Medicine and Health Sciences Commons^™

Naloxone Therapy In Opioid Overdose Patients: Intranasal Or Intravenous?, Leiah Carney

Natural Sciences Student Research Presentations

This slide presentation for the Natural Science Poster Session at Parkland College describes the chemical makeup and effect of Naloxone, an opioid antagonist used in the treatment opioid overdose and summarizes a study comparing intravenous and intranasal delivery methods. Concludes that although there are conflicting studies, evidence supports intranasal delivery.

Recent Analytical Methods For The Analysis Of Sweeteners In Food: A Regulatory Perspective, Romina Shah, Lowri S. De Jager

United States Food and Drug Administration: Publications

Non-nutritive or low calorie sweeteners are commonly used worldwide in the food industry, often in combination in order to limit undesirable tastes. The list of allowable sweeteners varies among countries and it is important for regulatory agencies and food safety laboratories to monitor these highly consumed products to ensure compliance with worldwide regulations. Current analytical methods for confirmation and quantification of sweeteners must allow for confirmation of analyte identity in order to be compatible with today’s standards. Various methods for the determination of non-nutritive sweeteners have been reported in the literature. Th e most common multi-sweetener methods involve high performance …

Cannabinoid Disposition In Oral Fluid After Controlled Smoked, Vaporized, And Oral Cannabis Administration, Madeleine J. Swortwood, Matthew N. Newmeyer, Maria Andersson, Osama A. Abulseoud, Karl B. Scheidweiler, Marilyn A. Huestis

United States Food and Drug Administration: Publications

Oral fluid (OF) is an important matrix for monitoring drugs. Smoking cannabis is common, but vaporization and edible consumption also are popular. OF pharmacokinetics are available for controlled smoked cannabis, but few data exist for vaporized and oral routes. Frequent and occasional cannabis smokers were recruited as participants for four dosing sessions including one active (6.9% Δ⁹-tetrahydrocannabinol, THC) or placebo cannabis-containing brownie, followed by one active or placebo cigarette, or one active or placebo vaporized cannabis dose. Only one active dose was administered per session. OF was collected before and up to 54 (occasional) or 72 (frequent) h …

Certain Dyes As Pharmacologically Active Substances In Fish Farming And Other Aquaculture Products, Eric Verdon, Wendy C. Andersen

United States Food and Drug Administration: Publications

The last 40 years have brought enormous changes to the aquaculture industry. The farming of fish and of seafood products has been continuously increasing from 3.9% by weight in 1970 to 36% in 2006 according to theWorld Health Organization (WHO) and Food and Agriculture Organization (FAO) of the United Nations.¹ The global trend of aquaculture development gaining importance in total fish supply has remained uninterrupted. Farmed food fish contributed a record 42.2% of the total 158 million tonnes of fish produced by capture fisheries and aquaculture in 2012 (Figure 9.1). This compares with just 13.4% in 1990 and 25.7% …

Color And Power Doppler Combined With Fetal Intelligent Navigation Echocardiography (Fine) To Evaluate The Fetal Heart, L. Yeo, R. Romero

United States Food and Drug Administration: Publications

Objective To evaluate the performance of color and bidirectional power Doppler ultrasound combined with Fetal Intelligent Navigation Echocardiography (FINE) in examining the fetal heart.

Methods A prospective cohort study was conducted of fetuses in the second and third trimesters with a normal heart or with congenital heart disease (CHD). One or more spatiotemporal image correlation (STIC) volume datasets, combined with color or bidirectional power Doppler (S-flow) imaging, were acquired in the apical four-chamber view. Each successfully obtained STIC volume was evaluated by STICLoop™ to determine its appropriateness before applying the FINE method. Visualization rates for standard fetal echocardiography views using …

Salmonella Inactivation During Extrusion Of An Oat Flour Model Food, Nathan M. Anderson, Susanne E. Keller, Niharika Mishra, Shannon Pickens, Dana Gradl, Tim Hartter, Galen Rokey, Christopher Dohl, Brian Plattner, Stuart Chirtel, Elizabeth M. Grasso-Kelley

United States Food and Drug Administration: Publications

Little research exists on Salmonella inactivation during extrusion processing, yet many outbreaks associated with low water activity foods since 2006 were linked to extruded foods. The aim of this research was to study Salmonella inactivation during extrusion of a model cereal product. Oat flour was inoculated with Salmonella enterica serovar Agona, an outbreak strain isolated from puffed cereals, and processed using a single-screw extruder at a feed rate of 75 kg/h and a screw speed of 500 rpm. Extrudate samples were collected from the barrel outlet in sterile bags and immediately cooled in an ice–water bath. Populations were determined using …

An Overview Of The Role Of Mathematical Models In Implementation Of Quality By Design Paradigm For Drug Development And Manufacture, Sharmista Chatterjee, Christine M.V. Moore, Moheb M. Nasr

United States Food and Drug Administration: Publications

A model is a representation of an underlying physical–chemical phenomenon. In the pharmaceutical industry, mathematical‐based models can be applied at all stages of development, starting with formulation design, continuing through process development and scale‐up, and extending into process monitoring and control of the commercial process. Implementation of models offers many benefits. These include, but are not limited to, (i) enhanced process understanding, (ii) reduction of experimentation cost, and (iii) improvement of productivity and product quality.

Models can be broadly categorized as either qualitative or quantitative. The focus of this chapter is quantitative models. These can be classified into three broad …

The Mechanism Of Cirp In Inhibition Of Keratinocytes Growth Arrest And Apoptosis Following Low Dose Uvb Radiation, Yi Liao, Jianguo Feng, Yi Zhang, Liling Tang, Shiyong Wu

United States Food and Drug Administration: Publications

UV induces CIRP expression and subsequent Stat3 activation, but the biological function and mechanism of CIRP and Stat3 in mediating UVB-induced skin carcinogenesis have not been fully elucidated. In this study, we demonstrate that CIRP is elevated in all tested melanoma and non-melanoma skin cancer cell lines; and the expression of CIRP is upregulated in keratinocytes after being irradiated with relatively low dose (<5 mJ/cm²), but not high dose (50 mJ/cm²), UVB acutely and chronically. The increased expression of CIRP, either induced by UVB or through overexpression, leads to resistance of keratinocytes to UVB-induced growth arrest and …

Monitoring Harm Perceptions Of Smokeless Tobacco Products Among U.S. Adults: Health Information National Trends Survey 2012, 2014, 2015, Shari P. Feirman, Elisabeth A. Donaldson, Mark Parascandola, Kimberly Snyder, Cindy Tworek

United States Food and Drug Administration: Publications

Introduction: Changes to the U.S. smokeless tobacco landscape in recent years include a change to health warnings on packages, the implementation of bans in some stadiums, and the launch of a federal youth pre- vention campaign. It is unclear whether such changes have impacted consumer beliefs about smokeless tobacco. This study examines relative harm perceptions of smokeless tobacco compared to cigarettes among adults and assesses changes in smokeless tobacco harm perceptions over time.

Methods: We analyzed data from three cycles (2012, 2014, 2015) of the Health Information National Trends Survey (HINTS). Using 2015 data, we assessed bivariate associations between smokeless …

Preparation And Characterization Of Acitretin-Loaded Niosomes For Psoriasis Treatment, Marey Abdulmootani Almaghrabi

Electronic Theses and Dissertations

Psoriasis is a chronic skin disease that manifests as impaired epidermal differentiation. The disease is typically treated with acitretin, an effective oral cytotoxic agent. However, due to its side effects, its use is highly limited. Topical delivery of acitretin may decrease the systemic toxicity and increase the drug’s bioavailability at the pathological site. However, this approach has some limitations. The decrease in skin integrity due to psoriasis could lead to escape of drug into the systemic circulation system and consequently compromise the topical approach. Also, the high instability of acitretin in the presence of heat could limit its topical application. …

Burden Of Depression Among Individuals With Irritable Bowel Syndrome(Ibs) In The Medicaid Population, Kaustuv Bhattacharya

Electronic Theses and Dissertations

Objective: to determine the period prevalence of IBS and comorbid depression among individuals with Irritable Bowel Syndrome (IBS) in multi-state Medicaid population, and to assess the impact of comorbid depression on healthcare utilization and costs among individuals with IBS enrolled in fee-for-service Medicaid program. Methods: a retrospective cohort study was conducted using 2006-2008 Medicaid analytic extract files for 39 states. Beneficiaries with IBS were identified based on any medical claims for the disease. Beneficiaries with one or more medical claims for depression during the study period were considered to have had comorbid depression. For each beneficiary, the first claim for …

Impact Of Prenatal Exposure To Antidepressants On Adverse Birth Outcomes, Sudeepti Pahuja

Theses and Dissertations

BACKGROUND: There has been an increase in the diagnosis of depression and the use of antidepressants, especially in women of childbearing age, in the past decade. This has drawn attention to the potential impact of depression and antidepressants on pregnancy and fetal development.

OBJECTIVE: (i) To determine the impact of prenatal exposure to antidepressant on the risk of adverse birth outcomes. (ii) To assess the effect of type of antidepressants on the risk of adverse birth outcomes using selective serotonin reuptake inhibitors as the referent group. (iii) To assess the effect of duration and time of prenatal exposure …

Target Based Design And Synthesis Of Fused Pyrimidines In The Potential Treatment Of Cancer And Opportunistic Infection, Khushbu Shah

Electronic Theses and Dissertations

This dissertation describes an introduction, background and research progress in the areas of agents designed as (a) selective Pneumocystis jirovecii dihydrofolate reductase (pjDHFR) inhibitors for pneumocystis pneumonia (PCP) infection; (b) inhibitors of microtubule polymerization and multiple receptor tyrosine kinase (RTK) for potential treatment of cancer; and (c) substrates for tumor-targeted therapy for cancer.

PCP is a host species-specific infection. Most of the drugs, synthesized and evaluated so far, have been tested against Pneumocystis carinii dihydrofolate reductase (the causative organism in rats), which would not necessarily be effective against pjDHFR (the causative organism in humans). Trimethoprim-sulfamethoxazole (TMP-SMX) combination, which has been …

Cyclodextrin As A Drug Carrier Increasing Drug Solubility, Malka Silberberg

The Science Journal of the Lander College of Arts and Sciences

The development of a new drug requires research and evaluation before the drug is approved to enter the market. One of the factors determining the efficacy of a drug is the aqueous solubility of the drug. A current problem in today’s pharmaceutical industry is the low aqueous solubility of many useful drugs. A drug with a low aqueous solubility will not readily be absorbed by the body. The low aqueous solubility of a drug is often due to the drug’s hydrophobic character. Drug enhancement methods are necessary to avoid the obstacle of drug insolubility and many methods have been developed. …

Development Of Emulsion-Based Adjuvants For Parenteral Influenza Vaccines, Sakalanunt Lamaisakul

Chulalongkorn University Theses and Dissertations (Chula ETD)

Generally, inactivated whole-cell and subunit vaccines are often less antigenic than live-attenuated vaccines, then they require the inclusion of adjuvants to improve immunostimulating activities. In the present study, microemulsion (ME) and nanoemulsion adjuvants were developed to evoke a safety and effective immune response of vaccine antigens. The emulsion systems including vegetable oil and nonionic surfactants have been formulated with or without cationic surfactant, cetyltrimethylammonium bromide (CTAB) and then sterilized by autoclaving. Physical properties, hemolytic activities and biological efficacies of all prepared emulsions were conducted. The results demonstrated that the autoclaving process caused a reduction in droplet size with narrow size …

Use Of Steroids For Early Stage Ards In Icu Patients, Jasmine Coatie Pharmd, Michael Todt Pharmd, Megan Straub Pharmd

Parkview Pharmacy Department

2017 ASHP Midyear Clinical Meeting / Orlando, FL / Poster #10-085

Poster Presentation

Compare outcomes in patients treated with high-dose and low-dose corticosteroids in the early stage of Acute Respiratory Distress Syndrome (ARDS).

Bladder Antimuscarinics And Cognitive Decline In Elderly Patients, Daniela Claudia Moga, Erin L. Abner, Qishan Wu, Gregory A. Jicha

Pharmacy Practice and Science Faculty Publications

Introduction: The evidence on the impact of bladder antimuscarinics initiation on cognitive function in older adults is inconsistent.

Methods: A retrospective analysis of data from the National Alzheimer's Coordinating Center (NACC) on enrollees 65 years and older evaluated the association between antimuscarinic initiation and cognitive decline. We defined decline from baseline (yes/no) for cognitive assessments included in the NACC Uniform Data Set 2.0 battery. New users were matched on year of enrollment and time in the cohort to randomly selected nonusers. Analyses were conducted using inverse probability of treatment weights based on baseline propensity scores.

Results: Our analyses included 698 …

A Comparison Of Sex Differences In Psychotropic Medication Use In Older People With Alzheimer's Disease In The Us And Finland, Daniela C. Moga, Heidi Taipale, Anna-Maija Tolppanen, Antti Tanskanen, Jari Tiihonen, Sirpa Hartikainen, Qishan Wu, Gregory A. Jicha, Danijela Gnjidic

Pharmacy Practice and Science Faculty Publications

Aims—Given the high prevalence of psychotropic medication use in people with dementia and the potential for different prescribing practices in men and women, our study aimed to investigate sex differences in psychotropic medication use in older adults with Alzheimer’s disease (AD) living in the US and Finland.

Methods—We used data collected between 2005 and 2011 as part of the National Alzheimer’s Coordinating Center (NACC) in the US, and Medication use and Alzheimer’s disease (MEDALZ) cohorts in Finland. We evaluated psychotropic medication use (antidepressant, antipsychotic, anxiolytic, sedative, or hypnotic) in participants aged 65 years or older. We employed multivariable …

Management Of Viral Central Nervous System Infections: A Primer For Clinicians, P Brandon Bookstaver, Phillip L. Mohorn, Ansal Shah, Lauren D. Tesh, April M. Quidley, Ravish Kothari, Christopher M. Bland, Sharon Weissman

Faculty Publications

Viruses are a common cause of central nervous system (CNS) infections with many host, agent, and environmental factors influencing the expression of viral diseases. Viruses can be responsible for CNS disease through a variety of mechanisms including direct infection and replication within the CNS resulting in encephalitis, infection limited to the meninges, or immune-related processes such as acute disseminated encephalomyelitis. Common pathogens including herpes simplex virus, varicella zoster, and enterovirus are responsible for the greatest number of cases in immunocompetent hosts. Other herpes viruses (eg, cytomegalovirus, John Cunningham virus) are more common in immunocompromised hosts. Arboviruses such as Japanese encephalitis …

The Big Patent Short: Hedge Fund Challenges To Pharmaceutical Patents And The Need For Financial Regulation, Ariel D. Multak

Fordham Journal of Corporate & Financial Law

The enactment of the America Invents Act (AIA) in 2011 ushered in a new system for post-grant patent review. In the interest of enhancing the efficiency of the patent regime by invalidating “bad” patents, certain requirements were relaxed. For example, the AIA created an examination process called inter partes review, which allows a party without legal standing to challenge the validity of a patent in front of the Patent Trial and Appeal Board. In the pharmaceutical patent context, it was expected that inter partes review would be utilized mostly by generic drug makers seeking to invalidate patents without incurring the …

Gastrointestinal Bleeding Events And Statin Use: A Large Propensity Score-Matched Retrospective Cohort Study, Ashley I. Martinez

Theses and Dissertations--Pharmacy

Literature is conflicting regarding the association between statin use and gastrointestinal (GI) bleeding. This study sought to determine whether there is an association between statin use and GI bleeding by comparing incidence of gastrointestinal events between statin users and an active comparator group.

Data was obtained from a large administrative claims database composed of subjects enrolled in a selection of insurance plans throughout the United States from 2009-2014. New statin users (exposed) and thyroid medication users (active comparator, unexposed) were followed from the baseline period (one year prior to medication initiation) until first event, discontinuation, or disenrollment. Subjects were matched …

The Development Of Bsn272 From Prevention Of Diet-Induced Hyperlipidemia In Mice To A Potential Therapy For Prader-Willi Syndrome In Humans, Jarrod B. Williams

Theses and Dissertations--Pharmacy

While type 2 diabetes mellitus (T2DM) is distinguished as a disorder of blood glucose homeostasis, the vast majority of patients afflicted with this disease in the US present with the entire complement of the metabolic syndrome: abdominal obesity, hypertriglyceridemia, low HDL levels, elevated blood pressure, and elevated fasting plasma glucose. Current guidelines aim to treat each of these disorders, but do so individually even though they are manifestations of common pathologies. In other words, a patient will be prescribed different medications for diabetes, blood pressure, CVD prevention, etc., while the only single treatment aimed at the myriad of disorders together …

Effects Of Core And Shell Modification To Tethered Nanoassemblies On Sirna Therapy, Steven Rheiner

Theses and Dissertations--Pharmacy

siRNA therapy is an emerging technique that reduces protein expression in cells by degrading their mRNAs via the RNA interference pathway (RNAi). Diseases such as cancer often proliferate due to increased protein expression and siRNA therapy offers a new method of treatment for those diseases. Although siRNA therapy has shown success in vitro, it often fails in vivo due to instability in the blood stream. To overcome this limitation, delivery vehicles are necessary for successful transfection of siRNA into target cells and cationic polymers have been widely studied for this purpose. However, complexes between siRNA and delivery vehicles made …

Development Of Diverse Size And Shape Rna Nanoparticles And Investigation Of Their Physicochemical Properties For Optimized Drug Delivery, Daniel L. Jasinski

Theses and Dissertations--Pharmacy

RNA nanotechnology is an emerging field that holds great promise for advancing drug delivery and materials science. Recently, RNA nanoparticles have seen increased use as an in vivo delivery system. RNA was once thought to have little potential for in vivo use due to biological and thermodynamic stability issues. However, these issues have been solved by: (1) Finding of a thermodynamically stable three-way junction (3WJ) motif; (2) Chemical modifications to RNA confer enzymatic stability in vivo; and (3) the finding that RNA nanoparticles exhibit low immunogenicity in vivo.

In vivo biodistribution and pharmacokinetics are affected by the physicochemical …

Halo- And Solvato-Fluorochromic Polymer Nanoassemblies For Cancer Theranostics, Derek Alexander Reichel

Theses and Dissertations--Pharmacy

Theranostics is an emerging treatment approach that combines diagnostics with therapy in order to personalize treatment regimens for individual patients and decrease cancer mortality. Previously, nanoparticles entrapping conventional fluorescent dyes were developed for cancer theranostics, but fluorescent nanoparticles did not allow clinicians to significantly improve cancer treatments.

The use of fluorescent dyes that are sensitive to solvent acidity (halo-fluorochromism) and polarity (solvato-fluorochromism) may overcome the limitations of fluorescent nanoparticles and improve cancer therapy by enabling researchers to detect chemical properties within the nanoparticle core environment. The model halo- and solvato-fluorochromic dye Nile blue was attached to the core of nanoscale …

Pneumococcal Conjugate Vaccine 13 Coverage In Children, High-Risk Adults 19-64 Years Of Age, And Adults Over 65 Years Of Age In A Commercially Insured U.S. Population, Joseph C. Vanghelof

Theses and Dissertations--Pharmacy

This thesis aimed to elucidate the demographic characteristics associated with elevated or reduced rates of pneumococcal conjugate 13 (PCV13) vaccination.

A retrospective cohort study was performed using the Truven Health MarketScan® Database. Three cohorts were created corresponding to populations for which the CDC recommends PCV13 vaccination. Cohort 1: children < 36 months of age. Cohort 2: adults 19-64 years of age with high infection risk. Cohort 3: adults > 65 years of age. Odds of having a PCV13 claim were calculated for each cohort.

For Cohort 1, 78% out of a total of 353,214 subjects had a sufficient number of PCV13 doses to meet CDC recommendations. For Cohort 2, 3.7% out of a total of 673,157 subjects had a PCV13 …

Rational Design, Synthesis, And Characterization Of Novel Mpges-1 Inhibitors As Next Generation Of Anti-Inflammatory Drugs, Ziyuan Zhou

Theses and Dissertations--Pharmacy

Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) are currently widely used as fever and pain relief in patients with arthritis and other inflammatory symptoms. NSAIDs effect by inhibiting cyclooxygenase-1 (COX-1) and/or cyclooxygenase-2 (COX-2). COX isozymes (COXs) are key enzymes in the biosynthesis of prostaglandin H₂ (PGH₂) from arachidonic acid (AA). It is now clear that prostaglandin E₂ (PGE₂), one of the downstream products of PGH₂, is the main mediator in both chronic and acute inflammation. Microsomal prostaglandin E synthase (mPGES-1) is the terminal enzyme of COX-2 in the PGE₂ biosynthesis pathway. …

Effects Of In Utero Nicotine Exposure On Immune Cell Disposition After P. Aeruginosa Lung Infection, Nayon Kang

Theses and Dissertations--Pharmacy

Current smoking cessation guidelines recommend nicotine replacement therapy (NRT) to assist pregnant smokers to quit, but this is without strong evidence for effectiveness and safety. Nicotine, the main addictive component of tobacco, is known to exert physiological effects by binding to its receptor, the nicotinic acetylcholine receptor (nAChR). Recent studies have identified the presence of nAChRs in non-neuronal cells, and in macrophages, functional alteration upon stimulation with nicotine has been documented.

To understand the impact of in utero nicotine exposure on various immune cell disposition and function, we designed preliminary studies using an in vivo model of P. aeruginosa infection. …

Gene Expression Profiles Reveal Alternative Targets Of Therapeutic Intervention For The Treatment Of Drug-Resistant Non-Small Cell Lung Cancers, Madeline J. Krentz Gober

Theses and Dissertations--Pharmacy

More than 80% of lung cancer patients die from drug-resistant, metastatic disease. Our focus is to identify new drug targets and alternative therapeutic strategies to improve outcomes for this majority of lung cancer patients. We aimed to satisfy the need for new treatment approaches by leveraging the information gained from the development of two multigene biomarker predictors of Epidermal Growth Factor Receptor Inhibitors (EGFRI) response in Non-Small Cell Lung Cancer (NSCLC). From these data, we first identified TGFβ signaling as a possible modulator of EGFRI resistance and I hypothesized that TGFβ signaling participates in the development and maintenance of erlotinib-resistance …

Insulin Actions On Hippocampal Neurons, Shaniya Maimaiti

Theses and Dissertations--Pharmacology and Nutritional Sciences

Aging is the main risk factor for cognitive decline. The hippocampus, a brain region critical for learning and memory formation, is especially vulnerable to normal and pathological age-related cognitive decline. Dysregulation of both insulin and intracellular Ca2+ signaling appear to coexist and their compromised actions may synergistically contribute to neuronal dysfunction with aging. This dissertation focused on the interaction between insulin, Ca2+ dysregulation, and cognition in hippocampal neurons by examining the contributions of insulin to Ca2+ signaling events that influence memory formation. I tested the hypothesis that insulin would increase cognition in aged animals by altering Ca2+-dependent physiological mechanisms involved …