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Formulations for PK/Efficacy/Tox Studies
Navigating Early Formulation Development

Early formulation development is a science, not trial-and-error. We utilize decision trees and 80+ years of innovative experience to deliver precise, high-performance PK studies.

Preclinical Formulation — PK/Efficacy/Tox Studies
SMART Approaches
Conventional Formulations
  • pH Adjustment
  • Co-solvents
  • Cyclodextrin
  • In-situ Salt
Enabling Formulations
  • Amorphous Solid Dispersion (ASD)
  • Nano-milling (<1000 nm)
  • Complex Delivery (Liposomes)
Technology Result/Platform Target
Micronization Jet-milling 1~10 μm
Nano-milling Nano-suspension <1000 nm
Spray Drying ASD Solubility Enhancement
Freeze Drying Lyophilization Stable Prototype
Extruder Liposome Complex Delivery
Speed Meets Science
Rapid ASD Screening Platform

Delivering PK/Tox-ready ASD prototypes in 2-4 weeks, not months.

01
Thermal Assessment

API thermal assessment & solvent compatibility screening for a scientific baseline.

02
Polymer Selection

Film casting and dissolution testing to ensure matrix compatibility.

03
Prototype Generation

Utilizing precision spray drying to create stable ASD formulations.

04
Lead Selection

Validated through in-vivo evaluation for performance verification.

The Result

Optimized lead ASD formulations that directly support IND-enabling studies and keep your development timelines on track.

Achieve Your Success with Our Expertise

Have a question or need support with your project? Please complete the form, and our team will get back to you shortly.




Our capabilities span three specialized platforms:

  • Small Molecule

  • Crystal Bio Solutions

  • Crystal NAX


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Related Resources
Small Molecule Crystal Bio Solutions
Biologics Characterization and CMC Analytics Bioanalytical and Biomarker Services Quantitative Clinical Pharmacology (QCP)
Crystal NAX
DNA Synthesis RNA Synthesis LNP Formulation Services Analytical & Characterization Services Early-Phase Manufacturing Catalogue Products
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

Floor 1, Bldg. 3, 68 Chunpu 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