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Pre-formulation studies

Pre-formulation studies

Formulating your lead compound

We offer pre-formulation services to help you choose the correct form of drug substance, determine its physico-chemical properties and evaluate its stability under different conditions.

Our Services

  • Polymorph identification and stability evaluation: Performed by PXRD and FTIR. Identification & monitoring of polymorphic form, solvates / hydrates, crystalline and amorphous behavior
  • Thermal behavior evaluation: Polymorph identification, melting temperature, phase transition by TGA and DSC
  • Morphology – crystal habits: Particle size and shape
  • Determination by optical microscopy and laser diffraction technique using Malvern master sizer
  • pH Solubility profiling: Solubility in aqueous, non- aqueous media and biorelevant media (FaSSIF, FeSSIF and SGF media)
  • Hygroscopicity: Vapor sorption analyzer at different % RH
  • Photo-stability as per ICH guidelines
  • Drug excipient compatibility for selection of excipients, for formulation and development of drug product by DSC, XRPD, FTIR, chromatographic techniques. Mixtures of API with excipients (binary or ternary) of different categories including solutions /solvents used for processing
  • Powder Characteristics: Particle size distribution, Bulk and tap density determination, Flow properties

An important step after synthesis of a lead compound is to check physico-chemical characterization of the lead compound. The data generated here becomes the starting point for NCE formulation development.

Physico-Chemical Characterization

To understand the behavior of drugs in physiological systems, a broad range of physical and chemical properties must be determined. Understanding the physicochemical properties of a compound such as solubility, stability, form definition, solid-state properties, partition coefficient and ionization constant(s) is essential so that the formulation process can be rational and streamlined.  

Salt Screening

We focus on salt screening at the early phase of development to check the impact of different counter-ions on physicochemical aspects of the NCE with solubility, counter ion structure, solid state properties and organoleptic properties. Further, we study the impact on biopharmaceutical aspects as bioavailability, pharmacological & toxicological considerations. Based on data generated in physico-chemical characterization, salts are ranked and screened for further studies.

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