Pharmaceutical Development Services
Preformulation and Preclinical CMC
You wouldnʼt build a house on unstable foundations and similarly you donʼt develop a pharmaceutical product without understanding the fundamental properties of the drug and its stability. During preformulation we rapidly evaluate and detail drug candidatesʼ physical and chemical profiles. These properties will ultimately define the parameters for producing a developable, stable and reproducible product. Our preclinical CMC services for development candidates, including purity, solubility, stability and form assessment. We also help improve the chances of success for challenging drug molecules by assessing developability and providing formulation strategies.
Our services typically include:
- LogP/LogD/pKa
- Purity
- Solubility (Aq, SGF, SIF & pH)
- Intrinsic dissolution
- Enhanced solubility (solubility in co-solvents, surfactants, complexation agents, salts etc.)
- Stability (forced degradation studies)
- Initial solid-state properties for crystalline / amorphous materials: optical microscopy, SEM, refractive index, particle size, XRPD, DSC, spectroscopy, moisture soprtion
- Excipient compatibility
- Mechanical screening: Youngʼs modulus, hardness, surface energy
We have also developed a unique technology called nanoPASS™. If you only have small amounts of material available we can tailor a preformulation program to meet your constraints.
Solid state chemistry
Do you have an unstable molecule in regards to polymorphism? If so, we offer a range of detailed characterisation services to help you understand and control the solid state chemistry. 