Tropical Journal Of Pharmaceutical Research
Antibacterial-enhancing efficacy of aloe vera and honey in salicylic acid topical formulations against acne
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Purpose: To compare the antibacterial-enhancing efficacy of aloe vera and honey in salicylic acid topical formulations against acne. Method: Six formulations containing 5 % salicylic acid were developed as creams and gels as follows: Formulations S, V and H were creams containing salicylic acid alone (S), salicylic acid with 28 % aloe vera (V), and salicylic acid with 10 % honey (H). Formulations J, M, and B were gels containing salicylic acid alone (J), salicylic acid with aloe vera 20 % (M) and salicylic acid with 12 % honey (B). Each formula was evaluated for colour, odour, pH, viscosity, spreadability, and stability under different temperatures (25, 30, and 60oC) and times (1 hour, 1 day, and 1 week). Furthermore, antibacterial

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Publication Date
Sat Oct 28 2023
Journal Name
Baghdad Science Journal
Indirect Flow Injection Spectrophotometric and Chromatographic Methods for the Determination of Mebendazole in Pharmaceutical Formulations
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Chromatographic and spectrophotometric methods for the estimation of mebendazole in
pharmaceutical products were developed. The flow injection method was based on the oxidation of
mebendazole by a known excess of sodium hypochlorite at pH=9.5. The excess sodium hypochlorite is then
reacted with chloranilic acid (CAA) to bleach out its color. The absorbance of the excess CAA was recorded
at 530 nm. The method is fast, simple, selective, and sensitive. The chromatographic method was carried out
on a Varian C18 column. The mobile phase was a mixture of acetonitrile (ACN), methanol (MeOH), water
and triethylamine (TEA), (56% ACN, 20% MeOH, 23.5% H2O, 0.5% TEA, v/v), adjusted to pH = 3.0 with
1.0 M hy

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Publication Date
Wed Jan 26 2022
Journal Name
International Journal Of Agricultural And Statistical Sciences
EFFECT OF CONTINUOUS AND DISCONTINUOUS LEACHING OF CALCIUM AND MAGNESIUM RELEASE FROM SOME CALCAREOUS SOIL
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Publication Date
Thu Jan 01 2015
Journal Name
Chemical And Process Engineering Research
Synthesis and Characterization of Gelatin-G-Poly (Acryloyl Amide) Proflavine and Controlled Release Study
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Gelatin-grafted N- proflavine acryl amide was synthesized through two steps; firstly the Gelatin was grafted with acrylic acid free radically using Ammonium per-sulfate at 60℃, Then it was modified to its corresponding acyl chloride derivation, second step included the substitution with amino group of proflavine, in this research Gelatin was used as a natural nontoxic, water soluble polymer as a drug carrier. The prepared pro drug polymer was characterized by FTIR and 1H-NMR spectroscopies, Controlled drug release was studied in different pH values at 37℃. Many advantages were obtained comparing with other known methods.

Publication Date
Tue Jan 01 2019
Journal Name
Indian Journal Of Public Health Research & Development
Spectrophotometric Determination of Nifedipine in Pharmaceutical Tablets Using Batch and Flow Injection Method Via Diazotization Coupling Reaction
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Publication Date
Fri Sep 15 2017
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison of Shear Bond Strength of Sapphire Bracket Bonded to Zirconium Surface after Using Different Surface Conditioning Methods (In Vitro Study)
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Background: The present study was carried out to compare shear bond strength of sapphire bracket bonded to zirconium surface after using different methods of surface conditioning and assessment of the adhesive remnant index. Materials and methods: The sample composed of 40 zirconium specimens divided into four groups; the first group was the control, the second group was conditioned by sandblast with aluminum oxide particle 50 μm, the third and fourth group was treated by (Nd: YAG) laser (1064nm)(0.888 Watt for 5 seconds) for the 1st laser group and (0.444 Watt for 10 seconds) for the 2nd laser group. All samples were coated by z-prime plus primer. A central incisor sapphire bracket was bonded to all samples with light cure adhesive res

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Publication Date
Thu Mar 30 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
The Release of Diazepam from Different Conventional and Hollow Type Suppository Bases
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The objective of this study was to investigate the release profile of different fat and water soluble bases using diazepam as a model drug , and then to develop  a satisfactory formula with a rapid release of diazepam from suppository bases .The study was conducted using theobroma oil ,glycerol-gelatin and glycerol-PEG1540 bases using conventional mold method for preparation .while the later base was utilized to incorporate diazepam ( buffered solution ) in a hollow type suppositories. The results indicated that all types of bases can be utilized to formulate diazepam as  rectal suppositories with acceptable disintegration time ( 12, 10, 6, and 6min.), respectively . While 100% of the  released drug had been shown differen

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Publication Date
Tue Jan 01 2019
Journal Name
Journal Of Global Pharma Technology
Synthesis and characterization of chitosan schiff base hydrogel for controlled drug release
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Chitosan-schiff base with three different ratios of para-Dimethyl aminobenzaldehyde& chitosan Schiff base hydrogels have been prepared for controlled drug release study. The synthesized chitosan Schiff base and chitosan Schiff base hydrogel were characterized by FT-IR, UV-Visible, SEM, analysis. Swelling properties of the hydrogel were investigated at three different media pH (2, 7, 10). The swelling degree varied with the pH, amount of crosslinking agent glutaraldehyde and with the amount of paraDimethylaminobenzaldehyde for the hydrogels. All hydrogels were used for controlled drug release system. Aspirin was used as model drug, in three different buffer solution (2, 7, 10) as release media. The rate of release of drugs in the pH2 is m

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