Search results for: prevalence of drug use
Commenced in January 2007
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Edition: International
Paper Count: 3497

Search results for: prevalence of drug use

3347 Important role of HLA-B*58:01 Allele and Distribution Among Healthy Thais: Avoid Severe Cutaneous Adverse Reactions

Authors: Jaomai Tungsiripat, Patompong Satapornpong

Abstract:

Allopurinol have been used to treat diseases that relating with the reduction of uric acid and be a treatment preventing the severity of, including gout, chronic kidney disease, chronic heart failure, and diabetes mellitus (type 2). However, allopurinol metabolites can cause a severe cutaneous adverse reaction (SCARs) consist of Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) and Stevens-Johnson Syndrome(SJS)/Toxic Epidermal Necrolysis (TEN). Previous studies, we found only HLA-B*58:01 allele has a strongly association with allopurinol-induced SCARs in many populations: Han Chinese [P value = 4.7 x 10−24], European [P value <10−6], and Thai [P value <0.001].However, there was no update the frequency of HLA-B alleles and pharmacogenetics markers distribution in healthy Thais and support for screening before the initiation of treatment. The aim of this study was to investigate the prevalence of HLA-B*58:01 allele associated with allopurinol-induced SCARs in healthy Thai population. A retrospective study of 260 individual healthy subjects who living in Thailand. HLA-B were genotyped using sequence-specific oligonucleotides (PCR-SSOs).In this study, we identified the prevalence of HLA-B alleles consist ofHLA-B*46:01 (12.69%), HLA-B*15:02 (8.85%), HLA-B*13:01 (6.35%), HLA-B*40:01 (6.35%), HLA-B*38:02 (5.00%), HLA-B*51:01 (5.00%), HLA-B*58:01 (4.81%), HLA-B*44:03 (4.62%), HLA-B*18:01 (3.85%) and HLA-B*15:25 (3.08%). Therefore, the distribution of HLA-B*58:01 will support the clinical implementation and screening usage of allopurinol in Thai population.

Keywords: allopurinol, HLA-B*58: 01, Thai population, SCARs

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3346 Solid Dispersions of Cefixime Using β-Cyclodextrin: Characterization and in vitro Evaluation

Authors: Nagasamy Venkatesh Dhandapani, Amged Awad El-Gied

Abstract:

Cefixime, a BCS class II drug, is insoluble in water but freely soluble in acetone and in alcohol. The aqueous solubility of cefixime in water is poor and exhibits exceptionally slow and intrinsic dissolution rate. In the present study, cefixime and β-Cyclodextrin (β-CD) solid dispersions were prepared with a view to study the effect and influence of β-CD on the solubility and dissolution rate of this poorly aqueous soluble drug. Phase solubility profile revealed that the solubility of cefixime was increased in the presence of β-CD and was classified as AL-type. Effect of variable, such as drug:carrier ratio, was studied. Physical characterization of the solid dispersion was characterized by Fourier transform infrared spectroscopy (FT-IR) and Differential scanning calorimetry (DSC). These studies revealed that a distinct loss of drug crystallinity in the solid molecular dispersions is ostensibly accounting for enhancement of dissolution rate in distilled water. The drug release from the prepared solid dispersion exhibited a first order kinetics. Solid dispersions of cefixime showed a 6.77 times fold increase in dissolution rate over the pure drug.

Keywords: β-cyclodextrin, cefixime, dissolution, Kneading method, solid dispersions, release kinetics

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3345 Drug Therapy Problem and Its Contributing Factors among Pediatric Patients with Infectious Diseases Admitted to Jimma University Medical Center, South West Ethiopia: Prospective Observational Study

Authors: Desalegn Feyissa Desu

Abstract:

Drug therapy problem is a significant challenge to provide high quality health care service for the patients. It is associated with morbidity, mortality, increased hospital stay, and reduced quality of life. Moreover, pediatric patients are quite susceptible to drug therapy problems. Thus this study aimed to assess drug therapy problem and its contributing factors among pediatric patients diagnosed with infectious disease admitted to pediatric ward of Jimma university medical center, from April 1 to June 30, 2018. Prospective observational study was conducted among pediatric patients with infectious disease admitted from April 01 to June 30, 2018. Drug therapy problems were identified by using Cipolle’s and strand’s drug related problem classification method. Patient’s written informed consent was obtained after explaining the purpose of the study. Patient’s specific data were collected using structured questionnaire. Data were entered into Epi data version 4.0.2 and then exported to statistical software package version 21.0 for analysis. To identify predictors of drug therapy problems occurrence, multiple stepwise backward logistic regression analysis was done. The 95% CI was used to show the accuracy of data analysis and statistical significance was considered at p-value < 0.05. A total of 304 pediatric patients were included in the study. Of these, 226(74.3%) patients had at least one drug therapy problem during their hospital stay. A total of 356 drug therapy problems were identified among two hundred twenty six patients. Non-compliance (28.65%) and dose too low (27.53%) were the most common type of drug related problems while disease comorbidity [AOR=3.39, 95% CI= (1.89-6.08)], Polypharmacy [AOR=3.16, 95% CI= (1.61-6.20)] and more than six days stay in hospital [AOR=3.37, 95% CI= (1.71-6.64) were independent predictors of drug therapy problem occurrence. Drug therapy problems were common in pediatric patients with infectious disease in the study area. Presence of comorbidity, polypharmacy and prolonged hospital stay were the predictors of drug therapy problem in study area. Therefore, to overcome the significant gaps in pediatric pharmaceutical care, clinical pharmacists, Pediatricians, and other health care professionals have to work in collaboration.

Keywords: drug therapy problem, pediatric, infectious disease, Ethiopia

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3344 Prevalence of Metabolic Syndrome According to Different Criteria in Population over 20 Years Old in Ahvaz

Authors: Armaghan Moravej Aleali, Hajieh Shahbazian, Seyed Mahmoud Latifi, Leila Yazdanpanah

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Objective: Metabolic syndrome or insulin resistance syndrome or syndrome X is a collection of abdominal obesity, hypertension, glucose intolerance and lipid abnormalities (elevated triglycerides, elevated LDL, and decrease the amount of HDL). That increases the incidence of diabetes and risk of cardiovascular disease. The aim of this study is to investigate the prevalence of metabolic syndrome in people over 20 years of Ahvaz according to IDF, ATPIII, Harmonized I and Harmonized II. Material & Methods: A cross-sectional study with a random cluster sampling in six health centers in Ahvaz was done. After obtaining informed consent, questionnaire for each person filled up including demographic data and examinations, including blood pressure in sitting position, weight, height, waist circumference, and waist circumference measurement. Results: From all participating 912 people, (434 (2/47%) male and 478 (2/52%) female) were evaluated. Mean age was 42/27± 14years (44/2±14/26 for male and 40/5±13/5 for female). Prevalence of metabolic syndrome was 22/8%, 28/4%, 30/9% and 16/9% according to ATPIII, IDF, Harmonized I and Harmonized II criteria respectively and increased with age in both sexes. IDF and Harmonized I had most kappa coordination (0/94). Conclusion: The results show a high prevalence of metabolic syndrome in Ahvaz. So, identification of the risk factors should be attempted to prevent metabolic syndrome.

Keywords: metabolic syndrome, IDF, ATP III, prevalence

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3343 Fabrication and Characterization of Dissolvable Microneedle Patches Using Different Compositions and Ratios of Hyaluronic Acid and Zinc Oxide Nanoparticles

Authors: Dada Kolawole Segun

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Transdermal drug delivery has gained popularity as a non-invasive method for controlled drug release compared to traditional delivery routes. Dissolvable transdermal patches have emerged as a promising platform for delivering a variety of drugs due to their ease of use. The objective of this research was to create and characterize dissolvable transdermal patches using various compositions and ratios of hyaluronic acid and zinc oxide nanoparticles. A micromolding technique was utilized to fabricate the patches, which were subsequently characterized using scanning electron microscopy, atomic force microscopy, and tensile strength testing. In vitro drug release studies were conducted to evaluate the drug release kinetics of the patches. The study found that the mechanical strength and dissolution properties of the patches were influenced by the hyaluronic acid and zinc oxide nanoparticle ratios used in the fabrication process. Moreover, the patches demonstrated controlled delivery of model drugs through the skin, highlighting their potential for transdermal drug delivery applications. The results suggest that dissolvable transdermal patches can be tailored to meet specific requirements for drug delivery applications using different compositions and ratios of hyaluronic acid and zinc oxide nanoparticles. This development has the potential to improve treatment outcomes and patient compliance in various therapeutic areas.

Keywords: transdermal drug delivery, characterization, skin permeation, biodegradable materials

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3342 A Diagnostic Challenge of Drug Resistant Childhood Tuberculosis in Developing World

Authors: Warda Fatima, Hasnain Javed

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The emerging trend of Drug resistance in childhood Tuberculosis is increasing worldwide and now becoming a priority challenge for National TB Control Programs of the world. Childhood TB accounts for 10-15% of total TB burden across the globe and same proportion is quantified in case of drug resistant TB. One third population suffering from MDR TB dies annually because of non-diagnosis and unavailability of appropriate treatment. However, true Childhood MDR TB cannot be estimated due to non-confirmation. Diagnosis of Pediatric TB by sputum Smear Microscopy and Culture inoculation are limited due to paucibacillary nature and difficulties in obtaining adequate sputum specimens. Diagnosis becomes more difficult when it comes to HIV infected child. New molecular advancements for early case detection of TB and MDR TB in adults have not been endorsed in children. Multi centered trials are needed to design better diagnostic approaches and efficient and safer treatments for DR TB in high burden countries. The aim of the present study is to sketch out the current situation of the childhood Drug resistant TB especially in the developing world and to highlight the classic and novel methods that are to be implemented in high-burden resource-limited locations.

Keywords: drug resistant TB, childhood, diagnosis, novel methods

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3341 Prevalence of Urinary Tract Infections and Risk Factors among Pregnant Women Attending Ante Natal Clinics in Government Primary Health Care Centres in Akure

Authors: Adepeju Simon-Oke, Olatunji Odeyemi, Mobolanle Oniya

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Urinary tract infection has become the most common bacterial infections in humans, both at the community and hospital settings; it has been reported in all age groups and in both sexes. This study was carried out in order to determine and evaluate the prevalence, current drug susceptibility pattern of the isolated organisms and identify the associated risk factors of UTIs among the pregnant women in Akure, Ondo State, Nigeria. A cross-sectional study was conducted on the urine of pregnant women, and socio-demographic information of the women was collected. A total of 300 clean midstream urine samples were collected, and a general urine microscopic examination and culture were carried out, the Microbact identification system was used to identify gram-negative bacteria. Out of the 300 urine samples cultured, 183(61.0%) yielded significant growth of urinary pathogens while 117(39.0%) yielded either insignificant growth or no growth of any urinary pathogen. Prevalence of UTI was significantly associated with the type of toilet used, symptoms of UTI, and previous history of urinary tract infection (p<0.05). Escherichia coli 58(31.7%) was the dominant pathogen isolated, and the least isolated uropathogens were Citrobacter freudii and Providencia retgerri 2(1.1%) respectively. Gram-negative bacteria showed 77.6%, 67.9%, and 61.2% susceptibility to ciprofloxacin, augmentin, and chloramphenicol, respectively. Resistance against septrin, chloramphenicol, sparfloxacin, amoxicillin, augmentin, gentamycin, pefloxacin, trivid, and streptomycin was observed in the range of 23.1 to 70.1%. Gram-positive uropathogens isolated showed high resistance to amoxicillin (68.4%) and high susceptibility to the remaining nine antibiotics in the range 65.8% to 89.5%. This study justifies that pregnant women are at high risk of UTI. Therefore screening of pregnant women during antenatal clinics should be considered very important to avoid complications. Health education with regular antenatal and personal hygiene is recommended as precautionary measures to UTI.

Keywords: pregnant women, prevalence, risk factor, UTIs

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3340 Similar Correlation of Meat and Sugar to Global Obesity Prevalence

Authors: Wenpeng You, Maciej Henneberg

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Background: Sugar consumption has been overwhelmingly advocated as a major dietary offender to obesity prevalence. Meat intake has been hypothesized as an obesity contributor in previous publications, but a moderate amount of meat to be included in our daily diet still has been suggested in many dietary guidelines. Comparable sugar and meat exposure data were obtained to assess the difference in relationships between the two major food groups and obesity prevalence at population level. Methods: Population level estimates of obesity and overweight rates, per capita per day exposure of major food groups (meat, sugar, starch crops, fibers, fats and fruits) and total calories, per capita per year GDP, urbanization and physical inactivity prevalence rate were extracted and matched for statistical analysis. Correlation coefficient (Pearson and partial) comparisons with Fisher’s r-to-z transformation and β range (β ± 2 SE) and overlapping in multiple linear regression (Enter and Stepwise) were used to examine potential differences in the relationships between obesity prevalence and sugar exposure and meat exposure respectively. Results: Pearson and partial correlations (controlled for total calories, physical inactivity prevalence, GDP and urbanization) analyses revealed that sugar and meat exposures correlated to obesity and overweight prevalence significantly. Fisher's r-to-z transformation did not show statistically significant difference in Pearson correlation coefficients (z=-0.53, p=0.5961) or partial correlation coefficients (z=-0.04, p=0.9681) between obesity prevalence and both sugar exposure and meat exposure. Both Enter and Stepwise models in multiple linear regression analysis showed that sugar and meat exposure were most significant predictors of obesity prevalence. Great β range overlapping in the Enter (0.289-0.573) and Stepwise (0.294-0.582) models indicated statistically sugar and meat exposure correlated to obesity without significant difference. Conclusion: Worldwide sugar and meat exposure correlated to obesity prevalence at the same extent. Like sugar, minimal meat exposure should also be suggested in the dietary guidelines.

Keywords: meat, sugar, obesity, energy surplus, meat protein, fats, insulin resistance

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3339 Self-Carried Theranostic Nanoparticles for in vitro and in vivo Cancer Therapy with Real-Time Monitoring of Drug Release

Authors: Jinfeng Zhang, Chun-Sing Lee

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The use of different nanocarriers for delivering hydrophobic pharmaceutical agents to tumor sites has garnered major attention. Despite the merits of these nanocarriers, further studies are needed for improving their drug loading capacities (typically less than 10%) and reducing their potential systemic toxicity. So development of alternative self-carried nanodrug delivery strategies without using any inert carriers is highly desirable. In this study, we developed a self-carried theranostic curcumin (Cur) nanodrug for highly effective cancer therapy in vitro and in vivo with real-time monitoring of drug release. With a biocompatible C18PMH-PEG functionalization, the Cur nanoparticles (NPs) showed excellent dispersibility and outstanding stability in physiological environment, with drug loading capacity higher than 78 wt.%. Both confocal microscopy and flow cytometry confirmed the cellular fluorescent “OFF-ON” activation and real-time monitoring of Cur molecule release, showing its potential for cancer diagnosis. In vitro and in vivo experiments clearly show that therapeutic efficacy of the PEGylated Cur NPs is much better than that of free Cur. This self-carried theranostic strategy with real-time monitoring of drug release may open a new way for simultaneous cancer therapy and diagnosis.

Keywords: drug delivery, in vitro and in vivo cancer therapy, real-time monitoring, self-carried

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3338 A Study of the Prevalence of Hypertension and Pre Hypertension in Adolescence Age between 10-17 in Ahvaz (2008-2009)

Authors: Armaghan Moravej Aleali, Seyed Mahmoud Latifi, Homeira Rashidi

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Objective: High blood pressure in a risk factor for some disease like stroke, coronary heart disease, and renal failure. High blood pressure in children is an increasing health problem. The aim of this present was to determine prevalence of hypertension and pre-hypertension age between 10 to 17 years old. Material & Methods: This descriptive-analytic study was conducted using multiphase sampling method in Ahvaz (Southwest of Iran). A questionnaire include: height, weight, and body mass index, systolic and diastolic blood pressures filled for each participant. Blood pressure was measured twice for each person. For the diagnosis of hypertension, the fourth report of the Diagnosis, Evaluation, and Treatment of High Blood Pressure in Children and Adolescents of the National Health Institute of United States was used. Results: The subject participants of the study were 1707children and adolescents including 922 boys (54%) and 785 girls 46%). The prevalence of high blood pressure was 1.7% (boys 2.5% girls 0.8%). The prevalence of pre-hypertension was 9 % (7.6% in boys, 10.6% in girls). The mean systolic and diastolic blood pressures increased with increasing body mass index. Conclusion: In this study, the prevalence of high blood pressure was found to be lower than other studies in our country. The prevalence of the high blood pressure in boys was significantly higher than girls. This study, like other studies, showed a high correlation between being overweight and an increase in systolic and diastolic blood pressure.

Keywords: hypertension, pre-hypertension, childhood, adolescence

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3337 Pattern of Adverse Drug Reactions with Platinum Compounds in Cancer Chemotherapy at a Tertiary Care Hospital in South India

Authors: Meena Kumari, Ajitha Sharma, Mohan Babu Amberkar, Hasitha Manohar, Joseph Thomas, K. L. Bairy

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Aim: To evaluate the pattern of occurrence of adverse drug reactions (ADRs) with platinum compounds in cancer chemotherapy at a tertiary care hospital. Methods: It was a retrospective, descriptive case record study done on patients admitted to the medical oncology ward of Kasturba Hospital, Manipal from July to November 2012. Inclusion criteria comprised of patients of both sexes and all ages diagnosed with cancer and were on platinum compounds, who developed at least one adverse drug reaction during or after the treatment period. CDSCO proforma was used for reporting ADRs. Causality was assessed using Naranjo Algorithm. Results: A total of 65 patients was included in the study. Females comprised of 67.69% and rest males. Around 49.23% of the ADRs were seen in the age group of 41-60 years, followed by 20 % in 21-40 years, 18.46% in patients over 60 years and 12.31% in 1-20 years age group. The anticancer agents which caused adverse drug reactions in our study were carboplatin (41.54%), cisplatin (36.92%) and oxaliplatin (21.54%). Most common adverse drug reactions observed were oral candidiasis (21.53%), vomiting (16.92%), anaemia (12.3%), diarrhoea (12.3%) and febrile neutropenia (0.08%). The results of the causality assessment of most of the cases were probable. Conclusion: The adverse effect of chemotherapeutic agents is a matter of concern in the pharmacological management of cancer as it affects the quality of life of patients. This information would be useful in identifying and minimizing preventable adverse drug reactions while generally enhancing the knowledge of the prescribers to deal with these adverse drug reactions more efficiently.

Keywords: adverse drug reactions, platinum compounds, cancer, chemotherapy

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3336 Avoidant Restrictive Food Intake Disorder and Its Impact on Other Eating Disorders

Authors: I. Caldas, T. Duarte

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Avoidant Restrictive Food Intake Disorder (ARFID) was included for the first time in DSM-5, replacing the old diagnosis of DSM-4 'Early Childhood Eating Disorder'. An ARFID is characterized by a restrictive/avoidant eating pattern that can lead to severe nutritional deficiency, weight loss, nutritional supplementation dependence, and poor psychosocial functioning. This eating pattern is associated with decreased interest in food, worries about food characteristics or the act of ingestion, and lack of concern with weight or body image. This paper aims to understand the impact of this new diagnosis in other Eating Disorders (ED) prevalence, as well as to compare their therapeutic approaches. Methodology: Literature reviewed by PubMed with the following keywords: 'ARFID', 'Prevalence', and 'Eating Disorders'. We selected articles related to this theme, written since 2016. Results: In a population of children hospitalized with ED, 5% to 14% was diagnosed with ARFID, and, as outpatient treatment, the prevalence was 22%. People diagnosed with ARFID have more prevalence of other comorbidities, especially autism spectrum, are younger, and are more often male. Regarding the treatment of ARFID, it most often required nasogastric feeding, and with less suffering associated with this procedure, compared to AN. Despite these differences, 12% of patients diagnosed with ARFID transited to AN during treatment, suggesting that the first pathology may be a risk factor for the development of AN. Conclusions: The differences identified between ARFID and the other EDs are important when analyzed as differential diagnostic hypotheses and therapeutic approaches. Further study is necessary regarding its prevalence, risk factors, and treatment.

Keywords: avoidant restrictive food intake disorder, ARFID, differential diagnoses, eating disorders, prevalence

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3335 Prevalence of Seropositivity for Cytomegalovirus in Patients with Hereditary Bleeding Diseases in West Azerbaijan of Iran

Authors: Zakieh Rostamzadeh, Zahra Shirmohammadi

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Human cytomegalovirus is a species of the cytomegalovirus family of viruses, which in turn is a member of the viral family known as herpesviridae or herpesviruses. Although they may be found throughout the body, HCMV infections are frequently associated with the salivary glands. HCMV infection is typically unnoticed in healthy people, but can be life-threatening for the immunocompromised such as HIV-infected persons, organ transplant recipients, or newborn infants. After infection, HCMV has an ability to remain latent within the body over long periods. Cytomegalovirus (CMV) causes infection in immunocompromised, hemophilia patients and those who received blood transfusion frequently. This study aimed at determining the prevalence of cytomegalovirus (CMV) antibodies in hemophilia patients. Materials and Methods: A retrospective observational study was carried out in Urmia, North West of Iran. The study population comprised a sample of 50 hemophilic patients born after 1985 and have received blood factors in West Azerbaijan. The exclusion criteria include: drug abusing, high risk sexual contacts, vertical transmission of mother to fetus and suspicious needling. All samples were evaluated with the method of ELISA, with a certain kind of kit and by a certain laboratory. Results: Fifty hemophiliacs from 250 patients registered with Urmia Hemophilia Society were enrolled in the study including 43 (86%) male, and 7 (14%) female. The mean age of patients was 10.3 years, range 3 to 25 years. None of patients had risk factors mentioned above. Among our studied population, 34(68%) had hemophilia A, 1 (2%) hemophilia B, 8 (16%) VWF, 3(6%) factor VII deficiency, 1 (2%) factor V deficiency, 1 (2%) factor X deficiency, 1 (2%). Sera of 50 Hemodialysis patients were investigated for CMV-specific immunoglobulin G (IgG) and IgM. % 91.89 patients were anti-CMV IgG positive and %40.54 was seropositive for anti-CMV IgM. 37.8% patient had serological evidence of reactivation and 2.7% of patients had the primary infection. Discussion: There was no relationship between the antibody titer and: drug abusing, high risk sexual contacts, vertical transmission of mother to fetus and suspicious needling.

Keywords: bioinformatics, biomedicine, cytomegalovirus, immunocompromise

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3334 Formulation and Evaluation of TDDS for Sustained Release Ondansetron HCL Patches

Authors: Baljinder Singh, Navneet Sharma

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The skin can be used as the site for drug administration for continuous transdermal drug infusion into the systemic circulation. For the continuous diffusion/penetration of the drugs through the intact skin surface membrane-moderated systems, matrix dispersion type systems, adhesive diffusion controlled systems and micro reservoir systems have been developed. Various penetration enhancers are used for the drug diffusion through skin. In matrix dispersion type systems, the drug is dispersed in the solvent along with the polymers and solvent allowed to evaporate forming a homogeneous drug-polymer matrix. Matrix type systems were developed in the present study. In the present work, an attempt has been made to develop a matrix-type transdermal therapeutic system comprising of ondansetron-HCl with different ratios of hydrophilic and hydrophobic polymeric combinations using solvent evaporation technique. The physicochemical compatibility of the drug and the polymers was studied by infrared spectroscopy. The results obtained showed no physical-chemical incompatibility between the drug and the polymers. The patches were further subjected to various physical evaluations along with the in-vitro permeation studies using rat skin. On the basis of results obtained form the in vitro study and physical evaluation, the patches containing hydrophilic polymers i.e. polyvinyl alcohol and poly vinyl pyrrolidone with oleic acid as the penetration enhancer(5%) were considered as suitable for large scale manufacturing with a backing layer and a suitable adhesive membrane.

Keywords: transdermal drug delivery, penetration enhancers, hydrophilic and hydrophobic polymers, ondansetron HCl

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3333 Pharmacovigilance: An Empowerment in Safe Utilization of Pharmaceuticals

Authors: Pankaj Prashar, Bimlesh Kumar, Ankita Sood, Anamika Gautam

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Pharmacovigilance (PV) is a rapidly growing discipline in pharmaceutical industries as an integral part of clinical research and drug development over the past few decades. PV carries a breadth of scope from drug manufacturing to its regulation with safer utilization. The fundamental steps of PV not only includes data collection and verification, coding of drugs with adverse drug reactions, causality assessment and timely reporting to the authorities but also monitoring drug manufacturing, safety issues, product quality and conduction of due diligence. Standardization of adverse event information, collaboration of multiple departments in different companies, preparation of documents in accordance to both governmental as well as non-governmental organizations (FDA, EMA, GVP, ICH) are the advancements in discipline of PV. De-harmonization, lack of predictive drug safety models, improper funding by government, non-reporting, and non-acceptability of ADRs by developing countries and reports directly from patients to the monitoring centres respectively are the major road backs of PV. Mandatory pharmacovigilance reporting, frequent inspections, funding by government, educating and training medical students, pharmacists and nurses in this segment can bring about empowerment in PV. This area needs to be addressed with a sense of urgency for the safe utilization of pharmaceuticals.

Keywords: pharmacovigilance, regulatory, adverse event, drug safety

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3332 PEG-b-poly(4-vinylbenzyl phosphonate) Coated Magnetic Iron Oxide Nanoparticles as Drug Carrier System: Biological and Physicochemical Characterization

Authors: Magdalena Hałupka-Bryl, Magdalena Bednarowicz, Ryszard Krzyminiewski, Yukio Nagasaki

Abstract:

Due to their unique physical properties, superparamagnetic iron oxide nanoparticles are increasingly used in medical applications. They are very useful carriers for delivering antitumor drugs in targeted cancer treatment. Magnetic nanoparticles (PEG-PIONs/DOX) with chemotherapeutic were synthesized by coprecipitation method followed by coating with biocompatible polymer PEG-derivative (poly(ethylene glycol)-block-poly(4-vinylbenzylphosphonate). Complete physicochemical characterization was carried out (ESR, HRTEM, X-ray diffraction, SQUID analysis) to evaluate the magnetic properties of obtained PEG-PIONs/DOX. Nanoparticles were investigated also in terms of their stability, drug loading efficiency, drug release and antiproliferative effect on cancer cells. PEG-PIONs/DOX have been successfully used for the efficient delivery of an anticancer drug into the tumor region. Fluorescent imaging showed the internalization of PEG-PIONs/DOX in the cytoplasm. Biodistribution studies demonstrated that PEG-PIONs/DOX preferentially accumulate in tumor region via the enhanced permeability and retention effect. The present findings show that synthesized nanosystem is promising tool for potential magnetic drug delivery.

Keywords: targeted drug delivery, magnetic properties, iron oxide nanoparticles, biodistribution

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3331 Effect of Different Sterilization Processes on Drug Loaded Silicone-Hydrogel

Authors: Raquel Galante, Marina Braga, Daniela Ghisleni, Terezinha J. A. Pinto, Rogério Colaço, Ana Paula Serro

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The sensitive nature of soft biomaterials, such as hydrogels, renders their sterilization a particularly challenging task for the biomedical industry. Widely used contact lenses are now studied as promising platforms for topical corneal drug delivery. However, to the best of the authors knowledge, the influence of sterilization methods on these systems has yet to be evaluated. The main goal of this study was to understand how different pairs drug-hydrogel would interact under an ozone-based sterilization method in comparison with two conventional processes (steam heat and gamma irradiation). For that, Si-Hy containing hydroxylethyl methacrylate (HEMA) and [tris(trimethylsiloxy)silyl]propyl methacrylate (TRIS) was produced and soaked in different drug solutions, commonly used for the treatment of ocular diseases (levofloxacin, chlorhexidine, diclofenac and timolol maleate). The drug release profiles and main material properties were evaluated before and after the sterilization. Namely, swelling capacity was determined by water uptake studies, transparency was accessed by UV-Vis spectroscopy, surface topography/morphology by scanning electron microscopy (SEM) and mechanical properties by performing tensile tests. The drug released was quantified by high performance liquid chromatography (HPLC). The effectiveness of the sterilization procedures was assured by performing sterility tests. Ozone gas method led to a significant reduction of drug released and to the formation of degradation products specially for diclofenac and levofloxacin. Gamma irradiation led to darkening of the loaded Si-Hys and to the complete degradation of levofloxacin. Steam heat led to smoother surfaces and to a decrease of the amount of drug released, however, with no formation of degradation products. This difference in the total drug released could be the related to drug/polymer interactions promoted by the sterilization conditions in presence of the drug. Our findings offer important insights that, in turn, could be a useful contribution to the safe development of actual products.

Keywords: drug delivery, silicone hydrogels, sterilization, gamma irradiation, steam heat, ozone gas

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3330 Computational Methods in Official Statistics with an Example on Calculating and Predicting Diabetes Mellitus [DM] Prevalence in Different Age Groups within Australia in Future Years, in Light of the Aging Population

Authors: D. Hilton

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An analysis of the Australian Diabetes Screening Study estimated undiagnosed diabetes mellitus [DM] prevalence in a high risk general practice based cohort. DM prevalence varied from 9.4% to 18.1% depending upon the diagnostic criteria utilised with age being a highly significant risk factor. Utilising the gold standard oral glucose tolerance test, the prevalence of DM was 22-23% in those aged >= 70 years and <15% in those aged 40-59 years. Opportunistic screening in Australian general practice potentially can identify many persons with undiagnosed type 2 DM. An Australian Bureau of Statistics document published three years ago, reported the highest rate of DM in men aged 65-74 years [19%] whereas the rate for women was highest in those over 75 years [13%]. If you consider that the Australian Bureau of Statistics report in 2007 found that 13% of the population was over 65 years of age and that this will increase to 23-25% by 2056 with a further projected increase to 25-28% by 2101, obviously this information has to be factored into the equation when age related diabetes prevalence predictions are calculated. This 10-15% proportional increase of elderly persons within the population demographics has dramatic implications for the estimated number of elderly persons with DM in these age groupings. Computational methodology showing the age related demographic changes reported in these official statistical documents will be done showing estimates for 2056 and 2101 for different age groups. This has relevance for future diabetes prevalence rates and shows that along with many countries worldwide Australia is facing an increasing pandemic. In contrast Japan is expected to have a decrease in the next twenty years in the number of persons with diabetes.

Keywords: epidemiological methods, aging, prevalence, diabetes mellitus

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3329 Prevalence and Intensity of Soil Transmitted Helminth Infections among the School Children in the State of Uttar Pradesh, India

Authors: Prasanta Saini, Junaid Jibran Jawed, Subrata Majumdar

Abstract:

Infections caused by soil-transmitted helminths (STH) are the major problem in all the nations of the world. The major focus of STH research is to study the prevalence of three major helminths, such as Ascaris, Trituris and hookworm. Here we are reporting the prevalence and intensity of the STH in the school children of the state of Uttar Pradesh, India. The aim of the study is to assess the prevalence and risk factors of STH infection among the school children, aged between 5-10 years in 27 districts randomly selected districts with covering nine agro-climatic zones of Uttar Pradesh, India. For this cross-sectional survey, we have selected the populations of government primary school going children in Uttar Pradesh. The sampling was performed in the nine different agro-climatic zones. Every individual of the study populations filled their daily information in the questioner's form and then the sample was collected and processed by kato-katz methods by following the guidelines of WHO. In this method, the sampling was performed in total of 6421 populations. A total of 6,421 children from 130 schools were surveyed. Infection with any soil-transmitted helminths was detected among 4,578 children with an overall prevalence of 75.6% (95% CI: 65.3-83.6). Among the 6421 population, the prevalence of Ascaris is 69.6% (95% CL 57.97-79.11), hookworm is 22.7% (95%CL 19.3-26.3) and Trichuris sp is 4.6% (95% CL 0.8-21.6), so the predicted prevalence map indicates that the STH infection was hyperendemic in this state. The findings of our survey in 130 schools covering 9 agro-climatic with one or more soil transmitted helminths. Majority of STH infections were of light intensity. STH infection was hyper-endemic in entire state, except three zones in western Uttar Pradesh. High prevalence ( > 75%) in all age groups also indicate little impact of existing deworming initiatives, including those among pre-school aged children. WHO recommends annual treatment in areas where STH prevalence is between 20% and 50%, and, a bi-annual treatment in areas with prevalence rates of over 50%. In view of high prevalence of STH infection in Uttar Pradesh, it is strongly recommended to initiate a deworming programme for school children in the state. Although our survey was among primary school children, high prevalence among children aged 4-6 years also indicates the need to strengthen the existing deworming programs for pre-school children. Extending the benefits of deworming to pre-school children through deworming in Anganwadi schools would further reduce to decrease the load of infection in community. As a long-term solution for control STH infection, it is also necessary to improve the sanitation levels in the area, as majority of the houses did not have latrines and most of the children were defecating in open fields, a factor that was found to be significantly associated with STH infection.

Keywords: prevalence, school going children, soil transmitted helminthes, Uttar Pradesh-India

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3328 The Determination of Total Microbial Count and Prevalence of Salmonella in the Shrimp Supply in Khuzestan Province

Authors: Sana Mohammad Jafar

Abstract:

Salmonella is one of the major causes of foodborne diseases throughout the world. Shrimp are an important commodity in world fishery trade. The microbiological quality of shrimp must be evaluated for assurance of shrimp. The aim of this study was to evaluate the microbiological quality and to determine the prevalence of Salmonella in shrimp sold in Khuzestan province. In this study, a total of 245 samples of shrimp sold in Khuzestan province were tested for Salmonella prevalence and total microbial population. The mean aerobic bacterial count in 50.2% of samples was 2200, in 29.8% of samples was 13,600, in 20% of samples was 36,700, and the mean aerobic bacterial count in the total samples was 20,000. (20,000 cfu/cc). Of the total samples, 33 samples were positive for Salmonella and the prevalence of Salmonella was determined 13.4%. These results indicate the possibility that shrimp contribute to foodborne infections. The improvement of shrimp quality is an important issue, and shrimp before consuming should be washed with water containing chlorine, with the aim of increasing safety. In addition, it should be avoided to eat shrimp as raw or not cooked properly.

Keywords: determination, total microbial, Salmonella, shrimp

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3327 The Disease That 'Has a Woman Face': Feminization of HIV/AIDS in Nagaland, North-East India

Authors: Kitoholi V. Zhimo

Abstract:

Unlike the cases of cases of homosexuals, haemophilic and or drug users in USA, France, Africa and other countries, in India the first case of HIV/AIDS was detected in heterosexual female sex workers (FSW) in Chennai in 1986. This image played an important role in understanding HIV/AIDS scenario in the country. Similar to popular and dominant metaphors on HIV/AIDS such as ‘gay plague’, ‘new cancer’, ‘lethal disease’, ‘slim disease’, ‘foreign disease’, ‘junkie disease’, etc. around the world, the social construction of the virus was largely attributed to women in India. It was established that women particularly sex workers are ‘carrier’ and ‘transmitter’ of virus and were categorised as High Risk Groups (HRG’s) alongside homosexuals, transgenders and injecting drug users. Recent literature reveals growing rate of HIV infection among housewives since 1997 which revolutionised public health scenario in India. This means shift from high risk group to general public through ‘bridge population’ encompassing long distance truckers and migrant labours who at the expense of their nature of work and mobility comes in contact with HRG’s and transmit the virus to the general public especially women who are confined to the domestic space. As HIV epidemic expands, married women in monogamous relationship/marriage stand highly susceptible to infection with limited control, right and access over their sexual and reproductive health and planning. In context of Nagaland, a small state in North-eastern part of India HIV/AIDS transmission through injecting drug use dominated the early scene of the epidemic. However, paradigm shift occurred with declining trend of HIV prevalence among injecting drug users (IDU’s) over the past years with the introduction of Opioid Substitution Therapy (OST) and easy access/availability of syringes and injecting needles. Reflection on statistical data reveals that out of 36 states and union territories in India, the position of Nagaland in HIV prevalence among IDU’s has significantly dropped down from 6th position in 2003 to 16th position in 2017. The present face of virus in Nagaland is defined by (hetero) sexual mode of transmission which accounts for about 91% of as reported by Nagaland state AIDS control society (NSACS) in 2016 wherein young and married woman were found to be most affected leading to feminization of HIV/AIDS epidemic in the state. Thus, not only is HIV epidemic feminised but emerged victim to domestic violence which is more often accepted as normal part of heterosexual relationship. In the backdrop of these understanding, the present paper based on ethnographic fieldwork explores the plight, lived experiences and images of HIV+ve women with regard to sexual and reproductive rights against the backdrop of patriarchal system in Nagaland.

Keywords: HIV/AIDS, monogamy, Nagaland, sex worker disease, women

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3326 Development of Drug Delivery Systems for Endoplasmic Reticulum Amino Peptidases Modulators Using Electrospinning

Authors: Filipa Vasconcelos

Abstract:

The administration of endoplasmic reticulum amino peptidases (ERAP1 or ERAP2) inhibitors can be used for therapeutic approaches against cancer and auto-immune diseases. However, one of the main shortcomings of drug delivery systems (DDS) is associated with the drug off-target distribution, which can lead to an increase in its side effects on the patient’s body. To overcome such limitations, the encapsulation of four representative compounds of ERAP inhibitors into Polycaprolactone (PCL), Polyvinyl-alcohol (PVA), crosslinked PVA, and PVA with nanoparticles (liposomes) electrospun fibrous meshes is proposed as a safe and controlled drug release system. The use of electrospun fibrous meshes as a DDS allows efficient solvent evaporation giving limited time to the encapsulated drug to recrystallize, continuous delivery of the drug while the fibers degrade, prevention of initial burst release (sustained release), tunable dosages, and the encapsulation of other agents. This is possible due to the fibers' small diameters and resemblance to the extracellular matrix (confirmed by scanning electron microscopy results), high specific surface area, and good mechanical strength/stability. Furthermore, release studies conducted on PCL, PVA, crosslinked PVA, and PVA with nanoparticles (liposomes) electrospun fibrous meshes with each of the ERAP compounds encapsulated demonstrated that they were capable of releasing >60%, 50%, 40%, and 45% of the total ERAP concentration, respectively. Fibrous meshes with ERAP_E compound encapsulated achieved higher released concentrations (75.65%, 62.41%, 56.05%, and 65.39%, respectively). Toxicity studies of fibrous meshes with encapsulated compounds are currently being accessed in vitro, as well as pharmacokinetics and dynamics studies. The last step includes the implantation of the drug-loaded fibrous meshes in vivo.

Keywords: drug delivery, electrospinning, ERAP inhibitors, liposomes

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3325 Iontophoretic Drug Transport of Some Anti-Diabetic Agents

Authors: Ashish Jain, Satish Nayak

Abstract:

Transdermal iontophoretic drug delivery system is viable drug delivery platform technology and has a strong market worldwide. Transdermal drug delivery system is particularly desirable for therapeutic agents that need prolonged administration at controlled plasma level. This makes appropriateness to antihypertensive and anti-diabetic agents for their transdermal development. Controlled zero order absorption, easily termination of drug delivery and easy to administration also support for popularity of transdermal delivery. In this current research iontophoretic delivery of various anti diabetic agents like glipizide, glibenclamide and glimepiride were carried out. The experiments were carried out at different drug concentrations and different current densities using cathodal iontophoresis. Diffusion cell for iontophoretic permeation study was modified according to Glikfield Design. Pig skin was used for in vitro permeation study and for the in-vivo study New Zealand rabbits were used. At all concentration level iontophoresis showed enhanced permeation rate compared to passive controls. Iontophoretic transports of selected drugs were found to be increased with the current densities. Results showed that target permeation rate for selected drugs could be achieved with the aid of iontophoresis by increasing the area in an appreciable range.

Keywords: transdermal, iontophoresis, pig skin, rabbits, glipizide, glibeclamide

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3324 Current Practices of Permitted Daily Exposure (PDE) Calculation and Selection

Authors: Annie Ramanbhai Mecwan

Abstract:

Cleaning validation in a pharmaceutical manufacturing facility is documented evidence that a cleaning process has effectively removed contaminants, residues from previous drug products and cleaning agents below a pre-defined threshold from the reusable tools and parts of equipment. In shared manufacturing facilities more than one drug product is prepared. After cleaning of reusable tools and parts of equipment after one drug product manufacturing, there are chances that some residues of drug substance from previously manufactured drug products may be retained on the equipment and can carried forward to the next drug product and thus cause cross-contamination. Health-based limits through the derivation of a safe threshold value called permitted daily exposure (PDE) for the residues of drug substances should be employed to identify the risks posed at these manufacturing facilities. The PDE represents a substance-specific dose that is unlikely to cause an adverse effect if an individual is exposed to or below this dose every day for a lifetime. There are different practices to calculate PDE. Data for all APIs in the public domain are considered to calculate PDE value though, company to company may vary the final PDE value based on different toxicologist’s perspective or their subjective evaluation. Hence, Regulatory agencies should take responsibility for publishing PDE values for all APIs as it is done for elemental PDEs. This will harmonize the PDE values all over the world and prevent the unnecessary load on manufacturers for cleaning validation

Keywords: active pharmaceutical ingredient, good manufacturing practice, NOAEL, no observed adverse effect level, permitted daily exposure

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3323 Drug Abuse among Immigrant Youth in Canada

Authors: Qin Wei

Abstract:

There has been an increased number of immigrants arriving in Canada and a concurrent rise in the number of immigrant youth suffering from drug abuse. Immigrant youths’ drug abuse has become a significant social and public health concern for researchers. This literature review explores the nature of immigrant youths’ drug abuse by examining the factors influencing the onset of substance misuse, the barriers that discourage youth to seek out treatment, and how to resolve addictions amidst immigrant youth. Findings from the literature demonstrate that diminished parental supervision, acculturation challenges, peer conformity, discrimination, and ethnic marginalization are all significant factors influencing youth to use drugs as an outlet for their pain, while culturally competent care and fear of family and culture-based addiction stigma act as barriers discouraging youth from seeking out addiction support. To resolve addiction challenges amidst immigrant youth, future research should focus on promoting and implementing culturally sensitive practices and psychoeducational initiatives into immigrant communities and within public health policies.

Keywords: approaches, barriers, drug abuse, Canada, immigrant youth, reasons

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3322 Prevalence and Antibiotic Resistance Patterns of Salmonella from Retail Dressed Chickens (Gallus gallus domesticus) in Wet Markets of Cavite, Philippines

Authors: Chester Joshua V. Saldana, Yolanda A. Ilagan

Abstract:

This study determines the prevalence of Salmonella from retail dressed chickens using chicken wings as samples in five wet city markets of Cavite, Philippines, compares the prevalence among the markets' samples and determines the serotypes and antibiotic resistance pattern of Salmonella isolates. The overall prevalence of Salmonella in five wet markets in Cavite was 13.33 percent. Samples from Bacoor yielded the highest prevalence rate of 26.6 percent, followed by Imus (23.3%), Dasmarinas (11.6%), Trece Martires (3.3%) and Tagaytay (1.6%). Seven serotypes (serogroups B, C2, C3, D1 and E1) were isolated which include Salmonella weltevreden, S. derby, S. newport, S. albany, S. typhimurium, and S. enteritidis. Salmonella weltevreden was the predominant serotype while S. typhi and S. albany were the least common. Among the 15 antibiotics tested, resistance to ampicillin, tetracycline, and cephalexin was exhibited by all the isolates while 5 percent showed resistance to gentamicin, 2.5 percent to streptomycin and 12.5 percent to nitrofurantoin. One isolate was resistant to four antibiotics whereas most isolates of S. enteritidis were resistant to 2 to 5 antibiotics. Four resistance patterns were recorded. This study revealed the emergence of multidrug-resistant Salmonella serotypes from chicken meat in Cavite, Philippines.

Keywords: antibiotics, dressed chickens, resistance patterns, Salmonella serovars

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3321 Iontophoretic Drug Transport: An Non-Invasive Transdermal Approach

Authors: Ashish Jain, Shivam Tayal

Abstract:

There has been great interest in the field of Iontophoresis since few years due to its great applications in the field of controlled transdermal drug delivery system. It is an technique which is used to enhance the transdermal permeation of ionized high molecular weight molecules across the skin membrane especially Peptides & Proteins by the application of direct current of 1-4 mA for 20-40 minutes whereas chemical must be placed on electrodes with same charge. Iontophoresis enhanced the delivery of drug into the skin via pores like hair follicles, sweat gland ducts etc. rather than through stratum corneum. It has wide applications in the field of experimental, Therapeutic, Diagnostic, Dentistry etc. Medical science is using it to treat Hyperhidrosis (Excessive sweating) in hands and feet and to treat other ailments like hypertension, Migraine etc. Nowadays commercial transdermal iontophoretic patches are available in the market to treat different ailments. Researchers are keen to research in this field due to its vast applications and advantages.

Keywords: iontophoresis, novel drug delivery, transdermal, permeation enhancer

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3320 Tuberculosis in Humans and Animals in the Eastern Part of the Sudan

Authors: Yassir Adam Shuaib, Stefan Niemann, Eltahir Awad Khalil, Ulrich Schaible, Lothar Heinz Wieler, Mohammed Ahmed Bakhiet, Abbashar Osman Mohammed, Mohamed Abdelsalam Abdalla, Elvira Richter

Abstract:

Tuberculosis (TB) is a chronic bacterial disease of humans and animals and it is characterized by the progressive development of specific granulomatous tubercle lesions in affected tissues. In a six-month study, from June to November 2014, a total of 2,304 carcasses of cattle, camel, sheep, and goats slaughtered at East and West Gaash slaughterhouses, Kassala, were investigated during postmortem, in parallel, 101 sputum samples from TB suspected patients at Kassala and El-Gadarif Teaching Hospitals were collected in order to investigate tuberculosis in animals and humans. Only 0.1% carcasses were found with suspected TB lesions in the liver and lung and peritoneal cavity of two sheep and no tuberculous lesions were found in the carcasses of cattle, goats or camels. All samples, tissue lesions and sputum, were decontaminated by the NALC-NaOH method and cultured for mycobacterial growth at the NRZ for Mycobacteria, Research Center Borstel, Germany. Genotyping and molecular characterization of the grown strains were done by line probe assay (GenoType CM and MTBC) and 16S rDNA, rpoB gene, and ITS sequencing, spoligotyping, MIRU-VNTR typing and next generation sequencing (NGS). Culture of the specimens revealed growth of organisms from 81.6% of all samples. Mycobacterium tuberculosis (76.2%), M. intracellulare (14.2%), mixed infection with M. tuberculosis and M. intracellulare (6.0%) and mixed infection with M. tuberculosis and M. fortuitum and with M. intracellulare and unknown species (1.2%) were detected in the sputum samples and unknown species (1.2%) were detected in the samples of one of the animals tissues. From the 69 M. tuberculosis strains, 25 (36.2%) were showing either mono-drug-resistant or multi-drug-resistant or poly-drug-resistant but none was extensively drug-resistant. In conclusion, the prevalence of TB in animals was very low while in humans M. tuberculosis-Delhi/CAS lineage was responsible for most cases and there was an evidence of MDR transmission and acquisition.

Keywords: animal, human, slaughterhouse, Sudan, tuberculosis

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3319 Pediatric Drug Resistance Tuberculosis Pattern, Side Effect Profile and Treatment Outcome: North India Experience

Authors: Sarika Gupta, Harshika Khanna, Ajay K Verma, Surya Kant

Abstract:

Background: Drug-resistant tuberculosis (DR-TB) is a growing health challenge to global TB control efforts. Pediatric DR-TB is one of the neglected infectious diseases. In our previously published report, we have notified an increased prevalence of DR-TB in the pediatric population at a tertiary health care centre in North India which was estimated as 17.4%, 15.1%, 18.4%, and 20.3% in (%) in the year 2018, 2019, 2020, and 2021. Limited evidence exists about a pattern of drug resistance, side effect profile and programmatic outcomes of Paediatric DR-TB treatment. Therefore, this study was done to find out the pattern of resistance, side effect profile and treatment outcome. Methodology: This was a prospective cohort study conducted at the nodal drug-resistant tuberculosis centre of a tertiary care hospital in North India from January 2021 to December 2022. Subjects included children aged between 0-18 years of age with a diagnosis of DR-TB, on the basis of GeneXpert (rifampicin [RIF] resistance detected), line probe assay and drug sensitivity testing (DST) of M. tuberculosis (MTB) grown on a culture of body fluids. Children were classified as monoresistant TB, polyresistant TB (resistance to more than 1 first-line anti-TB drug, other than both INH and RIF), MDR-TB, pre-XDR-TB and XDR-TB, as per the WHO classification. All the patients were prescribed DR TB treatment as per the standard guidelines, either shorter oral DR-TB regimen or a longer all-oral MDR/XDR-TB regimen (age below five years needed modification). All the patients were followed up for side effects of treatment once per month. The patient outcomes were categorized as good outcomes if they had completed treatment and cured or were improving during the course of treatment, while bad outcomes included death or not improving during the course of treatment. Results: Of the 50 pediatric patients included in the study, 34 were females (66.7%) and 16 were male (31.4%). Around 33 patients (64.7%) were suffering from pulmonary TB, while 17 (33.3%) were suffering from extrapulmonary TB. The proportions of monoresistant TB, polyresistant TB, MDR-TB, pre-XDR-TB and XDR-TB were 2.0%, 0%, 50.0%, 30.0% and 18.0%, respectively. Good outcome was reported in 40 patients (80.0%). The 10 bad outcomes were 7 deaths (14%) and 3 (6.0%) children who were not improving. Adverse events (single or multiple) were reported in all the patients, most of which were mild in nature. The most common adverse events were metallic taste 16(31.4%), rash and allergic reaction 15(29.4%), nausea and vomiting 13(26.0%), arthralgia 11 (21.6%) and alopecia 11 (21.6%). Serious adverse event of QTc prolongation was reported in 4 cases (7.8%), but neither arrhythmias nor symptomatic cardiac side effects occurred. Vestibular toxicity was reported in 2(3.9%), and psychotic symptoms in 4(7.8%). Hepatotoxicity, hypothyroidism, peripheral neuropathy, gynaecomastia, and amenorrhea were reported in 2 (4.0%), 4 (7.8%), 2 (3.9%), 1(2.0%), and 2 (3.9%) respectively. None of the drugs needed to be withdrawn due to uncontrolled adverse events. Conclusion: Paediatric DR TB treatment achieved favorable outcomes in a large proportion of children. DR TB treatment regimen drugs were overall well tolerated in this cohort.

Keywords: pediatric, drug-resistant, tuberculosis, adverse events, treatment

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3318 Development and in vitro Characterization of Loteprednol Etabonate-Loaded Polymeric Nanoparticles for Ocular Delivery

Authors: Abhishek Kumar Sah, Preeti K. Suresh

Abstract:

Effective drug delivery to the eye is a massive challenge, due to complicated physiological ocular barriers, rapid washout by tear and nasolachrymal drainage. Thus, most of the conventional ophthalmic formulations face the problem of low ocular bioavailability. Ophthalmic drug therapy can be improved by enhancing the precorneal drug retention along with improved drug penetration. The aim of the present investigation was to develop and evaluate a biodegradable polymer poly (D, L-lactide-co-glycolide) (PLGA) coated nanoparticulate carrier of loteprednol etabonate. PLGA nanoparticles were prepared by modified emulsification/solvent diffusion method using high-speed homogenizer followed by sonication. The nanoparticles were characterized for various parameters such as particle size, zeta potential, polydispersity index, X-ray powder diffraction (XRD), Transmission electron microscopy (TEM), in vitro drug release profile and stability. The prepared nanocarriers displayed mean particle size in the range of 271.7 to 424.4 nm, with zeta potential less than –10 mV. In vitro release in simulated tear fluid (STF) nanocarrier showed an extended release profile of loteprednol etabonate. TEM confirmed the spherical morphology and smooth surface of the particles. All the prepared formulations were found to be stable at varying temperatures.

Keywords: drug delivery, ocular delivery, polymeric nanoparticles, loteprednol etabonate

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