Dosage Forms

Articles

Near-infrared (NIR) assay and content uniformity of tablets provide fast, accurate means of monitoring tablet production that are in step with FDA's process analytical technology initiative.The authors discuss the process for testing a newly released NIR tablet analyzer to determine instrument precision and accuracy using chlorpheniramine maleate tablets.The data show promising results that could relieve laboratory workload of high-performance liquid chromatography analysis and bring analysis closer to real time for process monitoring.

Near-Infrared Assay and Content Uniformity of Tablets

A wealth of citations helps illustrate the applicability of the analytical methods and also highlights their pitfalls.

A Solid Contribution to Spectroscopy

When a dosage form or an API is introduced to the gastrointestinal tract, or dissolution media mimicking it, a transformation from a metastable to a more stable form with lower solubility and bioavailability is possible.

Monitoring of phase transformations during processing of solid dosage forms

Just because the wheels are turning doesn't mean they're going forward.

Maintain Your Moving Parts

Rakesh P. Patel is an associate professor in the Department of Pharmaceutics and Pharmaceutical Technology, S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Gujarat, India.

Madhabhai M. Patel is a professor in the Department of Pharmaceutics, Kalol Pharmacy College, Kalol, Gujarat, India.

The objectives of this study were to prepare and characterize inclusion complexes of lovastatin with hydroxypropyl-β-cyclodextrin (HPβ-CD) and to study the effect of the complexes on the dissolution rate of lovastatin (LVS). The findings suggest that LVS's poor dissolution profile can be overcome by preparing its inclusion complex with HPβ-CD.

Solid-State Characterization and Dissolution Properties of Lovastatin Hydroxypropyl-β-Cyclodextrin Inclusion Complex

For solid oral-dosage forms, water testing usually is performed to control the chemical, physical, or microbiological properties of the drug product. Measurements of total water as made with Karl Fischer (KF) techniques is not needed and water-activity often will provide a better correlation with changes in chemical, physical, or microbiological properties than KF techniques. In these cases, water activity testing can easily replace KF testing. Water-activity measurements are nondestructive, require little labor, and the equipment required is generally inexpensive. Only a few simple checks are needed to ensure the validity of measurements. Strategies for implementing water activity testing are described.

Implementation of Water-Activity Testing to Replace Karl Fischer Water Testing for Solid Oral-Dosage Forms

The same phenomena that create lightning and thunderstorms are around us every day, producing incredibly high voltages, which cause sparks and shocks. Static electricity is a mighty force. Each year excessive electrical charge build cause explosions in the grain industry.1 Look around any flammable storage area and you will see both grounding bars on the wall and cables, from the grounding bars connected to the drums of solvents. Take any material safety data sheet (MSDS) for a powder and look in section V; it highlights that any dry powder has the potential to attract and store a charge.

Static electricity in solid dosage manufacturing

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Pfizer's restructuring plan provides yet another example of new supply-chain strategies by the pharmaceutical majors, which involve rationalization of manufacturing facilities and cost improvement. A review of these moves, an outlook for the pharmaceutical market in 2007, and analysis of US pharmaceutical production and trade.

Changing Fortunes in Pharmaceutical Manufacturing

Ali Nokhodchi, PharmD, PhD, is an associate professor of pharmaceutics and visiting professor at King's College, Department of Pharmacy, School of Health and Life Sciences, Franklin-Wilkins Building, 150 Stamford St., London, Englad SE1 8WA.

Water interacts with pharmaceutical solids at virtually all stages of manufacture, from synthesis of raw materials to the storage of the final dosage form. The interactions of water with powders is, therefore, a major factor in the formulation, processing and product performance of solid pharmaceutical dosage forms.

The effect of storage conditions on the physical stability of tablets

This article describes the design and development of a material-sparing fluidization segregation tester for use with pharmaceutical powders. This tester offers several improvements over the current ASTM standardized test practice. Less than 20 mL of material is required to characterize the fluidization segregation potential of a sample. Features of the tester include powder containment for potent compounds, in-process monitoring of the fluidization conditions, and sample retrieval without the need for subsampling or riffling for typical analyses.

Solid/Semi-Solid Dosage