To support API solid state research and development (SSRD) programmes, we apply High-Throughput Screening Technology (HTST) for particle size engineering, development of automated crystallisation scale-up development, and expeditious discovery of new polymorphs, pharmaceutical salts, solvates and co-crystals.
Comprehensive polymorphism studies are IP enabling and crucial for NDA filling. We investigate isolation and crystallisation of APIs in solvents with different properties and under a variety of conditions to identify and characterise new solid forms and to understand the relationship between them.
Our flexible and cost-effective screening designs can be tailored to the client’s needs based on the phase of development as well as their concerns and limitations. The screening requires minimal amount of API while performing many crystallisation experiments (384 experiments per run), resulting in significant cost reduction. Some of the crystallisation techniques employed include:
Salt and co-crystal screenings are reliable solutions in modern drug development to address challenges such as low solubility, chemical instability and high hygroscopicity in APIs.
Utilising High-Throughput Screening (HTS) technologies, we investigate the formation of salts/co-crystals with pharmaceutically acceptable salt and co-formers in different solvent mixtures.
This screening approach provides us with a quick identification of lead candidates to be prepared for complete characterisation.
Analysing starting materials, intermediates and API’s solubility are essential to optimise different steps of the manufacturing process. Through solubility and intrinsic dissolution studies, potential bioavailability challenges of a compound can be identified far earlier during the development of new chemical entities, which could help clients reach their critical decision point faster.
Utilising high-throughput robotic technology and in-house analytical capabilities, our fast and accurate solubility screenings occur in many solvents while using minimum quantity of material and solvents.
Solubility and dissolution are also key parameters that control rate and extent of drug absorption and its bioavailability. Our miniaturised disk IDR apparatuses produce highly reproducible intrinsic dissolution results using in-situ fiber optic UV measurements.
