275
Views
3
CrossRef citations to date
0
Altmetric
Research Article

Novel method to construct large-scale design space in lubrication process utilizing Bayesian estimation based on a small-scale design-of-experiment and small sets of large-scale manufacturing data

, &
Pages 1451-1459 | Received 10 Sep 2011, Accepted 26 Dec 2011, Published online: 23 Feb 2012

References

  • ICH guideline. (2009). Pharmaceutical Development Q8 (R2).
  • Huang J, Kaul G, Cai C, Chatlapalli R, Hernandez-Abad P, Ghosh K et al. (2009). Quality by design case study: an integrated multivariate approach to drug product and process development. Int J Pharm, 382:23–32.
  • Lewis GA, Mathieu D, Phan-Tan-Luu R. (1999). Pharmaceutical Experimental Design. Marcel Dekker, New York.
  • Montgomery DC. (1997). Design and Analysis of Experiments. Wiley, New York.
  • AlKhatib HS, Sakr A. (2003). Optimization of methacrylic acid ester copolymers blends as controlled release coatings using response surface methodology. Pharm Dev Technol, 8:87–96.
  • Huang YB, Tsai YH, Yang WC, Chang JS, Wu PC. (2004). Optimization of sustained-release propranolol dosage form using factorial design and response surface methodology. Biol Pharm Bull, 27:1626–1629.
  • Marengo E, Cavalli R, Rovero G, Gasco MR. (2003). Scale-up and optimization of an evaporative drying process applied to aqueous dispersions of solid lipid nanoparticles. Pharm Dev Technol, 8:299–309.
  • Matsumura M, Nakagami H, Yamao T, Takayama K, Nagai T. (1994). Computer optimization for the formulation of controlled-release theophylline tablet made of micronized low-substituted hydroxypropylcellulose and methylcellulose. Chem Pharm Bull, 42:1902–1908.
  • Paterakis PG, Korakianiti ES, Dallas PP, Rekkas DM. (2002). Evaluation and simultaneous optimization of some pellets characteristics using a 3(3) factorial design and the desirability function. Int J Pharm, 248:51–60.
  • Rekhi GS, Nellore RV, Hussain AS, Tillman LG, Malinowski HJ, Augsburger LL. (1999). Identification of critical formulation and processing variables for metoprolol tartrate extended-release (ER) matrix tablets. J Control Release, 59:327–342.
  • Vojnovic D, Chicco D, Zenary HE. (1996). Doehlert experimental design applied to optimization and quality control of a granulation process in a high shear mixer. Int J Pharm, 145:203–213.
  • Ogawa S, Kamijima T, Miyamoto Y, Miyajima M, Sato H, Takayama K et al. (1994). A new attempt to solve the scale-up problem for granulation using response surface methodology. J Pharm Sci, 83:439–443.
  • Takagaki K, Arai H, Takayama K. (2010). Creation of a tablet database containing several active ingredients and prediction of their pharmaceutical characteristics based on ensemble artificial neural networks. J Pharm Sci, 99:4201–4214.
  • Takayama K, Morva A, Fujikawa M, Hattori Y, Obata Y, Nagai T. (2000). Formula optimization of theophylline controlled-release tablet based on artificial neural networks. J Control Release, 68:175–186.
  • Takayama K, Obata Y, Morishita M, Nagai T. (2004). Multivariate spline interpolation as a novel method to optimize pharmaceutical formulations. Pharmazie, 59:392–395.
  • Arai H, Suzuki T, Kaseda C, Ohyama K, Takayama K. (2007). Bootstrap re-sampling technique to evaluate the optimal formulation of theophylline tablets predicted by non-linear response surface method incorporating multivariate spline interpolation. Chem Pharm Bull, 55:586–593.
  • Arai H, Suzuki T, Kaseda C, Takayama K. (2009). Effect of an experimental design for evaluating the nonlinear optimal formulation of theophylline tablets using a bootstrap resampling technique. Chem Pharm Bull, 57:572–579.
  • Onuki Y, Ohyama K, Kaseda C, Arai H, Suzuki T, Takayama K. (2008). Evaluation of the reliability of nonlinear optimal solutions in pharmaceuticals using a bootstrap resampling technique in combination with Kohonen’s self-organizing maps. J Pharm Sci, 97:331–339.
  • Arai H, Suzuki T, Yada S, Kaseda C, Onuki Y, Takayama K. (2011). Reliability evaluation of the design space of the granulation process of mefenamic acid tablets using a bootstrap resampling technique. Chem Pharm Bull, 59:608–617.
  • Brone D, Alexander A, Muzzio FJ. (1988). Quantitative characterization of mixing of dry powders in V-blenders. AIChE J, 44:271–278.
  • Horsthuis GJB, van Laarhoven JAH, van Rooij RCBM, Vromans H. (1993). Studies on upscaling parameters of the Gral high shear granulation process. Int J Pharm, 92:143–150.
  • Leuenberger H, Luy B, Studer J. (1990). New development in the control of a moist agglomeration and pelletization process. STP Pharm Sci, 6:303–309.
  • Peterson JJ. (2008). A Bayesian approach to the ICH Q8 definition of design space. J Biopharm Stat, 18:959–975.
  • Lindley DV. (1965). Introduction to probability and statistics from a Bayesian viewpoint, Part 2. Inference. Cambridge University Press, Cambridge.
  • ISTM international. (2010). Manual on Presentation of Data and Control Chart Analysis: 8th Edition. America.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.