The core of STEERLife's technologies is the principle of continuity and self-cleaning. The STEERLife technologies allow for simultaneous charging and discharging of materials during the process. This not only allows for better consistency, it hugely impacts speed, scale of production and efficiency, besides significantly reducing the manufacturing footprint required for production.
NOVEL HOT MELT EXTRUSION (B2C - E)
The hot melt extrusion process typically involves melting of a drug substance with or without accompanying excipients such as polymers at elevated processing temperatures utilizing a combination of thermal and mechanical energy and requires a tight control of both quantum and uniformity of work being carried during the processing in order to meet stringent critical quality attributes of the final product. Hot melt extrusion is fast gaining widespread acceptance as a reliable means of increasing the biovailability / solubility of poorly bioavailable or poorly soluble compounds. One of the best known applications of hot melt extrusion is in the field of antiretrovirals. Fixed dose combination (FDC) therapy is the preferred approach to treat HIV in order to minimize the virus developing resistance. Protease inhibitors given either alone or in combination have an important role in the treatment of HIV. Currently available products in the market have been formulated using the hot melt extrusion process as solid amorphous solutions with hydrophilic polymers to increase aqueous solubility. Current hot melt extrusion processes are limited in the control they offer on the energy input due to which they are unable to process shear – or heat- sensitive materials at optimum efficiency.
STEERLife’s novel hot melt extrusion technology can be used even for shear or heat-sensitive materials and clearly demonstrates significant improvement in process efficiency as measured in terms of both improved throughput rate and quality attributes due to better control on fundamental processing factors such as residence time, shear peak and uniformity of work.*Patent pending
HOT MELT FRAGMENTATION*
(B2C - F)
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 proprietary hot melt fragmentation technology provides 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 which we have termed as “fragmentation:. The technology results in much more uniform size and a narrower distribution in comparison with the Erdmenger geometry.*Patent pending
ACTIVATED GRANULATION* (B2C - G)
Particle size distribution of pharmaceutical powders has an influence on every step of 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 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. STEERLife’s activated granulation technologies provide the much needed ability to produce customized granules measured both in terms of mean and distribution of particle size without having to resort to the use of multiple separate downstream processes such as drying and milling. STEERLife’s B2C-G technologies includes;Continuous wet Granulation*Moisture / Shear Activated Dry Granulation** Melt Granulation**Patent pending
CUSTOMISED SOLUTIONS FOR COMMERCIAL NEEDS
B2C -E (Novel Hot Melt Extrusion), B2C -F (Hot Melt Fragmentation) and B2C- G (Activated Granulation)
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STEERLife’s proprietary technologies are adaptable to meet differentiated needs during development. Different types of materials can be handled using the same principles, evident from the following continuous platform technologies developed;
Novel hot melt extrusion* (B2C –E) - can replace conventional hot melt extrusion
Hot Melt Fragmentation* (B2C- F) - can replace spray drying and spray congealing
Activated Granulation* (B2C –G) - which further includes continuous wet granulation, moisture / shear activated dry granulation and melt granulation. can replace conventional wet, dry and melt granulation. B2C - G can replace conventional wet, dry and melt granulation respectively.
* Patent pending