Peer-Reviewed Research

Using handheld Raman spectroscopy, methods were developed and evaluated for 198 substances widely used as raw materials.

Applying a moisture protective barrier to tablet cores can help prevent degradation caused by ambient moisture.

Endotoxin removal from a finished product is a major challenge for biopharmaceutical manufacturers; particularly as all endotoxin removal methods have operational limitations and may result in loss of protein.

Formoterol presents formulators and manufacturers in the asthma and chronic obstructive pulmonary disease marketplace many challenges.

The authors describe a comprehensive methodology for establishing functional equivalence among various lyophilizers.

Parteck ODT is a newly introduced ready-to-use excipient for fast melt tablets.

Human embryonic stem cells are of immense interest to researchers because of their ability to potentially develop into any kind of tissue.

When validating automated systems from third-party providers, using the V model and failure modes effects and criticality analysis (FMECA) early in the process can help.

The addition of superdisintegrants to oral solid dosage forms can improve disintegration and, in turn, drug dissolution.

The authors prepared granules containing cinnarizine using polyethylene glycol 6000 as a melting binder and lactose monohydrate as hydrophilic filler. The effects of binder concentration and size were studied.

The authors applied near-infrared (NIR) spectrophotometry to assess whether eight drug products were authentic or counterfeit.

This article provides an overview of the drug Recall Root Cause Research (RRCR) project, an initiative of the US Food and Drug Administration's Center for Drug Evaluation and Research.

The authors modified gellan gum using microwave technology and showed it can be used as an excipient in tablet formulations.

The authors discuss the theory of ion mobility spectrometry, its benefit over HPLC analysis in cleaning verification, and the experimental considerations for method validation and validation.

Cefaclor is a β-lactam cephalosporin antibiotic that has a wide particle size distribution. Because of the nonporous nature of the material, the specific surface area value accounts for a significant amount of fine particles possibly present in the samples under analysis.

The authors describe the importance of a rapid and an abbreviated screening strategy in initial solvent screening. This article contains bonus online-exclusive material.

Pharmacosomes can pass through biomembranes efficiently and possess several advantages over traditional vesicular drug-delivery systems.

The authors describe the importance of a rapid and an abbreviated screening strategy by initial solvent screening in 20-mL scintillation vials.

The authors investigate whether the addition of an antioxidant could be used to stabilize the solvent ethyl lactate by preventing the formation of peroxides

The author reviews the types of reference-standard materials used in drug-product manufacturing, discusses current regulatory requirements, and outlines a reference-standard qualification program.

A Position Paper from the AAPS In Vitro Release and Dissolution Focus Group

Ultra high performance liquid chromatography is advantageous in a contract laboratory because it is faster, more sensitive, and relies on smaller volumes of organic solvents than HPLC.

The authors investigate the effects of a polyethylene glycol plasticizer and water on cellulose acetate film properties.

The authors extend the range of a near-infrared calibration model for tablet assay using production 'seed' spectra and synthetic spectra generated from placebos and 'pure' active pharmaceutical ingredient spectra.

The author tests the ruggedness of VRL viewing conditions and defines optimal viewing conditions.

The authors present a simple and material-sparing approach for estimating the powder-flow performance of previously uncharacterized single-component bulk powders when only particle-size distribution data are available.

The authors formulated and developed taste-masked RDFs of cetirizine hydrochloride for patients who experience difficulty in swallowing the tablet dosage form of the drug.

The author defines sanitizers, disinfectants, and antibiotics, and examines the question of whether the rotation of disinfectants is scientifically warranted.

The authors examine the challenges of integrating a large-scale chromatography and nanofiltration process for purification of a polyclonal antibody.

The authors propose that a postapproval management plan can serve as a tool to apply science- and risk-based approaches to the manufacturing process.