Formulations 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 preclinical 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.
■ Conventional - Solution/Suspension Formulations
● pH Adjustment
● Co-solvents
● Surfactants
● Cyclodextrin
● In-situ Salt
■ Enabling - Enhance Solubility & Bioavailability
● Amorphous Solid Dispersion
- Spray drying or Lyophilization● Size Reduction
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Nano-milling: Nano-suspension
- Micronization by Jet-milling
● Lipid-based Formulation
● Self-emulsifying Drug Delivery Systems (SEDDS)
If you want to know more about preclinical formulation development services, please visit our website.
As a cdmo pharma company, we will do our best to meet all the needs of customers.
Crystal Pharmatech, established in 2010, is a global company with approximately 300 employees and four R&D centers located in Suzhou (China), New Jersey, San Francisco (USA), and Toronto (Canada). Our key differentiator is our integrated and specialized services, including API solid-state research, crystallization, preformulation, formulation development and manufacturing, clinical supply.
