Applications of NIR in early stage formulation development. Part II. Content uniformity evaluation of low dose tablets by principal component analysis

International Journal of Pharmaceutics

Volumn 380, Issue 1-2, 2009, Pages 49-54

  Li, Weiyong ^a   Bagnol, Laurent ^a   Berman, Maxine ^a   Chiarella, Renato A ^a   Gerber, Michael ^a  

^a JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

Author keywords

Content uniformity; Near infrared spectroscopy; Partial least squares; Principal component analysis; Tablet

Indexed keywords

ALPHA LACTOSE; LACTOSE;

ARTICLE; CALIBRATION; CHEMICAL COMPOSITION; CONTROLLED STUDY; DRUG FORMULATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; INTERMETHOD COMPARISON; NEAR INFRARED SPECTROSCOPY; PARTIAL LEAST SQUARES REGRESSION; PREDICTION; PRINCIPAL COMPONENT ANALYSIS; PRIORITY JOURNAL; REFERENCE VALUE; TABLET COMPRESSION; TABLET FORMULATION; TABLET MANUFACTURE;

CHEMISTRY, PHARMACEUTICAL; FEASIBILITY STUDIES; LACTOSE; PRINCIPAL COMPONENT ANALYSIS; QUALITY CONTROL; SPECTROSCOPY, NEAR-INFRARED; TABLETS;

EID: 69549084553     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2009.06.032     Document Type: Article

References (12)

1. Alcala M., Leon J., Ropero J., Blanco M., and Romanach R. Analysis of low content drug tablets by transmission near infrared spectroscopy: selection of calibration rangers according to multivariate detection and quantitation limits of PLS models. J. Pharm. Sci. 97 (2008) 5318-5327
2. Alcala M., Ropero J., Vazquez R., and Romanach R. Deconvolution of chemical and physical information from intact tablets NIR spectra: two- and three-way multivariate calibration strategies for drug quantitation. J. Pharm. Sci. 98 (2009) 2747-2758
3. Blanco M., and Villar A. Development and validation of a method for the polymorphic analysis pharmaceutical preparations using near infrared spectroscopy. J. Pharm. Sci. 92 (2003) 823-830
4. Blanco M., and Alcala M. Content uniformity and tablet hardness testing of intact pharmaceutical tablets by near infrared spectroscopy. A contribution to process analytical technologies. Anal. Chim. Acta 557 (2006) 353-359
5. Freitas M.P., Sabadin A., Silva L.M., Giannotti F.M., do Couto D.A., Tonhi E., Medeiros R.S., Coco G.L., Russo V.F., and Martins J.A. Prediction of drug dissolution profiles from tablets using NIR diffuse reflectance spectroscopy: a rapid and nondestructive method. J. Pharm. Biomed. Anal. 39 (2005) 17-21
6. Li W., Worosila G., Wang W., and Mascaro T. Determination of polymorph conversion of an active pharmaceutical ingredient in wet granulation using NIR calibration models generated from the premix blends. J. Pharm. Sci. 94 (2005) 2800-2806
7. Li W., Bashai-Woldu A., Ballard J., Johnson M., Agresta M., Rasmussen H., Hu S., Cunningham J., and Winstead D. Applications of NIR in early stage formulation development. Part I. Semi-quantitative blend uniformity analyses by reflectance NIR without calibration models. Int. J. Pharm. 340 (2007) 97-103
8. Merckle P., and Kovar K.A. Assay of effervescent tablets by near-infrared spectroscopy in transmittance and reflectance mode: acetylsalicylic acid in mono and combination formulations. J. Pharm. Biomed. Anal. 17 (1998) 365-374
9. Norris K.H., and Ritchie G.E. Assuring specificity for a multivariate near-infrared (NIR) calibration: the example of the Chambersburg Shoot-out 2002 data set. J. Pharm. Biomed. Anal. 48 (2008) 1037-1041
10. Ritchie G.E., Roller R.W., Ciurczak E.W., Mark H., Tso C., and MacDonald S.A. Validation of a near-infrared transmission spectroscopic procedure. Part B. Application to alternate content uniformity and release assay methods for pharmaceutical solid dosage forms. J. Pharm. Biomed. Anal. 29 (2002) 159-171
11. Roggo Y., Chalus P., Maurer L., Lema-Martinez C., Edmond A., and Jent N. A review of near infrared spectroscopy and chemometrics in pharmaceutical technologies. J. Pharm. Biomed. Anal. 44 (2007) 683-700
12. Xiang D., Berry J., Buntz S., Gargiulo P., Cheney J., Joshi Y., Wabuyele B., Wu H., Hamed M., Hussain A., and Khan M.A. Robust calibration design in the pharmaceutical quantitative measurements with near-infrared (NIR) spectroscopy: avoiding the chemometric pitfalls. J. Pharm. Sci. 98 (2009) 1155-1166