Solid Dosage - Pharmaceutical Technology

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Solid Dosage

Roche Recalls Viracept

June 14, 2007

ePT--the Electronic Newsletter of Pharmaceutical Technology

Basel, Switzerland (June 6)-Roche, in an agreement with the European Medicines Agency and the Swiss Agency for Therapeutic Products, recalled all batches of "Viracept" (nelfinavir) powder and tablets in Europe and some other regions of the world.

The Effect of Core and Coating Composition on Drug Release from Directly Compressed Time-Controlled Release Tablets

April 2, 2007

Pharmaceutical Technology

The authors prepared and tested press-coated tablets with various weight ratios of ethylcellulose to hydroxypropylcellulose (HPC) and various ratios of two different batches of HPC as an outer coating shell and fillers in core tablets. The tablets were examined for changes in time lag and release patterns of salbutamol sulfate.

Copolymerized PEGlyated Acrylate Hydrogels for Delivery of Dicolofenac Sodium

April 2, 2007

Pharmaceutical Technology

Hydrogels are biocompatible drug delivery systems by which the physical properties can be controlled by the cross-linking density. Hydrogels were prepared by copolymerization of acrylic acid monomers in the presence of poly(ethylene glycol)(PEG) to form polyethylene diacrylate (PEDGA). Various molecular weights of PEGs were used for the synthesis of PEGDA to study the effect of molecular weight of PEG on the properties of hydrogels. These hydrogels were further characterized for free water, swelling behavior, water diffusion, drug loading, and drug release profile. By analyzing the swelling behavior and release pattern of the hydrogels, the authors show that these systems can be suitably used for controlled delivery of drugs.

Near-Infrared Assay and Content Uniformity of Tablets

April 2, 2007

Pharmaceutical Technology

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.

Maintain Your Moving Parts

March 2, 2007

Pharmaceutical Technology

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

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

February 2, 2007

Pharmaceutical Technology

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.

Changing Fortunes in Pharmaceutical Manufacturing

January 31, 2007

PTSM: Pharmaceutical Technology Sourcing and Management

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.

Development of an Improved Fluidization Segregation Tester for Use with Pharmaceutical Powders

December 2, 2006

Pharmaceutical Technology

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.

Antimicrobial Preservatives in Protein Drugs

November 3, 2006

ePT--the Electronic Newsletter of Pharmaceutical Technology

AAPS, San Antonio (Oct. 31)-As biologic-based drugs become an increasingly larger part of pharmaceutical product portfolios, strategies for optimizing their formulation become increasingly important.

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