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Pre-Formulation Development

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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.

Pre Formulation Development

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

Medicilon brings the right equipment, facilities and highly dedicated formulation specialists to help you arrive at the optimal dosage form for your API and application. We ensure any forms we develop are scalable, compliant and commercializable for our customers.

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