Identifying Optimized Parameters to Enhance the Productivity of Gas Generating Pellets Using a Dome Type Extruder

Area of Science:

• Pharmaceutical Manufacturing
• Drug Delivery Systems
• Process Optimization

Background:

• Extrusion-spheronization is a key pharmaceutical manufacturing technique.
• Optimizing pelletization for high yield, quality, and cost-efficiency remains a challenge.

Purpose of the Study:

• To identify ideal parameters for maximizing production rates using a dome extruder.
• To maintain desired physical characteristics of pharmaceutical pellets.

Main Methods:

• Design of Experiments (DoE) and Response Surface Methodology (RSM) were employed.
• Central Composite Face-Centered design analyzed critical parameters: Extruder speed, Spheronization speed, and Spheronization time.
• Pellet characteristics (sphericity, friability, bulk density, yield) were measured.

Main Results:

• Extrusion and spheronization speeds are critical for maximizing production rates and pellet quality.
• Optimal conditions: 23-27 rpm extruder speed, 700-900 rpm spheronization speed, and 5-7 min spheronization time.
• Achieved over 90% yield of spherical pellets with desirable physical properties.

Conclusions:

• A Quality by Design (QbD) approach successfully optimized pellet production parameters.
• Identified key factors influencing pellet yield and quality for dome-type extruders.
• Optimized pellets show potential for gastro-retentive or floating drug delivery systems.