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Decoding the small size challenges of mini-tablets for enhanced dose flexibility and micro-dosing.
Biplob Mitra1, Prajwal Thool1, Saikishore Meruva2
1Drug Product Development, Bristol-Myers Squibb Company (formerly Celgene Corporation), Summit, NJ 07901, USA.
International Journal of Pharmaceutics
|December 7, 2019
Summary
Smaller mini-tablets enable precise micro-dosing for pediatric and geriatric patients. This study optimized mini-tablet size, drug particle size, and loading for acceptable quality and enhanced drug dissolution.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Formulation Development
Background:
- Mini-tablets are suitable oral dosage forms for pediatric and geriatric populations.
- Smaller mini-tablets offer improved micro-dose delivery of investigational drugs.
Purpose of the Study:
- To determine optimal drug substance particle size, drug loading, and mini-tablet size for acceptable quality attributes.
- To evaluate the impact of these parameters on content uniformity and dissolution performance.
Main Methods:
- Direct compression of ibuprofen mini-tablets with varying particle sizes (60-100 μm) and loadings (3-25%).
- Mini-tablets were manufactured in different sizes (1.2-2.5 mm diameter).
- Content uniformity and dissolution testing were performed according to USP guidelines.
Main Results:
- Most mini-tablet batches achieved acceptable content uniformity (USP <905> L1 and L2 criteria).
- Smaller mini-tablet size, smaller ibuprofen particle size, and lower drug loading enhanced dissolution.
- A validated dissolution method was successfully applied.
Conclusions:
- Development of smaller mini-tablets is feasible for enhanced dosing flexibility and micro-dosing.
- Optimized formulation parameters reduce excipient burden and leverage dispensing technology.
- This research provides guidance for creating tailored micro-dose formulations.
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