Formulation Development

Xcelience handles formulation development of both NDA and ANDA dosage forms, as well as formulation troubleshooting and process development of existing dosage forms. The Xcelience team can also provide quantitative and qualitative evaluation of proprietary dosage forms.

Services/Capabilities

• Excipient compatibility
• Formulation development of both NDA and ANDA dosage forms
• Formulation troubleshooting and Process Development of existing dosage forms
• Optimization of existing formulations
• Quantitative and Qualitative evaluation of proprietary dosage forms

Formulation Dosage Forms

Liquid Dosage Forms

• Development of dosage forms and preservative systems
• Development and optimization, lyophilization

Semi-Solid Dosage Forms (oral, mucosal, topical)

• Emulsions and micro-emulsions
• Gels (aqueous, nonaqueous)
• Lipid solutions and suspensions

Solid Dosage Forms

• Capsules (hard gelatin), (granulated or dilution blend)
• Direct compression, dry and wet granulation, bead coating, lyophilization
• Tablets (immediate release, modified release, sustained release, chewable, lozenge)

Topical Formulations

• Creams, ointments
• Gels, solutions
• Lotions

Parenterals

Test

Physical Testing of Powders

• Bulk and tap density
• Particle size analysis
  • Laser diffraction
  • Sonic sifter

Physical Testing of Solids

• Weight variation
• Thickness
• Hardness
• Friability
• Disintegration

Solutions, semi-solids

• Osmolality
• pH viscibility
• Sedimentation
• Viscosity
• Brookefield RVOVIII
• Rheometer