Lyophilization Techniques Offered
Callan Pharma Services has extensive experience in lyophilization of drug products, including:
Aqueous
- Most common lyophilization technique
- Offers the most flexibility in cycle parameters
- Callan works with crystalline and amorphous materials
Nanoparticles
- Alternative to liquid formulations when stability is a concern.
- Callan has the experience finding parameters needed to ensure stability and correct reconstitution of nanoparticles formulations
Organic co-Solvent
- Lyophilization from aqueous co-solvent solutions (e.g., tBuOH-water)
- Can be the best option for hydrophobic drugs
Lyophilization Cycle Development
Callan’s understanding of lyophilization, combined with thermal characterization performed through a partner laboratory, produces cycles that are efficient, robust, and transferable.
Freezing Phase
Ice crystal size drives everything downstream: larger crystals leave larger pores, and larger pores mean faster sublimation. A slower freezing ramp or an annealing step, where the temperature is raised and then lowered, grows those crystals deliberately.
Primary Drying Stage (Sublimation)
Pressure is reduced and the shelf temperature raised so that ice sublimes directly to vapor, removing roughly 95% of the water in the product. This is the longest and most critical stage of the cycle. Push too hard and the cake collapses. Too cautiously, and you are paying for days of drying you did not need. Striking the balance requires knowing the thermal behavior of the material, specifically its glass transition and collapse temperature.
Secondary Drying Stage (Desorption)
The temperature is raised above primary drying to desorb the bound water that remains adsorbed to the solid after the ice is gone. This is what takes residual moisture down to the level a stable product requires, and it is the stage most often cut short.
Partner with Callan Pharma
Callan Pharma provides its partners rapid, comprehensive and cost-effective solutions for their difficult formulation development projects.
