From the discovery of your new co-crystal to the optimization of your process, PCL Research & Manufacturing has a unique experience in dealing with your solid form — saving your time and de-risking your API development with high-quality, data-driven information.
Screening services that identify, characterize and select the optimal crystal form for your molecule — unlocking patentable forms and better drug performance.
Knowledge of solid-state properties at an early stage of drug development helps avoid manufacturing problems, fine-tune the performance of drugs and provides space for innovation. By definition, every new crystal form is novel — it is not possible to predict how many forms can be prepared, how to prepare them, or the properties of forms still unknown.
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 they are crystals formed by ionic multicomponent.
Salt formation is one of the primary solid-state approaches used to modify the physical properties of APIs. A major limitation 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.
For the selection of the optimal API, several solid forms may be available from one molecule. We provide an effective comparative programme leading to better orientation and targeted selection of the optimum solid form with the requested properties.
The amorphous form does not possess a defined order in its arrangement. Although it is the most soluble form, it exhibits the lowest stability. Amorphous compounds are produced when precipitation is kinetically faster than crystallisation, and through crystalline disorder caused by processing (e.g. milling or micronisation). More than one distinct amorphous phase may form from the same substance — a behaviour termed "amorphous polymorphism".
With broad experience in studying and modifying the physical, mechanical and chemical properties of an API, our goal is to select the proper form and enhance its performance to push it forward into animal and human trials.
From synthetic route scouting to scale-up — flexible, robust and transferable processes with consistent, optimized bulk properties.
We optimise synthesis and crystallization processes — from synthetic route scouting to process scale-up — allowing batches from grams to kilograms during development, while ensuring flexible and robust procedures that can easily be transferred to pilot-scale and finally to high-volume industrial production of API with consistent, optimised physical and bulk properties.
Our process optimization ensures flexible and robust procedures that transfer cleanly with optimised and consistent bulk properties.
Our team has a proven history with complex chemistry challenges and can support you in synthesizing challenging molecules by designing new, high-quality synthetic routes.
Our team of expert chemists and analysts is ready to support your drug development — from early-phase screening to non-GMP development and manufacturing.