Pharmacy and Pharmaceutical Sciences Commons^™

An Exploratory Study Of Suboxone (Buprenorphine/ Naloxone) Film Splitting: Cutting Methods, Content Uniformity, And Stability, Kristin L. Reindel, Michael J. Deangelis, Alexander S. Ferrara, Kelly Conn, Elizabeth Phillips, Anthony Corigliano, Fang Zhao

Doctoral External Publications

Suboxone films are U.S. Food and Drug Administration approved to treat opioid dependence. While the package insert states that films should not be cut, physicians often prescribe film fractions for treatment and tapering. There is no data to support this practice, and this study was initiated to evaluate cutting methods, content uniformity, and stability of split films. Suboxone 8-mg buprenorphine/2-mg naloxone films were split using four methods: 1) ruler/razor cut, 2) scissor cut, 3) fold/rip, and 4) fold/scissor cut. United States Pharmacopeia Chapter <905> was used to evaluate the weight variation and content uniformity of split films. The stability of split …

The Use Of Aloe Vera In Cancer Radiation: An Updated Comprehensive Review, Carrie-Jo E. Farrugia, Elizabeth Sutton Burke, Mariah E. Haley, Komul T. Bedi, Mona A. Gandhi

Doctoral External Publications

Introduction: Many cancer patients require radiation therapy and often experience adverse effects including erythema, itching, and pain. Aloe vera has been studied for its potential use in the prevention and treatment of radiation related adverse effects as it possesses a variety of properties and is considered an antioxidant and anti-inflammatory agent. Multiple controlled trials have been performed in order to evaluate the efficacy of aloe vera for the prevention and treatment of radiation side effects. Previous systematic reviews have examined the use of aloe vera for radiation-induced skin reactions, however updated literature now includes the use of aloe vera in …

Stability And Compatibility Of Diphenhydramine Hydrochloride In Intravenous Admixtures: A New Look At An Old Drug, Daniel Sabins, Tuong Diep, Pamela Mccartan, Shashi Patel, Fang Zhao

Doctoral External Publications

Purpose: Intravenous (IV) admixtures of diphenhydramine are widely used in hospitalized patients to prevent or treat hypersensitivity reactions. However, there is limited data to support the admixture preparation in this manner. This study was designed to investigate the stability and compatibility of diphenhydramine in IV admixtures with a goal to establish a 14-day beyond-use dating with storage under refrigeration. Methods: The commercially available 50 mg/mL diphenhydramine hydrochloride injection vials were used to prepare the 0.2 and 1.0 mg/mL IV admixtures in 0.9% sodium chloride injection and 5% dextrose injection in 50 mL polyvinyl chloride (PVC) bags. The IV bags were …

Pharmaceutical Care Management Association V. Rutledge, John J. Crean, Karl Williams

Doctoral External Publications

On June 8, 2018 the federal Eighth Circuit Court of Appeals announced its decision concerning Arkansas' attempt to regulate perceived unfair payment practices of pharmacy benefit managers (PBMs) in the case Pharmaceutical Care Management Association v. Rutledge.¹ Because pharmacies across the country face similar problems, and this ruling may influence other federal appellate courts, review and discussion is useful for the purpose of making strategic decisions.

Stability Of Extemporaneously Prepared Sodium Benzoate Oral Suspension, Julia Atkins, Melinda E. Lull, Andrew S. Decker, David Hutchinson

Doctoral External Publications

The stability of extemporaneously prepared sodium benzoate oral suspension in cherry syrup and Ora-Sweet was studied. Oral solutions of 250-mg/mL sodium benzoate were prepared in either cherry syrup or Ora-Sweet. To a beaker, 50 grams of Sodium Benzoate Powder USP was dissolved and filtered, the solution was divided equally into two parts, and each aliquot was added into two separate calibrated 100-mL amber vials. In the first vial, cherry syrup was added to make a final volume of 100 mL. In the second vial, Ora-Sweet was added to give a final volume of 100 mL. This process was repeated to …

Stability Of Extemporaneously Prepared Ophthalmic Solutions For Mydriasis, Nicole A. Camp, Jennifer T. Nadra, Susan E. Hughes, Justine M. Gilbert, Fang Zhao

Doctoral External Publications

Purpose Results of an evaluation of the physical and chemical stability of extemporaneously prepared adult and pediatric ophthalmic solutions containing combinations of phenylephrine, tropicamide, and cyclopentolate are reported.

Methods A stability study was conducted to help determine the feasibility of innovative formulations to meet an unmet clinical need for combination mydriatic ophthalmic eyedrops. An adult mydriatic ophthalmic solution containing phenylephrine hydrochloride 2.5% and tropicamide 1.0% and a pediatric formulation containing phenylephrine hydrochloride 2.5%, tropicamide 0.5%, and cyclopentolate hydrochloride 0.5% were prepared using proper aseptic techniques. Triplicate samples of each formulation were stored for 60 days at refrigeration temperatures (2–8 °C) …

Correlation Of Solid Dosage Porosity And Tensile Strength With Acoustically Extracted Mechanical Properties, Xiaochi Xu, Connor Mack, Zachary J. Cleland, Chaitanya Krishna Prasad Vallabh, Vivek S. Dave, Centin Cetinkaya

Doctoral External Publications

Currently, the compressed tablet and its oral administration is the most popular drug delivery modality in medicine. The accurate porosity and tensile strength characterization of a tablet design is vital for predicting its performance such as disintegration, dissolution, and drug-release efficiency upon administration as well as ensuring its mechanical integrity. In current work, a non-destructive contact ultrasonic approach and an associated testing procedure are presented and employed to quantify and relate the acoustically extracted mechanical properties of pharmaceutical compacts to direct porosity and tensile strength measurements. Based on a comprehensive set of experimental data, it is demonstrated how strongly the …

Telepharmacy And The Law, Hailey Button, Karl Williams

Doctoral External Publications

Recently, an "Advisory Notice" was placed on the website of the New York State Board of Pharmacy entitled "Automated Dispensing Machines" that provide "drugs for sale to customers outside of their respective registered pharmacy areas", and that it "considers this to be a violation of state law"¹. In support, the Notice cited the Education Law relating to the profession of pharmacy² and Regulations of the Commissioner of Education³. Finally, ownership of the pharmacy and the Supervising Pharmacist are responsible for compliance and "may be subject to disciplinary and unprofessional conduct action". The Notice did not …

In Vitro Evaluation Of Eslicarbazepine Delivery Via Enteral Feeding Tubes, Kristin Reindel, Fang Zhao, Susan Hughes, Vivek S. Dave

Doctoral External Publications

Purpose: The feasibility of preparing an eslicarbazepine acetate suspension using Aptiom tablets for administration via enteral feeding tubes was evaluated. Methods: Eslicarbazepine acetate suspension (40 mg/mL) was prepared using Aptiom tablets after optimizing the tablet crushing methods and the vehicle composition. A stability-indicating high-performance liquid chromatography (HPLC) method was developed to monitor the eslicarbazepine stability in the prepared suspension. Three enteric feeding tubes of various composition and dimensions were evaluated for the delivery of the suspensions. The suspension was evaluated for the physical and chemical stability for 48 hours. Results: The reproducibility and consistency of particle size reduction was found …

Compounded Apixaban Suspensions For Enteral Feeding Tubes, Maria Caraballo, Seda Donmez, Kobi T. Nathan, Fang Zhao

Doctoral External Publications

Objective: There is limited information on compounded apixaban formulations for administration via enteral feeding tubes. This study was designed to identify a suitable apixaban suspension formulation that is easy to prepare in a pharmacy setting, is compatible with commonly used feeding tubes, and has a beyond-use date of seven days.

Methods: Apixaban suspensions were prepared from commercially available 5 mg Eliquis® tablets. Several vehicles and compounding methods were screened for ease of preparation, dosage accuracy, and tube compatibility. Two tubing types, polyurethane and polyvinyl chloride (PVC), with varying lengths and diameters, were included in the study. They were mounted on …

Medication Adherence In Patients With Myotonic Dystrophy And Facioscapulohumeral Muscular Dystrophy, Bryan Fitzgerald, Kelly Conn, Joanne Smith, Andrew Walker, Amy L. Parkhill, James E. Hilbert, Elizabeth A. Luebbe, Richard T. Moxley Iii

Doctoral External Publications

Myotonic dystrophy (DM) and facioscapulohumeral muscular dystrophy (FSHD) are the two most common adult muscular dystrophies and have progressive and often disabling manifestations. Higher levels of medication adherence lead to better health outcomes, especially important to patients with DM and FSHD because of their multisystem manifestations and complexity of care. However, medication adherence has not previously been studied in a large cohort of DM type 1 (DM1), DM type 2 (DM2), and FSHD patients. The purpose of our study was to survey medication adherence and disease manifestations in patients enrolled in the NIH-supported National DM and FSHD Registry. The study …

Evaluation Of Over The Counter Medication Knowledge And Literacy In Middle School And High School Students, Tessa Kelly, Kelly M. Conn, Allison Bosworth, Matthew Zak

Doctoral External Publications

Over the counter (OTC) medications are commonly utilized by the public, including adolescents, to self-treat many conditions. Unfortunately, these products can be dangerous if not used safely and appropriately. Adolescents between 13 and 19 years old composed 7.32 percent of the human exposure cases reported to U.S. poison control centers in 2014. Among these cases, there were 53 fatalities involving pharmaceuticals. This is an age range where medication use becomes more independent and the education they receive throughout the school curriculum is unknown. This study was designed to evaluate OTC medication knowledge and literacy among middle and high school students.

A Pilot Chemical And Physical Stability Study Of Extemporaneously Compounded Levetiracetam Intravenous Solution, Chenzira D. Raphael, Fang Zhao, Susan E. Hughes, Katherine Juba

Doctoral External Publications

Levetiracetam is a commonly used antiepileptic medication for tumor-related epilepsy. However, the 100 mL intravenous (IV) infusion volume can be burdensome to imminently dying hospice patients. A reduced infusion volume would improve patient tolerability. The purpose of this study was to evaluate the stability of 1000 mg/25 mL (40 mg/mL) levetiracetam IV solution in sodium chloride 0.9%. We prepared levetiracetam 40 mg/mL IV solution and added it to polyvinyl chloride (PVC) bags, polyolefin bags, and polypropylene syringes. Triplicate samples of each product were stored at refrigeration (2–8°C) and analyzed on days 0, 1, 4, 7, and 14. Samples were subjected …

Stability Of Glutamate-Aspartate Cardioplegia Additive Solution In Polyolefin Iv Bags, Steven D. Rush, Stephanie E. Kim, Susan E. Hughes, Justine M. Gilbert, Peter P. Ciancaglini, Fang Zhao

Doctoral External Publications

Objective: Glutamate-aspartate cardioplegia additive solution (GACAS) is used to enhance myocardial preservation and left ventricular function during some cardiac surgeries. This study was designed to evaluate the stability of compounded GACAS stored in sterile polyolefin intravenous (IV) bags. The goal is to extend the default USP beyond-use date (BUD) and reduce unnecessary inventory waste.

Methods: GACAS was compounded and packaged in sterile polyolefin 250 mL IV bags. The concentration was 232 mM for each amino acid. The samples were stored under refrigeration (2°C-8°C) and analyzed at 0, 1, and 2 months. At each time point, the samples were evaluated by …

Drug-Drug Interactions Among Hepatitis C Virus (Hcv) And Human Immunodeficiency Virus (Hiv) Medications, Kirpal Kaur, Mona A. Gandhi, Judianne Slish

Doctoral External Publications

One-fourth of individuals diagnosed with the human immunodeficiency virus concomitantly have the hepatitis C virus infection. Since the discovery of highly active antiretroviral therapy, liver complications have become the leading cause of morbidity and mortality in HIV-HCV coinfected individuals. Optimal treatment in this patient population is critical, as coinfection has been linked to deterioration of both disease states. The objective of this review article is to highlight the current literature on drug-drug interactions between HIV and HCV treatments. The management of the treatment of coinfection patients has been covered extensively in numerous other publications.

Altered Cell-Surface Receptor Levels Result From Fructose Advanced Glycation End Product-Induced Inflammation, Matthew Stryker, Regina Blackley, Melinda E. Lull

Doctoral External Publications

Objective: As a result of the heightened reactivity fructose demonstrates compared to glucose and our current knowledge of glucose advanced glycation end-products, the aim of this research was to further elucidate the proinflammatory pathways involved in the response to fru-AGE exposure, including the effects of fru-AGEs on cell-surface receptor expression. We hypothesized that once microglia were activated in response to fru-AGE exposure, there would be an increase in the expression of RAGE and TLR4 to facilitate the proinflammatory cascade.

The Differential Effects Of Fructose And Glucose On Advanced Glycation End-Product Formation And Cellular Damage In Vitro, Regina Blackley, Matthew Stryker, Susan Denapoli, Melinda E. Lull

Doctoral External Publications

The protective mechanisms of microglia cells help to maintain central nervous system (CNS) homeostasis and function.1 Microglia are innate immune cells that constantly survey their surrounding CNS microenvironment for pathogens, damaged cells, and inflammatory molecules. Sugars from our diet, including glucose and fructose, combine with endogenous proteins non-enzymatically and form advanced glycation-end products (AGEs).2 AGEs are shown to produce reactive oxygen species, leading to inflammation and cellular damage that may be mediated by microglia.3 Fructose consumption has become increasingly prevalent within the American diet, as it is a lower cost sweetener.4 Microglia become activated and phagocytic in the presence of …

Educating Pharmacists And The Public About The Role Of Over-The-Counter Medications In The Management Of Autism Spectrum Disorders, Jillian M. Bankoff, Melinda E. Lull

Doctoral External Publications

Over-the-counter (OTC) medications are used by various populations as an adjunct to help improve various aspects of life, such as sleep cycles, disease prevention, and mood. The purpose of this study is to compile all of the available data from human trials of over-the-counter medications used in patients with Autism Spectrum Disorders (ASD). OTCs have been used in the treatment of ASD to minimize social impairments, suppress repetitive behaviors, and enhance quality of sleep to improve daytime behaviors. Ultimately, the main objectives of this project are to educate pharmacists and the public (both patients and their families) about the role …

An Examination Of The Effects Of Atorvastatin And Parathyroid Hormone On Osteoblast Activity, Inlok Lam, Andrea Traina, Melinda E. Lull

Doctoral External Publications

HMG-CoA reductase inhibitors, also known as statins, are a ubiquitous class of medication used for lowering cholesterol. In-vitro and animal studies have suggested that statins can activate osteoblast differentiation and have anabolic effects on bones; however, observational and experimental studies in humans have shown conflicting results.1-5 The exact mechanism of statins on bone growth is unknown; however, there are several hypotheses. The “Lipid Hypothesis” (Figure 1) suggests that lipid oxidation leads to activation of PPARγ, and production of isoprostanes including isoPGF2α and isoPGEα. PPARγ is associated with inhibition of osteoblast differentiation, while isoprostanes markers are associated with the induction of …

Development And Implementation Of Peer-Led Weekly Review Sessions And The Assessment Of Their Impact On Student Learning, Alyssa L. Ashworth, Inlok Lam, Nicole E. Moore, Melinda E. Lull

Doctoral External Publications

Peer tutoring services for a pathophysiology and therapeutics course have historically been made available to pharmacy students, but they were greatly underutilized. The role of peer tutors had been exclusively to hold office hours during which students could ask questions or review material. Peer tutoring services were updated and expanded based on the needs of the students. The objectives of this project were to develop, implement, and assess the impact of peer-led organized weekly review sessions in a pathophysiology and therapeutics course.

Student Self-Screening For Methicillin-Resistant Staphylococcus Aureus (Mrsa) Nasal Colonization In Hand Hygiene Education, Tia Lum, Kristin F. Picardo, Theresa Westbay, Amber Barnello, Lynn Fine, Jill Lavigne

Doctoral External Publications

Objective. To determine the feasibility and effectiveness of adding a hand hygiene exercise in self-screening for Methicillin-Resistant Staphylococcus Aureus (MRSA) nasal colonization to a health care delivery course for first-year pharmacy (P1) students.

Design. About one month after students were trained in hand hygiene technique and indications, faculty members demonstrated how to self-screen for MRSA nasal colonization. Students were then asked to screen themselves during the required class time. Aggregated class results were shared and compared to prevalence estimates for the general population and health care providers.

Assessment. The 71 students present in class on the day of the self-screening …

Analysis Of Compounded Pharmaceutical Products To Teach The Importance Of Quality In An Applied Pharmaceutics Laboratory Course, Alyssa M. Pignato, Christine R. Birnie

Doctoral External Publications

Objective. To assess the effectiveness of a product-analysis laboratory exercise in teaching students the importance of quality in pharmaceutical compounding.

Design. Second-year pharmacy students (N=77) participated in a pharmaceutical compounding laboratory exercise and subsequently analyzed their final product using ultraviolet (UV) spectrometry.

Assessment. Reflection, survey instruments, and quiz questions were used to measure how well students understood the importance of quality in their compounded products. Product analysis showed that preparations compounded by students had an error range of 0.6% to 140%, with an average error of 23.7%. Students’ reflections cited common sources of error, including inaccurate weighing, contamination, and product …

Stability Of Levetiracetam Oral Solution Repackaged In Oral Plastic Syringes, Daniel Prohotsky, Susan Hughes, Fang Zhao

Doctoral External Publications

Purpose The long-term stability of levetiracetam solution in oral syringes was investigated in order to define a suitable beyond-use date and demonstrate the feasibility of storing prepared syringes for extended periods as an alternative to commercial levetiracetam unit dose cups.

Methods Levetiracetam oral solution (100 mg/mL) was drawn into 1- and 10-mL amber polypropylene oral syringes. Triplicate samples of the syringe preparations were stored at refrigeration (2–8 °C) or room temperature (20–25 °C) and evaluated at monthly intervals for up to six months. At each time point, the samples were visually inspected and levetiracetam stability was assessed via pH measurement …

A Review Of The Role Of Melatonin In Irritable Bowel Syndrome, Nicole R. Brinn, Mona A. Gandhi

Doctoral External Publications

Irritable bowel syndrome (IBS) is a troubling disease experienced worldwide. The presentation of symptoms varies from patient to patient, and current prescription treatments can be inadequate in resolving symptoms. This article explores the available scientific literature supporting the use of melatonin in alleviating IBS symptoms.

Stability Of Diluted Adenosine Solutions In Polyolefin Infusion Bags, Elise Almagambetova, David Hutchinson, Danielle M. Blais, Fang Zhao

Doctoral External Publications

Background

Intravenous or intracoronary adenosine is used in the cardiac catherization lab to achieve maximal coronary blood flow and determine fractional flow reserve.

Objective

To determine the stability of adenosine 10 and 50 µg/mL in either 0.9% sodium chloride injection or 5% dextrose injection in polyolefin infusion bags stored at 2 temperatures, refrigeration (2°C-8°C) or controlled room temperature (20°C-25°C).

Methods

Adenosine 10 µg/mL and 50 µg/mL solutions were prepared in 50 mL polyolefin infusion bags containing 0.9% sodium chloride injection or 5% dextrose injection and stored at controlled room temperature or under refrigeration. Each combination of concentration, diluent, and storage …

A Survey Of Top 200 Drugs—Inconsistent Practice Of Drug Strength Expression For Drugs Containing Salt Forms, Daniel Prohotsky, Fang Zhao

Doctoral External Publications

Many ionizable drugs are developed and marketed as salt forms. However, there are no clear US regulatory guidelines on drug strength labeling for salts. The strengths of some drugs are expressed as salts and some as free acids/bases. This study surveyed the top 200 US drugs to assess the common practice in industry. The top 200 drugs prescribed in the United States were included in this survey. The drugs containing active pharmaceutical ingredient (API) salts were selected for analysis. Generic or combination products with redundant API salts were excluded. The package insert of each selected drug was reviewed, and the …

Stability Of Diluted Adenosine Solutions In Polyvinyl Chloride Infusion Bags, Melissa Kaltenbach, David Hutchinson, Jessica E. Bollinger, Fang Zhao

Doctoral External Publications

Purpose The stability of diluted adenosine solutions in polyvinyl chloride infusion bags was studied.

Methods Adenosine 50-, 100-, and 220-μg/mL solutions were prepared in 50-mL polyvinyl chloride (PVC) infusion bags containing 0.9% sodium chloride injection or 5% dextrose injection and stored at room temperature (23–25 °C) or under refrigeration (2–8 °C). Each sample of every combination of concentration, diluent, and storage temperature was prepared in triplicate, yielding 36 samples. The samples were assayed using a stability-indicating, reverse-phase high-performance liquid chromatographic method immediately after preparation (time zero) and at 24 hours, 48 hours, 7 days, and 14 days. pH was measured …