The crystallite-gel-model for microcrystalline cellulose in wet-granulation, extrusion, and spheronization

被引:88
作者
Kleinebudde, P
机构
[1] Dept. Pharmaceut. and Biopharmaceut., Chrstn.-Albrecht University of Kiel, D-24118 Kiel
关键词
microcrystalline cellulose; wet granulation; extrusion/spheronization; crystallite-gel-model; liquid saturation model;
D O I
10.1023/A:1012166809583
中图分类号
O6 [化学];
学科分类号
0703 ;
摘要
Purpose. A new model for the wet-extrusion/spheronization process with microcrystalline cellulose (MCC) is proposed. The crystallite-gel-model is able to elucidate the unique role of MCC in this process. Many other experimental results, which cannot be explained by the standard model of granulation, the liquid saturation model, give evidence for the crystallite-gel-model. Methods. Pellets were prepared from different types of MCC. Water content during extrusion, power consumption and aspect ratio were correlated. X-ray diffractograms of MCC powders, extrudates and pellets were taken in order to provide information on changes at the single crystallite level. SEM-photographs and leaching studies gave additional information on changes at the particulate level of MCC. Results. At the level of MCC powder particles, dramatic changes occurred during extrusion/spheronization. In contrast to this no changes could be observed at the level of individual crystallites. Conclusions. During granulation and extrusion MCC-particles are thought to be broken down into smaller particles and possibly ultimate single crystallites in the presence of water. The crystallite-gel-model serves as the framework for a new interpretation of the wet-extrusion/spheronization process. Apart from the ability to explain experimental data published previously in the literature it can be used to develop new experimental plans for further research. Consequently, the crystallite-gel-model exhibits explanatory as well as predictive power.
引用
收藏
页码:804 / 809
页数:6
相关论文
共 30 条
[1]   THE INFLUENCE OF MOISTURE-CONTENT ON THE PREPARATION OF SPHERICAL GRANULES OF BARIUM-SULFATE AND MICROCRYSTALLINE CELLULOSE [J].
BAINS, D ;
BOUTELL, SL ;
NEWTON, JM .
INTERNATIONAL JOURNAL OF PHARMACEUTICS, 1991, 69 (03) :233-237
[2]   CHANGES IN MATERIAL PROPERTIES ACCOMPANYING THE NATIONAL FORMULARY (NF) IDENTITY TEST FOR MICROCRYSTALLINE CELLULOSE [J].
BRITTAIN, HG ;
LEWEN, G ;
NEWMAN, AW ;
FIORELLI, K ;
BOGDANOWICH, S .
PHARMACEUTICAL RESEARCH, 1993, 10 (01) :61-67
[3]   Analysis of extrusion of some wet powder masses used in extrusion/spheronisation [J].
Chohan, RK ;
Newton, JM .
INTERNATIONAL JOURNAL OF PHARMACEUTICS, 1996, 131 (02) :201-207
[4]   COMPARATIVE COMPACTION PROPERTIES OF VARIOUS MICROCRYSTALLINE CELLULOSE TYPES AND GENERIC PRODUCTS [J].
DOELKER, E .
DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY, 1993, 19 (17-18) :2399-2471
[5]   THE EFFECT OF LACTOSE PARTICLE-SIZE ON THE EXTRUSION PROPERTIES OF MICROCRYSTALLINE CELLULOSE-LACTOSE MIXTURES [J].
FIELDEN, KE ;
NEWTON, JM ;
ROWE, RC .
JOURNAL OF PHARMACY AND PHARMACOLOGY, 1989, 41 (04) :217-221
[6]   MOVEMENT OF LIQUIDS THROUGH POWDER BEDS [J].
FIELDEN, KE ;
NEWTON, JM ;
ROWE, RC .
INTERNATIONAL JOURNAL OF PHARMACEUTICS, 1992, 79 (01) :47-60
[7]   THE INFLUENCE OF MOISTURE-CONTENT ON SPHERONIZATION OF EXTRUDATE PROCESSED BY A RAM EXTRUDER [J].
FIELDEN, KE ;
NEWTON, JM ;
ROWE, RC .
INTERNATIONAL JOURNAL OF PHARMACEUTICS, 1993, 97 (1-3) :79-92
[8]   THERMAL STUDIES ON THE INTERACTION OF WATER AND MICROCRYSTALLINE CELLULOSE [J].
FIELDEN, KE ;
NEWTON, JM ;
OBRIEN, P ;
ROWE, RC .
JOURNAL OF PHARMACY AND PHARMACOLOGY, 1988, 40 (10) :674-678
[9]  
FIELDEN KE, 1992, ENCY PHARM TECHNOLOG, V5
[10]   THE EFFECT OF WATER-CONTENT ON THE POROSITY AND LIQUID SATURATION OF EXTRUDED CYLINDERS [J].
JERWANSKA, E ;
ALDERBORN, G ;
NEWTON, JM ;
NYSTROM, C .
INTERNATIONAL JOURNAL OF PHARMACEUTICS, 1995, 121 (01) :65-71