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Pharmaceutical drug formulation and drug delivery systems
Thermo Fisher Scientific specializes in overcoming complex challenges in the pharmaceutical industry where API solubility and processing stability, taste-masking, enteric-coated, and specialized dosage forms are critical projects. Leveraging our state-of-the-art extruders and application expertise, we streamline the path from feasibility studies to full-scale production.
Drug formulation development methods
Techniques
Hot-melt extrusion
HME is a formulation technique used to process active materials into a polymer melt and continuously shape them into specific forms. HME offers several benefits to produce solid dispersions, improving the solubility and bioavailability of poorly soluble drugs. HME also enables controlled or modified release drug delivery systems. Additionally, HME offers advantages like continuous processing, scalability, reduced manufacturing time, and potential for personalized medicine.
Implants and drug delivery systems
HME is a key technology that can produce alternative drug delivery systems (DDS) such as subcutaneous, injectable implants for site specific and long-term treatments. HME can also be configured to create a fully automated and continuous implant production line offering high-precision control of implant dimensions. Novel DDS such as oral dispersive films or 3D filament for personized medicine can also be obtained from HME.
Continuous manufacturing and twin-screw granulation
Continuous manufacturing (CM) offers several benefits according to the FDA. It provides real-time product quality monitoring, reduces batch failures, minimizes variability, and enables prompt adjustments. CM also enhances product quality, reduces costs, and improves supply chain efficiency. Extruders play a central role in continuous manufacturing as they allow for continuous mixing and provide precise control over process parameters.
Pharmaceutical extruders
Pharmaceutical extruders offer a multitude of benefits for research and production. These space-saving instruments provide precise control over the extrusion process, allowing to produce consistent and high-quality drug formulations. Pharmaceutical extrusion is a versatile tool for the formulation and manufacturing of solid oral dosage forms as well as novel drug delivery systems.
Pharmaceutical rheology
Rheology provides valuable characterization on polymer melt flow and critical factors in the production of various pharmaceutical products. The behavior of the polymer melt during extrusion can significantly influence the quality and characteristics of the final product. Rheology also aids in comprehending the stability of liquid and semi-solid products such as nasal spray or topical creams.
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