The impact of low-level inorganic impurities on key physicochemical properties of paracetamol

International Journal of Pharmaceutics

Volumn 349, Issue 1-2, 2008, Pages 61-65

  Hulse, Wendy L ^a   Grimsey, Ian M ^a   De Matas, Marcel ^a  

^a UNIVERSITY OF BRADFORD   (United Kingdom)

Author keywords

Inorganic impurities; Paracetamol; PAT; Physicochemical properties; Processing; Surface free energy

Indexed keywords

ALUMINUM; PARACETAMOL;

ARTICLE; DIFFERENTIAL SCANNING CALORIMETRY; DISPERSION; DRUG IMPURITY; DRY POWDER; HUMIDITY; INVERSE GAS CHROMATOGRAPHY; MASS SPECTROMETRY; PARTICLE SIZE; PHYSICAL CHEMISTRY; POLARIZATION; PRIORITY JOURNAL; SCANNING ELECTRON MICROSCOPY; SURFACE PROPERTY; THERMAL ANALYSIS; THERMOGRAVIMETRY; X RAY POWDER DIFFRACTION;

ABSORPTION; ACETAMINOPHEN; ANALGESICS, NON-NARCOTIC; CALORIMETRY, DIFFERENTIAL SCANNING; CHEMISTRY, PHYSICAL; CHROMATOGRAPHY, GAS; DRUG CONTAMINATION; ELECTRON PROBE MICROANALYSIS; HUMIDITY; MASS SPECTROMETRY; MICROSCOPY, ELECTRON, SCANNING; PARTICLE SIZE; TEMPERATURE;

EID: 37349082419     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2007.07.037     Document Type: Article

References (22)

1. Buckton G., and Darcy P. Int. J. Pharm. 123 (1995) 265-271
2. De Boer A.H., Hagenedoorn P., Gjaltema D., Goede J., Kussendrager K.D., and Frijlink H.W. Int. J. Pharm. 260 (2003) 201-216
3. Derbyshire H.M., Grimsey I.M., Bland C.R., Broadhead J., Brocklehurst K.G., Malone N.J., and Smith G. J. Mater. Sci. 38 (2003) 57-63
4. Dolitzky, B.-Z., Lifshitz, I., 2006. CODEN: PIXXD2 WO 2006011874 A1 20060202. PCT Int. Appl. 18 pp.
5. EMEA, 2006. Note for guidance on pharmaceutical development (EMEA/CHMP/167068/2004).
6. Evans E.H., Wolff J.-C., and Eckers C. Anal. Chem. 73 (2001) 4722-4728
7. Forbes R.T., Davis K.G., Hindle M., Clarke J.G., and Maas J. J. Pharm. Sci. 87 (1998) 1316-1321
8. Grimsey I.M., Sunkersett M., Osborn J.C., York P., and Rowe R.C. Int. J. Pharm. 191 (1999) 43-50
9. Guidance for Industry, 2004. PAT-A framework for innovative pharmaceutical development, manufacturing, and quality assurance. http://www.fda.gov/cvm/guidance/published.html.
10. Heng J.Y.Y., Thielmann F., and Williams D.R. Pharm. Res. 23 (2006) 1918-1927
11. Hogan S.E., and Buckton G. Pharm. Res. 18 (2001) 112-116
12. Iida K., Hayakawa Y., Okamoto H., Danjo K., and Luenberger H. Chem. Pharm. Bull. 52 (2004) 350-353
13. Kaerger J.S., Edge S., and Price R. Eur. J. Pharm. Sci. 22 (2004) 173-179
14. Lindberg N.-O., and Lundstedt T. Drug Dev. Ind. Pharm. 20 (1994) 2547-3255
15. Mackin L., Sartnurak S., Thomas I., and Moore S. Int. J. Pharm. 231 (2002) 213-226
16. Rowe R.C., York P., Colburn E.A., and Roskilly S.J. Int. J. Pharm. 300 (2005) 32-37
17. Schultz J., and Lavielle L. In: Lloyd D.R., Ward T.C., and Schreiber H.P. (Eds). Inverse Gas Chromatography Characterisation of Polymers and other Materials, ACS Symp. Ser. 391 (1989), American Chemical Society, Washington, DC 185-202
18. Steckel H., and Muller B.W. Int. J. Pharm. 154 (1997) 31-37
19. Sunkersett M.R., Grimsey I.M., Doughty S.W., Obsorn J.C., York P., and Rowe R.C. Eur. J. Pharm. Sci. 13 (2001) 219-225
20. Swaminathan V., Cobb J., and Saracovan I. Int. J. Pharm. 312 (2006) 158-165
21. Ticehurst M.D., Rowe R.C., and York P. Int. J. Pharm. 141 (1994) 93-99
22. York P., Ticehurst M.D., Osborn J.C., Roberts R.J., and Rowe R.C. Int. J. Pharm. 174 (1998) 179-186