全部 标题 作者
关键词 摘要

OALib Journal期刊
ISSN: 2333-9721
费用:99美元

查看量下载量

相关文章

更多...

Sample Size Determination and Statistical Hypothesis Testing for Core Centration in Press Coated Tablets

DOI: 10.4236/ojs.2012.23032, PP. 269-273

Keywords: Core Centration, Statistical Hypothesis Testing, Dry-Coated Tablets, Sample Size

Full-Text   Cite this paper   Add to My Lib

Abstract:

A novel statistical approach to evaluate the manufacturing quality of press coated tablets in terms of the centering of their core is presented. We also provide a formula to determine the necessary sample size. This approach is applied to real data.

References

[1]  P. A. Kulkarni, M. Jaiswal, S. Jawale, S. V. Shirolkar and P. V. Kasture, “Development and Evaluation of Press Coated Tablets for Chronopharmaceutical Drug Delivery using Gellable and Permeable Polymers,” Der Pharmacia Lettre, Scholars Research Library, Vol. 2, 2010, pp. 482- 497.
[2]  Y. Ozeki, M. Ando, Y. Watanabe and K. Danjo, “Evaluation of Novel One-Step Dry-Coated Tablets as a Platform for Delayed-Release Tablets,” Journal of Controlled Release, Vol. 95, No. 1, 2004, pp. 51-60. doi:10.1016/j.jconrel.2003.10.028
[3]  M. Ito, T. Suzuki, N. Wakiyama, H. Teramoto, E. Yonemochi and K. Terada, “Development of a Rapid Process Monitoring Method for Dry-Coated Tableting Process by Using Near-Infrared Spectroscopy,” Chemical and Pharmaceutical Bulletin, Vol. 59, No. 7, 2011, pp. 868- 873. doi:10.1248/cpb.59.868
[4]  J. Windheuser and J. Cooper, “The Pharmaceutics of Coating Tablets by Compression,” Journal of the American Pharmaceutical Association, Vol. 45, No. 8, 1956, pp. 542-545. doi:10.1002/jps.3030450812
[5]  L. Lachman, P. P. Speiser and H. D. Sylwestrowicz, “Compressed Coated Tablets. I. Measurement and Factors Influencing Core Centration,” Journal of Pharmaceutical Science, Vol. 52, No. 4, 1963, pp. 379-390. doi:10.1002/jps.2600520415
[6]  Y. Ozeki, Y. Watanabe, S. Inoue and K. Danjo, “Comparison of the Compression Characteristics between New One-Step Dry-Coated Tablets (OSDRC) and Dry-Coated Tablets (DC),” International Journal of Pharmaceutics, Vol. 259, No. 1-2, 2003, pp. 69-77. doi:10.1016/S0378-5173(03)00208-4
[7]  Y. Ozeki, Y. Watanabe, S. Inoue and K. Danjo, “Evaluation of the Compression Characteristics and Physical Properties of the Newly Invented One-Step Dry-Coated Tablets,” International Journal of Pharmaceutics, Vol. 267, No. 1-2, 2003, pp. 69-78. doi:10.1016/j.ijpharm.2003.07.011
[8]  Y. Ozeki, Y. Watanabe, H. Okamoto and K. Danjo, “Development of Dividable One-Step Dry-Coated Tablets (Dividable-OSDRC) and Their Evaluation as a New Platform for Controlled Drug Release,” Pharmaceutical Research, Vol. 21, No. 7, 2004, pp. 1177-1183. doi:10.1023/B:PHAM.0000033004.88953.bc
[9]  S. Rujivipat, “Novel Formulation and Processing Aspects for Compression-Coated Tablets and for the Compression of Polymercoated Multiparticulates,” Ph.D. Thesis, Free University of Berlin, Berlin, 2010.
[10]  R. Srinivas, H. G. DeKay and G. S. Banker, “New Approach to Development and Manufacture of Enteric Compression Coatings,” Journal of Pharmaceutical Sciences Vol. 55, No. 3, 1966, pp. 335-340. doi:10.1002/jps.2600550314
[11]  S. A. Yehi, A. H. Elshafeey, I. Sayed and A. H. Shehata, “Optimization of Budesonide Compression-Coated Tablets for Colonic Delivery,” AAPS PharmSciTech, Vol. 10, No. 1, 2009, pp. 147-157.
[12]  B. Efron and R. J. Tibshirani, “An Introduction to the Bootstrap, Ser. Monographs on Statistics and Applied Probability,” Chapman and Hall, New York, 1993.
[13]  Development Core Team, A Language and Environment for Statistical Computing, Foundation for Statistical Computing, Vienna, 2010. http://www.R-project.org

Full-Text

Contact Us

service@oalib.com

QQ:3279437679

WhatsApp +8615387084133