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Solid form services

Form.....Formation.....Formulation.....The 3 "Fs"

Solid pharmaceuticals exist as polymorphs, salts, cocrystals, 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 physicochemical 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.

Crystallics' solid form screening and selection 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 cocrystallization 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 cooperation 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.