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Bioequivalence and Pharmacokinetics Comparison of Two Formulations of Extended-Release Pentoxifylline Tablets in Healthy Subjects after Fasting and Fed Conditions

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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Mar 14 2020
Journal Name
Medico-legal Update,
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Publication Date
Tue Nov 19 2024
Journal Name
Journal Of Baghdad College Of Dentistry
Measurement of salivary Immunoglobulin A of participants with a healthy, gingivitis and chronic periodontitis conditions

Background: Secretory Immunoglobulin A (SIgA) is a subclass of Immunoglobulin A (IgA), It is an antibody that plays an important role in mucosal immunity. It is the main immunoglobulin found in mucous secretions from mammary glands, tear glands and salivary glands, every pathologic process in the body involves the immune system, and periodontal inflammation is one of them and is not an exception. Material and methods: this study was consisted of 60 healthy male participants of an age ranged between (35-50) years old ; 25 of them with generalized moderate chronic periodontists(Clinical Attachment Loss equal to 3-4mm at ≥ 30% of the sites; 20 participants with plaque induced gingivitis and 15 participants had clinically healthy pe

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Publication Date
Thu Aug 27 2020
Journal Name
European Journal Of Ophthalmology
Comparison of corneal epithelial thickness profile in dry eye patients, keratoconus suspect, and healthy eyes
Purpose:

To compare the corneal epithelial thickness profile in patients with dry eyes and keratoconus suspect with normal healthy eyes.

Methods:

The study involved 120 eyes with an age range from 19 to 30 years. Forty eyes had normal corneal topography and no dry eyes. Forty eyes had dry eyes but had normal corneal topography. The last 40 eyes were keratoconus suspect and had no symptoms or signs of dry eyes.

Results:

Central epithelial thickness was not different statistically for all eyes. ( p-value: 0.1). The superior epithelial thickness was 53.5 µm ±3.1 in the control

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Publication Date
Tue Nov 19 2024
Journal Name
Journal Of Baghdad College Of Dentistry
Ions release from fixed orthodontic appliance in two different mouthwashes

Background: Metal ions can be released from metallic orthodontic appliances due to corrosion in the oral cavity; prophylactic mouthwashes may have an effect on ion release from orthodontic wires. Materials and Methods: Thirty six orthodontic sets of half maxillary fixed appliance with 2 types of arch wires SS and NiTi(Morelli) were constructed and immersed in 2 types of mouthwashes; Claradone (non-fluoridated) and Silver Care (fluoridated) for 28 days at 37°C, then the released Ni and Cr ionswere measured using atomic absorption spectrophotometer and compared statistically. Results: Ni ion release was higher from NiTi wire group than SS wire group for both mouthwashes and also was higher for Silver Care group than for Claradone group.

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Publication Date
Tue Nov 19 2024
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison of metal ions release and corrosion potential from different bracket archwire combinations (An in vitro study)

Background: Esthetic treatment is the options of patient seeking orthodontic treatment. Therefore this study was conducted to measure the concentration of Aluminum, Nickel, Chromium and Iron ions released from combination of monocrysralline brackets with different arch wires immersed in artificial saliva at different duration, to evaluate the corrosion point on different parts of the orthodontic appliances before and after immersion in artificial saliva, and to evaluate the corrosion potential of each group of the orthodontic appliances. Material and methods: Eighty orthodontic sets prepared. Each set represents half fixed orthodontic appliance, from the central incisor to the first molar, for the maxillary arch, each set consisted of molar

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Publication Date
Sun Jul 01 1990
Journal Name
Bulletin Of The Iraq Natural History Museum (p-issn: 1017-8678 , E-issn: 2311-9799)
COMPARISON OF ALFALFA WEEVIL POPULATIONS UNDER EPIZOOTIC AND ENZOOTIC CONDITIONS OF ERYNIAPHYTONOMI IN WISCONSIN

Comparisons of two life tables constructed to display alfaifa weevil Hypera posticoa (Gryllenhal), populations in southeentral Wisconsin, U. S. A. under epizootic and enzootic conditions of fungal diseasea, caused by Erynia phytonomi Arthur suggests that the “prepupal” stage provided the greates contribution to population changes under both conditions due to the high mortality rate. The principle mortality agents during this stage are E. phytonomi and the parasitoids complex of Bathyp1ectes curculionis and Buthyp1ectes anurus respectively under the two condition.

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Publication Date
Sat Mar 02 2019
Journal Name
World Heart Journal
The Effects of Chronic Cigarette Smoking on the Right Ventricular Functions in Healthy Young Male Subjects: A Speckle Tracking Echocardiographic Study

Background: Chronic cigarette smoking is one of the major risk factors for coronary artery disease. However, it has additional cardiac adverse effects independent of coronary atherosclerosis. Patient and Methods: After informed consent and perm- ission from the review board of the hospital, 80 healthy subjects who were classified as smokers or non-smokers were included in the study. They were examined by standard echocardiography protocol which was followed by two-dimensional speckle tracking to assess the functions of the right ventricle. Results: The tricuspid annular plane systolic excursion (TAPSE) was significantly reduced in smokers as compared to non-smokers (P < 0.05). The tricuspid flow peak late diastolic velocity (A wave) was sig

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Scopus
Publication Date
Fri Sep 15 2017
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison among pulp capping materials in: calcium ion release, pH change, solubility and water sorption (An in vitro study)

Background: Calcium hydroxide and calcium-silicate materials used as direct pulp capping materials. The aims of this in vitro study is to compare among these materials in, the calcium ion release and pH change in soaking water after immersion of materials’ specimens in deionized water. Also Solubility and water sorption of materials’ specimens measured after soaking time. Calcium-silicate materials used were Biodentine, TheraCal and MTA Plus. Materials and methods: Four materials used in this study; Urbical lining (as control group), Biodentine, TheraCal and MTA Plus. Ten discs fabricated from each tested material, by using plastic moulds of 9 mm diameter and 1 mm thickness. Each specimen was immersed in 10 ml of d

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Publication Date
Fri Apr 01 2022
Journal Name
Baghdad Science Journal
Comparison of Protein Concentration in Red and White Muscles in Two Species of Bony Fish

The current study deals with estimating the protein concentration and the effect of fish weight on protein concentration values in red and white muscles in two different regions ( R1 : Anterior region lies 2 cm behind the head and R2: posterior region lies 2cm from caudal fin  (in  two types of bony fish, namely common carp (Cyprinus carpio) and Nile tilapia (Oreochromis niloticus). Samples were collected from Karmat Ali river- north of Basrah between October 2019 and February 2020. The protein was extracted using protein extraction buffer, the current study show that the average of  protein concentration in red muscles of Nile tilapia ranged between  7.74-7.4 mg / ml  and ( 6.8-8.85 mg / ml) in R1 and R2 region re

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Publication Date
Sun Mar 07 2010
Journal Name
Baghdad Science Journal
Comparative Bioequivalence Studies of doxysam and doxycycline (Pfizer) by reversed phase HPLC.

Isocratic high performance liquid chromatography on reversed phase a (150x 4.6 mm I.D), 5 ?m ?-Bondapak RP-8 column (with acidic mobile phase allow the separation of doxcycycline hydrochloride with low detection limit of 0.2 µg/ml detected by UV set at 226 nm. The method was validated for Doxycycline between 0.156- to 5 µg/ml. The concentration of doxycycline was assessed in two single dose randomized crossover studies with intervals of one week between two period. In sera of 20 adults healthy male volunteers with average age of (42 + 10) year, body weight 48-85 kg, body height of (160-185cm) after a single dose of doxycycline hydrochoride 100 mg in form of capsules were orally administrated for both formulations. The blood sa

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