Drug Development

Cormac Smyth is a product manager and Breda O’Driscoll is managing director at Ultrasonic Scientific Ltd, 1 Richview Office Park, Clonskeagh, Dublin 14, Ireland. Tel. +353 1 218 0600 Fax +353 1 218 0601 info@ultrasonic-scientific.com www.ultrasonic-scientific.com

Articles

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

Analysing Raw Materials and Formulations Using High Resolution Ultrasonic Spectroscopy

New Excipient Guidance Doesn?t Fill Regulatory Gap

IPEC-Americas has just completed a major update to its significant change guideline to address current issues in the manufacture of excipient ingredients and to assist manufacturers in developing an impurity profile.

IPEC-Americas? Updated Significant Change Guide for Bulk Pharmaceutical Excipients

Pharmaceutical Science & Technology Innovations

In the Spotlight-December 2004

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

Specifications of chemical substances for pharmaceutical use

Ashish A. Joshi, PhD, is a project coordinator at Roquette America Inc., 1417 Exchange Street, Keokuk, IA 52632, tel. 319.526.2219, ashish.joshi@roquette.com

Added functionality excipients facilitate the development of novel drug delivery methods and improve processing techniques.

Added Functionality Excipients: An Answer to Challenging Formulations

R. Christian Moreton, PhD, is vice-president of pharmaceutical sciences at Finnbrit Consulting and a member of Pharmaceutical Technology’s editorial advisory board.

The author suggests that an excipient's functionality can only be determined in the context of a specific formulation and manufacturing process.

Excipient Functionality

Ronelle Russell is an associate editor at 

Synthetic excipients frequently offer advantages over all-natural compounds.

Synthetic Excipients Challenge All-Natural Organics

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.

Selecting Lactose for a Capsule-Based Dry Powder Inhaler

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.

APIs and Excipients