• For NCE development, at late discovery stage, the focus is to select the right (de-risked) candidate for development. Many multi-national pharmaceutical companies have a preclinical CMC group to provide support and guidance for candidate selection.  HLK strives to provide the same capabilities. Our scientific team is experienced in providing such support: Physicochemical characterizations             Solubility and stability assessments             pKa, LogP measurements             Pre-formulation assessment Formulation development for tox studies and pharmacology studies in animals
  • Currently many new pharmaceutically active compounds, including small molecules and botanical active ingredients, are poorly water soluble, leading to marginal in vivo absorption. Our scientific team possesses advanced formulation techniques for poorly water soluble compounds, with a proven track record: Salt selection Solid dispersion technique – spray drying, melt extrusion, etc             Particularly skilled in assessment of long term stabilization of amorphous solid dispersion systems Lipid drug delivery systems – SEDDS, soft gel encapsulation, hard gel encapsulation               Skilled in assessment of chemical stability of SEDDS systems and selection of gel systems Micronization Nano milling
  • Pharmaceutical markets in the US and EU prefer once daily, ideally one tablet/capsule per dose, drug products. Controlled release technologies could help those molecules with short in vivo half life, potentially achieving once daily use. Many pharmaceutically active ingredients from botanical medicines have short in vivo half-lives Technologies including matrix tablet, film coating, osmotic tablet, particle processing, etc, could provide controlled release profiles.  
  • Oral solid dosage forms         Tablets, capsules Oral liquids         Solutions, suspensions Injectable formulations         Liquids, freeze dried formulations          
  • With the technical expertise and executive management experience of our founders and consultancy team members, as well as with resources from carefully screened CROs, HLK provides customized integrated drug product development solutions to our customers.