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Preparation, <i>In-vitro, Ex-vivo</i>, and Pharmacokinetic Study of Lasmiditan as Intranasal Nanoemulsion-based <i>In Situ</i> Gel
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Background:

Lasmiditan (LAS) is a recently developed antimigraine drug and was approved in October, 2019 for the treatment of acute migraines; however, it suffers from low oral bioavailability, which is around 40%.

Objective:

This study aimed to improve the LAS bioavailability via formulation as nanoemulsionbased in situ gel (NEIG) given intranasally and then compare the traditional aqueous-LASsuspension (AQS) with the two successful intranasal prepared formulations (NEIG 2 and NEIG 5) in order to determine its relative bioavailability (F-relative) via using rabbits.

Method:

Two successfully prepared nanoemulsion (NE) formulas, a and b, were selected for the incorporation of different percentages of pH-sensitive in situ gelling polymer (Carbopol 934) to prepare NEIGs 1, 2, 3, 4, 5, and 6. The pH, gelation capacity, gel strength, and viscosity were predicted for the prepared NEIGs. The release (in vitro) and the nasal permeation (ex vivo) were determined for NEIG 2 and 5, and then both were subjected to pharmacokinetics in vivo studies. Eighteen male rabbits weighing 2.0 to 2.5 kg were employed in the parallel design study. The body surface area (BSA) normalization method was applied for LAS dose calculation. Serial blood samples were taken out and subjected to drug analysis using the HPLC method previously developed and validated by Kumar et al. Primary pharmacokinetics parameters, including maximum drug concentration in plasma (Cmax), time to reach C-max (T-max), and area under the concentration-time curve from time zero to affinity (AUCt0-∞) were calculated. Both NE (a and b), together with NEIG (2 and 5) formulas, were subjected to the stability study. Finally, a nasal ciliotoxicity study was carried out to evaluate the nasal toxicity of developed NEIGs 2 and 5.

Result:

The results showed that NEIGs 2 and 5 could be selected as the optimized NEIGs as both achieved 100% permeation within 20 min and then released within 25 and 35 min, respectively, thus achieving 3.3 folds with higher permeation percentages as compared to the AQS. Both NEIGs 2 and 5 exerted comparable release and permeation values as the corresponding NE a and b with more residence time in order to overcome the normal nasal physiological clearance. The values of C-max, Tmax, and AUC0- ∞ for NEIG 2 and NEIG 5 were 8066 ± 242 ng/ml, 0.75 ± 0.05 h, 19616.86 ± 589 ng. h/ml, and 7975.67 ± 239 ng/ml, 1.0 ± 0.05 h, 17912.36 ± 537 ng. h/ml, respectively, compared to the traditional AQS, which is equal to 4181.09 ± 125 ng/ml, 2 ± 0.2 h, and 8852.27 ± 266 ng. h/ml, respectively. It was discovered that NEIGs 2 and 5 had better intranasal delivery of LAS and could significantly (p < 0.05) achieve a higher value of permeability coefficient (3.3 folds) and 2.5 folds improvement in bioavailability when compared to AQS. The NE a, NE b, NEIG2, and NEIG5 formulations showed good stability at various temperatures. According to the nasal ciliotoxicity study, the nasal mucosal membrane, which was treated with NEIG 5, showed irritation with a bit of damage. However, damage was not observed when it was treated with NEIG 2, indicating the biocompatibility of the last one to be selected as the optimum formula.

Conclusion:

NEIG 2 and NEIG 5 are promising new intranasal formulas with a faster onset of action and greater bioavailability than the oral dosage form (AQS). Finally, the selected optimum gold formula that will be ready for further clinical study is NEIG 2.

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Publication Date
Sun Jun 05 2016
Journal Name
Baghdad Science Journal
Effect of varicocelectomy on sperm parameters, oxidative stress and Chromatin maturity in seminal fluid of infertile patients with varicocele
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This study aimed to determine the effect of varicocelectomy on sperm parameters, oxidant- antioxidant status and chromatin maturity percent. The current study has been conducted on 154 infertile patients complaining from varicocele and varicocelomized men in addition to 25 fertile men as control. The results revealed significant decrease (P<0.05) in sperm concentration, progressive motile sperm percent, normal sperm morphology percent, GSH, SOD1, CAT levels and chromatin maturity percent and significant increase (P<0.05) in MDA and ROS concentrations in infertile patients with varicocele when compared to fertile men. The results revealed improvement (P<0.05) of sperm parameters quality, GSH, SOD1, CAT, MDA, ROS concentration and chromatin m

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Publication Date
Tue Oct 20 2020
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
Comparison of Artificial Neural Network and Box- Jenkins Models to Predict the Number of Patients with Hypertension in Kalar
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    Artificial Neural Network (ANN) is widely used in many complex applications. Artificial neural network is a statistical intelligent technique resembling the characteristic of the human neural network.  The prediction of time series from the important topics in statistical sciences to assist administrations in the planning and make the accurate decisions, so the aim of this study is to analysis the monthly hypertension in Kalar for the period (January 2011- June 2018) by applying an autoregressive –integrated- moving average model  and artificial neural networks and choose the best and most efficient model for patients with hypertension in Kalar through the comparison between neural networks and Box- Je

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Publication Date
Sat Dec 01 2018
Journal Name
Baghdad Science Journal
Seasonal variation and modeling of disinfection by-products (DBPs) in drinking water distribution systems of Wassit Province Southeast Iraq
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Scopus (7)
Scopus
Publication Date
Thu Aug 01 2019
Journal Name
Journal Of Economics And Administrative Sciences
The use of the Biz method and classical methods in estimating the parameters of the binary logistic regression model
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Abstract

          Binary logistic regression model used in data classification and it is the strongest most flexible tool in study cases variable response binary when compared to linear regression. In this research, some classic methods were used to estimate parameters binary logistic regression model, included the maximum likelihood method, minimum chi-square method, weighted least squares, with bayes estimation , to choose the best method of estimation by default values to estimate parameters according two different models of general linear regression models ,and different s

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Crossref
Publication Date
Thu Apr 02 2020
Journal Name
Iop Conference Series: Materials Science And Engineering
The effects of additives in to heat treatment temperature and time on the crystallinity of lithium silicate glass-ceramic
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Scopus (1)
Crossref (1)
Scopus Crossref
Publication Date
Mon Jan 01 2018
Journal Name
Indian Journal Of Public Health Research &amp; Development
Environmental Assessment of the Quality of Water and the Hydrochemical Formula Used for Some Groundwater Wells in Karbala Governorate
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Scopus (1)
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Publication Date
Sun Sep 07 2014
Journal Name
Baghdad Science Journal
The Aqueous Crude Extract of Carrot Seeds ( Daucus carota L.) and it Role in Fertility of Male Albino Mice
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This study was designed to test the effect of the treatment with aqueous extract of carrot seeds( Daucus carota) on fertility of male albino mice by effected on Body weight , testis weight ,secondary sex organs (prostate , seminal vesicle) and sperms properties .This experiment used (24) albino male mice aged(8-10)weeks. these animals were randomly divided into three groups contain two doses (200,400mgkg) were used from both extracts ,they were daily and orally given for (35)days ,and control group was given physiological saline. After the end of the experiment the animals were sacrificed after taken their body weights. The results were show: 1. A significant (p<0.05) increase in body weight and reproductive organs. 2

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Crossref
Publication Date
Thu Dec 26 2019
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Evaluation of Risk Management practices and their relationship to the Entrepreneur behavior of managers in insurance companies: applied research
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The objective of the research is to evaluate the risk management practices of the variables (risk management structure, risk management methods, key components of risk management) and their relation to the principled behavior of managers behavior(innovation, proactive, risk acceptance) By adopting the questionnaire as a main tool in collecting data from managers in the National and raq insurance companies of (50) officials Department manager, department administrator, unit administrator, and analyzed their answers using the SPSS In calculating arithmetic mean, standard deviation, percentage weight and simple correlation coefficient. The most prominent conclusions were:1.There is a positive trend in the sample in both companies and a high

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Publication Date
Sun Dec 01 2002
Journal Name
Bulletin Of The Iraq Natural History Museum (p-issn: 1017-8678 , E-issn: 2311-9799)
CORRELATIVE INFLUENCE OF SEEDLING AGE, COTYLEDONS AND TERMINAL BUDS ON ADVENTITIOUS ROOT FORMATION IN STEM CUTTINGS OF MUNG BEAN
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Rooting response in stem cuttings of mung bean increased considerably with inresing
seedling age, due to endogenous IAA or supplied IBA. However, after the day 7- or 8-old of
seedling age. The cotyledons sheivel and drop-off spontaneously at day-8 of seedling age. So
that cotyledons excision after cuttings were made during the period between seedling
emergence (the day 4) and cotyledons dropping off (which starts at day 8 and its completion
at day 10) causes decrease in rooting at any time during cutting treatment ,in particular, at
zero time . In addition, results of this study revealed that terminal buds do not influence
significantly adventitious root formation whether IBA supplied or not. Whereas in leafless
c

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Publication Date
Mon Jun 30 2014
Journal Name
Al-kindy College Medical Journal
Epidemiological, Clinical, and immunological characteristics of Mycoplasma pneumonia infections among a group of hospitalized children in Suleimani city/Iraq
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Background: Mycoplasma pneumoniae (M. pneumoniae) is an important respiratory bacterial pathogen, especially among children. It causes acute upper and lower respiratory infections.Objective: This study was aimed to measure anti- M. pneumoniae antibodies among hospitalized children who were admitted to hospital diagnosed with acute respiratory tract infections.Method: Automated ELISA technique was performed to detect anti- M. pneumoniae antibodies (IgM and IgG antibodies) in serum from 108 children less than 5 years old. The children were admitted to the Pediatric Teaching Hospital in Suleimani city/Kurdistan Region/Iraq because of acute respiratory tract infections. A questionnaire was designed to collect demographic and clinical data fr

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