Solid dosage form manufacturing via twin screw extrusion

September 11, 2024

Remove from favorites

Add to favorites

The text describes the use of Twin Screw Extrusion (TSE) in pharmaceutical solid dosage form manufacturing, particularly focusing on the advantages of TSE for granulation and hot melt extrusion (HME). Key points include:

*Extrusion Granulation: TSE is preferred over traditional granulation techniques due to its continuous processing, reproducibility, and ability to combine multiple process steps, such as mixing, granulating, and devolatilization, in one machine. This method allows for gentle product handling at low temperatures and short residence times.

*Hot Melt Extrusion (HME): HME is a process used in the pharmaceutical industry to create solid dosage forms without using water or solvents. It involves melting a blend of active pharmaceutical ingredients (API) and polymers, resulting in improved bioavailability and controlled drug release. HME is also used for bioadhesives, transdermal patches, and edible films.

*Wet Granulation: TSE is also used for wet granulation, where a liquid binder is mixed with powdered excipients and APIs. This method offers flexibility in the granulate's characteristics and is more cost-effective than traditional batch techniques.

*Role of Loss-in-Weight (LIW) Feeders: LIW feeders ensure consistent mass flow of ingredients to the extruder, crucial for maintaining uniform product quality. These feeders are used to deliver both liquid and powder feeds accurately during the extrusion process.

*Liquid Additives: LIW technology is also applied to control the delivery of liquid additives, ensuring accurate mass flow rates by adjusting pump speeds.

*Refill Operations: Proper refill operations are critical for continuous extrusion processes, with pneumatic receivers often used for reliable refilling.

*Coperion's Equipment: The text highlights Coperion’s ZSK extruders and K-Tron feeders, which are designed for the pharmaceutical industry. These machines conform to cGMP standards, are easy to clean, and offer precise control over the extrusion process. Coperion provides integrated control systems for raw material handling, feeding, and extrusion, ensuring optimal performance and compliance with regulations.

The overall emphasis is on the benefits of TSE and HME in pharmaceutical manufacturing, including efficiency, flexibility, and improved product quality.