Solid State R&D
Crystallising your ideas
We can help you through the entire process of solid form selection, from initial screening to development and scale-up stability tests
Oral administration is still the preferred route for most patients, and as a result, many active pharmaceutical ingredients are formulated as solids. Having the optimal solid form of an API is crucial to ensure an optimal bioavailability profile, long-term stability and strong intellectual property stratergy.
At Enantia, we can help you through the entire process of solid form selection: from initial screening, characterisation, stability and performance tests, to development and scale-up and long-term stability tests.
Factors such as solubility, stability or melting point, can be improved by having an adequate crystalline structure. This is independent of whether the molecule has points which are able to be ionised or not. Our programs are based on:
- Understanding: through a study of the current form and its behaviour in different solvents and conditions, we acquire the knowledge to be able to design the correct experiments so the screening phase is as smooth and as efficient as possible.
- Screening: both our salt and cocrystal programs are based on a combination of oriented-screening experiments, which are carefully planned as a mixture of our extensive internal expertise and parallelisation techniques. The experiments take into account further potential development, so the counter-ions and co-formers are selected from FDA GRAS (Generally Recognised as Safe) or EAFUS (Everything Added to Food in the United States) lists.
- Selection: careful study of the found forms is performed by submitting them to stressed stability conditions. This allows us to select the most promising one(s) for the development phase.
- Development: once the desired crystalline form is selected, we develop a process for the preparation of larger quantities of target compound through a scalable, robust and reproducible crystallisation method, keeping the quality by design parameters in mind.
Any molecule or compound arranged in an ordered crystal lattice is susceptible to exhibit polymorphism. Different polymorphs and solvates of a pharmaceutical solid may have different chemical and physical properties. They may appear under certain conditions therefore the study of the polymorphic landscape of a molecule or compound is a necessary step in order to ensure a quality drug substance. This also increases the IP strength of the compound in question.
We undertake comprehensive polymorph screenings and use techniques to favour the appearance of stable and metastable forms.
For our services related to solid form characterisation, please see this page.