The Test of Logical Thinking as a predictor of first-year pharmacy students' performance in required first-year courses.

OBJECTIVES: To investigate the correlation of scores on the Test of Logical Thinking (TOLT) with first-year pharmacy students' performance in selected courses. METHODS: The TOLT was administered to 130 first-year pharmacy students. The examination was administered during the first quarter in a single session. RESULTS: The TOLT scores correlated with grades earned in Pharmaceutical Calculations, Physical Pharmacy, and Basic Pharmacokinetics courses. CONCLUSION: Performance on the TOLT has been correlated to performance in courses that required the ability to use quantitative reasoning to complete required tasks. In the future, it may be possible to recommend remediation, retention, and/or admission based in part on the results from the TOLT.

The impact of pharmacy students' remediation status on NAPLEX first-time pass rates.

OBJECTIVE: To determine whether there is a difference in pass rates on the North American Pharmacist Licensure Examination (NAPLEX) between students who did and did not require remediation for deficient course grades. METHODS: Student-specific data were collected regarding course grade deficiencies and completion of a comprehensive examination or course for remediation. Student-specific first-time NAPLEX performance data for the graduating classes of 2008, 2009, and 2011were provided by the National Association of Boards of Pharmacy (NABP). RESULTS: A significant difference was found in first-time NAPLEX mean pass rates between students who did not need to undergo remediation versus those who did ( 97% vs 70%). CONCLUSION: Students requiring remediation for deficient course grades had a lower pass rate on the NAPLEX compared with those who did not require remediation. The difference can be attributed to several factors and therefore further study is needed.

Effects of lipophilic components on the compatibility of lipid-based formulations with hard gelatin capsules.

The present study investigated the effect of lipophilic components on the compatibility of propylene glycol (PG)-containing lipid-based drug delivery system (LBDDS) formulations with hard gelatin capsules. The presence of a lipophilic active pharmaceutical ingredient (API) (log P approximately 6.1) and an additional lipophilic excipient (Capmul MCM) significantly affected the activity of PG in the fills and the equilibrium of PG between capsule shells and fills. These changes in activity and equilibrium of PG were furthermore correlated to the mechanical and thermal properties of the liquid-filled capsules and subsequently linked to the shelf-life of the capsules on stability with respect to capsule deformation. The present study also investigated the mechanism by which lipophilic component(s) might affect the activity of PG in the fill formulations and the equilibrium of PG between capsule shells and fills. The activities of PG in two series of "binary" mixtures with Capmul MCM and with Cremophor EL were measured, respectively. The mixtures of PG containing Capmul MCM were found to be more nearly ideal than those containing Cremophor EL. The observed negative deviation from Rauolt's law indicates that the excess free energies of mixing are less then zero indicating favorable interaction between PG and the other component. It is speculated that enhanced hydrogen bonding opportunities with Cremophor EL are responsible for the decreased excess free energy of mixing. Replacement of Cremophor EL with lipophilic API also reduces the hydrogen bonding opportunities for PG in the mixtures. This hypothesis may further explain the increased activity of PG in the fills and the shifted equilibrium of PG toward the capsule shells. Activity determination utilizing headspace gas chromatography (GC) using short 30 min incubation time seems to be a time-efficient approach for assessing capsule-fill compatibility. Direct measurements of PG migration and other physical properties of the capsules took much longer time (7 weeks) for ranking the predicted capsule deformation at 40 degrees C. Asides from the time savings, activity determination can be considered to be material sparing by offering capsule-fill compatibility assessment even without the need for preparing liquid-filled capsules once appropriate positive and negative references are established. With further optimization, this approach should enable high throughput screening of LBDDS for capsule-fill compatibility in liquid-filled capsule development.

PQRI recommendations on particle-size analysis of drug substances used in oral dosage forms.

This document provides information for the Pharmaceutical Industry and the Federal Drug Administration (FDA) regarding the selection of suitable particle-size analysis techniques, development and validation of particle-size methods, and the establishment of acceptance criteria for the particle size of drug substances used in oral solid-dosage forms. The document is intended for analysts knowledgeable in the techniques necessary to conduct particle-size characterization (a table of acronyms is provided at the end of the document). It is acknowledged that each drug substance, formulation, and manufacturing process is unique and that multiple techniques and instruments are available to the analyst.

Use of texture analysis to study hydrophilic solvent effects on the mechanical properties of hard gelatin capsules.

The aim of this work was to explore texture analysis for quantitative evaluation of the effect of hydrophilic solvent systems used as capsule fills on the mechanical properties of hard gelatin capsules. For this purpose, a texture analyzer (Stable Micro Systems, model TA.XT Plus) equipped with a capsule separating rod fixture was used. The tests were conducted in a tension mode. Elastic stiffness, tensile force and elongation at break were determined from the experimental stress-strain curve in order to quantitatively describe both brittleness and softening of capsules. In this paper, it has been demonstrated that the effect of various hydrophilic solvent (i.e. propylene glycol (PG), polyethylene glycol 400 (PEG 400), ethanol) mixtures on the mechanical properties of hard gelatin capsules can be easily monitored using texture analysis. Significant counteractive effects between PG and PEG 400 or ethanol on the integrity of capsule shells were discovered in this study. Texture analysis is found to be a convenient tool for studying formulation compatibility. It can be invaluable in early screening studies of liquid filled hard gelatin capsules.

New Approach to the Study of Particle-Surface Adhesion Using Atomic Force Microscopy.

The colloidal probe technique is commonly employed to determine the adhesion force between a particle and a solid surface. Characterization of the adhesion of a particle across a surface can be as important, if not more so, as the determination of an average value for the adhesion. Unfortunately, the measurement of the variation in adhesion can be difficult at best. A new approach for studying particle-surface adhesion based on the force-volume technique is presented. Upon combining the force-volume technique with a colloidal probe, not only is it possible to determine the average adhesion force, but an image of the spatial variation of the adhesion can also be obtained. This method is envisioned to have great potential for examining and analyzing the adhesion behavior in complex natural and technological systems. Copyright 2000 Academic Press.