Crystallics’ expertise is in the area of solid state research and pre-formulation.

Solid state research plays a central role in the pharmaceutical industry. Solid pharmaceuticals exist as polymorphs, salts, co-crystals, hydrates, or amorphous forms, which collectively are described as solid forms. Various solid state properties of the same Active Pharmaceutical Ingredient (API) will have different characteristics. These characteristics can have a significant impact on the safety and efficacy of a drug product. All delivery routes, e.g. intravenous, transdermal, oral, etc. have their specific requirements with respect to the solid form to be used. Solid state research is carried out during virtually all phases of drug development, from candidate selection to successful marketing and Intellectual Property (IP) protection. Solid-state research aims to produce the solid forms of a drug substance, understand their physico-chemical characteristics and utilize those to develop a drug with the desired properties. Proper application of solid state knowledge can reduce the time to market and ensure a well protected drug substance and product by strong composition of matter IP.

The pre-formulation phase is a stage of pharmaceutical development during which the physico-chemical properties of the drug substance are characterised and the appropriate solid form is selected in view of the intended dosage form and delivery route. Commonly evaluated parameters include solubility, dissolution behaviour, excipient compatibility, stability and other solid state properties. Pre-formulation activities usually stretch out from the candidate selection into clinical phase I, with optimization of the formulation and further characterization of the API taking place in or after phase II clinical studies. Comprehensive pre-formulation work is the foundation of developing robust pharmaceutical formulations.

Crystallics' solid state research and pre-formulation services span multiple stages of the drug development process. Already in an early preclinical stage, salt screening and polymorph screening can assist in identifying the optimal solid form for a given compound to be used for further development in clinical phases. For APIs that are difficult to crystallize, alternative routes can be investigated such as co-crystallization and stabilization of the amorphous form. Typically during phase II clinical trials, increased attention is paid on enhancing patent protection. Comprehensive screening programs are the basis for a successful patenting strategy and potential patent extension. Parallel to (pre)clinical drug development, the synthetic process is developed with the crystallization process as final step influencing for example yield, flowability, particle size and/or bulk density to facilitate downstream processing and formulation.

Crystallics' research programs are undertaken in close co-operation with the customer. Customer focus is at the core of our organization and we strive for timely and effective communication throughout the entire project. Our projects are tailored to meet the needs of the customer and the API and we provide comprehensive and clear reports including concise recommendations ensuring successful drug development.