Press Room

The use of spray drying in the pharmaceutical industry is growing at a fast pace. The need for robust scale-up methods is essential in order to control critical quality attributes and improve powder properties during drug development. Moreover, poor scale-up is likely to lead to considerable losses of expensive materials. Process understanding and simulation is a very powerful tool to support the scale-up of spray drying processes. A scale-up methodology based on scientific principles is proposed in this study. The method is divided in two steps: thermodynamic and atomization & particle formation. The method is relatively straightforward to apply and has been tested in numerous spray-dried formulations across all production scales. An illustrative example is also shown covering the main steps of the proposed methodology. Read article here

Article
Chemistry Today, July/August 2010

Scale-up methodology for pharmaceutical spray drying

Jul 31, 2010

Counterfeit medicines are an acknowledged crisis that takes patient risk to unacceptable levels – the authors argue that this is but the visible part of the iceberg. Counterfeit APIs are the much larger submerged part of the iceberg. Counterfeit APIs are a more serious issue as it represents a threat to the integrity of the legal supply chain of medicines, it potentially impacts a much larger number of patients and European and Japanese authorities do not yet perceive it as a threat – as such they may well remain outside the scope of proposed falsified medicines legislation and enforcement objectives. The pharmaceutical industry and its supply chain appear alone at taking steps to address this criminal threat. Read article here

Article
Chemistry Today, July/August 2010 (Supplement)

Who is making the Pharmaceutical Supply Chain safe?

Jul 01, 2010

Custom manufacturers take on drug solubility issues to help pharmaceutical firms move products through development When they get together, pharmaceutical researchers call drug compounds by nicknames such as “brick dust” and “grease.” Whether compounds are crystalline rocks, lipophilic goo, or something in between, getting them to be water soluble can be a major hurdle for making therapies bioavailable in the body. If the bioavailability is low, meaning only a fraction of a dose gets into circulation, even the best molecule can fail as a drug. About 40% of marketed drugs are thought to be poorly water soluble. Development efforts might have to be redoubled, however, because between 70 and 90% of drug candidates in the pipeline are believed to have low solubility. In fact, solving solubility problems is considered to be the leading challenge in drug development. Read article here

Article
C&EN, 31 May, 2010

Finding Solutions

May 31, 2010

Drug manufacturer Hovione has opened a new spray drying facility in Loures, Portugal, for potent active ingredients. Marco Marques, head of production, describes the safety protocols. Pharmaceutical contract manufacturer Hovione has recently received a significant number of new spray drying projects with special containment requirements. The company’s answer to this market demand has been to install a new spray dryer unit in a dedicated manufacturing suite at its site in Loures, Portugal. The facility design allows the handling of potent compounds up to class III, according to independent health & safety consultant SafeBridge, and it complies fully with good manufacturing practices (GMP) as required by international drug authorisation bodies. Read full article

Article
Cleanroom Technology, May 2010

Handling potent drug materials

May 31, 2010

Advances in drug formulation and inhalation device design are creating new opportunities for inhaled drug delivery as an alternative to oral and parenteral delivery methods. Much of the interest in pulmonary delivery of systemic drug therapies is focused on chronic diseases and refractory conditions, ailments that require frequent drug administration for a protracted period of time. Read article here

Article
Drug Delivery Technology, April 2010

Inhalation: Going Beyond Asthma. Interview: Peter Villax and Jason Suggett

Apr 30, 2010

“It is much harder to be in this business today than it was five or 10 years ago,” admits Hovione Chief Executive Officer Guy Villax. Although Villax believes that having a clear strategy is increasingly fundamental to success, he admits that “it’s quite tough and requires much better thinking to come up with the value proposition that you present to your customers.” Read article here

Article
C&EN, 8 February, 2010

Custom Chemicals. After struggling through 2009, contract manufacturers are honing their strategies and hoping for a better 2010

Feb 08, 2010

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