Case Studies

ORAL FORMULATION (small molecule)

Goal:

  • IR Tablet for oral application containing 200mg API
  • Faster onset of action compared to reference product

Challenge:

  • API practically insoluble in water at pH 4,5 (< 100 µg / ml)
  • Size of tablet should allow patent convenient application

Achievements:

  • Nanoparticles below 200 nm
  • Faster dissolution compared to reference product (anticipated faster onset of action)
  • Nanoparticles with high drug content >90% allow dosage form with >40% drug loading (patient convenient application possible)

 

Simulation of Onset of Action

Parenteral Formulation (small molecule)

Goal:

  • From emulsion with potential allergic excipient to water based ready to use product

Challenge:

  • API practically insoluble in water at pH 4,5 (< 100 µg / ml)
  • API prone to hydrolysis and oxidation

Achievements:

  • Water-based ready-to-use formulation
  • Immediate release of API after injection
  • Switched storage from refrigerator to room temperature
  • Increase chemical & physical stability compared to the reference product
  • Prolongation of shelf life to >24 months

Improvement of Chemical & Physical Stability

Parenteral Depot Formulation (Peptide)

Goal:

  • Encapsulation of API within polymer (PLGA) microspheres with mean diameter 50µm

Challenge:

  • Complete encapsulation to avoid initial drug burst.
  • Terminal sterilisation needed (heat-sensible polymer)
  • Extended release profile according to the release profile of originator

Achievements:

  • Polymeric (PLGA) micro-particles with mean diameter 50µm
  • In-vitro release profile comparable to originator product
  • 3-months stability under accelerated conditions shown
  • Terminal sterilization possible

Peptide Depot Formulation: in vitro Release

 

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