Dear Partners,

Necessitated by the unprecedented situation created by Covid-19, several industry events and tradeshows across the world have been postponed or stand cancelled. While we were looking forward to meet you, we at Piramal Pharma Solutions have had to take several precautionary measures to protect both our employees and customers, worldwide.

As we move forward in these extraordinary times, we want to assure you that that we are operational by taking the right safety measures and abundant precautions to ensure that we continue to support you and your patients.

While all of us are working remotely for now, you can schedule a discussion with us and we would be glad to help ensure you meet your pharmaceutical development and supply needs and thereby, your clinical and commercial timelines.

Please feel free to reach out to us at:

Our best wishes to colleagues, friends and family.

Best Regards,
Piramal Pharma Solutions

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Pre-Formulation Studies

By utilizing small quantities of Active Pharmaceutical Ingredients (API) or druggable candidates, our preformulation services can provide valuable information and expertise to guide the compounds towards the next steps.

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, and ICH photo stability
  • Inherent properties: pKa, Log p/Log D, Intrinsic dissolution
  • DOE based solvent, buffer, ionic strength, and stabilizer excipient screening for formulation development

Formulation development for testing

  • 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
    • Includes PXRD, TGA, DSC, Polarized Light Microscope (PLM), Dynamic Vapor Sorption (DVS/hygroscopicity), and Particle Size Analysis (PSA)
  • Polymorph screening
    • Identify multiple polymorphs to avoid surprises later in drug development to recommend thermodynamically most stable form
  • Crystallization process development
    • Includes but not limited to polymorphism investigation, crystal size distribution measurement, and drying investigation to deliver API with desired properties
  • Formulation support
    • Excipient compatibility studies
    • Micrometrics (Powder properties evaluation)