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Part of US based
Semler Group of Companies,
in business since 1946

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Pre-Formulation

Semler Research Center recognizes pre-formulation as a critical phase in the drug development cycle and has developed a basket of services that ranges from scientifically justified experiments for salt selection to establishing chemical specifications for the active pharmaceutical ingredient (API).

Physicochemical tests conducted during discovery and lead optimization using advanced analytical techniques – DSC/TGA/XRD and so on - enable rational decisions for compound, salt or polymorph selection that maximize the probability of compound success and are essential to the establishment of a sound intellectual property position.

Upon thorough understanding of the physico-chemical properties of the API, the development routine will include characterization of API – excipient mixtures, materials of construction effects, process variables that affect API or formulation attributes.

Pre-Formulation Services

  • Physico chemical evaluation
  • Solubility studies:
    • pH dependent aqueous solubility
    • solubility in co-solvents
    • surfactant assisted solubility
    • equilibrium solubility
  • Intrinsic dissolution study in various pH conditions
  • Salt design/screening and selection
  • Dissociation constant redetermination
  • Partition coefficient and log P determination
  • Polymorphism studies
  • Particle size, surface area, bulk/ tapped density determination
  • Particle size distribution
  • Bulk/tapped density determination
  • Binding constant determination
  • Drug-excipient compatibility studies
  • Containers:
    • Closure integrity testing
    • Rubber stopper & tubing compatibility
    • Filter compatibility
    • Stress stability
    • Photo stability
    • Hold-time study
 

About This Service

SRC offers top-notch scientific expertise across dosage forms and modes of administration. Our scientists have several decades of experience in developing products for US, EU, India, Brazilian, Turkish, South African & other markets across diverse therapeutic areas.