Stability and repeatability of a continuous twin screw granulation and drying system

Area of Science:

• Pharmaceutical Manufacturing Technology
• Process Engineering
• Drug Delivery Systems

Background:

• Traditional batch fluid bed granulation and drying methods present challenges in achieving consistent long-term production.
• Transitioning to continuous manufacturing offers potential for improved efficiency and product quality in pharmaceutical production.
• Twin screw granulation serves as a key intermediate step in integrated continuous manufacturing lines.

Purpose of the Study:

• To evaluate the process transfer and performance of a commercial product from batch to continuous manufacturing.
• To assess the stability and repeatability of an integrated "powder to tablet" line using twin screw granulation.
• To monitor critical process parameters and product quality attributes during extended continuous runs.

Main Methods:

• Utilized the ConsiGma™-25 continuous manufacturing system for "powder to tablet" production.
• Monitored key process parameters including torque, temperature, and differential pressure.
• Evaluated granule attributes (LOD, PSD, friability, flow) and tablet quality (weight, hardness, content uniformity, dissolution) over time.

Main Results:

• Process parameters stabilized to steady-state conditions after an initial period.
• Minor variations in granule properties were observed during start-up, but tablet quality remained consistent.
• Consistent granule and tablet quality was maintained for several hours, with highly repeatable process data trends.

Conclusions:

• The ConsiGma™-25 system, incorporating twin screw granulation, is a stable and repeatable platform for continuous tablet manufacturing.
• Continuous wet granulation via twin screw technology enables consistent production of high-quality pharmaceutical tablets.
• The study validates the feasibility of transferring established products to a continuous manufacturing paradigm.