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Preformulation Studies

As an integrated part of our formulation services, Aurigene Pharmaceutical Services pre-formulation offering, covers the assessment of a wide range of physical and chemical properties, which are critical to establish the ideal formulation and delivery method for your lead candidates. The knowledge of various parameters based on regulatory and client specific requirements are essential to formulate a high-quality drug product to satisfy your scientific requirements.

 

Our Pre-Formulation Services offerings include:

  • Physicochemical Characterization
    • Dissociation Constant (pka)
    • Partition Coefficient (log P)
    • Distribution Coefficient (logD)
    • Molar Absorption Coefficient
  • Solubility and Stability studies
    • Aqueous and Non-aqueous
    • pH Buffers
    • Solubilizers and Excipients
    • Bio-relevant Media (FaSSIF, FeSSIF and SGF)
  • Dissolution Studies
    • Intrinsic
    • Bio-relevant (Mono or Biphasic)
    • QC Media
  • Bulk Characterization Studies
    • Particle Size Distribution and Shape
    • Bulk Density
    • Tapped Density
    • Compressibility and Flowability
    • Hygroscopicity (Dynamic Vapor Sorption)
  • Solid State Characterization
    • Crystal Habit
    • Crystalline or Amorphous
    • Anhydrous/Hydrate/Solvate
    • Polymorph Identification
    • Thermal Behaviour Evaluation (Melting Temperature and Phase Transition)
  • Stability
    • ICH Compliant Stability Studies
    • Intermediate
    • Accelerated
    • Photo Stability
  • Stress Studies
    • Hydrolytic
    • pH
    • Photo
    • Oxidative
    • Thermal
  • Drug Excipient Compatibility
    • Mixtures of API with excipients (binary or ternary) of different categories including solutions /solvents used for processing
  • Drug Developability Assessment
    • BCS and DCS classifications.
    • Developability assessment to identify suitable formulation technology
  • Salt/co-crystal and Polymorph Selection
    • Evaluation and identification of the most suitable form to increase drug product performance
    • Process induced phase transformation