Formulation Development

Formulation development services cover the wide development spectrum from early safety studies to toxicity studies; proof of concept formulation development and late stage formulation development, to dosage manufacturing, packaging, and development for product life cycle management extension. Packaging and storage conditions are suggested based on thorough stability studies.

Proof of concept formulation development for early stage clinical trials:

  • Solutions
  • Suspensions (microsuspensions & nanosuspensions)
  • API filling into bottles (powder in bottles)
  • API encapsulation / vial filling using Xcelodose 120S & 600S
  • Dry blending and encapsulation
  • Liquid fill into hard gelatin capsules (enabling technology)
  • Spray drying (enabling technology)
  • Granulation (dry & wet) and encapsulation/ tableting
  • Direct compression
  • Sachets

Late stage formulation development:

  • Initial formulation design and screening leading to lead prototype (composition and processes) identification
  • Choosing suitable manufacturing process
  • Scale-up of prototype
  • Process parameters optimization for manufacturing process using QbD approaches
  • Manufacturing of batches for stress stability (ICH conditions)
  • Scale-up of batches and technology transfer

Life cycle management – new formulation development support:

  • Enable and impart late stage NCE or “marketed compounds” with new product attributes
    • Improve safety profile
    • Enhance efficacy and or afford new treatments
    • Improve compliance and usage
      • Rapid onset, taste masking, new route delivery, etc.
      • Controlled or sustained release to reduce dosing frequency
  • Extend market exclusivity
    • Create product differentiation and enhance product performance through formulation innovation
    • Enable new product extension
    • Potential market protection through new IP generation

Enabling formulation technology support:

  • Solubilization improvement
    • Micronization using air jet mill
    • Nanosuspension or microsuspension followed by granulation
    • Spray dried amorphous solid dispersion
    • Hot melt extrusion
    • Liquid filled hard gelatin capsules
  • Modified release tablet formulations with one or two layers
  • Sustained release or delayed release pellets in capsules

Instrument Highlights

The PDS formulation development laboratories are equipped with state-of-the-art fluid bed dryers and coater, high shear granulators, hot melt extruder, dry granulator, spray drier, automated monolithic and bilayer tablet press machines, automated capsule filling machines including Xcelodose Precision Micro-filling Systems, Bosch, In-Cap and Bonapace, autocoaters, weight sorters, metal detectors, automatic blister packaging machines, sachet filling machine and bottle packaging line.