Formulation Development Services

NDA Formulation Strategy

• 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

ANDA Formulation Strategy

• Select of RLD, overall profile of RLD
• Formulation development by screen critical factors
• Process development base on QbD
• Package
• Scale up and technical transfer
• Stability

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