An Integrative Review of Approaches Used to Assess Course Interventions.

Objective. The objectives of this review are to describe the utility of approaches used for the assessment of course interventions in pharmacy education and to provide recommendations that may guide faculty members in their scholarship of teaching and learning (SoTL) efforts that encompass assessment of course interventions.Findings. Thirty-four articles that included educational interventions published between 2016 and 2020 in the American Journal of Pharmaceutical Education and Currents in Pharmacy Teaching and Learning were selected for analysis. Those articles used various approaches for the assessment of course interventions. In the order of decreasing frequency of use, those methods were surveys, student academic performance, student evaluations, mixed quantitative and qualitative methods, pre- and posttest, and learning analytics.Summary. The use of more than one assessment approach, ie, triangulation, and multiple student cohorts are advantageous. When multiple cohorts are used, it is beneficial to present the students' demographic information. Student academic performance should be part of an assessment of course interventions whenever relevant. Surveys about student perceptions and confidence may contribute to the assessment of course interventions. However, since the information collected is subjective and is usually unrelated to student learning, such an approach should be coupled with other assessment approaches that reflect student learning, such as academic performance and/or a pre- and a posttest. Depending on the research question, qualitative methods and learning analytics may also be a part of the assessment of course interventions.

In-class Exercises Regarding the Roles of Excipients in a Pharmaceutics Course.

Objective: To assess student perceptions regarding: 1) exercises designed to enhance student comprehension of the roles of pharmaceutical excipients in dosage forms and 2) the use of resources to identify the roles of excipients. Description: In-class exercises regarding the roles of excipients were implemented in a foundational pharmaceutics course. The exercises covered the topics of liquid single-phase systems, liquid multiphase systems, drug delivery to the skin, and parenteral, ophthalmic, and nasal dosage forms. Students were introduced to resources to identify the roles of excipients. The exercises included the presentation of pharmaceutical preparations with various fundamental excipients, followed by student polling and class discussion. A survey was administered to evaluate student perceptions regarding the exercises about the roles of excipients and the use of resources to identify the roles of excipients. Findings: Eighty students participated in the study (response rate = 99%). Student perceptions indicated that the exercises helped them understand the material better and enhanced their performance in the non-sterile compounding course taught concurrently with the pharmaceutics course. Students indicated that the resources they used during the exercises were lecture notes from the course (95%), lists with excipients that the instructor provided (24%), a Web search, e.g., Google, Bing (20%), the sixth edition of the Handbook of Pharmaceutical Excipients (18%), Micromedex/Martindale (16%), and the International Journal of Pharmaceutical Compounding (6%). Conclusion. Targeted excipient exercises are a practical approach to enhance student understanding and can be utilized in pharmaceutics and non-sterile compounding courses across various pharmacy curricula.

Lead/Drug Discovery from Natural Resources.

Natural products and their derivatives have been shown to be effective drug candidates against various diseases for many years. Over a long period of time, nature has produced an abundant and prosperous source pool for novel therapeutic agents with distinctive structures. Major natural-product-based drugs approved for clinical use include anti-infectives and anticancer agents. This paper will review some natural-product-related potent anticancer, anti-HIV, antibacterial and antimalarial drugs or lead compounds mainly discovered from 2016 to 2022. Structurally typical marine bioactive products are also included. Molecular modeling, machine learning, bioinformatics and other computer-assisted techniques that are very important in narrowing down bioactive core structural scaffolds and helping to design new structures to fight against key disease-associated molecular targets based on available natural products are considered and briefly reviewed.

The use of ratio and proportion, dimensional analysis, and equations to solve pharmacy calculations problems.

INTRODUCTION: To evaluate the effects of using different problem-solving approaches on the success rates of student pharmacists in solving problems throughout a pharmacy calculations course. METHODS: A survey was administered to first-year students (N = 96, response rate 100%) near the completion of a pharmacy calculations course. The survey assessed whether students used the approaches of ratio and proportion (RP) or equations vs. dimensional analysis (DA) to solve calculation problems involving conversions, weight-based doses, flow rates, electrolyte solutions, and expressions of concentration. Questions used on course exams were tagged according to topics. Mean success rates in solving tagged questions were correlated with the problem-solving approaches that students used. RESULTS: Approximately 60% of students used RP/equations, 30% used DA, and 10% used both approaches equally. The success rate of students solving conversions was 74% ± 24% for RP, 84% ± 14% for DA (P < .05 vs. RP), and 91% ± 12% for the use of both approaches equally (P < .05 vs. RP). Success rates in solving calculation problems of weight-based doses, flow rates, electrolyte solutions, and expressions of concentration were similar across all approaches. CONCLUSIONS: The use of DA, or the combination of RP and DA equally, may be advantageous for solving conversions but not for the other types of calculation problems studied. Therefore, for most topics, pharmacy calculations instructors can demonstrate the method of their choice. Since a considerable number of students use each of the approaches, the demonstration of both approaches in class may be advantageous.

Course design, delivery, and assessment strategies for pharmaceutical calculations course in a doctor of pharmacy program: A review.

BACKGROUND: Pharmaceutical calculations is a fundamental course taken by doctor of pharmacy students in United States schools and colleges of pharmacy. To minimize medical errors and increase the accuracy with which future pharmacists perform calculations, a comprehensive training during the program is deemed. This review attempts to summarize research outcomes of interventions described thus far in the literature concerning the improvement of course design, delivery, and assessment strategies. METHODS: A detailed literature review of various educational resources was conducted using pharmaceutical calculations and related terms. RESULTS: The literature review outcomes were divided into three major categories: educational interventions in design, delivery, and assessment of pharmaceutical calculations courses. The research findings of course design describe a standalone course vs. an integrated course, a computer-aided course, use of compact disc read-only memory, and implementation of Gagne's Nine Events of Instructions. Findings in course delivery include the use of self-paced vs. integrated courses, flipped classroom vs. traditional lecture, Keller's Personalized System of Instruction, condensed videos, and podcasts. Finally, different types of assessments are presented such as those based on selected- vs. constructed-response questions, collaborative quizzes, the approach of repeated testing, and the use of technology. IMPLICATIONS: While the review intends to present educational interventions available to construct and/or modify an existing pharmaceutical calculations course, the choice of design, delivery, and assessment approaches depends upon various factors such as the purpose of course modification, resources available, and the number of students in class.

Evaluating the effects of a mindfulness mobile application on student pharmacists' stress, burnout, and mindfulness.

PURPOSE: Pharmacists report high levels of burnout. Mindfulness approaches have been demonstrated to have positive results in the general population and in other healthcare professions. However, limited studies have been performed evaluating mindfulness approaches in student pharmacists. The aim of this study was to evaluate the effectiveness of daily use of a mindfulness mobile application in improving student pharmacists' perceived stress, burnout, and mindfulness. METHODS: This study was a randomized, longitudinal, waitlist-controlled trial. The intervention group was asked to meditate using the mindfulness application Headspace daily for at least 6 weeks. The waitlist control group was asked to abstain from using the application for the entire study. Stress, burnout, and mindfulness were assessed using validated survey instruments at baseline, 6 weeks, and 10 weeks. A secondary outcome was to assess the persistence of application use after the intervention period. RESULTS: Fifty-six participants completed the study. The intervention group reported significantly lower scores on stress and burnout at 6 weeks compared to the control group. The intervention group also reported significantly higher scores on mindfulness. The differences in stress, burnout, and mindfulness persisted at follow-up. The mean percentage of students in the intervention group who used the application each day was 90% over the intervention period and 62% over the follow-up period. CONCLUSION: A mindfulness mobile application significantly improved student pharmacists' stress, burnout, and mindfulness with daily use. Most participants continued to use the application for 4 weeks after the end of the intervention. Positive effects on stress and mindfulness persisted even with decreased use.

Survey data on orientations, boot camps, and pre-matriculation programs in schools/colleges of pharmacy.

A survey about orientations, boot camps, and pre-matriculation programs in schools/colleges of pharmacy was approved by the South College Institutional Review Board (IRB). The survey was sent electronically to Assistant/Associate Deans of Academic Affairs or administrators in similar positions at schools/colleges of pharmacy in October 2016. The survey was closed two months later, in December, with 50 responses. The data that was collected from the survey included characteristics and components of orientations, boot camps, and pre-matriculation programs, such as session content and the frequency sessions appeared. The survey also collected descriptive information from respondents regarding certain demographics related to their schools/colleges of pharmacy (e.g., public or private institutions, a 4-year program or a 3-year program). The data can be used by schools/colleges of pharmacy and other healthcare professions that wish to revise or establish orientations, boot camps, and pre-matriculation programs.

Implementation, Revisions, and Student Perceptions of a Pre-Matriculation Program in a School of Pharmacy.

Objective. To characterize the development, revision, and student perceptions of a pre-matriculation program entitled Pharmacy Readiness and Enrichment Program (PREP) in a school of pharmacy. Methods. The program was first implemented in June 2013 for the incoming class of 2016. The main components of PREP were curriculum and scientific content review, professionalism, time management, critical thinking, and personal interactions. Entering student pharmacists were surveyed immediately and six or more months after PREP concluded. Statistical analysis was performed to determine if participation in PREP affected students' academic performance. Results. Student perceptions regarding the program and its components were favorable immediately after PREP but less favorable six or more months later. Statistical analysis showed that students who completed PREP had significantly higher cumulative grade point average (GPA) in pharmacy year one and year two. Conclusion. It is possible to implement a two-day pre-matriculation program with a wide range of components and deliver it prior to the start of the first professional year. It is also possible to deliver some PREP components during the first professional year rather than prior to matriculation into the program. The PREP may serve as a model for other schools of pharmacy that are considering the implementation of a pre-matriculation program, or that have a pre-matriculation program in place and are seeking to modify or update their program.

Corneal gene delivery: chitosan oligomer as a carrier of CpG rich, CpG free or S/MAR plasmid DNA.

BACKGROUND: Corneal gene therapy can potentially treat acquired and inherited corneal disorders that otherwise lead to blindness. In a previous study on the development of effective vectors for corneal gene delivery, we showed that a particular formulation of chitosan-DNA nanoparticles, based on ultrapure chitosan oligomers injected into rat corneas, led to transgene expression that was 5.4-fold higher than that obtained using polyethylenimine-DNA nanoparticles. METHODS: In the present study, we investigate the same formulation of chitosan-DNA nanoparticles as carriers of six different plasmids for corneal gene delivery. Size, zeta potential, the ability to condense plasmid DNA, and transfection efficiency in cell cultures and in rat corneas, were all investigated. RESULTS: Size, zeta potential, the ability to condense plasmid DNA, and transfection efficiency in cell cultures did not substantially vary for nanoparticles based on different plasmids. One day post-injection of nanoparticles into rat corneas, we found that a CpG-free plasmid DNA, pCpG-Luc, which has an EF1α promoter, led to transgene expression that was 7.1-fold higher than that for gWiz-Luc, a commercially available plasmid DNA with a cytomegalovirus (CMV) promoter used in our previous study; 116.8-fold higher than that for pEPI-CMV, a commercially available plasmid that has a scaffold/matrix attachment region (S/MAR) sequence and a CMV promoter; and 76.8-fold higher than that for pEPI-UbC, an experimental plasmid that has an S/MAR sequence and a ubiquitin C promoter. CONCLUSIONS: The present study reveals the potential of comparing various plasmids as an approach for enhancing transgene expression. The delivery system designed in the present study represents the next step in the development of effective vectors for corneal gene therapy.

Ultrapure chitosan oligomers as carriers for corneal gene transfer.

NOVAFECT chitosans are ultrapure chitosan oligomers that were recently marketed as carriers for non-viral gene therapy. There are no reports on systematic design and improvement of formulations based on NOVAFECT chitosans for gene delivery. Therefore, we have designed and characterized chitosan-DNA nanoparticles based on NOVAFECT. We found that the size of oligomeric chitosan-DNA nanoparticles is small, or=44.1+/-3.5 millivolt. In vitro transfection studies demonstrated the ability of oligomeric chitosan-DNA nanoparticles to effectively transfect COS-7 cells. In rat corneas, injection of a select formulation of oligomeric chitosan-DNA nanoparticles into the stroma showed that (a) luciferase gene expression was 5.4 times greater than following administration of polyethylenimine-DNA nanoparticles; and (b) the cells that express the transgene, green fluorescent protein, were keratocytes (corneal fibroblasts). This study lays the foundation for evaluating oligomeric chitosan-DNA nanoparticles as pharmaceuticals for corneal gene therapy, a promising approach for the treatment of acquired and inherited corneal diseases that otherwise lead to blindness. Oligomeric chitosan-DNA nanoparticles can also be evaluated for the treatment of ocular diseases outside of the cornea, and for various additional gene therapy applications.

Corneal gene therapy.

Gene therapy to the cornea can potentially correct inherited and acquired diseases of the cornea. Factors that facilitate corneal gene delivery are the accessibility and transparency of the cornea, its stability ex vivo and the immune privilege of the eye. Initial corneal gene delivery studies characterized the relationship between intraocular modes of administration and location of reporter gene expression. The challenge of achieving effective topical gene transfer, presumably due to tear flow, blinking and low penetration of the vector through epithlelial tight junctions left no alternative but invasive administration to the anterior chamber and corneal stroma. DNA vaccination, RNA interference and gene transfer of cytokines, growth factors and enzymes modulated the corneal microenvironment. Positive results were obtained in preclinical studies for prevention and treatment of corneal graft rejection, neovascularization, haze and herpetic stromal keratitis. These studies, corneal gene delivery systems and modes of administration, and considerations regarding the choice of animal species used are the focus of this review. Opportunities in the field of corneal gene therapy lie in expanding the array of corneal diseases investigated and in the implementation of recent designs of safer vectors with reduced immunogenicity and longer duration of gene expression.

Novel gastroretentive dosage forms: evaluation of gastroretentivity and its effect on levodopa absorption in humans.

PURPOSE: To design novel expandable gastroretentive dosage form (GRDFs) and evaluate their gastroretentive properties. Then, to assess the pharmacokinetics of levodopa compounded in such a GRDF in healthy volunteers. METHODS: Thin (<0.07 cm), large-dimensioned (> or = 5 x 2.1 cm), multi layer dosage forms (DFs) with different rigid polymeric matrices an mechanical properties were folded into gelatin capsules and wer administered to healthy volunteers with a light breakfast. GRDF unfolding and physical integrity were evaluated in vitro and in vivo (by gastroscopy and radiology). The pharmacokinetics of levodopa GRDF were compared to Sinemet CR in a crossover design. RESULTS: The combination of rigidity and large dimension of the GRDFs was a decisive parameter to ensure prolonged gastroretentivity (> or = 5 h). Large-dimension DFs lacking rigidity had similar gastroretentivity as a nondisintegrating tablet (10 mm). The GRDF rapidly unfolded and maintained their mechanical integrity. The absorption phase of levodopa was significantly prolonged following GRDF administration in comparison to Sinemet CR. CONCLUSIONS: The combination of size and rigidity of the novel GRDF enables a significant extension of the absorption phase of a narrow absorption window drug such as levodopa. This approach is an important step toward the implementation of such GRDFs in the clinical setting.

Furosemide pharmacokinetics and pharmacodynamics following gastroretentive dosage form administration to healthy volunteers.

The objective of this study was to evaluate the pharmacokinetic and pharmacodynamic properties of furosemide following gastroretentive dosage from (GRDF) administration. A furosemide (60 mg) GRDF, releasing the drug during 6 hours in vitro, or an immediate-release tablet was administered to healthy male volunteers (N = 14) in a crossover design. Food and liquid intake were standardized; urine was collected, weighed, and assayed for furosemide and sodium concentrations. Pharmacokinetics of furosemide following the GRDF administration, as compared to the tablet, showed lower Cmax and indicated a prolonged absorption phase leading to longer mean residence time in the stomach. The sustained input of the drug significantly improved diuretic and natriuretic efficiencies during the first 5 hours and thereby increased the total effects measured over 24 hours. The unfolding controlled-release GRDF of furosemide improved the pharmacodynamic actions due to the sustained absorption in the stomach and jejunum, which delayed the body's counteractivity to the drug effect.

Expandable gastroretentive dosage forms.

Expandable gastroretentive dosage forms (GRDFs) have been designed for the past 3 decades. They were originally created for possible veterinary use, but later the design was modified for enhanced drug therapy in humans. These GRDFs are easily swallowed and reach a significantly larger size in the stomach due to swelling or unfolding processes that prolong their gastric retention time (GRT). After drug release, their dimensions are minimized with subsequent evacuation from the stomach. Gastroretentivity is enhanced by the combination of substantial dimensions with high rigidity of the dosage form to withstand the peristalsis and mechanical contractility of the stomach. Positive results were obtained in preclinical and clinical studies evaluating GRT of expandable GRDFs. Narrow absorption window drugs compounded in such systems have improved in vivo absorption properties. These findings are an important step towards the implementation of expandable GRDFs in the clinical setting. The current review deals with expandable GRDFs reported in articles and patents, and describes the physiological basis of their design. Using the dog as a preclinical screening model prior to human studies, relevant imaging techniques and pharmacokinetic-pharmacodynamic aspects of such delivery systems are also discussed.

Novel levodopa gastroretentive dosage form: in-vivo evaluation in dogs.

Due to its narrow absorption window, levodopa has to be administered continuously to the upper parts of the intestine in order to maintain sustained therapeutic levels. This may be achieved by a controlled release (CR) gastroretentive dosage form (GRDF). The aim of this work was to develop a novel GRDF, based on unfolding polymeric membranes, that combines extended dimensions with high rigidity, and to examine the pharmacokinetics of levodopa compounded in the GRDF. Levodopa CR-GRDFs were administered to beagle dogs pretreated with carbidopa. The CR-GRDF location in the gastrointestinal tract was determined by X-ray, and serial blood samples were collected and assayed for levodopa. Optimization of the pharmacokinetic profile of levodopa from the CR-GRDFs was carried out based on the in-vitro in-vivo correlation following modifications of the release rates (adjusted by various membrane thicknesses) and drug loads. The successful CR-GRDF maintained therapeutic levodopa concentrations (>500 ng ml(-1)) over 9 h. In comparison to non-gastroretentive CR-particles and oral solution, mean absorption time was significantly extended. These outcomes demonstrate that the CR-GRDF may be used to improve levodopa therapy and can be applied to extend the absorption of other narrow absorption window drugs that require continuous input.

Novel gastroretentive dosage forms: evaluation of gastroretentivity and its effect on riboflavin absorption in dogs.

PURPOSE: [corrected] The purpose of this study was to design novel gastroretentive dosage forms (GRDFs) based on unfolding multilayer polymeric films, to investigate the mechanism of their gastroretentivity in dogs, and to assess the effect of compounding a narrow absorption window drug in a GRDF on the drug's absorption properties. METHODS: Dosage forms (DFs) with different dimensions and mechanical properties were administered to beagle dogs with acidic buffer (pH = 1.5), whose gastric retention time (GRT) was then determined by X-ray pictures. Concurrent administration of radiopaque markers was used to assess the effect of the GRDF and/or acidic buffer on GRT. The absorption of riboflavin from a prototype GRDF was compared with a nongastroretentive controlled-release DF and to an oral solution of the drug. RESULTS: Large DFs (> or = 2.5 x 2.5 cm) containing rigid frame had prolonged GRT (>4 h). Administration of 400 mL of acidic buffer (or water) prolonged GRT whereas the GRDF did not cause additional prolongation. The extended absorption phase (>48 h) of riboflavin administered in a GRDF led to 4-fold increased bioavailability. CONCLUSION: The combination of large dimensions with rigidity produce gastroretentivity that can be used to improve absorption properties of a model of narrow absorption window drugs in the gastrointestinal tract.