Manufacturing

Mar 01, 2004
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Electrical resistance, low temperature scanning calorimetry, and freeze-drying microscopy are three analytical methods that can be used to determine the thermal characterization of a product during processing for intended development of a lyophilization cycle.
Mar 01, 2004
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The author covers the fundamentals of lyophilization and provides case studies about the development of lyophilized biopharmaceutical products and the importance of biophysical characterization in formulaiton and the lyophilization process.
Feb 01, 2004
Pharmaceutical Technology Europe
This article describes the use of a one-pot processor for the cleaning and cleaning validation of two drug compounds - water-soluble theophylline and water-insoluble mebendazole. Both substances were produced using wet granulation and microwave drying, after which the processor was cleaned using its clean-in-place (CIP) system. Swab samples were taken from areas considered critical during processing and analysed for remains of active ingredient. It was concluded from the results that the processor's CIP system is capable of removing both moieties to a level well within accepted regulations.
Jan 02, 2004
Pharmaceutical Technology
With new features such as servo-controlled operations and modularity, today's packaging machines offer enhanced flexibility, increased uptime, and reduced product waste.
Dec 01, 2003
Pharmaceutical Technology Europe
The use of solid dispersion technology to increase the bioavailability of poorly water-soluble drugs has always been limited by processing and scale-up difficulties. A new approach may help to overcome some of the problems.
Nov 02, 2003
Pharmaceutical Technology
By Pharmaceutical Technology Editors
FDA's aseptic processing draft guidance and the industry's state-of-the-art isolator technologies prepare manufacturers for the next generation of contamination control solutions.
Nov 01, 2003
Pharmaceutical Technology Europe
Previous articles have presented a general review of the different types of spheres that can be obtained using a rotary fluidized bed process.1,2 Part I of this study focussed on lipid spheres prepared using hydrogenated castor oil for formulations with low active drug content. The feasibility of the process and the main characteristics of spheres obtained were also studied. In Part II, formulations with higher concentrations of active drug are examined.
Oct 02, 2003
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The author brings attention to the connectivity problems among various data-gathering systems and discusses the drivers and benefits of change, including PAT.
Oct 02, 2003
Pharmaceutical Technology
The process of designing a new drug package must follow specific steps to ensure low costs and rapid market approval.
Oct 01, 2003
Pharmaceutical Technology Europe
Determining whether a data point is an "outlier" - a result that does not fit, is too high or too low, is extreme or discordant - is difficult when using small data sets, such as the data from three, four or five conformance runs. In this article, the authors demonstrate that the Weisberg t-test is a powerful tool for detecting deviations in small data sets.
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