Share This Article:

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

Abstract Full-Text HTML Download Download as PDF (Size:436KB) PP. 269-273
DOI: 10.4236/ojs.2012.23032    4,333 Downloads   7,037 Views   Citations

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.

Conflicts of Interest

The authors declare no conflicts of interest.

Cite this paper

P. Micheaux and V. Lemaire, "Sample Size Determination and Statistical Hypothesis Testing for Core Centration in Press Coated Tablets," Open Journal of Statistics, Vol. 2 No. 3, 2012, pp. 269-273. doi: 10.4236/ojs.2012.23032.

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

  
comments powered by Disqus

Copyright © 2019 by authors and Scientific Research Publishing Inc.

Creative Commons License

This work and the related PDF file are licensed under a Creative Commons Attribution 4.0 International License.