Pre-formulation
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The unsatisfactory physicochemical properties of drug molecules can lead to problems such as low solubility, permeability, and bioavailability, as well as high toxicity, poor efficacy, and manufacturing challenges. These issues can result in the abandonment of numerous molecules and increased clinical failure rates. Our pre-formulation studies assist in selecting the most developable molecules at the preclinical stage. We develop suitable preclinical formulations to support pharmacokinetic (PK), pharmacodynamic (PD), and toxicology studies in animals. Moreover, we determine formulation strategies to aid in clinical formulation development and manufacturing.
Our pre-formulation labs are located at the Shanghai Waigaoqiao site and the Wuxi City site, each staffed with dedicated teams of formulation and analytical scientists.
The development risks we can identify and mitigate:
- Poor and/or variable bioavailability (Due to low solubility & permeability)
- Poor physical & chemical stability (oxidation, hydrolysis, light sensitivity, color change, etc.)
- Complex polymorphs related formulation issues
What we can deliver:
- Help to select most developable molecules (With a comprehensive set of tools for physicochemical property characterization, along with a broad range of in-vitro, in-vivo, and in-silico tools)
- Preclinical formulation and clinical formulation strategy for IND filing (Utilizing a full set of bioavailability enhancement technologies, including spray drying, hot melt extrusion, nano-suspensions, and lipid formulations)
Service Roadmap
Discovery
Development
Profiling
- pKa, LogP
- Tm, Tg, Tc, Td
- Solubility
- Supersaturation
Analysis
- Force degradation
- Solution stability
- Solid stability
- Photo stability
- Excipient compatibility
Physical Form
- Recrystallization
- Polymorph
- Salt/Co-crystal
Development
Formulation
- Preclinical formulation screening and seletion
- Formulation preparation for PK and toxicology studies
Enabling Formulation
- Spray dried dispersion (SDD)
- Hot melt extrusion (HME)
- Lipid based emulsion
- Nano suspension
- Micronization (Jet milling)
In Silico
Prediction
- PDo prediction
- DCS/BCS classification
- Food effect prediction
- PPI/ARA prediction
- Gastro Plus modelling
IND Enabling Preformulation Package (IEPP)
IEPP is an integrated developability assessment service for new chemical entities (NCEs) to efficiently identify challenges and provide solutions earlier for increasing success rate and lower overall costs. It usually takes 8-12 weeks for IND ready formulation. Read more.
Related Resources
White paper: Absorption prediction tools for drug formulation at the preclinical stage white paper
IEPP: IND Enabling Prefomulation Package
Flyer: IND Enabling Preformulation Package（IEPP）
