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製剤化予備検討

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With a very small quantity of active pharmaceutical ingredients (API) or druggable candidate molecules, Medicilon’s pre-formulation service can provide valuable information and expertise to guide the compounds to next steps. Our pre-formulation team has extensive experience on handling a wide range of compounds and we can suggest the path forward for early success.

Preclinical Candidate Characterization

Solubility:

  • pH solubility profile
  • Solubility in organic solvents
  • Solubility in Fasted State Simulated Intestinal Fluid (FaSSIF), Fed State Simulated Intestinal Fluid (FeSSIF) and Simulated Gastric Fluid (SGF)

Stability:

  • Solution stability, solid state stability, ICH photostability

Inherent Properties:

  • pKa, Log p/Log D, Intrinsic dissolution, etc.

Enabling Formulation Development for Screening

  • Vehicle selection
  • pH adjustment and co-solvent
  • Surfactant solubilization
  • Nanosuspension
  • Microemulsion
  • Amorphous solid dispersion

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