38 DRUG DISCOVERY AND DEVELOPMENT
“An improper tablet shape can cost millions in lost production and sometimes even cause a complete disaster.”
Fig. 2. Stress distribution on the punch face. Red designates tool failure.
punch tip and towards the die wall, which in turn extruded through the punch and die clearance (Fig.1).
Te FFBE tablet design became common as it helped to deflect or guide the powder back into the tablet, hence reducing soft edges. Although the FFBE design proved to be beneficial for reducing soft edges, it presented a new problem, which was punch tip failure. On an FF punch tip, there was virtually no cup or cup
depth of the punch tip: it was simply flat, so there was not a cup limiting compression force, pressure limits were determined by the punch tip size to reduce tip bending and distortion. Today there is an alternative to the FFBE tablet design and it is referred to as the Flat Face Radius Edge or FFRE design. Te FFRE is much more robust and has several advantages over the FFBE:
n Te FFRE can accept more
pressure than the FFBE due to eliminating the bevel and replacing it with a radius. Doing this allows maximum compression forces in many cases to almost double, allowing more pressure to alleviate conditions such as sticking and picking (Fig. 2).
n Better uniform tablet hardness as the powder has a natural flow across the radius, which can reduce hot spots and or discolouration to the perimeter
Parkinson’s vaccine: top experts unite in European consortium
An international consortium of top European research teams has received significant EU funding for the development of therapeutic vaccines against Parkinson’s Disease (PD) and Multiple System Atrophy (MSA). Led by the Austrian biotech company
AFFiRiS AG, the consortium will use a novel tandem strategy to advance the development of two therapeutic vaccine candidates in parallel. They are both unique in the potential for disease modification, something which is sorely missing in PD as well as in MSA. Both candidates target a protein called alpha-synuclein, which plays a key role in the onset and progression of PD and MSA. Additionally, the group attempts to
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identify biomarkers with diagnostic and prognostic value. The project SYMPATH has been awarded €6m from the 7th Framework Program of the EU and will run for 48 months. Parkinson’s disease is the second
most common neurodegenerative disorder among the elderly with approximately 1.2m European patients alone. Currently there is no cure for the disease and existing therapeutic measures are only able to treat its symptoms.
Multiple system atrophy is a rare,
orphan status neurodegenerative disorder. It progresses rapidly leading to death of the affected individual within, on average, 6-9 years. There is currently
no cure for the disease. The leader in the field of alpha-syn-
Immunotherapy, AFFiRiS rallied medical experts and basic scientist from eight high-profile European organisations for the successful FP7 project named SYMPATH. These institutions include the Forschungszentrum Jülich in Germany, the INSERM F-CRIN Toulouse and the departments of Neurology at the University Hospitals of Bordeaux and Toulouse from France, as well as the Medical University of Innsbruck’s Department of Neurology and PROSENEX from Austria. The SYMPATH project especially
focuses on an outstanding, innovative approach to the clinical testing of the
two candidate vaccines. Using a novel tandem strategy, the consortium will concomitantly evaluate the safety and explore the activity of both vaccine candidates in clinical phase I studies for both indications, PD and MSA. In fact, the tandem strategy allows for direct comparison of the two vaccines already at an early stage in clinical development. Dr. Markus Mandler of AFFiRiS AG
adds: “.Based on the excellent safety profile of all vaccine candidates, this programme allows for a very quick testing of new vaccine candidates in man.”
For more information, visit
www.sympath-project.eu
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