Pharmaceutical Technology-03-02-2008

Pharmaceutical Technology

Product Annual/Quality Review: US–EU Comparative Analysis and Interpretations

March 02, 2008

Peer-Reviewed Research

32

3

There are significant differences between the United States and European Union requirements for the annual review of records related to the manufacturing and control for pharmaceutical products and active pharmaceutical ingredients.

Report from: India

March 02, 2008

News

32

3

A. Nair discusses patent disputes in India.

Holding Back

March 02, 2008

Agent-In-Place

32

3

If not properly monitored, filters and plastic bags can keep back more than they should.

Inside USP: Metrology and USP Dissolution

March 02, 2008

Inside USP

32

3

The United States Pharmacopeia emphasizes mechanical calibration and a performance test to esnure integrity of the dissolution procedure.

Pharmaceutical Technology's Equipment and Machinery Trends Survey

March 02, 2008

Special Report

32

3

The pharmaceutical industry plans moderate increases in spending for equipment and machinery in 2008. Investments include equipment for solid-dosage manufacturing, active pharmaceutical ingredients, and parenteral manufacturing.

Peer-Reviewed Technical Note: Influence of Common Excipients on the Crystalline Modification of Freeze-Dried Mannitol

March 02, 2008

Peer-Reviewed Research

32

3

Mannitol is the most commonly used bulking agent in freeze-drying formulation design. The benefit of using mannitol is that it crystallizes during freezing and permits drying processes at higher product temperatures, and thus with higher sublimation rates relative to purely amorphous systems (1). Mannitol, however, is known to form different crystalline modifications which compromises reproducibility of product characteristics and storage stability due to phase transformations (2, 3).

SAFC Sets Forth an Ambitious Growth Strategy

March 02, 2008

Online Exclusive

32

3

SAFC is delivering on its plan for double-digit annual growth by increasing its businesses through organic growth and targeted technology acquisitions.

Salt Selection in Drug Development

March 02, 2008

Peer-Reviewed Research

32

3

The selection of an appropriate salt form for a potential drug candidate is an opportunity to modulate its characteristics to improve bioavailability, stability, manufacturability, and patient compliance.

In the Spotlight March 2008

March 02, 2008

In the Spotlight

32

3

Editors' Picks of Pharmaceutical Science & Technology Innovations; Analytical system provides multiuser capability; Encapsulator aids dosage design; Versatile drive offers quick setup

Innovation at Interphex

March 02, 2008

Online Exclusive

32

3

A preview of some product enhancements and launches for Interphex 2008, the large trade show being held Mar. 26–28 in Philadelphia.

Peer-Reviewed Topical Review: The Importance of Quality in Corrosion-Resistant Alloys in Biopharmaceutical Manufacturing

March 02, 2008

Peer-Reviewed Research

32

3

In this topical review, the authors discuss the rationale behind microstructural requirements for biopharmaceutical equipment and problems that may be encountered during the fabrication of high-performance corrosion-resistant equipment.

Packing-Line Improvement Based on a Fault-Tree Analysis Approach

March 02, 2008

Peer-Reviewed Research

32

3

This article focuses on upgrading and improving a packing process to comply with current good manufacturing practices. The authors sought to maintain proper quality assurance for finished products.