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Process Model Approach to Predict Tablet Weight Variability for Direct Compression Formulations at Pilot and
Raghu V G Peddapatla1,2, Gerard Sheridan2,3, Conor Slevin2,3
1SSPC Pharmaceutical Research Centre, School of Pharmacy, University College Cork, T12 K8AF Cork, Ireland.
Pharmaceutics
|August 10, 2021
Summary
This study developed an empirical model to optimize tablet manufacturing processes. The model ensures consistent tablet weight by adjusting processing conditions for different formulations and equipment scales.
Area of Science:
- Pharmaceutical Manufacturing
- Process Engineering
- Quality by Design (QbD)
Background:
- Optimizing processing conditions for critical quality attributes (CQAs) is essential in pharmaceutical manufacturing.
- Process translation across different scales and formulations presents significant challenges due to equipment and material dependencies.
- Current methods often struggle to reliably predict optimal processing parameters for direct compression formulations.
Purpose of the Study:
- To develop an empirical model for optimizing direct compression tablet manufacturing processes.
- To determine optimal processing conditions that minimize tablet weight variability across pilot- and production-scale tablet presses.
- To enable reliable process translation for formulations with varying flow properties.
Main Methods:
- An experimental design was employed using three model placebo blends with diverse flow properties.
- Compaction experiments were conducted on one pilot-scale and two production-scale tablet presses.
- An empirical process model was developed to correlate processing parameters with tablet weight variability (target <1% RSD).
Main Results:
- The developed empirical model successfully optimized processing parameters for specific formulations on different tablet presses.
- The model achieved the target tablet weight variability of less than 1% RSD across various scales and formulations.
- Model validation using additional placebo and active formulations demonstrated its robustness and applicability.
Conclusions:
- An empirical modeling approach provides an effective strategy for optimizing direct compression tablet manufacturing.
- The developed model facilitates process scale-up and formulation transfer by accounting for material and equipment variations.
- This QbD-based approach enhances process understanding and ensures consistent product quality in pharmaceutical manufacturing.
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