Formulation Development

Sol Tech® Solutions focus on the Solid State Science and Enabling Technology in pharmaceutical product development, ranging from polymorph selection to formulation development.

Sol Tech® Solutions provide the precise control of the solid state properties of drug substance both in API manufacturing and in finish product commercialization, with rigorous science and real data.

Sol Tech® Solutions enable the development of drug products with challenging bioequivalence or IP issues .

Formulation Development

Goal

  • Product (tablet, capsule, injectable, etc.) quality assurance
  • IP value addition
  • Regulatory filing risk minimization

Technology Package

  • Analytical method development and validation
  • Dissolution method development
  • Excipient compatibility report
  • Critical process parameter evaluation
  • Process safety assessment
  • Dissolution study as compared to RLD
  • Stability study report
  • Packaging compatibility report
  • Standard operation procedure
  • Patent assessment report
  • CTD format dossier

Preformulation

Goal

  • Drug substance physiochemical property evaluation (pKa, LogP/D, solubility, etc.)
  • Key excipients selection
  • Critical formulation parameter identification

Technology Package

  • Drug substance physiochemical property assessment
  • Powder bulk property characterization
  • Excipient compatibility
  • Formulation parameter evaluation
  • Formulation strategy recommendation

RLD Reverse Engineering

Goal

  • Decoding the quantitative formula
  • Solid-state characterization of drug substance
  • Identifying the manufacturing process

Technology Package

  • Solid-state characterization report of drug substance
  • Formulation composition table and analytical report
  • Prediction of manufacturing process flow chart