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Understanding the Factors That Control the Quality of Mini-Tablet Compression: Flow, Particle Size, and Tooling

Junshu Zhao¹, David Yin¹, Jasmine Rowe¹

¹Drug Product Science and Technology, Bristol-Myers Squibb, New Brunswick, New Jersey 08903.

Journal of Pharmaceutical Sciences

|December 14, 2017

Summary

Manufacturing 1.7-mm mini-tablets requires careful control of particle size. Optimal powder properties, achieved through granulation and milling, prevent issues like poor flow and tooling damage for successful pediatric formulations.

Keywords:

oral drug delivery particle size pediatric powder technology processing solid dosage form tableting

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Area of Science:

Pharmaceutical Sciences
Materials Science
Chemical Engineering

Background:

Mini-tablets are valuable pediatric formulations and modified-release dosage forms.
Limited formulation and processing knowledge hinders widespread mini-tablet development.
Successful manufacturing relies on understanding critical material properties for mini-tablet production.

Purpose of the Study:

To identify critical material properties for successful 1.7-mm mini-tablet manufacturing.
To evaluate the impact of particle size and granulation on mini-tablet production.

Main Methods:

Utilized common microcrystalline cellulose grades and roller compacted granules with varied powder properties.
Investigated the effect of particle size distribution on die filling, flowability, and tooling performance.
Assessed granulation and milling strategies to optimize powder characteristics for mini-tablet compression.

Main Results:

Small particle size blends exhibited poor flow, inconsistent die filling, and tooling damage.
Granulation improved flow by increasing particle size, but excessively large particles caused die blockage.
Optimal mini-tablet compression was achieved by controlling particle size, removing particles >1/3 die diameter, or milling with screens <1/3 die diameter.

Conclusions:

Particle size control is crucial for successful mini-tablet manufacturing.
Granulation and specific milling parameters are essential for optimizing powder flow and preventing production issues.
Establishing particle size limits ensures consistent die filling and prevents tooling damage during mini-tablet compression.