The Score Card Approach: A First Step Toward an Evidence-based Differentiation Assessment for Tablets.

Background: The differentiation of tablets by their physical appearance is a contributing factor to the safe use of medications. In this study, a "score card" was developed to assess how well one tablet is differentiated from another tablet on the basis of the physical attributes of color, size, and shape.

Methods: The score card was derived from a "2-out-of-5" difference test, in which participants were presented with groups of 5 tablets with varying color, size, and shape, and were asked to identify the 2 tablets that were different from the other 3 tablets.

Investigation of critical factors for the resolution of SR695, a key impurity, from efavirenz in the reversed-phase assay of efavirenz dosage forms.

An investigation of the critical factors effecting the resolution of SR695 from efavirenz in the assay of efavirenz by reversed-phase HPLC was performed. This study was implemented to address the inability of a subset of the Zorbax SB-CN columns used in this method to adequately perform this separation, which were otherwise indistinguishable from columns of this type that could. In this study, column temperature, detector time-constant, pre-gradient isocratic hold-time, pre-column mixing volume, column, and HPLC type were considered.

Photoinduced particulate matter in a parenteral formulation for bisnafide, an experimental antitumor agent.

This paper assesses the cause of particulate formation in vials of the experimental antitumor agent bisnafide and investigates pharmaceutical techniques to reduce the number of particulates in the product. Solution preparation and particulate isolation were performed under Class 100 laminar air flow. Reversed-phase HPLC and infrared microscopy were used to characterize drug and isolated particulate matter, whereas a Hiac particle counter was used to quantify the particulate matter.

Validation of cleaning procedures for highly potent drugs. II. Bisnafide.

The objective of this work was the development and validation of procedures designed to clean glass and stainless steel surfaces after exposure to the experimental anticancer drug, bisnafide. The cleaning procedures, using 5% acetic acid water, Alconox, and water, were validated using a wipe test and an HPLC method developed to quantitate low levels of bisnafide. The procedure developed for cleaning stainless steel is more stringent than that for glass because of the apparent greater affinity of bisnafide for stainless steel.

Development and validation of a reversed-phase liquid chromatographic method for analysis of aspirin and warfarin in a combination tablet formulation.

A stability-indicating liquid chromatographic method for the simultaneous analysis of aspirin and warfarin in warfarin sodium/aspirin combination (DuP 647) tablets has been developed and validated. This paper presents linearity, accuracy, precision, robustness, recovery, limits of detection and quantitation, and cross-validation data. The method has been shown to be specific and stability-indicating, and to give results comparable to existing methods for the individual components.