Pharmaceuticals
BASF Pharma Solutions offers a comprehensive portfolio of functional solutions in combination with extensive processing know-how. With functional polymers designed for all major processing technologies, our team is ready to support your hot-melted and spray-dried formulations. This allows us to help you to find the optimal solution for your drug, combining sufficient solubility & bioavailability with economic & efficient production processes.
Hot Melt Extrusion Spray Drying And Fluid Bed Coating Quality by Design Product Overview
Our aim is to help our customers discover the many benefits of this technology, and assist them in leveraging it for their products. The true potential of hot-melt extrusion for pharmaceutical applications is just beginning to be uncovered – and our research continues to blaze new trails in this exciting field.
Hot-melt extrusion is used to prepare solid dispersions of poorly soluble active pharmaceutical ingredients, and for creating controlled-release medications. In this process, active ingredients are compounded with polymers that have suitable glass transition temperatures (such as Kollidon® VA 64 and Soluplus®), and extruded at an appropriate temperature to form a solid dispersion. This polymer matrix acts as a solid solvent for the drug molecules, and brings advantages in stability, solubility, and bioavailability. The API can be amorphous, molecularly dispersed or crystalline dispersed within the polymer – depending on the application.
These technologies are used for the production of solid dispersions to overcome solubility challenges of drug candidates. These techniques are especially suited for thermally labile, and also relevant to inhalable particles. Rapidly spraying a solution of dissolved polymer and active ingredient traps the active in its amorphous form within the polymer carrier, whether as a free powder, as from spray drying, or coated onto existing microspheres or granules, as from fluid bed coating. Key for a successful spray process is the use of the right functional polymer to ensure a stable solid dispersion that is dissolved in the spray solvent.
BASF offers a wide range of functional polymers to choose from that are soluble at high loadings for maximized efficiency
Spray drying and drug layering enable robust formulation and product development driven by the principles of Quality-by-Design (QbD). Critical Quality Attributes of the spray dried intermediate and the final tablets or granules can be optimized through controlled variables like loading, solvent selection, inlet temperature, and atomization pressure.
