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 material
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 understand of lyophilization and utilization of thermal analysis ensures an efficient and effective lyophilization cycle.
Freezing Phase
Freezing is necessary to form large ice crystals. This can be accomplished with a slower freezing process or through the incorporation of an annealing step in which the temperature is raised and then lowered
Primary Drying Stage (Sublimation)
In this stage, the pressure is reduced, and the temperature is raised to facilitate sublimation of approximately 95% of the water. This is the most critical stage for efficient lyophilization. Striking the correct balance of pressure and the temperature increase is assisted with thermal analysis of the material being lyophilized; differential scanning calorimetry (DSC) and freeze-drying microscopy (FDM).
Secondary Drying Stage (Adsorption)
The final stage involves further increasing the temperature above primary drying to remove water ionically-bound to the drug product.