Single-tablet-scale direct-compression: An on-demand manufacturing route for personalized tablets.

Area of Science:

• Pharmaceutical Manufacturing
• Drug Delivery Systems
• Personalized Medicine

Background:

• The pharmaceutical industry faces challenges in supply chain security and meeting the demand for personalized medicine.
• Decentralized and flexible manufacturing approaches are needed to address these issues.

Purpose of the Study:

• To present and evaluate a single-tablet-scale, direct-compression setup for personalized pharmaceutical manufacturing.
• To assess the performance of dosing and mixing technologies for personalized tablet production.
• To analyze the critical quality attributes (CQAs) of personalized tablets.

Main Methods:

• Development of a single-tablet-scale direct-compression manufacturing setup.
• Investigation of dosing accuracy and vibratory mixing performance using various pharmaceutical powders.
• Analysis of critical quality attributes (CQAs) for immediate-release ibuprofen and loratadine tablets.

Main Results:

• The dosing device achieved >90% acceptance rates for doses ≥20 mg across various powders.
• Optimal vibratory mixing performance was observed at 100 Hz and ~90 G, though efficacy varied with granular systems.
• Produced tablets met U.S. Pharmacopeia standards for mechanical stability and dissolution.

Conclusions:

• The developed single-tablet-scale setup is a proof of concept for producing personalized tablets.
• This technology can reduce reliance on complex pharmaceutical supply chains.
• It offers a flexible solution for patient-specific medication needs.