Bring your product to the clinic and market
For small-molecule parenteral formulation development, the interplay between solubility, local tolerance and systemic toxicity is key for a successful formulation development needing a minimum of resources and time. Our DPS experts have significant experience in developing parenteral small molecule products and a track record of bringing products to the clinic and the market.
Mitigate risks so small molecule parenteral reformulation is avoided
Small molecules are often characterized by very low aqueous solubility, and this is the first challenge for delivering small molecules parentally. However, when focusing only on solubility and stability during formulation development, there is a risk of detecting local tolerance limitations, systemic toxicity or hypersensitivity issues during preclinical testing, making a later reformulation necessary.
Our parenteral formulation experts have an extensive track record in balancing these challenges so that reformulation is avoided.
Verification for your peace of mind
The feasibility of different solubilisation techniques is systematically verified based on a formulation decision tree, which considers e.g. charge modification by pH adjustment, micellarisation, co-solvency, cyclodextrin-chelation, emulsification.
Freeze drying is also proposed when appropriate. Complex drug dosage forms such as emulsions or liposomes are taken into consideration when no more straightforward techniques are possible since these approaches entail significantly more resources and costs.