Effect of formulation and process variables on lipid based sustained release tablets via continuous twin screw...

Area of Science:

• Pharmaceutical Technology
• Drug Delivery Systems
• Materials Science

Background:

• Conventional methods for sustained release tablet formulation include wet granulation and direct compression.
• Lipid excipients are widely used to control drug release profiles.
• Twin-screw granulation presents a continuous manufacturing alternative.

Purpose of the Study:

• To prepare lipid-based sustained release tablets using twin-screw granulation.
• To compare the performance of twin-screw granulation with wet granulation and direct compression.
• To evaluate the physicochemical properties and in vitro drug release of the formulated tablets.

Main Methods:

• Twin-screw granulation, wet granulation, and direct compression were employed to prepare sustained release tablets.
• Lipid excipients (Compritol® 888 ATO, Precirol® ATO 5, Geleol™) and a binder (Klucel™ EF, HPC SSL) were utilized.
• Tablets were characterized for mechanical strength, physicochemical properties, in vitro drug release, water uptake, and erosion.

Main Results:

• Twin-screw granulation produced granules with good flow and compaction properties.
• Tablets from twin-screw granulation demonstrated sustained drug release over 24 hours.
• Conventional methods showed either incomplete release (wet granulation) or burst release (direct compression).
• Stability studies confirmed the robustness of twin-screw granulation formulations.

Conclusions:

• Twin-screw granulation is a viable, efficient single-step process for developing sustained release tablets.
• This continuous manufacturing approach offers advantages over traditional methods for lipid-based formulations.
• The study highlights new opportunities for sustained release tablet development using twin-screw technology.