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Published on: July 4, 2014
An integrated framework streamlining the manufacturing of high drug loading pharmaceutical tablets
Eftychios Hadjittofis1, Selim Douieb1, Adam Hill2
1UCB S.A, Allée de la Recherche, 60, 1070 Brussels, Belgium.
This study presents a new workflow to accelerate direct compression (DC) formulation development in the biopharma industry. It integrates particle engineering and formulation design for efficient tableted solid dosage forms.
Area of Science:
- Pharmaceutical Sciences
- Chemical Engineering
- Materials Science
Background:
- Biopharma industry faces pipeline volatility and demands shorter development times for tableted solid dosage forms.
- Traditional functional silos hinder efficient drug product development.
- Need for integrated workflows that enhance inter-functional communication and synergy.
Purpose of the Study:
- To present and validate a novel workflow for accelerating Direct Compression (DC) development.
- To demonstrate the integration of particle engineering and formulation design.
- To improve the efficiency of tableted solid dosage form development.
Main Methods:
- Utilized the CrystalGrower platform for particle engineering via crystallization strategies.
- Conducted small-scale experiments and utilized miniaturized powder characterization tools.
- Employed the EleGent platform for high drug loading DC formulation development.
- Validated predictions on a tablet press.
Main Results:
- Successfully mapped the relationship between particle and powder properties.
- Identified suitable DC formulations with high drug loading.
- Demonstrated workflow effectiveness with a challenging New Chemical Entity (NCE), Minzasolmin.
- Achieved successful tablet production on a tablet press.
Conclusions:
- The developed workflow significantly accelerates DC development.
- The integrated approach, combining particle engineering and formulation, is effective for challenging APIs.
- This workflow shows potential for future Chemistry, Manufacturing, and Controls (CMC) development activities.
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