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Pre-Formulation Studies

Preformulation Studies

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

Pre-Clinical 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, Solid State & ICH Photo Stability
  • Inherent Properties: pKa, Log p / Log D, Intrinsic Dissolution

Enabling Formulation Development for Screening

  • Vehicle Selection
  • pH adjustment and co-solvent
  • Surfactant solubilization
  • Nano-Suspension
  • Micro-emulsion
  • Amorphous Solid Dispersion

Clinical Phase Analytical Support – Drug Product

  • Solid-state characterization
  • Analytical methods development and transfer
  • Analytical method validation
  • Dissolution assay development and testing
  • Stability Studies –accelerated and Full ICH

CMC Support Service

Solid State Characterization

A full spectrum of solid state characterization including PXRD, TGA, DSC, Polarized light microscope (PLM), dynamic vapor sorption (DVS / hygroscopicity), particle size analysis (PSA) and water content is provided to ensure the solid form is well characterized for various aspects

Polymorph Screening

Polymorph screening is provided to help clients identify as many polymorphs as possible at an early stage to avoid any surprise later in development. The thermodynamically most stable form is determined and recommended to clients.

Crystallization Process Development

Piramal provides full support on crystallization process including but not limited to polymorphism investigation, crystal size distribution measurement and drying investigation to ensure a robust crystallization process able to deliver API with desired properties

Formulation Support

  • Excipient Compatibility Studies
  • Micrometrics (Powder Properties Evaluation)

Locations

  • Mumbai, India
  • Ahmedabad, India
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