A statistical support for using spectroscopic methods to validate the content uniformity of solid dosage forms

Journal of Pharmaceutical Sciences

Volumn 92, Issue 7, 2003, Pages 1526-1530

  Li, Tonglei ^a   Donner, Amy D ^b   Choi, Candice Y ^b   Frunzi, Gerard P ^b   Morris, Kenneth R ^c  

^a University of Kentucky   (United States)

^b BRISTOL MYERS SQUIBB   (United States)

^c PURDUE UNIVERSITY   (United States)

Author keywords

Content uniformity; Mixing; Near infrared spectroscopy; Sample size; Statistical analysis; Tableting; Unit operations

Indexed keywords

ARTICLE; CONCENTRATION (PARAMETERS); DRUG DOSAGE FORM; NEAR INFRARED REFLECTANCE SPECTROSCOPY; SAMPLING; SPECTROSCOPY; STATISTICAL MODEL; TABLET; VALIDATION PROCESS;

EID: 0038082475     PISSN: 00223549     EISSN: None     Source Type: Journal    
DOI: 10.1002/jps.10417     Document Type: Article

References (13)

1. Food and Drug Administration. 1999. CDER 1999 Report to the Nation.
2. Williams RL, Adams WP, Poochikian G, Hauck WW. 2002. Content uniformity and dose uniformity: Current approaches, statistical analyses, and presentation of an alternative approach, with special reference to oral inhalation and nasal drug products. Pharm Res 19:359-366.
3. Berman J, Schoeneman A, Shelton JT. 1996. Unit dose sampling: a tale of two thieves. Drug Dev Ind Pharm 22:1121-1132.
4. Berman J, Planchard JA. 1995. Blend uniformity and unit dose sampling. Drug Dev Ind Pharm 21:1257-1283.
5. Carstensen JT, Dali MV. 1996. Blending validation and content uniformity of low-content, noncohesive powder blends. Drug Dev Ind Pharm 22:285-290.
6. Ufret C, Morris KR. 2001. Modeling of powder blending using on-line near-infrared measurements. Drug Dev Ind Pharm 27:719-729.
7. Sekulic SS, Ward HW, Brannegan DR, Stanley ED, Evans CL, Sciavolino ST, Hailey PA, Aldridge PK. 1996. On-line monitoring of powder blend homogeneity by near-infrared spectroscopy. Anal Chem 68:509-513.
8. Berntsson O, Danielsson LG, Lagerholm B, Folestad S. 2002. Quantitative in-line monitoring of powder blending by near infrared reflection spectroscopy. Powder Tech 123:185-193.
9. El-Hagrasy AS, Morris HR, D'Amico F, Lodder RA, Drennen JK. 2001. Near-infrared spectroscopy and imaging for the monitoring of powder blend homogeneity. J Pharm Sci 90:1298-1307.
10. De Maesschalck R, Sánchez FC, Massart DL, Doherty P, Hailey P. 1998. On-line monitoring of powder blending with near-infrared spectroscopy. Appl Spectrosc 52:725-731.
11. Blanco M, Coello J, Iturriaga H, Maspoch S, Serrano D. 1998. Near-infrared analytical control of pharmaceuticals. A single calibration model from mixed phase to coated tablets. Analyst 123:2307-2312.
12. Wildfong PLD, Samy A-S, Corfa J, Peck GE, Morris KR. 2002. Accelerated fluid bed drying using NIR monitoring and phenomenological modeling: Method assessment and formulation suitability. J Pharm Sci 91:631-639.
13. Scheiwe M-W, Schilling D, Aebi P. 1999. Near infrared spectroscopy analysis of intact pharmaceutical diclofenac coated tablets in transmission. Pharm Ind 61:179-183.