In-Process Control Methods for the Manufacture of APIs 01 October 2005 By: Jose Zayas, Victor Sanchez, Michelle Talley

In-process methods are key components of quality control in a chemical manufacturing plant. These methods ensure that a production reaction step conducted by trained operators within the entire validated process will produce a quality chemical entity in the expected yields. The presence of impurities and related compounds (derived from the reaction or secondary reactions) is a critical parameter that determines a synthetic material's quality.

HR-US is a nondestructive technique with enormous potential for the analysis of materials and formulations used in the pharmaceutical industry.

A harmonized global specification is possible providing that the procedures and acceptance criteria defined are acceptable to regulatory authorities in all regions.

Physicochemical Approaches to Enhancing Oral Absorption 01 September 2004 By: Luigi G. Martini, Patrick J. Crowley

This article reviews various physicochemical approaches that may be employed to enhance absorption following oral administration of solid dosage forms in humans. This article also examines strategies based on capitalizing or neutralizing physiological processes.

Selecting Lactose for a Capsule-Based Dry Powder Inhaler 01 April 2004 By: Hartwig Steckel, Peter Villax, Fadi Eskandar, Malte Borowski

Dry powder inhalers are a well-accepted dosage form for pulmonary drug delivery and a wide variety are either currently available or in development. This article examines a premetered, capsule-based multidose inhaler for which different qualities of a-lactose monohydrate were screened.

Development of PVA Copolymer Capsules 01 April 2004 By: Noboru Hoshi, Shunji Uramatsu, Toshio Shimamoto, Toshihiro Ogura

The bioavailability of some insoluble drugs is enhanced when they are dissolved in the solubilizing agent macrogol 400, although conventional hard capsules cannot tolerate the agent. This article investigates a PVA copolymer, which has been developed by the authors, examining its properties and its suitability as a material in capsule formulations.

Predicting Flowability and Characterizing Powders 01 January 2004 By: Reg Freeman

This article reflects on the challenges that predicting powder flowability currently pose to the pharmaceutical manufacturing industry and considers some of the benefits that can accrue when companies overcome these issues.

Manufacture and Dissolution Studies of Lipid Spheres: Part I 01 October 2003 By: Jean-Marc Aiache, Pascale Gauthier

Previous articles have presented a general review of the different types of spheres that can be obtained with a rotary fluidized bed process.1,2 This two-part study focusses on lipid spheres that can be prepared using hydrogenated castor oil, as well as examining the feasibility of the process and the main characteristics of the spheres obtained.

Erythritol: A New Multipurpose Excipient 01 October 2003 By: Geertrui Haest, Jacques Michaud

Erythritol is a bulk sweetener polyol that is suitable for a variety of reduced-calorie and sugar-free foods. It has been part of the human diet for thousands of years because of its presence in foods such as fruit, mushrooms and fermentation-derived products including wine, soy sauce and cheese. This article investigates the properties of erythritol and describes how it can be used as a pharmaceutical excipient.