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Technologies aim to improve hot melt extrusion processes
November 21, 2017
By: Kristin Brooks
Managing Editor, Contract Pharma
STEERLife showcased its technologies at the AAPS Annual Meeting in San Diego. The STEERLife technologies are designed to allow for simultaneous charging and discharging of materials during the manufacturing process to allow better consistency, improve speed, scale of production and efficiency. The company’s technologies are adaptable for different types of materials to be handled with the following continuous platform technologies: The B2C –E is designed to replace conventional hot melt extrusion. Hot melt extrusion is a process used to improve biovailability / solubility of poorly bioavailable or poorly soluble compounds. The process involves melting a drug substance with or without excipients, such as polymers, at elevated processing temperatures using a combination of thermal and mechanical energy that requires tight control in order to meet critical quality attributes of the final product. An example of applications of hot melt extrusion is the field of antiretrovirals, where fiixed dose combination (FDC) therapy is the preferred approach to treat HIV in order to minimize the virus developing resistance. Current hot melt extrusion processes can have limitations in the control they offer on the energy input which can result in inability to process shear – or heat- sensitive materials at optimum efficiency. STEERLife’s hot melt extrusion technology can be used for heat-sensitive materials and, according to the company, can improve process efficiency as measured in terms of throughput rate and quality attributes. The B2C- F Hot Melt Fragmentation is designed to replace spray drying and spray congealing. Conventional hot melt extrusion requires significant downstream processing such as size reduction after the formation of melt and is not amenable for applications involving low melting excipients such as lipids. Typical size reduction processes involve generation of plastic energy which needs to be dissipated efficiently for optimum milling to take place. STEERLife’s hot melt fragmentation technology is designed to provide uniform shear fields which enables size reduction of materials with lower melting point or glass transition to take place within the equipment itself, a process termed as fragmentation. The technology aims to create uniform size and a narrower distribution in compared to Erdmenger geometry. The B2C –G Activated Granulation includes continuous wet granulation, moisture / shear activated dry granulation and melt granulation. This can replace conventional wet, dry and melt granulation, according to the company. Particle size distribution of pharmaceutical powders has an influence on manufacturing processes for solid oral dosage forms, including pre-mixing/mixing, granulation, drying, milling, blending, coating, encapsulation or compression. STEERLife’s activated granulation technologies involve particle agglomeration due to various activating factors such as water, moisture, mechanical shear or heat either alone or in combination. The technologies aim to enable integration of various unit operations such as mixing, granulation, drying and sizing, typically followed in a batch process into a single seamless continuous process to produce free flowing and compressible granules. The company’s activated granulation technologies are designed to produce customized granules measured in terms of mean and distribution of particle size without having to use multiple separate downstream processes such as drying and milling.
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