Roller compaction and tabletting of St. John's wort plant dry extract using a gap width and force controlled roller compactor. II. Study of roller compaction variables on granule and tablet properties by a 3(3) factorial design.
The purpose of this study was to investigate the influence of roller compaction parameters and the amount of magnesium stearate used in dry granulation on granule and tablet properties of a dry herbal extract from St. John's wort (Hypericum perforatum L.). Two different extract batches were blended with magnesium stearate and compacted using a gap width and force controlled roller compactor. A 3(3) factorial design was used to evaluate the influence of the three independent variables, the amount of magnesium stearate, the roller compaction force, and the granulating sieve size on the mean particle size of granulated extracts and on the disintegration time of tablets containing these granulated extracts. The evaluation was done by multilinear stepwise regression analysis. The mean particle size d50 (R2 > 0.9) of both compacted extracts increased with increasing compaction force and with granulating sieve size. The disintegration time of the tablets was mostly in the range 5-15 min and increased slightly with increasing magnesium stearate concentration in the compacted extract and with decreasing compaction force of the roller compaction. The incorporation of magnesium stearate into the granulated extract reduced its potential negative influence on the disintegration time, while maintaining its functionality as a lubricant.
von Eggelkraut-Gottanka
Stephan G
SG
Department of Pharmaceutical Technology, Auf der Morgenstelle 8, D-72076 Tübingen, Germany.
Abed
Salah Abu
SA
Müller
Wolfgang
W
Schmidt
Peter C
PC
D019245:Compressive Strength; D020902:Hypericum / Q000737:chemistry*; D010316:Particle Size; D010936:Plant Extracts / Q000138:chemical synthesis / Q000493:pharmacokinetics; D012044:Regression Analysis; D013229:Stearic Acids / Q000138:chemical synthesis / Q000493:pharmacokinetics; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000295:instrumentation* / Q000379:methods*
D010936:Plant Extracts; D013229:Stearic Acids; D013607:Tablets; C031183:stearic acid