Early formulation overview

Early formulation overview

Early Formulation for animals

 

In vivo experiments require appropriate formulations. Research programs are full of examples where drug PK profiles, tolerance, oral bioavailability or efficacy results have been significantly biased due to poor dosing vehicles or protocols.

Because in vivo experiments are so critical for project teams to make relevant decisions, they have to be conducted right the first time. Drugabilis therefore designs and characterizes early formulations that are adapted to the compounds physicochemical profile, the animal model physiology and the route of administration, in order to achieve each specific experimental objectives.

We are committed to work on minimal API amount and to meet very short deadlines. Depending on the selected early formulations and animal models, we may suggest modifications to optimize the dosing protocols and secure the study outcome. At request, we may also assist our customers in deciding what study to be performed as well as in interpreting the study findings.

Early formulation support includes:

  • Formulation of low soluble compounds for parenteral injection Read more >
  • IV/PO formulations for pharmacokinetic studies
  • Formulations of suspensions (including highly concentrated suspensions and reduced particle size suspensions)
  • Aqueous gels formulation
  • Formulation of oral solutions

Bioavailability enhancing approaches

Bioavailability enhancing approaches

Bioavailability enhancing approaches

 

Drugabilis conducts rational assessment of most of the bioavailability enhancing approaches to help select the most appropriate ones for drug candidates:


Physical approach

  • Salt screening Read more >
  • Micronization interest assessment
  • Nanosuspension set up for animal testing
  • Co-crystal screening Read more >

Formulation approach

  • Solution with enhancing solubility excipients
  • Solution in lipids
  • Emulsions screening capabilities
  • Micro-emulsion screening capabilities
  • Solid dispersions*            
  • Solid solutions*
  • Micellar systems formulations


* Supported by a technical platform adapted to characterize the physical state of the API in the formulation

Low soluble compounds parenteral formulation

Low soluble compounds parenteral formulation

Low soluble compounds parenteral formulation

 

Drugabilis performs customized small-scale formulation studies to rapidly and in a cost effective manner solubilize poorly soluble compounds in parenteral vehicles adapted to the clients needs (e.g. PK studies, efficacy studies, clinical formulation rational).

Different solubilization mechanism will be tested from direct ones (complexation, surfactant approach) to lipidic formulations.