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Formulation Development & Pharmacokinetics

CSIR-CDRI provides a comprehensive suite of physicochemical analysis solutions and expertise essential for advancing drug formulation development. These services ensure that each formulation is optimized for bioavailability and processing requirements, including detailed characterization of drug properties, rigorous solubility and stability testing, and thorough compatibility studies with excipients and delivery systems.

  • 1. In vitro ADME
    • a) Solubility
    • b) Simulated intestinal and gastric fluid with and without enzymes
    • c) Permeability
    • d) Plasma stability and plasma protein binding
    • e) Blood to plasma ratio
    • f) Metabolic stability (microsomal/S9)
  • 2. Method Development
    • a) Bioanalytical method development
    • b) Method validation as per FDA guidelines
  • 3. Single dose PK studies in rodents
    • a) Oral
    • b) Intravenous
  • 4. Metabolic reaction phenotyping
    • a) Preclinical species
    • b) Human (microsomes and recombinant enzymes)
  • 5. Tissue distribution
  • 6. Excretion (urine and feces)
  • 7. PK in non-human primates (samples provided by Toxicology Div.)
  • 8. Dose proportionality study ( at three dose X, X/2 and 2X)
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