Friday, November 30, 2012

The optimal solid form

From an advertisement:
 
Selection of the optimal solid form is a critical decision in the development lifecycle. It is also an effective means to overcome development challenges and accelerate the development and commercialization of small-molecule drug candidates.

Each solid-state form of an API has unique physicochemical properties that can have a profound impact on bioavailability, stability, and manufacturability. By discovering and characterizing the diversity of solid-state forms, it becomes possible to select an optimal form that displays an appropriate balance of properties that is critical for successful preclinical evaluation and product development, as well as robust manufacturing processes.

The optimal solid form such as crystal-form, salt or cocrystal can:
 
  • Enhance the solubility and bioavailability relative to a crystalline form of the parent molecule
  • Reduce pharmacokinetic variations (dose-to-dose, inter-subject and inter-species)
  • Improve the stability of the API and drug product
  • Increase the robustness of the manufacturing process of the API and drug product, and
  • Accelerate development and commercialization
Which solid form is more suitable for your product?

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