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https://www.crystalpharmatech.com/preclinical-formulation-development/

Preclinical Formulation for PK/Efficacy/Tox Studies
Contrary to popular belief, early preclinical formulation development is not simply dumping API in a vehicle and gavage feeding an animal. If you do this, you will most likely lose time and money with unnecessary and confusing PK studies. This led to the development of our SMART biopharmaceutical solutions that offer input from our scientific advisory board: A one-stop shop from candidate selection through GMP FIH.

This is an integrated approach to finding the right form and formulation at every step of the development cycle using decision trees and guidance documents built from our over 80 years of innovative pharmaceutical experience. Using our SMART services will lead to the shortest possible development timelines with limited resource utilization.

Our formulation approaches to deliver molecules to support PK/Efficacy/Tox Studies include solution and suspension formulation selection through vehicle screening, solubilization through pH adjustment, co-solvents, surfactants, cyclodextrin, in-situ salt formation. In addition, we also apply special drug delivery technologies for insoluble compounds.

Solution/Suspension Formulations

Solubilization through pH Adjustment, Co-solvents, Surfactants, Cyclodextrin, In-situ Salt Formation

Special Drug Delivery Technologies

Amorphous Solid Dispersion
Particle Size Reduction
Nano-milling: Nano-suspension/powder
Micronization by Jet-milling
Lipid-based Formulation
Self-emulsifying Drug Delivery Systems (SEDDS)
Liposome

If you want to know more preclinical formulation development services, please visit our website.

As a cdmo pharma company, we can provide professional cdmo services for clients, anything you need, please leave us a message.