International Journal of

Pharmaceutical Quality Assurance

ISSN: 0975 9506
Peer Review Journal

doi prefix: 10.25258/ijpqa

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1. Identification of the Binding Interaction of Anti-tuberculous Drugs with Human Serum Albumin: A Computational Molecular Docking, Fluorescence and Absorption Spectroscopy Study
Sarfaraaz Vallie*, Sivapregasen Naidoo
The accuracy in Anti-tuberculous drug assaying was supported by computational modeling using a 2 and 3-dimensional thermodynamic binding affinity prediction of each drug during multiple drug co-administration regimens. The United States Food and Drug Administration has highlighted the need for extensive research to improve the recovery during analytical drug method development, where the recovery affects the slope of the calibration curve. Here we focused on the drug-protein binding variation that affects the extrapolation of the patient sample drug concentration from the slope of the calibration curve. The binding constants calculated at a physiological temperature from the fluorescence spectroscopy data were as follows: Rifampicin 5.379 X 102 M-1 (moderate affinity), Isoniazid 9.285 M-1 (low affinity), 25-Desacetyl Rifampicin 3.156 M-1 (low affinity), Ethambutol 3.443 M-1 (low affinity) and Pyrazinamide 3.076 X 102 M-1 (moderate affinity). These drugs Gibbs free energy were below zero, indicating spontaneous binding reactions. Rifampicin a non-polar weak acid with a higher affinity indicating the most stable complex formation with albumin as opposed to soluble Isoniazid due to it being polar and an ionized form to be easily excreted in the urine resulting in low levels of detection. This will affect the bioavailability and accuracy of the assay levels for patients experiencing hyper and hypoalbuminemia with related competition and induction processes of the enzymes. These complications are apparent where larger numbers of patients are involved in clinical trials, bioequivalence and bioavailability studies with varying protein levels that may be more crucial for drugs with a narrow therapeutic index

2. Anthocyanins Profile Characterization of Common Grape Hyacinth (Muscari neglectum Guss. ex Ten.) Flowers Growing in Hungary by Highperformance Liquid Chromatography Coupled to Diode Array Detector and Mass Spectrometry using the Electrospray Ionization Interface
Dmitry Olegovich Bokov1,2*, Eszter Riethmüller3
Objective: Anthocyanins are one of the biologically active substances group playing an important role in the state of physiological functions referring to human health. This research aimed to investigate the anthocyanins profiles in the grape hyacinth (Muscari neglectum Guss. ex Ten.). Materials and methods: The identification of individual anthocyanins was carried using the method of high-performance liquid chromatography with diode array detection and mass spectrometry with electrospray ionization (DAD-ESI-MS) analysis. Chromatographic separation and tandem mass spectrometric analyses were performed on an Agilent 1100 HPLC system and Agilent 6410 triple quadrupole system equipped with an electrospray ion source (ESI) in positive ion mode. Results: In the M. neglectum flowers (tepals), nine individual anthocyanins, containing delphinidin, petunidin, malvidine, pelargonidin aglycones were found. In this research, we report anthocyanin profiles for the M. neglectum flowers for the first time. Conclusion: The obtained results concerning anthocyanins composition may be very useful for researchers in the field of the standardization and activity evaluation of extracts produced from M. neglectum.

3. Solid Dispersion (Kneading) Technique: A Platform for Enhancement Dissolution Rate of Valsartan Poorly Water Soluble Drug
Vinod T. Wagh1*, Ritu M. Gilhotra2 , Rajendra D. Wagh3
The objective of this study was to the enhancement of dissolution rate of Valsartan. Using a solid dispersion (kneading) method with Kollidon and Povidone K30 as a carrier. Eight different drugs: Carrier ratios were prepared. Using factorial design taking 3 factors i.e., the concentration of Valsartan (x1), Kollidon (x2), and Povidone K30(x3). The enhancement of dissolution depends on the amount of carrier and an increase in the concentration of carrier. Enhancement of dissolution rate depends on reduce particle size of drug place on the surface of carrier and increased wettability of drug particle by carrier. Solid Dispersions prepared with Kollidon as a carrier in ratio 1:4 shows the enhancing dissolution in 30 mins to drug and Physical Mixture. Formulation evaluated by fourier-transform infrared spectroscopy, differential scanning colorimetry, X-ray diffraction, Scanning Electron Microscopy

4. Development and Validation for Simultaneous Estimation of Sofosbuvir and Daclatasvir Dihydrochloride in Pharmaceutical Dosage form by Ratio Derivative and Dual Wavelength Methods
Sapna M Rathod*1 , Paresh U Patel2
Development and validation of new simple, sensitive, accurate and precise spectrophotometric method involving ratio derivative and dual-wavelength method, was done as per ICH Q2 (R1) for simultaneous estimation of Sofosbuvir (SOFO) and daclatasvir dihydrochloride (DACLA) in a combined dosage form. The overlapping in the spectra of both drugs was the reason for the selection of both methods. The absorbance difference (ΔA) value between 235.8 nm and 270.6 nm was selected for the quantitative determination of SOFO, where DACLA gives equal absorbance at the selected wavelength in the dual-wavelength method (Method A). The determination of DACLA is done quantitatively by measuring the difference in absorbance value at 249 nm and 268.6 nm where SOFO gives equal absorbance at a selected wavelength. Ratio spectra method (Method B) was based on dividing the spectra of a mixture with standard spectra of one of the analytes, and the first derivative spectra was recorded with Δλ = 8 nm and scaling factor 1. The amount of SOFO and DACLA was estimated in the binary mixtures by computing the first derivative signal at 247.0 nm and 341.0 nm, respectively. The calibration curve was linear in the concentration range of 10–90 µg/mL for SOFO and 4–20 µg/mL for DACLA for both the methods. The methods were successfully applied for the simultaneous determination of these drugs in combined dosage form with acceptable recoveries.

5. Antioxidant Enzymes Level Detection in Cisplatin Treated Iraqi Lung Cancer Patients and in vitro Estimating the Cytotoxic and Reactive Oxygen Species Generation in A549 Cell Line
Firas Hassan1 , Ali Z. Al-Saffar2* and Ahmed F. Al-Shanon
Cisplatin is one of the most important and effective antitumor drug used as treatment against different types of tumors. Cisplatin directly affects DNA integrity as well as the generation of reactive oxygen species (ROS) and cell death induction. Changes in the activities of antioxidant enzymes catalase (CAT), glutathione peroxidase (GPx) and superoxide dismutase (SOD) were investigated in healthy controls and lung tumor patients before and after cisplatin treatment. Untreated patients showed a significant reduction in CAT, GPx, and SOD levels, while cisplatin-treated patients retained the normal levels of antioxidant enzymes compared with healthy controls. Cisplatin exhibited cytotoxic activity against A549 lung tumor cells in a dose-dependent manner with an IC50 of 10.33 µg mL-1. Cisplatin was found to induce the generation of ROS in cisplatintreated A549 cells compared with a negative control. Such an increase in ROS production was significantly correlated with increasing cisplatin concentration.

6. Synthesis and Characterization of Some New Heterocyclic Derivatives and Studying of their Biological Activity (Anti-bacteriaa)
Zahraa F. Khudair, Shaimaa A. Behjet
In this work synthesis, many kinds of heterocyclic derivatives by many steps, the first we preparation 1-(4-((1H-imidazol_2-yl-) diazenyl) phenyl) ethan-1_one.(1) by coupling of diazonium salt of p-amino acetophenone with imidazole in alkaline alcoholic media, the second step include react (1) with 2_amino_6_methylpyrimidin _4_ol in acid medium to get Schiff base derivatives(2)the last step include react(2) with (sodium azide, thioglycolic acid, glycine, alanine, Tryptophan, (2 aminobenzoic acid), (2-mercaptobenzoic acid) to give (tetrazole(3) thiazolidine(4), imidazolidine(5-7), Thiazinie(8), Quinazoline (9) derivatives respectively all these derivatives Characterization by FTIR, 1HNMR, 13C-NMR, After that we studied the biological activity for all derivatives for all derivatives studied the anticancer for (2).

7. Quality Assurance in Drug Assaying and Pharmacokinetics-Blood Protein Evaluation in Calibration Curves
Vallie S., Naidoo S.*
In bioanalytical drug assays, plasma protein/albumin content can challenge the biomatrix and reduce drug recovery through the albumin-binding affinity (ABA) of drug molecules. Global quality assurance in sample preparation for analyte quantification during bioavailability assessments has evolved extensively, and the quality standards of the strictly regulated current global quality controlled drug manufacturing processes (cGQMP) now apply in pharmacokinetics (PK) studies. Previous analyses in large clinical trials had found that laboratory-prepared calibrator plasma/serum protein levels differed significantly from those of patients with occasional hyperproteinemia/hypoproteinemia and disease-related hyperalbuminemia/hypoalbuminemia. We, therefore, investigated improving assay accuracy by including adjustments for patient plasma/serum protein levels in protein evaluation calibrations curves (PROTEC). Using a combined PROTEC of two calibrators (with 1.6 ± 0.5 g/dL and 4.3g/dL albumin, respectively) to test rifampicin recovery from patients with hypoalbuminemia (1.6 ± 0.5 g/dL), we found that relative accuracy of drug recovery differed by minimum 0.1% for low ABA drugs and maximum >20% for moderate ABA drugs. Assay accuracy improved after accommodating for varying patient plasma/serum protein levels. We, therefore, propose using patient-calibrator PROTEC-PK in validation assay development/therapeutic drug monitoring to ensure that patient albumin levels are within acceptable validation accuracy ranges.

8. Synthesis and Characterization of some new Formazan Derivatives from 2-Amino-4-Hydroxy-6-Methyl Pyrimidine and Study the Biological Activity (Anti-Bacteria and Anti-Cancer)
Abdullah Shakir, Shaimaa Adnan⃰
This study involves a synthesis of some formazan derivatives starting from react chloro acetyl chlorid with 2-amino-4- hydroxy-6-methyl pyrimidine to gate compound (a), (a) react with hydrazine hydrate to give compound (b) also (b) react with 3-4-dimethoxy benzaldehyd to product Schiff base derivative (c) then (c) react with deferent amin derivatives to get formazan derivatives. All these compounds characterized by 13C-NMR, fourier transform infrared spectroscopy (FTIR), 1 HMNR. After that, we study the biological activity for all formazan derivatives toward two different kinds of bacteria and anti-cancer.

9. Analytical Method Development and Validation of First Order Derivative Spectrophotometric Method for Simultaneous Estimation of Telmisartan and Metformin Hydrochloride in their Combined Pharmaceutical Dosage Form
Avani Khristi*, John Baraka, Brijesh Dasvani
Ultra Violet (UV) Sectrophotomertic method has been developed for simultaneous estimation of telmisartan and metformin hydrochloride in bulk drug in their combined dosage form by first-order derivative. This method developed by using Methanol: Water (50: 50 v/v). Linearity was found near to 1, for telmisartan and Metformin hydrochloride. For Intraday, Interday, Intermediate precision, Robustness, %RSD was found less than 2. % Recovery was found to be between ranges 98-106% for both the drugs. These results indicate that the method is accurate, precise, and simple. All validation Parameter results comply with ICH guidelines

10. Clinical and Immunological Response to Doxycycline Versus Doxycycline Plus Vitamin C in Patients with Acne Vulgaris
Zahraa I.J. Shubber1 , Entisar J. Al mukhtar2 *, Ifad K. Al-Shibly
Objective: Study the influence of doxycycline versus doxycycline with vitamin C drugs in the management of acne vulgaris on some immunological parameters which include [Interleukin 1 beta (IL-1β), interleukin 1 (IL-8), interferon gamma (IFN-γ), tumor necrosis factor alpha (TNF-α), and toll-like receptor 2 (TLR2)] and the following objectives were adapted: 1-Selection of population for the study (control, patients) groups and follow up the patients after one month of treatment, the first group receive doxycycline and the second group receive doxycycline with vitamin C,2- Blood samples collection and separation of serums for immunological analysis, 3- Statistical analysis. Methods: This study is a randomized clinical trial carried out in clinical dermatology in Merjan Medical city in Babylon from September 2018 to March 2019. The number of subjects enrolled in the present study was 60; their age was between (14–30 years), among whom 30 were acne patients, the remaining 30 subjects were apparently healthy individuals, and they were served as control. A dermatologist diagnosed a total of 30 acne patients to having moderate to severe acne and divided into two groups (15 patients in each group). Patients in the first group were treated with doxycycline (100mg) once daily after meal for 30 days, while in the second group patients were treated with doxycycline (100mg) capsule once daily after a meal in combination with vitamin C (500mg) chewable tablets once daily. After 1-month of therapy, the response was evaluated clinically and immunologically by measure the concentration of pro-inflammatory cytokines (IL-8, IL-1β, IFN-γ, TNF-α) and (TLR-2 ) by using enzyme-linked immunosorbent assay (ELISA) and the results were compared to their levels before treatment and that in the control group. Results: Significant elevation in the serum levels (p ≤0.001) of immunological parameter IL-8, IL-1β, IFN-γ, TNF-α, and TLR-2 among acne patients in comparison to the control. The clinical response in the first group was good, moderate and poor in 5 (33%), 7(47%) and 3(20%) respectively, while in the second group was good, moderate and poor in 7 (47%), 7(47%) and 1(6%) respectively, the immunological results showed that the serum levels to the (IL-1β, IL-8, IFN-γ, TNF-α) and (TLR-2) were more reduced in the second group compared to their levels in the first group. Conclusion: Significant elevation (p <0.001) in the serum levels of (IL-8, IL-1β, IFN-γ, TNF-α, and TLR-2) among moderate to severe acne patients in comparison to control group. Clinically the combination of doxycycline plus vitamin C was more efficient as therapeutically in comparison to doxycycline alone. Immunologically doxycycline plus vitamin C was more effective in reducing serum levels of (IL-8, IL-1β, IFN-γ, TNF-α, and TLR-2) in comparison to doxycycline alone.

11. Removal of Congo Red by Acrylic Acid-co-[2-[2- (Benzimidazole) Azo]-3-Methyl-4-Nitro Phenol] Composite from Aqueous Solution by Adsorption process
Khalid J. AL-adilee, Ali M. Taher
This study is concerned with the adsorption of Congo red from solution on acrylic acid-co-[2-[2- (benzimidazole) azo]-3- methyl-4-nitro phenol] composite (AA-co-L2H ). The purpose of this study into the search for an active surface to be used to remove dyes from wastewater. Fourier transform infrared spectroscopy (FTIR) and SEM-EDX characterized the morphology and chemical structure of prepared samples. Ultraviolet-visible (UV-vis.) spectrophotometric technique has been used to produce quantitative adsorption at different conditions of time, temperature and concentration of dyes. The calculated data were in accordance with Langmuir equation and the adsorption isotherms are of L-curve. The results obtained show greater removal uptake of dye on composite. The calculated data were in accordance with Langmuir equation and the adsorption isotherms are of L-curve. The results obtained show greater removal uptake of dye on composite. The adsorption was a function of temperature (10, 20 and 30o C). The extent of adsorption of Congo red on the composite was found to increase with decreasing temperature (endothermic process). The basic thermodynamic functions have also been calculated.

12. Study the Biological Activity for Shiff Base and Β–Lactam Compounds that Synthesis and Identification from Pyrimidine Derivatives
Rawaa Neamah, Shaimaa Adnan
In This study We are synthesis and characterization of some Schiff base and β- lactam derivatives) by three steps. The First react 2-amino-4-Chloro-6-methyl pyrimidine with 4-amino acetophenone in an acid medium to get shiff base derivative(E)- 4-(1-((4-Chloro-6-methyl pyridine-2-yl)imino)ethyl)aniline (1), the second step (1) react with (3,4- dimethoxybenzal dehyde,4-methyl benzaldehyde,4-dimethylamino benzaldehyde,4-bromo benzaldehyde,4–hydroxy benzaldehyde, 4-Nitro benzaldehyde) to get Schiff base derivatives (2-7), the last step (2-7) derivatives react with Chloro acetyl chloride to get –β-lactam derivatives.(8-13) All these compounds are characterization by Fourier Transform Infrared Spectroscopy (FTIR), ( 1 H-NMR),(13C- NMR). After that study, the biological activity for all these derivatives to word two kinds of bacteria study the Enzymatic and Cancer Cell.

13. A Study of Iron Oxide Nanoparticles Synthesis by Using Bacteria
Abdulsahib S. Jubran1 , Oda M. Al-Zamely2 , Mahdi H. Al-Ammar3
The biosynthesis of nanoparticles by using microorganisms is developing as an ecofriendly method for nanoparticle synthesis because of its cheap, simple and non-toxic. Bacillus sp. can be used for producing iron oxide nanoparticles. In addition, it has the ability for the biosynthesis of Fe3O4 nanoparticles. The nanoparticles producing was evaluated by using ultra violate-visible (UV-visible) and Fourier-transform infrared spectroscopy (FT-IR) methods also the production and size of the nanoparticle was confirmed by X-ray Diffraction and Field Emission Scanning Electron Microscope (FESEM) to confirm the accuracy of iron oxide nanoparticles. pH, Temperature, and Incubation time of production of iron oxide nano-particle also studied.

14. Determination of Ni(II) in Alloy by Spectrophotometric Method with a new Chromogenic Reagent (IDPBS)
Esraa R. Abbas1 , Salih H. Kadhim2 *, Muneer A. Abbas AL-Da, amy1
A new chromogenic reagent 4-((imidazole-2-yl)diazenyl)-N-(pyrimidin-2-yl)benzenesulfonamide was synthesized by the reaction between imidazole and Sulphadiazine as azo reagent and used as new spectrophotometric method with highly sensitive to determined Nickel (II). The reagent reacts with nickel(II) in aqueous solution at pH= 7 to form dark- brown colored complex. The reagent and its complex were identified by Fourier transform infrared (FT-IR), Uv-visible,1 HNMR, and 13CNMR spectroscopies and investigate the formula and charge of the prepared complex by molar ratio and molar conductivity measurements. The complex shows λmax at 486 nm with a molar absorptivity 0.3299 x 104 and Sandell’s sensitivity 0.0177μ’s law is obeyed in the concentration range (0.5–7.6μg.mL-1) of Ni (II) with excellent linearity depicted by correlation coefficient value of 0.9995 with a detection limit of 0.1927μ Recovery and relative error values of precision and accuracy of method were found to be R.S.D.% = 0.39221, Re=98.7% and Erel = -1.3% . The nature of the complex showed that (M:L) ratio was 1:2. This method was applied for the determination of Ni(II) in alloy due to Sensitive, accurate, and rapid spectrophotometric method. The results obtained were compared with the flame atomic absorption spectrometry method, and results are in conformity.

15. Protection Anticonvulsant effect of Irbesartan in lidocaine Induced Seizure in Mice
Huda N. Tehewel1, Shihab A. Shihab2
Background: Epilepsy is one of the most common serious brain disorders and may have many possible causes due to many different cellulars or biochemical changes such as alterations in ion channels function, neurotransmitter level, neurotransmitter receptor function, energy metabolism, and oxidative stress. The chronic and intermittent nature of epilepsy and the inability of the current drugs to sustain long term remission made a continuous need to investigate a new drug that aims to minimize the morbidity and to improve the quality of patient life. Aim of the study To investigate protection anticonvulsant effects of irbesartan in lidocaine induced Seizures in male mice. Methods: A total of 40 albino male mice were equally divided into four groups. The blank group was given vehicles only. The model of seizure was induced by a single intraperitoneal injection of Lidocaine (75 mg/kg). Irbesartan group was pretreated intraperitoneally (20 mg/kg) for 7 days and lidocaine injection on the 8th day as an acute induction, and the same was applied to the diazepam group (2 mg/kg) which served as a positive control. On the 8th day, the level of N-methyl-D-aspartate receptor (NMDA-R) and caspase-3 were measured. Furthermore, the body weights were daily documented before each administration. Results: The results revealed a highly comparable significant reduction in NMDA-R and Caspase-3 in both irbesartan and diazepam groups, also both modestly decreased in potency and duration of the seizure. Conclusion: Irbesartan significantly reduces NMDA-receptor and Caspase-3 in lidocaine induced seizure in mice model and decrease the potency and duration of the seizure.

16. The Therapeutic Efficacy of Microneedling Combined with Topical Tacrolimus versus Microneedling Alone in Treatment of Stable Vitiligo. A Comparative Study.
Huda Nahi Tehewel1, Shihab Abdlrahman Shihab2
Background: Vitiligo is an acquired depigmentary disorder of multifactorial etiology. Several treatment modalities have been attempted with partial success, but the recent focus on surgical treatment like micro-needling. Objective: To compare the safety and ability of micro-needling alone in the induction of pigmentation in stable vitiligo versus combined tacrolimus treatment and micro-needling. Patients and methods: Twenty three patients with stable vitiligo were recruited from the Department of Dermatology and Venereology of Salah Aldeen General Hospital. The patients then subjected to micro-needling of the two vitiliginous patches after that application of topical tacrolimus to the left patch. This procedure was repeated every two weeks for a maximum of 5 months ( 10 sessions). Results: Microneedling with topical tacrolimus showed better but non-significant response than micro-needling alone ( p = 0.519). Moderate improvement occurred in 13% of patches treated with micro-needling alone, while only 9% show moderate
improvement in combined treatment. Although 9% show good improvement in combined treatment. Conclusion: Micro-needling induces pigmentation in vitiligo patients, and the addition of topical tacrolimus induces a better response.However, no statistically significant response was observed in any group.

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18. Modulation of GILZ and Erg upon non-steroidal treatment in chicken leukemic cells
Israa N A Al-ibad1*, Hiba T Atyia2, Mahasen A A Khudeir3, Miran A A A Alrammahi4 , Hala M Mutter5, Ahmed J Neamah6
Background and aims: Glucocorticoids (GCs) have been successfully employed in the treatment of human leukemia; however, those effects can be deteriorated as the metabolic side effects occurred due to the activation glucocorticoid-induced leucine zipper (GILZ) leading to the induction of the GC resistance which is initiated via the Ets-related gene (Erg). In the present work, we recruited this antagonist influence on ERG for aiming to understand the physiological potential that might be of benefit in the treatment of leukemia using a non-steroidal compound (CPDA). Methods: We examined the effect of dexamethasone, as a steroid, and CPDA, as a non-steroid substance, on the GILZ and ERG receptor gene expression in The chicken leukemia cells (CLCs), DT40 cells, after treating them with the drug at 1µM followed by a 24-hour incubation. A real-time-polymerase chain reaction (RT-PCR) method was used to measure gene expression. Results: An increase (two-fold) in the expression of GILZ receptor was unveiled. This enhanced-GILZ model presents the steroidal positive actions and refers to the CPDA ability to mimic this action of steroids. The results also demonstrated a downregulation in the mRNA expression level of ERG, indicating of antagonism of steroids in responding cells and as a positive finding for the effect of the non-steroidal compound A tested. Conclusions: Steroid-induced upregulation in the GILZ receptor provides proof of GC undesirable effects leading to correlated ERG-initiated resistance to the steroids used in exposed cells. Interestingly, CPDA has a GC-based treating activity low GILZ expression.

19. An Application Study of a Zingiber officinale Extraction in The Biological and Medical Fields
Fadhel Y. Khudheyer*
This study included a clarify of the biological and medical application of Zingiber officinale extraction, which regarded as an antibiotic against almost types of microorganisms, and as a medicine for treat of many deceases in the human body. Ginger is a spice and medicinal plant, and it is gained a very important role in agronomy production, pharmacy, and exportation because of its increased use as a raw material for the pharmaceutical industry and in everyday life. Ginger, the rhizome of Zingiber officinale, species of the ginger family (Zingiberaceae) has a long history of medicinal and biological uses for more than 2000 years as one of the most versatile medicinal plants having a wide spectrum of biological activity and a common condiment for many various foods and beverages. Currently, there is a renewed interest in ginger, and several scientific investigations goal at isolation, identification of active constituents, scientific verification of its pharmacological actions for the treatment of deferent diseases and difficult conditions.

20. Molecular identification and genotyping of Atopobium vaginae, 16s rRNA gene from Bacterial Vaginosis miscarriage women in AL-Hillah city
Ilham A. Bunyan*, Asmaa K. Gatea**and Alaa K. Hameed*
This study was aimed to determine the Atopobium vaginae associated BV in vaginosis women and women with miscarriage. Also other aim, the DNA sequencing was performed for phylogenetic tree analysis of 16SrRNA gene in local Atopobium vaginae isolates in comparison with NCBI-Genbank global Atopobium vaginae isolates and finally submission of the present isolates in NCBI-Genbank database. One hundred fifty (150) high vaginal swabs were collected from women with vaginosis(Seventy five samples were taken from married vaginosis women without miscarriage and Seventy five samples from vaginosis women with miscarriage) from Babylon city hospital and private clinics. The age of patient (15– 45) years. The sample was collected by disposable swabs, genomic DNA was extracted from these swabs. 16s rRNA gene detection by polymerase chain reaction technique . Atopobium vaginae was isolated on Columbia blood agar supplemented with antibiotic for the first time in Iraq, the study confirmed that 9 (12.00%) and 5(6.66%) of Atopobium vaginae out of 150 swabs isolated from miscarriage and non-miscarriage vaginosis women respectively. According to the detection of the 16S rRNA gene, the study revealed that 69(92.00%)and 47(62.66%)of Atopobium vaginae out of 150 swabs obtained from miscarriage and non-miscarriage vaginosis women respectively. BLAST analysis showed that the 16S rRNA gene shared more than 98- 99% sequence compatibility with the sequences of Atopobium vaginae. Furthermore, the phylogenetic tree analysis of the 16S rRNA gene indicated that local Atopobium vaginae (NO.1 and NO. 2 ) isolates shared higher homology with other Atopobium vaginae isolates available in the GenBank. The homology of the nucleotides was between (99.17% and 98.75%) respectively

21. Study on Genetic and Non-Genetic Anemia Poverty Types and Their Relationship with Residential Areas
Zahra M. Al-Hakak
Anemia is the most common pathological condition in hematology. There are more than (400) types of anemia, can be divided into three main types: anemia caused by blood loss as in people with ulcers and hemorrhoids, during menstruation, at birth and anemia caused by dysfunction in the production of erythrocytes that occurs due to red blood cell damage this is called hemolytic anemia, and iron deficiency anemia is the most common type of anemia at all. Through the results obtained from the AL- Hussein Teaching Hospital in the holy province of Karbala for the year (2018), found (152 )cases, of which (92) cases were males by (60.53%) and (60) cases were females by (39.47%). Thus, the incidence of females is lower than that of males. The number and percentage of anemia for each age group shows that the highest age group is (21-30 years) with (43) and (28.3%). The lowest age group was (+60) with (8) and (5.27%), the number of males infected (6) by (3.94%) and the number of females (2) by (1.31%). Types of anemia recorded in the research were hereditary and non- hereditary (other types)—hereditary number (14) by (9.21%). Types of hereditary anemia recorded were Thalassemia and Sickle by number and percentage respectively (9) and (5) by (5.92%) and (3.28%), The number and percentage of males and females of the two species, respectively, males (4) and (2) by (2.63%) and (1.31%), females with (5) and (3) by (3.28%) and (1.98%), The rate of hereditary anemia in males is higher than in females. Non-hereditary anemia was (138) by (90.79%), which is higher than hereditary anemia. The types of non-hereditary anemia recorded are six types (nutritional, hemorrhagic, inflammatory, tumor, immune and renal failure). In the residential sectors, the highest incidence was recorded in the center sector (90), (59.22%), while the lowest incidence rate was in the AL-huor sector (10), (6.57%). We concluded from the study that the incidence of males is higher than females and that the higher incidence was in the AL-center sector, which increased the disease in urban areas and less in rural areas.

22. Isolation, characterization, and biological activity of some fatty acids and volatile oils from Iraqi Eucalyptus microtheca plant
Omar T. Ali 1, Muthanna J. Mohammed2
This study aims at investigating the chemical composition, antimicrobial and antioxidant activity of some extracted essential and fixed oils from leaves of Eucalyptus microtheca plant grown in Iraq. Analysis of the isolated oils has been achieved by gas chromatography coupled with mass spectrometry GC-MS Technology. The study reveals existence of sixteen compounds. Camphene (20.60%), 4-carene (18.53%), 1,8-cineole (11.96%), terpin-4-ol (8.70%) and p-cymene (8.39%) were the highest components in these essential oils. While nine compounds were obtained as fixed oils, pentadecanoic acid (36.47%) and cisvaccenic acid (30.31%) were the major components. The antimicrobial activity of the leaves extracts was evaluated against six different gram-positive and Gram-negative bacteria using disk diffusion method and exhibited good inhibition activity. Moreover, antioxidant assay (free radical scavenging activity) demonstrated good activity for the extracted oils. The results show that the aerial parts (leaves) of the Iraqi Eucalyptus microtheca plant possess antibacterial and antioxidant properties and may suggest it as a good candidate to use for medicinal purposes.

23. The Evaluation of Antiproliferative Effect of Imatinib derivatives Against Breast and Colon Cell-Lines
Ali N Hussein1 , Omar F Abdul- Rasheed2*, Monther F Mahdi3 , Ayad M R Raauf4
Background: Cancer is considered as one of the major leading causes of death. Tyrosine kinase inhibitors are recognized for their potential antiproliferative effects. Materials and methods: In the previous study, the authors designed, synthesized, and characterized two imatinib derivatives. These derivatives were biologically evaluated with the utilization of MCF-7, HCT116, and MDCK cell lines. Results: In respect to the imatinib standard, compound 2b has superior activity against HCT116 cell line (IC50; 15.88 µg/ mL against 18.52 µg/mL for imatinib) and an improved cytotoxic activity on MDCK cell line (IC50; 0.654 mg/mL against 0.272 mg/mL for imatinib). Conclusion: The two synthesized compounds showed biological activity against cancerous cell lines and improved cytotoxic activity against normal non-cancerous cell line with respect to the imatinib standard.

24. Implementing Educational Game in Pharmacy
Elham Alshammari*
Educational games are a teaching strategy that allows students to examine various parts of a game as a method of learning. These are games meant of severe purposes instead of just entertainment. Through their design, education games allow students to gain new skills and knowledge, arouse physical activities, and enhance social-emotional development. Educational games require learners to participate in competitive activities with preset regulations. The objective of this study was to obtain pharmacy students’ satisfaction and perception towards educational game implementation in the classroom setting. The author
implemented a prospective study design that involved first-year pharmacy students at Princess Nourah bint Abdulrahman University (PNU). All the students who took part in the study were implementing this type of education for the first time.Thirty students were placed into two teams of 15 and took part in a jeopardy game. All the students were satisfied with the educational game. Key benefits of the game as noted in the study findings include improved cognition functions like memory and reasoning, promoted mental stimulation, learning was better and faster, improved concentration, recall, and thinking, resulted in motivation and more engagement with the team members, resulted in timed responses that were similar to reallife, promoted immediate scoring and there was no need to wait for the outcome, and the learning environment was quite fun. The study can be useful in designing educational games for use in pharmacy courses.

25. Physiochemical Features, Qualitative and Quantitative Analysis, Present Status and Application Prospects of Polysaccharide Gums
Bokov Dmitry O., Sokurenko Maria S., Malinkin Alexei D., Khromchenkova Elena P., Shevyakova Lyudmila V., Bessonov Vladimir V.
Gums, generally plant-derived polysaccharides, have been widely used in various fields of the pharmaceutical and food industries in recent years. Natural gums are formed as a result of a protective reaction to plant damage or due to negative conditions (drought), as a result of the destruction of cell walls (gummosis); also bacteria cultures, seaweeds can serve as gum sources. Gums are of great interest due to the wide application spectrum; it is based both on their physicotechnological (structure-forming agents) and the biological properties (inertness). This is an important factor in the development of food products and drugs. They also find applications in cosmetics, inks, paper, and textiles. The article aims to summarize the numerous obtained data and to establish current and prospects for gum quality control and application.

26. Eukaryotic Probiotic Saccharomyces boulardii Application in Clinical Trails: A Review
Rahem E. ALzaidi1 , Hanaa D. Al-Mozan2 , Nuha J. Alrikabi
Probiotics are live microbes that assist in restoring the symbiotic intestinal gut flora balance and thus bestow health benefits to the host. The most commonly used human probiotics are members of the Lactobacillus and Bifidobacterium species. Besides these bacteria, Saccharomyces boulardii, a yeast strain, is also widely used as a probiotic to treat a variety of conditions, including antibiotics-associated diarrhea and recurrent Clostridium difficile infection. A primary advantage of using Saccharomyces boulardii as a probiotic is that it can be used by patients undergoing antibiotic regimen due to its natural resistance to antibiotics. The genetic transfer of antibiotic resistance genes, a frequent event between pathogenic and gastrointestinal tract (GIT) bacteria, is not as frequent between yeast and bacteria. Furthermore, Saccharomyces boulardii is also tolerant to various local stresses such as the presence of gastrointestinal (GI) enzymes, bile salts, organic acids, etc. and can withstand considerable variations in pH and temperature while transiting through the human GIT. Saccharomyces boulardii is known as generally regarded as safe (GRAS)with probiotic activity against a wide range of pathogens. This yeast is often marketed in a lyophilized form, “ S. boulardii lyo” , complete sequence of the genome was performed, and a comparative analysis of the genome was performed. From clinical studies, the results of randomized controlled trials in patients repeatedly confirmed the significant positive effect in the treatment of acute and chronic diseases.

27. Impact of Automation in Pharmaceutical Industry on Roles and Responsibilities of Quality Assurance: A Review
Thomas GeorgePalamattathkuttiyil, Hemanth Kumar Somareddy*, Shailesh Thirumaleshwar, Mysore Prakash Gowrav
Automation is the use of different control technologies in sectors with minimal or decreased human interference to operate a range of procedures. Automation has made its way to the pharmaceutical industries in the recent past. Automation has been implemented in production, packaging, labeling, and warehousing departments. Production of personalized medicines has become a reality after implementing automated machines. The R&D sector has also been affected by incorporating the latest technologies. The conventional functions of Quality Assurance (QA) department were limited to preparing standard operating procedures (SOPs), carrying out audits, qualification, and validation of equipment and processes. This review focuses on the implementation of automated technologies in pharmaceutical industries and the impact it has had on the pharmaceutical quality assurance department. This article covers topics such as the Raman probe and the different ways it has been made use of in the pharmaceutical industries. The conventional role played by the QA department has also been enlisted while also mentioning how they change with the implementation of automated technologies.

28. Simulated Role-playing in Pharmacy
Elham Alshammari*
Role-play refers to a situation that allows learners to examine realistic situations by interacting with other individuals in a controlled way to develop experience and try different strategies within a supported environment. Depending on the objective of the activity, learners may play a role that is related to their own or could take on an opposite part as well. In this study, the author sought to investigate the satisfaction and perception of pharmacy students toward role-playing. The study used a prospective study design and collected data from students at Princes Nourah bint Abdulrahman University (PNU). The researcher used a rubric that allowed the learners to select their responses as either “Poor,” “Average,” “Proficient,” or “Excellent.” The rubric was distributed to 6th level pharmacy students who experienced role-play for the first time in a classroom session. The findings showed that role play helped in the development of professional skills, recognized possible arguments and solutions, facilitated better understanding, developed the confidence of the learners, enhanced their communication skills, promoted effective discussion, and encouraged active participation. These observations were discussed in light of past studies that have focused on the domain of role-playing. Based on these findings, the study recommends the use of simulation and role-play in teaching pharmacy programs.

29. Impact of Quality Risk Management Process in Pharmaceutical Industry to Curtail the Non Conformity
Aachchhadita Sharma, Raju Mari Jeyaprakash* , Rinchi Bora, Abinash Chandra
Risk is intertwined with every drug product in a market. This article’s intent is to provide ground rule and praxis of different tools for quality risk management (QRM) in various aspects of pharmaceutical science. QRM comprises of tools and processes which helps in establishing objectives. Hence they are also known as Enablers. Enablers help in risk mitigation of product quality throughout a lifecycle in such a way that benefit outweighs the risk. The key properties of Enablers or QRM, i.e., attempts made, solemnness and records shall be compatible with risk scale. The Enablers accomplishment gives recognized, obvious and steps of Enabler process produced by regeneratable methods which is based on customary comprehension to evaluate feasibility, ability to find out risk prejudice. The QRM or Enabler tools can assist the manufacturing company and regulatory bodies to scrutinize, handle, notify, and inspect the risk

30. Comparative Study of Pre-Market Approval Process and Denovo Process for Medical Devices
Akash Dambal1 , Harrison Michael Zaphrey*2 , M.P. Venkatesh3 , Kaushik Devaraju4, T. M. Pramod Kumar5
FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. Regulatory control increases from Class I to Class III. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require pre-market notification 510(k); and most Class III devices require Pre-market Approval.The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the De Novo classification option as an alternate pathway to classify novel medical devices that had automatically been placed in Class III after receiving a “not substantially equivalent” determination in response to a premarket notification [510(k)] submission.Class III Devices are those considered as high risk along these lines requiring the regularly lengthier Pre-market approval (PMA) process. The new De Novo process was designed to usher through any new device that was both Unprecedented (novel) and Low to moderate risk (or with a risk that was easily mitigated). The most inventive gadgets are considered high-hazard due to the non-attendance of equivalent items and follow either the De Novo or PMA path. Truly high-risk devices, in which deficient data exists to decide if general and special controls are sufficient to give sensible attestation of the item’s safety and effectiveness, follow the PMA pathway. Novel devices that do not have a predicate are classified in the highest risk class,despite the level of genuine risk it postures or the capacity of general and special controls to guarantee safety and effectiveness. The De Novo process allows these novel devices with low to moderate risk to be reclassified from a high-risk class, which requires a PMA.

31. Data Integrity Violations: A Challenge to the Pharmaceutical Industry
Himani Jaiswal1 , Muddukrishna B S2 , Girish Pai Kulyadi1*
Data integrity refers to data reliability throughout the data lifecycle. Terminology “ALCOA” means that the data should be attributable, legible, contemporaneously recorded, original, and accurate. “ALCOA Plus” was introduced later. Violation of the integrity of data is termed as a breach of data integrity. It can take place in various fields, but not limited to manufacturing, quality control (QC), quality assurance (QA), and research. Some of the reasons for breach in data integrity are fabrication or duplication of data, out of specification, out of trend, back-dating, manipulation of data, inadequate standard operating procedures (SOPs), common usernames, and shared passwords. A study to assess the impact of data integrity violations based on the US FDA warning letters was conducted. The majority of data integrity breaches belonged to QC. The frequency of letters based on the country has been presented in the form of a graph. China and India received the highest number of letters for breach of data integrity in the year 2018 and 2017 respectively. It can be concluded that it is important to enforce data integrity and develop strategies for the same. The study is beneficial to understand the reason, affected field of work and remediation methods for data integrity, and improve regulatory compliance.

32. UV Spectroscopy Assay Method Development and Validation of Dimethylfumarate and Cyclosporine Drugs in Nano Dosage Forms
Sneha Patel, Drashti Pathak, Deepa Patel*
An easy, precise and accurate spectroscopic technique for the estimation of cyclosporine and dimethylfumarate in pure form and nano dosage form has been developed. The proposed method involves dissolving dimethylfumarate in distilled water and cyclosporine in ethanol and subjecting resulting solution to UV spectroscopic assessment. Absorption maximum was found 210 nm and 214 nm respectively. Beer’s law was obeyed in the concentration range of 1-5µg/ml and 1-8 µg/ml for dimethylfumarate and cyclosporine. Calibration curve showd linearity between absorbance and concentration as per line equation with R2 value near 1. Validation was performed as ICH guildelines for linearity, accuracy, precision, Robustness, System suitability


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