Simultaneous Comparison of Two Roller Compaction Techniques and Two Particle Size Analysis Methods

• Published in: AAPS PharmSciTech Vol. 18; no. 8; pp. 3198 - 3207
• Main Authors: Saarinen, Tuomas, Antikainen, Osmo, Yliruusi, Jouko
• Format: Journal Article
• Language: English
• Published: New York Springer US 01.11.2017
• Subjects: Biochemistry; Biomedical and Life Sciences; Biomedicine; Biotechnology; Cellulose - chemical synthesis; Drug Compounding - methods; Particle Size; Pharmacology/Toxicology; Pharmacy; Powders; Pressure; Research Article; Tablets; Technology, Pharmaceutical - methods; gas-assisted roller compaction; flowability; microcrystalline cellulose; sieve analysis; fast imaging particle size analysis; roller compaction
• ISSN: 1530-9932; 1530-9932
• DOI: 10.1208/s12249-017-0778-1

A new dry granulation technique, gas-assisted roller compaction (GARC), was compared with conventional roller compaction (CRC) by manufacturing 34 granulation batches. The process variables studied were roll pressure, roll speed, and sieve size of the conical mill. The main quality attributes measured were granule size and flow characteristics. Within granulations also the real applicability of two particle size analysis techniques, sieve analysis (SA) and fast imaging technique (Flashsizer, FS), was tested. All granules obtained were acceptable. In general, the particle size of GARC granules was slightly larger than that of CRC granules. In addition, the GARC granules had better flowability. For example, the tablet weight variation of GARC granules was close to 2%, indicating good flowing and packing characteristics. The comparison of the two particle size analysis techniques showed that SA was more accurate in determining wide and bimodal size distributions while FS showed narrower and mono-modal distributions. However, both techniques gave good estimates for mean granule sizes. Overall, SA was a time-consuming but accurate technique that provided reliable information for the entire granule size distribution. By contrast, FS oversimplified the shape of the size distribution, but nevertheless yielded acceptable estimates for mean particle size. In general, FS was two to three orders of magnitude faster than SA.