Analytics

Using melt extrusion to prepare glass solutions of poorly water-soluble drugs with hydrophilic excipients offers an exciting and advantageous alternative to existing formulation methods such as spray-drying and co-melting. Investigating potential methods to increase water solubility begins early in drug development. Techniques described in this paper show how only a small quantity of drug can be used to determine its suitability for melt extrusion, allowing the method to be considered at the same time as salt screening and particle size reduction work, and could speed up the formulation process.

A limit test using ion mobility spectrometry (IMS) has the potential to dramatically reduce the time required for cleaning verification and cleaning method development. The traditional approach to cleaning verification, often using HPLC, is relatively resource intensive and can lead to significant delays in reporting results. The main advantage of IMS is that results are seen virtually instantaneously, so any necessary re-measurement can be done very quickly. If the results demonstrate cleanliness, production can resume in a matter of hours not days.

The author discusses the potential effect on CROs of pending major-pharma mergers and consolidations.

The author explains how a sponsor company can select and partner with a CRO for the redevelopment and revalidation of analytical test methods.

Measurements of lyophilization pressure are accurate only if the gauges that are used have been properly calibrated.

The authors subjected ibuprofen bulk drug and tablet assay preparations to various stresses to evaluate the selectivity and specificity of the drug substance and product samples.

Eventual change in the dissolution characteristics of some dosage forms, which is ascribed to cross-linking of gelatin, continues to present challenges to drug manufacturers. The authors discuss the causes, mechanisms, and solutions to the problem.

This study investigated the effectiveness of the direct extraction of tablets and shaking time on the disintegration of tablets, solubilization, and recovery of ibuprofen from tablets of various formulations, strengths, and spiked placebo.

This article presents the findings of PhRMA's annual workshop, held in September 2000, that convened to draft an acceptable analytical practice that would clarify the essential elements of a complete and compliant transfer.

EVA takes into account a project's schedule and budget to determine the true cost performance.

Because drug delivery at a zero-order rate provides uniform concentration of a drug for absorption, this study attempts to identify a simple mathematical method to quantitatively express the deviation from zero-order kinetics.

Appropriate sampling procedures, proper preparation, and correct instrumental parameters may yield differing, but correct, results.

Special considerations and cautions must be adhered to when designing virus safety studies and developing appropriate virus contamination control programs.