Polymorphism refers to different crystalline forms of a drug substance that differ in physical properties. Polymorphism often occurs unintentionally during drug development and manufacturing. About half of drug candidates fail clinical trials due to efficacy, safety or solubility issues related to polymorphism. Proper evaluation of a drug's polymorphic forms and their stability is important to ensure the drug's effectiveness and safety.

1. Polymorphism

2. ICH Q6A defines polymorphism as
“some new drug substances exist in
different crystalline forms which
differ in their physical properties.”

5. Polymorphism unavoidably occurs during discovery,
development, and/or manufacturing process.
“Almost every substance can exist in two or
more solid phases provided the experimental
conditions are suitable.”
W. Ostwald

6. “About 50 % of drug candidates that enter clinical
trials fail due to efficacy and safety concerns, and the
remaining 40%fizzle due to patent concerns and
issues like solubility and drug interaction.”
J. Garnier
Polymorphism greatly contributes to biological activity.

14. How to evaluate stability ?

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