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Aspects on the Quality of Lisuride TDS (Nenad ®) |
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| Putting a special focus on quality and
physical stability Lisuride TDS have been developed as a formulation with
a minimized risk of drug recrystallization over the shelf life. This could be achieved not only by an optimized manufacturing process but also by a composition containing excipients like a crystallization inhibitor and a solubilizer ensuring that the drug substance is kept completely dissolved within the active matrix and in addition Lisuride drug substance by itself does not exhibit any polymorphism. The efficacy of these measures has been demonstrated in a stability testing program evaluating the appearance of Lisuride TDS: Even after long-time storage at low temperatures no formation of Lisuride-crystals could be observed. With the drug substance remaining dissolved in the active layer at all storage conditions Lisuride TDS provide a constant transdermal flux and therefore a consistent and stable high efficacy throughout the shelf life. The full documentation of respective data, specifications and evaluations is part and contained in the regulatory dossier which was submitted to the European Regulatory Authorities (EMEA, London) in May 2008. |
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