Evaluation of the plug formation process of silicified microcrystalline cellulose

被引:19
|
作者
Guo, MT
Muller, FX
Augsburger, LL [1 ]
机构
[1] Univ Maryland, Sch Pharm, Dept Pharmaceut Sci, Baltimore, MD 21201 USA
[2] GSK Pharmaceut R&D, King Of Prussia, PA 19406 USA
关键词
silicified microcrystalline cellulose; capsule formulation; capsule filling machine; simulator; plug; compaction;
D O I
10.1016/S0378-5173(01)00931-0
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
To investigate the powder plug formation process of silicified microcrystalline cellulose (SMCC) under compression forces consistent with automatic capsule-filling machines, a single-ended saw-tooth wave was used to make powder plugs with different heights (6, 8, 12 mm), at two different punch speeds (I and 50 mm/s) on a tablet compaction simulator. SMCC was compared to Starch 1500, anhydrous lactose (direct tableting grade), and microcrystalline cellulose, Heckel analysis showed that 'apparent mean yield pressures' (AMYP) of all tested materials increased with an increase in the plug height and punch speed. AMYP appeared to depend on the material type and punch speed. Not all materials fit the Shaxby-Evans relationship at such low compression forces (less than 250 N). Only SMCC 90, SMCC HD90 and anhydrous lactose data fit the equation at both punch speeds. Due to poor axial load transmission, the R values of all tested materials decreased with an increase in the plug height. The experimental data fit the Kawakita equation quite well. Overall, Kawakita's b values were inversely related to AMYP values. The maximum breaking force (MBF) of a 12 mm plug formed at a punch speed of 50 mm/s correlated well with the work of compaction, except for SMCC HD90 and SMCC X, which exhibited very high MBF values. This research demonstrated that several grades of SMCC produced plugs having higher MBF than anhydrous lactose and Starch 1500 under similar compression conditions, The apparently higher compactability of these materials at low plug formation forces may be beneficial in developing direct fill formulations for automatic capsule filling machines. (C) 2002 Elsevier Science B.V. All rights reserved.
引用
收藏
页码:99 / 109
页数:11
相关论文
共 50 条
  • [1] Physicochemical comparison between microcrystalline cellulose and silicified microcrystalline cellulose
    Tobyn, MJ
    McCarthy, GP
    Staniforth, JN
    Edge, S
    [J]. INTERNATIONAL JOURNAL OF PHARMACEUTICS, 1998, 169 (02) : 183 - 194
  • [2] The mechanical properties of compacts of microcrystalline cellulose and silicified microcrystalline cellulose
    Edge, S
    Steele, DF
    Chen, AS
    Tobyn, MJ
    Staniforth, JN
    [J]. INTERNATIONAL JOURNAL OF PHARMACEUTICS, 2000, 200 (01) : 67 - 72
  • [3] Retention of water in silicified microcrystalline cellulose
    Nikolakakis, I
    Kipouros, K
    Malamataris, S
    [J]. EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES, 2003, 19 : S42 - S42
  • [4] Functional performance of silicified microcrystalline cellulose versus microcrystalline cellulose: a case study
    Aljaberi, Ahmad
    Chatterji, Ashish
    Shah, Navnit H.
    Sandhu, Harpreet K.
    [J]. DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY, 2009, 35 (09) : 1066 - 1071
  • [5] Comparative evaluation of silicified microcrystalline cellulose II as a direct compression vehicle
    Rojas, John
    Kumar, Vijay
    [J]. INTERNATIONAL JOURNAL OF PHARMACEUTICS, 2011, 416 (01) : 120 - 128
  • [6] Adsorption of an amine drug onto microcrystalline cellulose and silicified microcrystalline cellulose samples
    Steele, DF
    Edge, S
    Tobyn, MJ
    Moreton, RC
    Staniforth, JN
    [J]. DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY, 2003, 29 (04) : 475 - 487
  • [7] Characterization of microcrystalline cellulose and silicified microcrystalline cellulose wet masses using a powder rheometer
    Luukkonen, P
    Schæfer, T
    Podczeck, F
    Newton, M
    Hellén, L
    Yliruusi, J
    [J]. EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES, 2001, 13 (02) : 143 - 149
  • [8] Physicochemical and mechanical evaluation of a novel high density grade of silicified microcrystalline cellulose
    Steele, DF
    Tobyn, M
    Edge, S
    Chen, AS
    Staniforth, JN
    [J]. DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY, 2004, 30 (01) : 103 - 109
  • [9] Identification of silicified microcrystalline cellulose by IR and Raman spectroscopy and evaluation of water interaction
    Nikolakakis, I
    Kipouros, K
    Kachrimanis, K
    Malamataris, S
    [J]. EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES, 2003, 19 : S41 - S42
  • [10] Silicified microcrystalline cellulose based pellets and their physicochemical properties
    Mustafa, Oluwabukola
    Chaw, Cheng Shu
    [J]. JOURNAL OF APPLIED POLYMER SCIENCE, 2016, 133 (33)