During the Preformulation stage of development, extensive characterisation is performed to establish the key physiochemical characteristics of a drug substance.
It is through the discovery of the physiochemical properties of the active ingredient that we are able to guide the appropriate formulation, production and delivery method for pre-clinical studies
Knowledge of a materials fundamental properties is essential to guide all future development of drug formulation, that’s why our staff at Cubi-Tech have the expertise to carry out a variety of physiochemical analysis techniques, including:
Thermal analysis is a vital tool to determine a materials physical structure, stability, miscibility, ideal processing temperatures. These factors are crucial for guiding drug development, allowing us to determine whether the substance is suited to its intended function or if not, giving insight into what properties need to be enhanced. In addition to this, knowing a drugs thermal properties is essential to determining the critical processing parameters in a variety of manufacturing processes.
Furthermore, thermal analysis is a valuable screening tool; allowing for polymorph identification and insight into whether an API is compatible with another material to form a multi-component drug product such as, cocrystals, salts, solvates, hydrates and solid dispersions.
As such, Cubi-Tech is equipped with a comprehensive thermal analysis suite, containing a differential scanning calorimeter (DSC) and a Thermogravimetric Analyzer (TGA) to provide comprehensive overview of a drugs thermal behaviour.
Characterising the inherent structural make up of a molecule is essential to understanding the way a drug will behave during development and a vital tool in verifying the quality of a substance. Structural analysis is a powerful tool for identifying exactly what, and how much of it, is present in your sample.
Cubi-Tech can offer a range of powerful structural characterisation tools to fit the needs of our customers including:
X-Ray Diffraction (XRD)
XRD is a an powerful technique used to analyse all kinds of matter. This rapid and non-destructive technique allows for the identification of the different crystalline phases which make up a given material. The properties and functions of a material is greatly influenced by its crystal structure, making XRD an indispensable technique for material characterisation, quality control and crystal structure determination. As such Cubi-tech staff have optimised a range of XRD techniques to analyse allow us to offer expedient, versatile and economic diffraction analysis.
Applications of this method include:
- Qualitative and quantitative analysis of a materials chemical composition
- Determination of crystal structures
- Measurement of sample purity
- Determination of unit cell dimensions
- and more
Fourier Transform Infrared Spectroscopy (FTIR)
FTIR analysis is commonly considered the first approach in investigative chemistry due to the techniques sensitivity, speed, and simplicity in providing qualitative analysis to identify unknowns in a sample. FTIR utilises infrared light to scan samples and identify unique chemical patterns and bond properties based upon the light absorbed vs light reflected. Due to this FTIR is an extremely effective technique in quality control, helping identify unknowns, contaminants, additives, assist in material selection as well as being a highly reliable mechanism for determining polymer composition.
At Cubi-Tech we can provide advance FTIR analysis, with a high turnover at a competitive rate, as well as having our experts interpret the data to confidently guide you on the next steps to understanding your material.
Additional applications of FTIR include:
- Identifying unknown content in a range of different materials, be it in the Solid, Liquid or gaseous form
- Assist with screening experiments for multi component systems such as cocrystals, salts and co-amorphous dispersions
- Identify surface contamination
- Exploring polymer compositions
- Assessing the purity of pharmaceutical systems
Nuclear magnetic resonance (NMR)
NMR is a powerful analytical technique for material characterisation. Through NMR it is possible to not only elucidate the structure and composition of your material, but to also understand the functions, reaction kinetics and dynamics of biopharmaceutical material.
Through placing the nuclei under a magnetic field, we are able to apply a Radio frequency energy to it, and once removed the nuclei will relax to its original state, releasing an electromagnetic pulse which is converted to spectral data. From this data it is possible to understand key aspects of a material, assisting in areas ranging from compositional analysis and quality control to drug discovery and quantitative analysis. Cubi-Tech offers advanced customisable services, from a team of experienced scientists to fit your materials needs.
The Applications of NMR include:
- Chemical composition analysis for both organic and inorganic compounds
- Compound structure discovery
- Quantifying levels of API and impurities in materials for quality control purposes
- Monitoring reaction kinetics to study drug metabolism, substrate consumption, rate of reaction and more
- Investigating dynamics and disorder of Biopharmaceuticals to elucidate the structural basis for their functions (Cellular signalling, catalysis, regulation etc.)
- Exploration of a materials geometries, morphology and composition for drug discovery purposes
- Protein production and Isotope labelling