Evaluation of disintegration testing of different fast dissolving tablets using the texture analyzer

被引:46
作者
El-Arini, SK [1 ]
Clas, SD [1 ]
机构
[1] Merck Frosst Canada & Co, Pharmaceut Res & Dev, Ctr Therapeut Res, Pointe Claire, PQ, Canada
关键词
disintegration; fast-dissolving tablets; texture analyzer method;
D O I
10.1081/PDT-120005732
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
The in vitro disintegration behavior of fast dissolving systems manufactured by the main commercialized technologies was studied using the texture analyzer (TA) instrument. Quantitative parameters were employed to characterize the effect of the major test variables on the disintegration profiles. The average disintegration profiles of the products were compared using the test conditions that minimized these effects and at the same time mimicked the in vivo situation in the patient's mouth. The differences in the disintegration mechanisms of the fast dissolving systems were reflected in the shape of their disintegration profiles and in the parameters derived from the profiles. The differences were explained in relation to the technology and/or formulation characteristics involved in the manufacture of each product. The in vitro disintegration times obtained under the simulated in vivo conditions were correlated with the reported in vivo disintegration times.
引用
收藏
页码:361 / 371
页数:11
相关论文
共 13 条
[1]  
ABUIZZA K, 2000, P AM ASS PHARM SCI I
[2]  
BONADEO D, 1999, Patent No. 9904758
[3]  
Cima Labs Inc, 2001, Interesting patent about common fluidized bed approaches on taste masking, Patent No. [US6221392, 6221392]
[4]  
Cousin G, 1995, US Patent, Patent No. 5464632
[5]  
DOBETTI L, 2000, PHARM TECHNOL EU SEP, P32
[6]   In vitro determination of disintegration time of quick-dissolve tablets using a new method [J].
Dor, PJM ;
Fix, JA .
PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY, 2000, 5 (04) :575-577
[7]  
DOR PJM, 1999, P AM ASS PHARM SCI N
[8]  
Habib W, 2000, CRIT REV THER DRUG, V17, P61
[9]  
Mizumoto T., 1996, US Patent, Patent No. [5576014A, 5576014]
[10]  
Myers GL, 1999, US Patent, Patent No. 5866163