Pre-formulation studies

Stability studies

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mercoledì 22 aprile 2015

The thermodynamic relationships between polymorphic forms is crucial and must be established carefully, because as drug crystallises from different conditions the kinetically favoured metastable polymorph appears first.

However, this metastable polymorph may undergo environmental induced transformation to produce thermodynamically stable form at its own expense, affecting important properties such as the ability to process and/or manufacture the drug substance and the drug product, as well as on drug product stability, dissolution rate, and bioavailability.

How can we help you?

  • Obtain a detailed knowledge of the stability of different crystal forms and their interrelationship
  • Identification of the best physical form by evaluating physical and chemical changes in accelerated storage tests

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