mSAS® applications to progress your 2020 drug pipeline
As 2020 gets underway, many companies are formalising their pipelines and priorities for the year ahead. But with this often comes the realisation of pharmaceutical development challenges that need to be resolved. Crystec are in the business of overcoming such challenges through crystal and particle engineering, using supercritical fluid based technologies. Here are some of the areas where our mSAS® (modified Supercritical Anti-Solvent) platform can be of help.
Many drugs in development, and production, are poorly soluble. mSAS® can be applied to overcome this challenge through crystal engineering (generating alternative polymorphs, hydrates, solvates and co-crystals) or particle engineering (optimising particle size and shape, generating composite particles containing API and solubilising agents, or limiting agglomeration of particles for a more uniform dissolution profile).
Co-crystals provide a variety of benefits including improved product performance (e.g. enhanced solubility or for delivering combination products) and in generating novel IP. While co-crystals are often difficult to manufacture using conventional technologies, Crystec are able to identify and generate co-crystals in a reproducible and commercially scalable process.
Composite and coated composites have a range of used such as improving dissolution, overcoming challenges of dose uniformity in combination products, protecting the API against moisture ingress and agglomeration, as well as smell and taste masking. They can also be used to incorporate agents that improve absorption (e.g. across the BBB) or retention (e.g. in the nasal cavity). mSAS® is a single step process that enables the generation of such materials, with simultaneous control over particle size and shape.
Developing inhaled therapies can be complex, in part due to particle size constraints for effective delivery to the lung. Conventional size reduction techniques can introduce challenges through top-down micronisation of API, but mSAS® particles are precipitated directly from solution with control of particle size and shape. mSAS® particles are free flowing, readily aerosolised and can be tuned to enable optimised delivery to the lung for systemic or localised uptake.
mSAS® can provide a gentler alternative to spray drying and lyophilisation for biotherapeutics. This is because processing can be performed close to body temperature, in a system free from damaging shear forces, with the ability to tune pH, water and excipient content. As a result, biomolecules can be process with high levels of retained activity and increased stability. Furthermore, mSAS® provides opportunities for alternative routes of biotherapeutic delivery, such as nasal or inhaled.
In addition to small and large molecules, mSAS® can be applied to generate optimised formulations of natural products. By tuning the solvent/anti-solvent properties of the supercritical fluid, mSAS® can be used to remove residual impurities and extract solvent to generate free flowing powders, improving performance and enabling optimised dosage forms.
For more information about mSAS® technology and how it can be applied to overcome specific development challenges, or add value to your pipeline, please get in touch (firstname.lastname@example.org)!