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Published on: December 23, 2013
Improved processability of ethambutol hydrochloride by spherical agglomeration.
Ashwini Nitsure1, Dhrumi Patel1, Sarika Wairkar1
1Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM's NMIMS, Mumbai, Maharashtra, India.
Spherical agglomeration improved the flow and compressibility of ethambutol hydrochloride (ETB), a high-dose anti-tubercular drug. This particle engineering technique enhances the processability of challenging drug formulations.
Area of Science:
- Pharmaceutical Technology
- Materials Science
- Drug Delivery
Background:
- Ethambutol hydrochloride (ETB), a critical anti-tubercular medication, suffers from poor flow and compressibility, hindering its manufacturing.
- Effective particle engineering is essential to overcome processing challenges associated with high-dose drugs like ETB.
Purpose of the Study:
- To enhance the flow, compressibility, and packing characteristics of ethambutol hydrochloride (ETB).
- To improve the overall processability of ETB through spherical agglomeration.
Main Methods:
- Utilized the quasi-emulsion solvent diffusion method for spherical agglomeration of ETB.
- Optimized the process using a 3^2 factorial design, varying stirring speed and anti-solvent ratios.
- Characterized the resulting ethambutol hydrochloride spherical agglomerates (ETB-SA) using sieve analysis, solid-state techniques, and Kawakita analysis.
Main Results:
- Spherical agglomeration significantly improved the flow properties and packability of ETB.
- SEM confirmed the uniformity of the spherical agglomerates (ETB-SA).
- XRPD, DSC, and FTIR studies indicated no significant changes in crystallinity or chemical integrity.
Conclusions:
- Spherical agglomeration is an effective particle engineering strategy for enhancing the processability of high-dose drugs like ethambutol hydrochloride.
- The optimized ETB-SA exhibited superior flowability and compressibility without compromising dissolution profiles.
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