Medicine and Health Sciences Commons^™

Implementing A Public Health Perspective In Fda Drug Regulation, Patricia J. Zettler, Margaret Foster Riley, Aaron S. Kesselheim

Faculty Publications By Year

There is, without question, a public health crisis in the United States arising from both illicit and prescription opioid misuse, addiction, and overdose. The Food and Drug Administration (FDA) is one regulator with an important role to play in minimizing the harms associated with prescription opioids, while also ensuring that prescription opioids are available for the evidence-based management of pain. One question, however, is to what extent the agency can consider in its decisions to approve opioids and keep existing ones on the market the provider and patient behaviors contributing to the epidemic. This is, in part, because FDA’s approval …

Laptop Versus Longhand Note Taking In A Professional Doctorate Course: Student Performance, Attitudes, And Behaviors, Shane P. Desselle, Patricia A. Shane

Faculty Publications & Research of the TUC College of Pharmacy

Objective: To determine the relationship between longhand note taking versus laptop note taking on pharmacy students’ examination performance and identify differences in attitudes and behaviors as it relates to the note taking process.

Methods: A small group of students consented voluntarily to take longhand notes, doing away with their laptops during portions of the course administered by study investigators. Analyses were conducted on block examination performance, with each student’s score on the first examination serving as a performance benchmark to assess change. Laptop and longhand note takers completed a survey regarding various aspects of their note taking attitudes …

Propafenone (Rythmol), Maria Figueiredo

Natural Sciences Student Research Presentations

For this poster presented at the Natural Science Poster Session at Parkland College, the student chose the drug Propafenone, also known as Rythmol, whose labeled uses are to treat ventricular arrhythmias, atrial fibrillation, and paroxysmal supraventricular tachicardia. Chemical information, identification, and effects on the body are also included on the poster.

Communicating Nutrition Information At The Point Of Purchase: An Eye‐Tracking Study Of Shoppers At Two Grocery Stores In The United States, Mike Bartels, Katherin Tillack, Chung‐Tung Jordan Lin

United States Food and Drug Administration: Publications

Providing nutrition information at the point of purchase is one approach that can be used to help consumers adopt and maintain a healthy diet. Previous research has examined consumer self‐reported notice and use of the information as well as how the design of the information affects its attention and use in a laboratory environ‐ ment using eye‐tracking methodology. This study advances the literature by applying eye‐tracking methodology to explore consumer visual and choice behavior in a real shopping environment, and by recognizing that nutrition information competes with other visual stimuli in the store and consumers are vulnerable to a “limited …

Synthetic Investigation Of Natural Products Causing Dopaminergic Neurodegeneration, Michael John Cunningham

Electronic Theses and Dissertations

The terrestrial organisms Streptomyces venezuelae and Rhaponticum repens produce toxic secondary metabolites that likely function as chemical deterrents. The polyketide SV-6 from S. venezuelae and the sesquiterpene lactone repin from R. repens both produce dose-dependent and selective degeneration of dopaminergic neurons. These molecules represent two possible tools that can be used to explore chemotoxic induction of Parkinson’s disease. In the case of SV-6, a newly isolated metabolite, total synthesis was undertaken to confirm its structure and biological activity. The natural product was produced from methacrolein and Roche ester starting materials that were elaborated to their respective fragments, a vinyl iodide …

The Role Of Brand Name Fluency: A Pharmaceutical Marketing Perspective, David Wamble

Electronic Theses and Dissertations

Background: consumers are exposed to thousands of advertisements, most all of which are designed to promote a particular brand and accompanying brand name. The selection of a brand name is a critical strategic decision and is an important means to building brand equity. The importance of branding elements, specifically brand names, has led pharmaceutical manufacturers to become more creative and open the possibilities of language in brand name development. Given the complexities associated with brand name development in the U.S. pharmaceutical industry and the trends observed in recent pharmaceutical brand names, advancing the understanding of how brand name selection can …

Functionality And Role Of Different Fatty Alcohols In Topical O/W Cream Formulation, Supriya Bhide

Electronic Theses and Dissertations

Fatty alcohols are excipients that are abundantly used in various pharmaceutical formulations. The objective of the present study was to evaluate the impact of incorporating different fatty alcohols on microstructural and formulation characteristics of topical o/w clotrimazole cream formulation. The formulations containing different fatty alcohols as Kolliwax® CSA 50 (CSA 50), Kolliwax® CSA 70 (CSA 70), Kolliwax® MA (MA), Kolliwax® CA (CA), Kolliwax® SA (SA) were prepared by selecting suitable RPM and homogenization time. The M.P. of API and fatty alcohols were determined using DSC technique. The prepared cream formulations were evaluated for their phase separation. The various tests like …

Polymer Based Delivery Of Doxycycline Hyclate For The Prevention Of Peri-Implant Mucositis Infection, Sagar Deepak Sawant

Electronic Theses and Dissertations

Peri-implant mucositis is a silent inflammatory condition that is destructive in nature affecting only the soft tissues in the vicinity of dental implants. The current line of treatment includes the use of systemic antibiotics, mechanical debridement using LASER decontamination, the use of mouthwash or oral rinsing with chlorhexidine, maintenance and improvement of oral hygiene, mechanical debridement with or without systemic antibiotic treatment, mechanical debridement with or without the use of local drug delivery systems. However, these treatments do not solve the problem of implant rejection as peri-mucositis progresses to per-implantitis which causes severe bone loss and ultimately leading to implant …

Novel Applications Of Hot-Melt Extrusion Technology, Ajinkya Moreshwar Bhagurkar

Electronic Theses and Dissertations

Hot-melt extrusion, an adaptable technology, has established its position in a wide spectrum of manufacturing operations like amorphous solid dispersions, immediate and controlled oral formulations, implants, and taste masked products. In recent years the industrial focus has shifted towards continuous manufacturing, thus melt extrusion is being explored for new applications. The aim of this research work was to investigate the novel applications of hot-melt extrusion by carrying out an in depth study to understand the interplay between the process and the product. The conventional techniques used for the preparation of ointments and nanostructured lipid carriers are multi-step and time consuming …

The Morality Of Compulsory Licensing As An Access To Medicines Tool, Margo A. Bagley

Faculty Articles

This Article contemplates the validity of theft rhetoric in relation to the right of countries to grant compulsory licenses from an unconventional perspective; that of biblical teachings on what it means to steal.

Part I describes the use of theft rhetoric in relation to IP infringement broadly and drug-patent compulsory licenses in particular.

Part II challenges the contention, suggested by theft rhetoric, that compulsory licenses are morally wrong as a form of stealing, by considering the meaning of theft in the context of its Judeo-Christian origins.

Part III considers the cogency of the accusation that the issuance of compulsory licenses …

Longitudinal Patterns Of Potentially Inappropriate Medication Use Following Incident Dementia Diagnosis, Christine M. Ramsey, Danijela Gnjidic, George O. Agogo, Heather Allore, Daniela Moga

Pharmacy Practice and Science Faculty Publications

Introduction: Potentially inappropriate medication (PIM) use in older adults with dementia is an understudied area. We assessed longitudinal changes in PIM exposure by dementia type following dementia diagnosis.

Methods: We followed 2448 participants aged ≥ 65 years (52% women, 85.5% Caucasian, mean age 80.9 ± 7.5 years) diagnosed with dementia after enrollment in the National Alzheimer's Coordinating Center (2005-2014). We estimated the association between dementia type and PIM annually for 2 years after diagnosis, using Generalized Estimating Equations.

Results:Participants with Lewy body dementia had more PIM use, and participants with frontotemporal dementia had less PIM use than participants with …

Development And Characterization Of Fluocinolone Acetonide Loaded Nanosized Lipid Carriers For Ocular Delivery Via Subconjunctival Route: Synergistic Effect Of Vitamin A Palmitate, Bhavik Soneta

Electronic Theses and Dissertations

Though nanotechnology which exploits the use of nanoparticles for therapeutic application have embarked as an emerging tool for drug delivery applications, the delivery of therapeutic molecules into deep ocular compartments has always been a challenging task. In this regard, the main objective of our current investigation was to develop and evaluate the fluocinolone acetonide (FA) loaded nanostructure lipid carrier (FA-NLC) in situ gel for improved ocular bioavailability by subconjunctival injection. FA, a corticosteroid administered for inhibiting the ocular inflammation either as intravitreal injection or as intravitreal implants. The FA-NLCs were developed by using vitamin A palmitate as one of the …

Feasibility Of Aquasolvetm Hpmc-As Lg Via Hot-Melt Extrusion: Effect Of Pressurized Co2 On Physico-Mechanical Properties, Mashan Almutairi

Electronic Theses and Dissertations

The objective of the current study was to investigate the processability of Aquasolve™ HPMC-AS LG via hot-melt extrusion, and to examine the effect of pressurized carbon dioxide (P-CO2) on the physico-mechanical properties of Efavirenz (EFA)-loaded extrudates (EXT). EFA is as a poorly water-soluble drug and HPMC-AS LG was chosen as a carrier for this study. To optimize the process parameters and formulations, various physical mixtures were prepared with the following composition: EFA (30-40-50% w/w) and HPMC-AS LG (70-60-50 % w/w) respectively. Physical mixtures were extruded through the co-rotating twin-screw extruder (16mm Prism Euro Lab, Thermo Fisher Scientific) utilizing a standard …

Synthesis And Characterization Of Redox-Sensitive Polymer And Prodrug For Targeted Drug Delivery, Chang-Hee Whang

Electronic Theses and Dissertations

Systemic administration of chemotherapeutics is associated with various side effects deriving from accumulation in off-target sites and acute toxicity of the drugs. In the past decade, engineering targeted drug delivery platforms arose as a novel paradigm to overcome such obstacles and ultimately achieve advanced forms of chemotherapy. This thesis reports successful syntheses of l-RSP, a redox-sensitive self-immolative polymer, and DNS-SN38, thiol-sensitive SN-38 prodrug, as potential candidates for targeted drug delivery platforms. By covalently conjugating a redox-trigger (p-nitrobenzyl alcohol) and self-immolative linker (p-hydroxybenzyl alcohol) to the cyclization spacer (n-2-(hydroxyethyl)ethylene diamine), a novel self-immolative monomer was obtained. Polymerization of the respective monomer …

Crystalline Salt Formation Of An Acidic Drug Indomethacin Using Hot Melt Extrusion Technology, Mustafa Bookwala

Electronic Theses and Dissertations

Although salt formation is the most ubiquitous and effective method of increasing the solubility and dissolution rates of acidic and basic drugs, it consumes large quantities of organic solvents and is a batch process. Herein, we show that the dissolution rate of indomethacin (a poorly water-soluble drug) can be increased by using hot melt extrusion of a 1:1 (mol/mol) indomethacin:tromethamine mixture to form a highly crystalline salt, the physicochemical properties of which are investigated in detail. Specifically, pH–solubility studies demonstrated that this salt exhibited a maximal solubility of 19.34 mg/mL (>1000 times that of pure indomethacin) at pH 8.19. …

A Novel Acetaminophen Soft-Chew Formulation Produced Via Hot Melt Extrusion With Inline Near-Infrared Monitoring As A Process Analytical Technology Tool, Pengchong Xu

Electronic Theses and Dissertations

People suffer dysphagia when swallowing hard tablets and capsules. Gelatin based soft chewable tablets was used as an alternative and novel drug delivery format to overcome dysphagia. But conventional method of producing gelatin based soft chewable tablets has many potential issues. The objective of this study is using glycerol and hot-melt extrusion technique to address potential issues and optimizing the formulation. Gelatin (15%), acetaminophen (30%), saccharin (1.5%), xylitol (6.5%), sodium chloride (2%) and six different ratios of water (45-0%) and glycerol (0-45%) were used in seven formulations. The extrusion process temperature of formulation 1-6 and formulation 7 were 90 ëšc …

The Prevention And Control Of Cancer By Metformin In Patients With Type 2 Diabetes: A Systematic Mapping Review Protocol, Michelle Price, Gabriela Cipriano, Albania Mitchell

Lavery Library Faculty/Staff Publications

No abstract provided.

Association Between Dispensing Channel And Chronic Obstructive Pulmonary Disorder Exacerbations Among Medicare Beneficiaries, April S. Prather

Theses and Dissertations--Pharmacy

Elderly patients with chronic obstructive pulmonary disease may be at increased risk of exacerbation due to physical and cognitive deficits that make proper inhaled medication adherence more difficult despite consistent medication access. This retrospective study utilized administrative medical and pharmacy claims data to examine the likelihood of having a COPD exacerbation requiring acute medical care by means of an emergency room visit or hospitalization in elderly patients receiving maintenance COPD medications from mail order and retail pharmacies. It was hypothesized that mail order patients would be more likely to experience exacerbations despite differences in medication access when compared to retail …

Exploring The Effect Of Chronic Inflammation On Response To Immune Checkpoint Inhibitors In Cancer, Sherif M. El-Refai

Theses and Dissertations--Pharmacy

Precision medicine has allowed for the development of monoclonal antibodies that unmask the anti-tumor immune response. These agents have provided some patients durable clinical benefit. However, PD-1 and PD-L1 inhibitor therapies are effective in a small group (10-20%) of non-small cell lung cancer (NSCLC) patients when used as single-agent therapy. The approved companion diagnostic is expression of the immune cell surface molecule, programmed death ligand 1 (PD-L1), on tumors measured by immunohistochemistry (IHC). Studies in tumor biology and immune surveillance dictate that PD-1 inhibitor efficacy should depend on the level of PD-L1 expression; however, the literature has not followed with …

Dual Lox/Cox Inhibition: A Novel Strategy To Prevent Neurovascular Leakage In Epilepsy, Brent S. Sokola

Theses and Dissertations--Pharmacy

Epilepsy affects 3.4 million patients in the USA and is characterized by recurring seizures. The blood-brain barrier is leaky in epilepsy and may contribute to seizure progression but the mechanisms which cause this leakage are not fully understood. We hypothesized that seizures trigger LOX- and COX-mediated blood-brain barrier leakage and that dual LOX/COX inhibition prevents barrier leakage in vivo. To test this hypothesis, we administered either the dual LOX/COX inhibitor licofelone or a combination of the 5-LOX inhibitor zileuton and the COX-2 inhibitor celecoxib to rats that experienced status epilepticus (SE). Serum and brain capillaries were isolated 48 hours …

Investigating The Role Of Prescription Drug Monitoring Programs In Reducing Rates Of Opioid-Related Poisonings, Nathan James Pauly

Theses and Dissertations--Pharmacy

The United States is in the midst of an opioid epidemic. In addition to other system level interventions, almost all states have responded to the crisis by implementing prescription drug monitoring programs (PDMPs). PDMPs are state-level interventions that track the dispensing of Controlled Substances. Data generated at the time of medication dispensing is uploaded to a central data server that may be used to assist in identifying drug diversion, medication misuse, or potentially aberrant prescribing practices.

Prior studies assessing the impact of PDMPs on trends in opioid-related morbidity have often failed to take into account the wide heterogeneity of program …

Understanding The Thermodynamics And Oral Absorption Potential Of Pharmaceutical Amorphous Solid Dispersions, Nico Setiawan

Theses and Dissertations--Pharmacy

Supersaturating drug delivery systems, such as amorphous solid dispersions (ASDs), have been used extensively to elevate the apparent solubility and oral bioavailability of poorly water-soluble drugs. However, despite the numerous examples of success in increasing solubility and oral bioavailability using ASDs, physical stability challenges remain as formulators seek to employ high drug loading for cost reduction and improved patient compliance. Therefore, stability in both the solid and solution state must be considered for ASDs to be successful. In the solid state, the drug must remain amorphous in the solid matrix throughout the shelf life of the product. Although excipients, such …

Using Machine Learning To Predict Acute Kidney Injuries Among Patients Treated With Empiric Antibiotics, Wilbur Cliff Rutter Iv

Theses and Dissertations--Pharmacy

Acute kidney injury (AKI) is a significant adverse effect of many medications that leads to increased morbidity, cost, and mortality among hospitalized patients. Recent literature supports a strong link between empiric combination antimicrobial therapy and increased AKI risk. As briefly summarized below, the following chapters describe my research conducted in this area.

Chapter 1 presents and summarizes the published literature connecting combination antimicrobial therapy with increased AKI incidence. This chapter sets the specific aims I aim to achieve during my dissertation project.

Chapter 2 describes a study in which patients receiving vancomycin (VAN) in combination with piperacillin-tazobactam (TZP) or cefepime …

The Impact Of Bioactive Phytosterol, Stigmasterol, On Cholesterol Elimination Pathways In Mice, Hannah C. Lifsey

Theses and Dissertations--Pharmacy

Despite advances in healthcare, cardiovascular disease (CVD) remains the leading cause of death in the United States. Elevated levels of plasma cholesterol are highly predictive of CVD and stroke and are the principal driver of atherosclerosis. Unfortunately, current cholesterol lowering agents, such as statins, are not known to reverse atherosclerotic disease once it has been established. In preclinical models, agonists of nuclear receptor, LXR, have been shown to reduce and reverse atherosclerosis. Phytosterols are bioactive non-cholesterol sterols that act as LXR agonists and regulate cholesterol metabolism and transport. We hypothesize that stigmasterol would act as an LXR agonist and alter …

The Development Of Novel Non-Peptide Proteasome Inhibitors For The Treatment Of Solid Tumors, Zachary C. Miller

Theses and Dissertations--Pharmacy

The proteasome is a large protein complex which is responsible for the majority of protein degradation in eukaryotes. Following FDA approval of the first proteasome inhibitor bortezomib for the treatment of multiple myeloma (MM) in 2003, there has been an increasing awareness of the significant therapeutic potential of proteasome inhibitors in the treatment of cancer. As of 2017, three proteasome inhibitors are approved for the treatment of MM but in clinical trials with patients bearing solid tumors these existing proteasome inhibitors have demonstrated poor results. Notably, all three FDA-approved proteasome inhibitors rely on the combination a peptide backbone and reactive …

Discovery Of Novel Muraymycin Antibiotics And Insight Into The Biosynthetic Pathway, Zheng Cui

Theses and Dissertations--Pharmacy

New antibiotics with novel targets or mechanisms of action are needed to counter the steady emergence of bacterial pathogens that are resistant to antibiotics used in the clinic. MraY, a promising novel target for antibiotic development, initiates the lipid cycle for the biosynthesis of peptidoglycan cell wall, which is essential for the survival of most, if-not-all, bacteria. MraY is an enzyme that catalyzes the transfer and attachment of phospho-MurNAc-pentapeptide to a lipid carrier, undecaprenylphosphate. Muraymycins are recently discovered lipopeptidyl nucleoside antibiotics that exhibit remarkable antibiotic activity against Gram-positive as well as Gram-negative bacteria by inhibiting MraY. We conducted a thorough …

Discovery Of New Antimicrobial Options And Evaluation Of Aminoglycoside Resistance Enzyme-Associated Resistance Epidemic, Selina Y. L. Holbrook

Theses and Dissertations--Pharmacy

The extensive and sometimes incorrect and noncompliant use of various types of antimicrobial agents has accelerated the development of antimicrobial resistance (AMR). In fact, AMR has become one of the greatest global threat to human health in this era. The broad-spectrum antibiotics aminoglycosides (AGs) display excellent potency against most Gram-negative bacteria, mycobacteria, and some Gram-positive bacteria, such as Staphylococcus aureus. The AG antibiotics amikacin, gentamicin, kanamycin, and tobramycin are still commonly prescribed in the U.S.A. for the treatment of serious infections. Unfortunately, bacteria evolve to acquire resistance to AGs via four different mechanisms: i) changing in membrane permeability to …

Development And Preclinical Evaluation Of Long-Lasting Cocaine Hydrolases For Cocaine Overdose And Cocaine Use Disorder Treatment, Ting Zhang

Theses and Dissertations--Pharmacy

Cocaine is a plant-based illicit drug commonly involved in substance use disorder. Although cocaine overdose and cocaine use disorders cause adverse health consequences to individuals and the economic burden on their family and society, there are no FDA (Food and Drug Administration) approved medications for treatment. Recently, it has been recognized that delivery of cocaine hydrolase (CocH) is a promising therapeutic strategy. Human butyrylcholinesterase (hBChE), the primary enzyme involved in cocaine metabolism in human, have advantages over other candidates for the development of CocH. Previous studies in our laboratory have designed and characterized hBChE mutants that have ~4,000-fold improved catalytic …

Using The Qbest Equation To Evaluate Ellagic Acid Safety Data: Generating A Qnoael With Confidence Levels From Disparate Literature, Cynthia Rose Dickerson

Theses and Dissertations--Pharmacy

QBEST, a novel statistical method, can be applied to the problem of estimating the No Observed Adverse Effect Level (NOAEL or QNOAEL) of a New Molecular Entity (NME) in order to anticipate a safe starting dose for beginning clinical trials. The NOAEL from QBEST (called the QNOAEL) can be calculated using multiple disparate studies in the literature and/or from the lab. The QNOAEL is similar in some ways to the Benchmark Dose Method (BMD) used widely in toxicological research, but is superior to the BMD in some ways. The QNOAEL simulation generates an intuitive curve that is comparable to the …

Synthesis And Biological Evaluation Of Novel Drug Candidates To Address Drug Resistance In Tuberculosis And Fungal Diseases, Huy Ngo

Theses and Dissertations--Pharmacy

Tuberculosis (TB) and fungal infections are two of the most lethal infectious diseases worldwide due to the emergence of drug-resistant Mycobacterium tuberculosis (Mtb) and fungal strains that can resist the most potent antimicrobial drugs currently employed. Due to the rise of these drug resistant strains, effective treatment options for these two infections are limited. This dissertation aims at exploring novel drug scaffolds to help combat drug resistance in TB and fungal infections.

TB caused by the pathogenic Mtb is, alongside with human immunodeficiency virus acquired immunodeficiency virus (HIV), the deadliest infectious disease worldwide with approximately 2-3 billion people …