Pharmacy and Pharmaceutical Sciences Commons^™

U.S. Adult Perceptions Of The Harmfulness Of Tobacco Products: Descriptive T Findings From The 2013–14 Baseline Wave 1 Of The Path Study, Geoffrey T. Fong, Tara Elton-Marshall, Pete Driezen, Annette R. Kaufman, K. Michael Cummings, Kelvin Choi, Jonathan Kwan, Amber Koblitz, Andrew Hyland, Maansi Bansal-Travers, Charles Carusi, Mary E. Thompson

Food and Drug Administration Papers

Introduction: This study is the first nationally representative survey of U.S. adults (18+) to examine perceptions of the relative harms of eight non-cigarette tobacco products.

Methods: Data are from Wave 1 of the Population Assessment of Tobacco and Health (PATH) Study Adult Questionnaire, a nationally representative study of 32,320 adults in the United States conducted from September 2013 to December 2014.

Results: 40.7% of adults believed that electronic cigarettes were less harmful than cigarettes, and 17.8% of adults believed that hookah was less harmful than cigarettes. Those less knowledgeable about the health risks of smoking were more likely to believe …

Associations Of Risk Factors Of E-Cigarette And Cigarette Use And Susceptibility To Use Among Baseline Path Study Youth Participants (2013–2014), Michael D. Sawdey, Hannah R. Day, Blair Coleman, Lisa D. Gardner, Sarah E. Johnson, Jean Limpert, Hoda T. Hammad, Macieji L. Goniewicz, David B. Abrams, Cassandra A. Stanton, Jennifer L. Pearson, Annette R. Kaufman, Heather L. Kimmel, Cristine D. Delnevo, Wilson M. Compton, Maansi Bansal-Travers, Raymond S. Niaura, Andrew Hyland, Bridget K. Ambrose

Food and Drug Administration Papers

Introduction: Improved understanding of the distribution of traditional risk factors of cigarette smoking among youth who have ever used or are susceptible to e-cigarettes and cigarettes will inform future longitudinal studies examining transitions in use.

Methods: Multiple logistic regression analysis was conducted using data from youth (ages 12–17 years) who had ever heard of e-cigarettes at baseline of the PATH Study (n = 12,460) to compare the distribution of risk factors for cigarette smoking among seven mutually exclusive groups based on ever cigarette/e-cigarette use and sus- ceptibility status.

Results: Compared to committed never users, youth susceptible to e-cigarettes, cigarettes, or …

Selection And Consumption Of Lunches By National School Lunch Program T Participants, Janet G. Peckham, Jaclyn D. Kropp, Thomas A. Mroz, Vivian Haley-Zitlin, Ellen M. Granberg

Food and Drug Administration Papers

The Healthy, Hunger-Free Kids Act of 2010 requires schools participating in the National School Lunch Program (NSLP) to offer a variety of healthy food options each day. Using digital photography data collected from two suburban elementary schools in the spring of 2013, we examine NSLP participant's selection and consumption of all five NSLP lunch components ((1) milk, (2) vegetable, (3) fruit, (4) meat/meat alternate (MA), and (5) grain). We use logit regressions to analyze the selection of the various lunch components by race/ethnicity, gender, grade, and household income level. In addition, ordinary least squares regressions are used to analyze the …

Responsible, Safe, And Effective Use Of Biologics In The Management Of Low Back Pain: American Society Of Interventional Pain Physicians (Asipp) Guidelines, Annu Navani, Laxmaiah Manchikanti, Sheri L. Albers, Richard E. Latchaw, Jaya Sanapati, Alan David Kaye, Sairam Atluri, Sheldon Jordan, Ashim Gupta, David Cedeno, Alejandro Vallejo, Bert Fellows, Nebojsa Nick Knezevic, Miguel Pappolla, Sudhir Diwan, Andrea M. Trescot, Amol Soin, Adam M. Kaye, Steve M. Aydin, Aaron K. Calodney, Kenneth D. Candido, Sanjay Bakshi, Ramsin M. Benyamin, Ricardo Vallejo, Art Watanabe, Douglas Beall, Todd P. Stitik, Patrick M. Foye, Erik M. Helander, Joshua A. Hirsch

School of Pharmacy Faculty Articles

BACKGROUND: Regenerative medicine is a medical subspecialty that seeks to recruit and enhance the body's own inherent healing armamentarium in the treatment of patient pathology. This therapy's intention is to assist in the repair, and to potentially replace or restore damaged tissue through the use of autologous or allogenic biologics. This field is rising like a Phoenix from the ashes of underperforming conventional therapy midst the hopes and high expectations of patients and medical personnel alike. But, because this is a relatively new area of medicine that has yet to substantiate its outcomes, care must be taken in its public …

Novel Application Of Melt Extrusion And Additive Manufacturing On Developing Diverse Dosages, Jiaxiang Zhang

Electronic Theses and Dissertations

New drug product development is a time consuming and costly process. One of the significant challenges is the poor aqueous solubility of many active pharmaceutical ingredients (APIs). Among those techniques, hot-melt extrusion(HME) is optimal for pharmaceutical solid dispersion development because of it free of using an organic solvent, easy scale up, and suitable for continuous processing with ensured optimal quality control.

Investigation Of Theophylline Nicotinamide Pharmaceutical Co-Crystals Utilizing Hot Melt Extrusion, Priyanka Srinivasan

Electronic Theses and Dissertations

The objective of the current study was to investigate the feasibility of Theophylline and Nicotinamide pharmaceutical co-crystals by hot melt extrusion technology and to evaluate the processability by using HPMCAS-MG and PEO as polymer carriers. Theophylline, a BCS class I was chosen as a model drug and Nicotinamide, a vitamin B family was selected as a suitable co-former for the co-crystals study. HPMCAS-MG, a synthetic polymer and PEO, water-soluble polymer were chosen as polymer carriers for the study. To optimize the process parameters and formulations, a physical mixture of 1:1 molar ratio of theophylline and nicotinamide were prepared. Physical mixture …

Rethinking Consumer Protection: Escaping Death By Regulation, Thomas L. Tacker

Publications

This book is designed to appeal to anyone who is at all interested in topics related to making life better and safer—for all us consumers. Our current approach to consumer protection is extremely flawed; sometimes costing lives rather than saving them. There are better ways to protect ourselves and the people we love.

Semisynthetic Aurones: A Family Of Newly Discovered Tubulin Inhibitors As Antineoplastic Agents, Yanqi Xie

Theses and Dissertations--Molecular and Cellular Biochemistry

Aurones belong to an uncommon class of plant flavonoids that provide the bright yellow coloration of some ornamental flowers and that possess a range of biological activities. Structure-activity relationships (SAR) in the aurone pharmacophore identified heterocyclic variants of the (Z)-2-benzylidene-6-hydroxybenzofuran-3(2H)-one scaffold that possessed low nanomolar in vitro potency in cell proliferation assays using various cancer cell lines, in vivo potency in prostate cancer PC-3 xenograft and zebrafish models, selectivity for the colchicine-binding site on tubulin, and absence of appreciable toxicity. Among the biologically active analogs developed in the course of this dissertation work were (Z …

Xflow: An Algorithm For Extracting Ion Chromatograms, Mathew M. Gutierrez, Rob Smith

Graduate Student Theses, Dissertations, & Professional Papers

Abstract: Mass spectrometry is a fundamental tool for modern proteomics. The increasing availability of mass spectrometry data paired with the increasing sensitivity and fidelity of the instruments necessitates new and more potent analytical methods. To that end, we have created and present XFlow, a feature detection algorithm for extracting ion chromatograms from MS1 LC-MS data. XFlow is a parameter-free procedurally agnostic feature detection algorithm that utilizes the latent properties of ion chromatograms to resolve them from the surrounding noise present in MS1 data. XFlow is designed to function on either profile or centroided data across different resolutions and instruments. This …

Development And Characterization Of Sustained-Release Formulations Via Novel Hot Melt Extrusion Techniques, Bjad Khalaf Almutairy

Electronic Theses and Dissertations

Hot melt extrusion (HME) is a leading technology that can be applied to many pharmaceutical preparations as solid dispersions. Part of this research project focus on injecting pressurized carbon dioxide (P-CO2) gas during the HME process. These combined techniques have an additional advantage of being adaptable and portable to a hot melt extruder instrument. The use of HME alongside with other techniques (P-CO2 or co extrusion process) for preparing an improved controlled/sustained release formulation is the main theme of this research project. Current research focusing on Active Pharmaceutical Ingredients (APIs) with good aqueous solubility requires novel approach to obtain tailored …

Effect Of Solvent Interaction & Soluble Microneedles On Skin Permeability To Drug Molecules, Abhijeet Maurya

Electronic Theses and Dissertations

Skin forms a formidable barrier protecting the human body from external environmental rigors and excessive loss of water; maintaining equilibrium. The barrier properties of the skin can be attributed to its unique macromolecular organization and morphology. As a route for drug administration, skin presents a large surface area and can be used for both systemic and localized targeted drug delivery applications offering several advantages over conventional drug therapy; avoidance of first pass metabolism, patient compliance, sustained or controlled delivery for an extended period, to name a few. However, the organized structure of the skin, since intended to prevent entry of …

Synthesis Of A Novel Surface Active, Light Sensitive Polymer For Encapsulation And Delivery Of Paclitaxel, Amit Raviraj Pillai

Electronic Theses and Dissertations

Melanoma and non-melanoma (basal cell and squamous cell carcinoma) skin cancer (NMSC) have been recognized as an epidemic as they happen to be the most comtype of cancers in the white population. Cancer cell targeting i.e. differentiating cancer cells from normal cells has been an area of active research to reduce the side effects of cancer chemotherapy. For this research project, we have developed a novel light sensitive Methylene Blue (MB)-Polyethylene glycol (PEG) conjugate with significant surfactant properties. The aim of this study was to synthesize a smart light sensitive polymer which activates and releases the encapsulated drug on exposure …

In-Situ Gel Of Cyclosporine A – Loaded Solid Lipid Nanoparticles For Topical Occular Delivery For Dry Eye Disease, Samir Shyambabu Senapati

Electronic Theses and Dissertations

Cyclosporine (CSA) is a highly potent immunosuppressant drug and has been used to treat rheumatoid arthritis, psoriasis, organ rejection post-transplant, and chronic dry eye disease. The objective of this investigation was to increase the CSA residence time on the ocular surface using solid lipid nanoparticles (SLNs) and its in-situ gel formulation (CSA-SLN-IG), for treatment of dry eye disease. CSA loaded SLNs (CSA-SLN) were prepared with the homogenization method, using Precirol ® ATO 5 as a solid lipid and Tween® 80 and Poloxamer 188 as surfactants. Prepared SLNs were optimized based on particle size, zeta potential (ZP), PDI, assay and stability. …

Formulation Development, Preclinical Testing, And Primary Packaging Optimization For Cannabinoids And Other Therapeutics, Pranjal Taskar

Electronic Theses and Dissertations

Through the process of drug development, a molecule goes through discovery screening; lead selection and optimization, ADME testing, toxicity profiling, dosage form determination, preclinical testing in an in vitro and in vivo setup, folloby clinical research, FDA review and approval until eventually it is manufactured in the determined dosage form and reaches the patient. At every point through this process, scientists actively work towards a smoother transition and a quick and safe approval of the molecule towards the next step. The different chapters in this research would cover various phases of drug development; from discovery stage to fill-finish and primary …

Protective Actions Of Oxytocin On Aortic Wistar And Shr Vsmcs, Varun Kumar Soti

Student Theses, Dissertations and Capstones

Background. Oxytocin, known as a female reproductive hormone, has emerged as a cardiovascular hormone showing cardioprotective effects, for instance, negative chronotropic and inotropic effects and ANP release in cardiomyocytes and endothelium. However, oxytocin’s effect in VSMCs remains to be explored. Objectives. This study had three goals: characterizing oxytocin’s effect on proliferation, inflammation, oxidative stress, and vasocontraction pathway in Wistar VSMCs; determining oxytocin’s effect on Ang II; describing oxytocin’s effect and its interaction with Ang II in SHR VSMCs. Methods: Aortic VSMCs were isolated from Wistar rats and SHRs. Hemocytometer, MTT and 3H-Thymidine incorporation assays, and flow cytometry were employed for …

Enhancing The Sublingual Permeability Of Atropine Sulfate: Effect Of Ph And Penetration Enhancers, Rawan Saeed Bafail

Student Theses, Dissertations and Capstones

Atropine Sulfate (AS) auto-injector (AtroPen®) is being used as an effective and safe antidote for the treatment of organophosphate (OP) pesticides or nerve gas poisoning. The use of AtroPen® is associated with several drawbacks including: bulky size, availability, affordability, invasiveness, and administration errors. Previously, AS fast disintegrating sublingual tablets (FDSTs) were developed and the feasibility of AS sublingual permeability were demonstrated. However, AS permeability was delayed due to the negative impact of higher doses of AS on FDST’s physical characteristics. Therefore, the aim in this research project was to optimize the previously developed AS FDSTs. It was hypothesized that optimizing …

Effect Of Sulfobutyl Ether Β-Cyclodextrins On Oral And Dermal Pharmacokinetics Of Drugs, Vijay Kumar Shankar

Electronic Theses and Dissertations

Silymarin is an extract of Milk Thistle, major constituents are taxifolin, silychristin, silydianin, silybin A, silybin B, isosilybin A and isosilybin B. The in vitro, preclinical and clinical studies have demonstrated silymarin possesses hepatoprotective, anticancer, hypocholesterolemic, cardioprotective effect and dermatological beneficial effect (treatment of UV induced erythema, melanoma, non-melanoma skin cancer, rosacea, melasma, vitiligo and psoriasis) both individually and collectively. Solubility enhancement of silymarin constituent is utmost important to increase bioavailability and to improve drug developability property. The solubility of silymarin in water was enhanced by SBE-β-CD by conventional and heating method, heating method was found to be more efficient …

Drug Classification Scheme Review And The Economic Impact Analysis Of Abandoning Non-Prescription Drug Reimbursement In Thailand, Doungporn Leelavanich

Chulalongkorn University Theses and Dissertations (Chula ETD)

In Thailand, controversies regarding the drug classification system persist; it was believed that the number of schemes should be changed, and most drugs classified into improper schemes. The system is not also fully used to allocate healthcare budgets, while several other countries cease non-prescription (OTC) drugs reimbursement to allocate this expenditure to catastrophic diseases instead. This study thus aims to (i) review drug classification system in Thailand by comparing to other countries, (ii) evaluate the economic impact of delisting OTC drugs from drug reimbursement list using non-sedating antihistamines (AH) in patients suffering from intermittent allergic rhinitis as a case study, …

Precision Medicine Reimbursement Policy Landscape, Nisita Jirawutkornkul

Chulalongkorn University Theses and Dissertations (Chula ETD)

Background: Access to precision medicine is limited due to many factors such as precision medicine technology of each country, high-cost technology that requires high finance, limitations on knowledge and competency of personnel and access to precision medicine. Each country manages access to precision medicine differently. The existing evidences of precision medicine reimbursement policy were limited. Objective: To explore reimbursement decision of precision medicine focusing on diagnostic tests and factors associated with reimbursement decision among high-income and upper-middle-income countries. Methods: A targeted review of literatures was conducted through PubMed, MEDLINE, Embase, Cochrane Library, and hand-searching. The study included 13 selected precision …

Development Of Prediction Model For Chronic Kidney Disease In Type 2 Diabetics In Thailand, Wilailuck Tuntayothin

Chulalongkorn University Theses and Dissertations (Chula ETD)

Diabetes mellitus (DM) is a major contributing factor that leads to end stage renal disease (ESRD) with unsuitable clinical management. Chornic kidney disease (CKD) prediction model could prevent the progression of CKD to ESRD. However, current CKD prediction models in patients with type 2 DM were developed to predict ESRD. This study aimed to develop prediction model for CKD stage 3 in patients with type 2 DM in Thailand. This was a 10-year retrospective cohort study obtaining data of patients with type 2 DM from electronic database of Taksin hospital during 1 January 2008 to 31 December 2017. The outcome …