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Formulations for PK/Efficacy/Tox Studies

Contrary to popular belief, early 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.


preclinical formulation


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 preclinical formulation development services—delivered through our SMART biopharmaceutical solutions—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 tox formulation development, solution and suspension formulation selection through vehicle screening, and solubilization through pH adjustment, co-solvents, surfactants, cyclodextrin, and 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

             Nano-milling: Nano-suspension

             Micronization by Jet-milling

         - Lipid-based Formulation

         - Self-emulsifying Drug Delivery Systems (SEDDS)


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Nano-milling.pngSpray_Drying.pngFreeze_Drying.pngExtruder
Micronization

1~10 μm

Nano-milling

<1000 nm

Spray Drying

ASD

Freeze Drying

Lyophilization

Extruder

Liposome

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Contact Us
bd_global@crystalpharmatech.com (925) 558-5040
U.S
NJ Sites: Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey, USA 08512
2005 Eastpark Blvd, Cranbury, New Jersey, USA 08512
CA Site: 7133 Koll Center Parkway, Suite 200, Pleasanton, California, USA 94566
Canada
6800 Kitimat Rd, Unit 1, Mississauga, Ontario, Canada L5N 5M1
China
No. 288, Jiangyun Road, Suzhou Industrial Park, Suzhou, China 215123

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NJ Sites: Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey, USA 08512
2005 Eastpark Blvd, Cranbury, New Jersey, USA 08512
CA Site: 7133 Koll Center Parkway, Suite 200, Pleasanton, California, USA 94566
bd_global@crystalpharmatech.com (925) 558-5040