Development of mini-tablets with 1mm and 2mm diameter

Area of Science:

• Pharmaceutical Technology
• Materials Science

Background:

• Mini-tablets offer advantages in drug delivery, but manufacturing challenges exist for smaller sizes.
• Optimizing the production of 1mm mini-tablets requires understanding drug compression characteristics and formulation strategies.

Purpose of the Study:

• To investigate the feasibility of producing 1mm mini-tablets on a rotary-die press.
• To evaluate the mechanical properties, content uniformity, and dissolution of 1mm mini-tablets compared to 2mm counterparts.
• To assess the suitability of direct compression and roll compaction methods for 1mm mini-tablet formulation.

Main Methods:

• Formulation of 1mm mini-tablets using quinine hydrochloride, ibuprofen, and gentian extract via direct compression or roll-compaction/dry granulation.
• Assessment of tablet mechanical properties including tensile strength and mass variation.
• Analysis of content uniformity and dissolution behavior for selected batches.

Main Results:

• Successful production of 1mm mini-tablets by direct compression (90% quinine hydrochloride; 90% gentian extract) and roll compaction (70% ibuprofen).
• 1mm mini-tablets with quinine hydrochloride exhibited robust mechanical properties (median tensile strength of 2.02N/mm²) with comparable or lower variance than 2mm tablets.
• Content uniformity of 1mm mini-tablets (80% quinine hydrochloride) met European Pharmacopeia standards (AV=6.8).

Conclusions:

• The study demonstrates the successful manufacturing of 1mm mini-tablets using established pharmaceutical techniques.
• 1mm mini-tablets can achieve desirable mechanical strength and content uniformity, comparable or superior to 2mm tablets.
• These findings support the potential of 1mm mini-tablets for advanced drug delivery applications.