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Sample Size Determination and Statistical Hypothesis Testing for Core Centration in Press Coated Tablets
Département de Mathématiques et Statistique Université de Montréal Montréal, Québec, H3T 1J4, Canada
230 East Grand Avenue South San Francisco CA 94080 USA
- 1 Département de Mathématiques et Statistique Université de Montréal Montréal, Québec, H3T 1J4, Canada
- 2 230 East Grand Avenue South San Francisco CA 94080 USA
Open Journal of Statistics·Volume 02 (2012)·Pages 269–273·Published 27 June 2012·DOI10.4236/ojs.2012.23032
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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.
KeywordsCore CentrationStatistical Hypothesis TestingDry-Coated TabletsSample Size
- 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.
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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.
- 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