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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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