Formulation Development

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Featured Publication
Recent Options for Phase 1 Formulation Development and Clinical Trial Material Supply. By: Balaji V. Kadri - Featured in the August 2008 Issue of Pharmaceutical Technology







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Preformulation

At Xcelience, we are aware of the extensive amounts of information that are required for preformulation and we can tailor our research to only those pieces of information that are immediately relevant for developing a certain dosage form. Xcelience’s capabilities include but are not limited to the following preformulation development studies.

Services/capabilities

X-Ray Diffraction of small molecules
Accelerated stability studies, pH temperature degradation profiles
Active pharmaceutical ingredient and excipient according to official monographs ( USP-NF, EP, BP)
API lot-to-lot analysis
Bulk and tap density
Drug substance characterization, structural identity and confirmation
Excipient selection and compatibility studies
Identification and quantification of impurities
Particle sizing
Partition coefficient & distribution coefficient as a function of pH
Photostability
pH-solubility profile (mini-shake flask method)
pKa determination
Polymorph screening (Thermal analysis, Microscopy)
Purity determination (Phase solubility, chromatographic purity, purity by thermal analysis)
Residual solvent analysis
Salt form selection
Solid-state stability
Solubility determination
Solution phase stability
Stability-indicating methods development and validation
Thermal analysis
Toxicology formulations (solutions/suspensions, gels/creams, API/blend in a capsule)
Vapor sorption (hydroscopicity) profile


Instruments/Equipment View PDF
Heraeus SunTest CPS+ and SunCool Temperature Controller
Mettler Toledo FP82HT Hot Stage and FP90 Central Processor
Olympus BX51 Polarizing Microscope (10x, 40x, and 50x objectives) with digital camera
Perkin Elmer Spectrum One FTIR
Sirius GLpKa
TA Instruments Q100 Modulated DSC
TA Instruments Q500 TGA with Hi-Res and Modulated Modes
VTI SGA-100 Vapor Sorption Analyzer




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