The knowledge of solid-state properties in an early stage of drug development helps to avoid manufacturing problems, to fine-tune the performance of drugs and provides space for innovations. By definition, every new crystal form is novel and not possible to predict how many different crystal forms can be prepared, how to prepare any crystal forms and the properties of any crystal forms as yet unknown.
How can we help you?
Co-crystals are drug solids defined as multicomponent molecular crystals in which at least one of the compounds is an active pharmaceutical ingredient (API). Salts are considered different from co-crystals provided that they are crystals formed by ionic multicomponent.
How can we help you?
Salt formation is one of the primary solid-state approaches used to modify the physical properties of APIs. However, a major limitation within this approach is that the API must possess a suitable (basic or acidic) ionisable site. In comparison, co-crystals offer a different pathway, where any API regardless of acidic, basic or ionisable groups, could potentially be co-crystallized.
How can we help you?
For the selection of the optimal API, several solid forms may be available from one molecule. We provide an effective comparative programmethat will lead to a better orientation and targeted selection of the optimum solid form of a certain pharmaceutical molecule with requested properties.
The amorphous form does not possess a defined order in its arrangement. Although the amorphous form is the most soluble form, it exhibits the lowest stability. Amorphous compounds are produced in the conditions when precipitation is kinetically faster than crystallisation and crystalline disorder caused by processing (i.e. milling or micronisation).
It is also possible that more than one distinct amorphous phase may be formed from the same substance. In analogy with the phenomenon of crystalline polymorphism, this behaviour has been termed “amorphous polymorphism”.
How can we help you?
With a broad experience in the study and modification of the physical mechanical and chemical properties of an API, the goal is to select the proper form and enhance its performance to push it forwards into animal and human trials.
We can optimise synthesis and crystallization processes, ranging from synthetic route scouting to process scale-up allowing for batches of grams to kilograms of small-scale production, while ensuring flexible and robust procedure that can easily be transferred to pilot-scale, and finally to high volume industrial production of API that exhibit consistent, and optimised, physical and bulk properties.
We can optimise synthetic and crystallization processes, thus ensuring flexible and robust procedures that can easily be transferred with optimised and consistent bulk properties.
Our team has a proven history of achievement with complex chemistry challenges and can support you to synthesize any challenging molecules by designing new synthetic routes and high quality.
Impurities contained in drug substances might occur from intermediates, excipients, degradation or manufacturing as an unwanted by-product.