Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), SAS. Nagar, Punjab, India.
J Pharm Sci. 2011 Feb;100(2):758-66. doi: 10.1002/jps.22315. Epub 2010 Aug 27.
The mechanism of loss of "reworkability" or tabletability of dry granulated microcrystalline cellulose (MCC) was investigated in relation to both granule size enlargement and granule hardness. Slugs of MCC were prepared under three pressures (12.5, 37.5, and 93.8 MPa) and tabletability (tensile strength vs. pressure) of respective granules (three different sizes) was determined. Nominal single granule fracture strength and granule friability were measured. The reduction in tabletability was profound for harder granules, which were obtained from higher slugging pressure. This is consistent with their ability to resist granule fragmentation during tableting. Variation in granule size exhibits negligible effect on tabletability for the lowest slugging pressure and only a small effect for the middle and highest slugging pressure. This observation is again related to different tendency to granule fragmentation during compaction. The results suggest that granule-hardening negatively affects tensile strength more than that of granule size enlargement for MCC.
研究了干法制粒微晶纤维素（MCC）的“可返工性”或可压性损失的机制，涉及颗粒尺寸增大和颗粒硬度。在三种压力（12.5、37.5 和 93.8 MPa）下制备 MCC 条，测定了相应颗粒（三种不同尺寸）的可压性（拉伸强度与压力的关系）。测量了名义单颗粒断裂强度和颗粒脆性。对于更硬的颗粒，压片性降低得非常明显，这些颗粒是由更高的制粒压力获得的。这与其在压片过程中抵抗颗粒破碎的能力一致。颗粒尺寸的变化对最低制粒压力下的可压性几乎没有影响，而对中高制粒压力下的可压性只有很小的影响。这一观察结果再次与压实过程中颗粒破碎的不同趋势有关。结果表明，与颗粒尺寸增大相比，颗粒硬化对 MCC 的拉伸强度有负面影响。
