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A novel method for estimating solid fraction of roller-compacted ribbons.

Paul Nkansah¹, Sy-Juen Wu, Stephanie Sobotka

¹Pfizer Global Research & Development, Pharmaceutical Sciences, Ann Arbor, Michigan 48105, USA. paul.nkansah@pfizer.com

Drug Development and Industrial Pharmacy

|February 28, 2008

Summary

A new method estimates solid fraction of roller compacted ribbons using weight, offering an alternative to dimensional measurements. Accounting for ribbon relaxation significantly improves accuracy for pharmaceutical formulations.

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Area of Science:

Pharmaceutical Sciences
Materials Science
Chemical Engineering

Background:

Roller compaction is a key process in pharmaceutical manufacturing for producing granules and compacts.
Accurate determination of solid fraction (relative density) is crucial for controlling product quality and performance.
Traditional methods like dimensional measurement can be challenging for certain formulations.

Purpose of the Study:

To develop a simple, weight-based method for estimating the solid fraction of roller compacted ribbons.
To provide an alternative to dimensional measurements, particularly for challenging formulations.
To incorporate surface texture and ribbon relaxation into the mathematical model for improved accuracy.

Main Methods:

A novel mathematical model was developed to estimate solid fraction using the weight of produced ribbons.
The model incorporates surface texture of compaction rolls and a correction factor for ribbon relaxation.
Ribbon relaxation was estimated based on roll geometry, roll gap, and ribbon thickness.

Main Results:

The weight-based method provided solid fraction estimates comparable to traditional caliper measurements.
Inclusion of ribbon relaxation significantly reduced the error sum of squares (SSE) for microcrystalline cellulose/dicalcium phosphate and microcrystalline cellulose/lactose monohydrate formulations.
The SSE decreased by four-fold and twelve-fold, respectively, demonstrating the model's improved accuracy with relaxation correction.

Conclusions:

The proposed weight-based method is a viable and accurate alternative for estimating the solid fraction of roller compacted ribbons.
Accounting for ribbon relaxation is essential for precise solid fraction determination, especially for specific pharmaceutical formulations.
This throughput method offers practical utility for quality control in pharmaceutical manufacturing.