Particularly Relevant to Explore the Properties of Oral
Solid Dose Formulations.
Solid state chemistry is the study of the synthesis, structure, and properties of solid phase materials, particularly, but not necessarily exclusively of non-molecular solids. This area of inquiry and analysis is particularly relevant to explore the properties of oral solid dose formulations. Alcami fields this analytical capability through its Center of Excellence for Crystallization and Solid State Chemistry at our active pharmaceutical ingredient (API) development facility in the Netherlands.
- Crystallization Study – crystallize to obtain stable solids, for purification or isolation
- Material Characterization – polymorph identification
- Solubility Determination – in production solvents and buffer solutions
- Salt Selection – suitable form selection
- Polymorph Study – behavior in production solvents
- Crystallization Process Development – combine optimal synthesis conditions with optimal crystallization conditions
- Crystal Habit Optimization – control of particle size and shape
ON-DEMAND WEBINAR: Accelerating Drug Development through Automation
Drug development is based on making the right decisions at the right moment; where R&D focuses on providing that information as rapidly as possible. At Alcami, we use automation as a tool to provide the overall design space of the reaction sequence, form selection and crystallization from gram to multi-kilogram scale. The approach of combined Principle Component Analysis (PCA) and Design of Experiments (DoE) provides a broad overview, with a high diversity in conditions and optimal route for further development. The integrated process chemistry, analytics and pre-formulation allow for a parallel approach to the program that shortens timelines without the loss of information due to transfer between departments and/or companies. The seamless integration of these activities eliminates unnecessary repetition of what has worked before by secondary labs and keeps the research at Alcami focused on finding the best overall conditions to optimize quality and quantity.
This webinar will:
- Introduce the Alcami API development workflow
- Discuss automation as a tool that provides a broad overview allowing selection of optimal form and process conditions
- Explain how integrated chemistry, analytics and pre-formulation shortens development timelines and focuses on a producible drug