Pharmaceutical Technology Europe-08-01-2005

Cold chain management is becoming pivotal to success in the pharmaceutical industry.

The question of pharmaceutical pricing is going to be resurrected by the European Commission, despite French President Jacques Chirac's rejection of the new EU treaty. Günther Verheugen, the Commission vice president, made this announcement at the annual meeting of the European Federation of Pharmaceutical Industries and Associates in Brussels (Belgium) responsible for competitiveness.

To help meet the needs of the fast-growing, global biopharmaceuticals industry, Pall Corporation has launched five innovative technologies aimed at increasing drug-manufacturing efficiency through customization and disposability. The Mustang XT5000 capsule is the company's novel chromatography technology for efficient capture of large molecules, especially used to develop DNA and virus-based drugs. Expanding its portfolio of technologies for disposable processing, Pall offers both the customizable Tangential Flow Filtration system, which incorporates single-use components for downstream processing applications, and the Kleenpak Connector — a new single-use device, which enables aseptic connections to be made instantly.

API and fine chemicals companies in Asia are flexing their muscles in a bid to increase their market share in key territories. This has been demonstrated by India's Malladi Drugs and Pharmaceuticals, which earlier this summer acquired Novus, a US company, to boost its presence in the pseudoephedrine (an ingredient used in cough and cold formulations) market. Reportedly, this is the first time (and it certainly won't be the last) that an Indian API manufacturer has bought a US counterpart and drives home the message that Indian companies are looking at providing products on a global scale. The deal gives Malladi an almost vice-like grip on a third of the global pseudoephedrine market, and more importantly, a foot in the lucrative US sector.

The first part of this article introduced the basic features of Raman spectroscopy and presented some examples of its application in the pharmaceutical industry. This second part focusses on the technique's application as a PAT tool within the pharmaceutical manufacturing environment. FDA's PAT initiative has provided motivation to explore the application of 'new' analytical technologies to the pharmaceutical manufacturing process and Raman spectroscopy shows great promise. The strengths and weaknesses of the technique as a potential PAT tool are discussed together with some examples of how this works in practice in a pharmaceutical manufacturing environment.

Reading the good automated manufacturing practice (GAMP 4) guide acquaints you with the now classic and almost famous V-model.1 The V-model, originally used for describing a validation workflow of IT and automated systems, is easy to understand and very good at ensuring that the requirements and design are built into the final solution. It is also extremely versatile and can be used for almost any type of validation task you could meet in a development phase.

Measuring, understanding and ultimately controlling manufacturing processes offers pharmaceutical companies a route to greatly enhance the business effectiveness of both their product development process and facilities. PAT creates technological, business process and regulatory frameworks to enable this. This paper looks at a PAT overview within the context of developing and manufacturing a tablet product, highlighting the potential of FT-NIR spectroscopy.

The aim of this study was to analyse the process of tablet formation and the properties of the final tablets for six different carrageenans. The carrageenans used were based on the basic types of ?-, ?- and ?-carrageenan. Microcrystalline cellulose was used for comparison. Determination of material properties, compression analysis and tablet properties were described. Water content, particle size and morphology, glass transition temperature, and crystallinity were studied. The results show that the carrageenans are predominantly amorphous fibres, which are in the rubbery state during tabletting.

Process analysers have evolved from basic analogue devices with adjustable potentiometers, analogue current outputs and alarm relays into smart, powerful, two-way digital transmitters with advanced features, such as automatic calibration and self-diagnostics, that can transmit more information, more accurately. This article will discuss advances in process analytical devices and how they can be applied to both new and existing pharmaceutical facilities.

Colorcon has opened three specially equipped design centres devoted to tablet brand imaging. Located in West Point (PA, USA), Dartford (UK) and Goa (India), the facilities form an integral part of the brand enhancement system for tablets — a unique service supporting new product development and brand management of an existing product. Each design facility is equipped for collaboration between Colorcon experts and a client's own project team.