Reliability assessment for the optimal formulations of pharmaceutical products predicted by a nonlinear response surface method

International Journal of Pharmaceutics

Volumn 374, Issue 1-2, 2009, Pages 5-11

  Kikuchi, Shingo ^a   Takayama, Kozo ^a  

^a HOSHI UNIVERSITY   (Japan)

Author keywords

Design space; Optimization; Reliability assessment; Response surface; Sensitivity analysis

Indexed keywords

INDOMETACIN; KETOPROFEN; MACROGOL; PACLITAXEL;

ARTICLE; DRUG FORMULATION; EMULSION; HYDROGEL; NONLINEAR SYSTEM; OINTMENT; PRIORITY JOURNAL; RELIABILITY; RESPONSE SURFACE METHOD; SENSITIVITY ANALYSIS;

CHEMISTRY, PHARMACEUTICAL; EMULSIONS; HYDROGELS; MODELS, STATISTICAL; MULTIVARIATE ANALYSIS; NONLINEAR DYNAMICS; OINTMENTS; PHARMACEUTICAL PREPARATIONS; POLYETHYLENE GLYCOLS; REPRODUCIBILITY OF RESULTS; TECHNOLOGY, PHARMACEUTICAL;

EID: 67349238185     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2009.02.016     Document Type: Article

References (14)

1. Arai H., Suzuki T., Kaseda C., Ohyama K., and Takayama K. 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 (2007) 586-593
2. Efron B., and Tibshirani R.J. An Introduction to the Bootstrap (1993), Chapman and Hall, New York
3. Fan T., Takayama K., Hattori Y., and Maitani Y. Formulation optimization of paclitaxel carried by PEGylated emulsions based on artificial neural network. Pharm. Res. 21 (2004) 1692-1697
4. ICH Draft Consensus Guideline, Pharmaceutical Development, Annex to Q8, November 2007, http://www.ich.org/cache/compo/276-254-1.html.
5. MacGregor J.F., and Bruwer M.-J. A framework for the development of design and control spaces. J. Pharm. Innov. 3 (2008) 15-22
6. Onuki Y., Hoshi M., Okabe H., Fujikawa M., Morishita M., and Takayama K. Formulation optimization of photocrosslinked polyacrylic acid modified with 2-hydroxyethyl methacrylate hydrogel as an adhesive for a dermatological patch. J. Control. Release 108 (2005) 331-340
7. Onuki Y., Morishita M., and Takayama K. Formulation optimization of water-in-oil-water multiple emulsion for intestinal insulin delivery. J. Control. Release 97 (2004) 91-99
8. Onuki Y., Ohyama K., Kaseda C., Arai H., Suzuki T., and Takayama K. 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 (2008) 331-339
9. Sandwell D.T. Biharmonic spline interpolation of GEOS-3 and SEASAT altimeter data. Geophys. Res. Lett. 14 (1987) 139-142
10. Takayama K., Imaizumi H., Nambu N., and Nagai T. Mathematical optimization of formulation of indomethacin/polyvinylpolypyrrolidone/methyl cellulose solid dispersions by the sequential unconstrained minimization technique. Chem. Pharm. Bull. 33 (1985) 292-300
11. Takayama K., Obata Y., Morishita M., and Nagai T. Multivariate spline interpolation as a novel method to optimize pharmaceutical formulations. Pharmazie 59 (2004) 392-395
12. Wahba G. Spline Models for Observational Data (1990), Society for Industrial and Applied Mathematics, Philadelphia
13. Wu P.-C., Obata Y., Fujikawa M., Li C.J., Higashiyama K., and Takayama K. Simultaneous optimization based on artificial neural networks in ketoprofen hydrogel formula containing O-Ethyl-3-butylcyclohexanol as percutaneous absorption enhancer. J. Pharm. Sci. 90 (2001) 1004-1014
14. Yu L.X. Pharmaceutical quality by design product and process development, understanding, and control. Pharm. Res. 25 (2008) 781-791