Ceutix Labs Services

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Preformulation and Developability

Ceutix Labs scientists can provide insight into physical form challenges and developability solutions.  

Services include:

  • Solubility Studies
  • Polymorph Characterization
  • Particle size analysis 

Techniques inlcude:

  • Vapor Sorption Analyis
  • Modulated Differential Scanning Calorimetry (mDSC)
  • Thermogravimetric Analysis (TGA)
  • Optical Microscopy 
  • X-Ray Diffraction (XRD)
  • Laser scattering particle size analysis  (Malvern Mastersizer 3000)

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Formulation Development

Ceutix Labs formulation development scientists offer a wide array of techniques for formulation design and development for:

  • Toxicolgy Studies
  • First in Human studies 
  • Poorly soluble drug substances
  • Pediatric options including ODTs (Orally Disintegrating Tablets)
  • Solid, Oral Dosage Forms
    • Immediate Release
    • Modified Release

Formulation development capabilities include:

  • Size reduction (impact, jet and bead mills)
  • High shear granulation
  • Dry sizing
  • Fluid bed granulation
  • Blending
  • Melt granulation
  • Compression
  • Tablet coating
  • Encapsulation

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Analytical Development

Ceutix Labs analytical scientists provide method development and formulation development support.  Formulation development support include support of internal projects, as well as client in-house or other CDMO-based development projects.

Method development activities include:

  • Drug Substance
    • Intermediates
    • Potency
    • Stability-indicating related substance
  • Drug Product
    • Assay
    • Uniformity of Dosage Units
    • Forced degradation studies
    • Stability-indicating related substances
    • Dissolution sample analysis
  • Biopharmaceutics
    • Dissolution method development and NDA-fileable report

Types of equipment include:

  • High Performance Liquid Chromatography (HPLC) with diode array detection
  • Karl Fischer
  • Dissolution- USP Apparatus I and Apparatus II
  • UV/Vis spectrometer
  • Laser scattering particle size analysis

Stability Studies

Ceutix Labs provides full-service stability study programs, including:

  • Stability study design and protocol development
  • Sample storage
  • Analytical testing, including stability indicating assay and related substances 
  • Data management, including individual sample reports and stability study summary tables
  • Statistical analysis of data

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Ready to begin?