Tablet splitting: Product quality assessment of metoprolol succinate extended release tablets

International Journal of Pharmaceutics

Volumn 401, Issue 1-2, 2010, Pages 25-31

  Zhao, Na ^a   Zidan, Ahmed ^a,b   Tawakkul, Mobin ^a   Sayeed, Vilayat A ^a   Khan, Mansoor ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b Zagazig University   (Egypt)

Author keywords

Near infrared mapping; Quality assessment; Tablet splitting

Indexed keywords

EXCIPIENT; GENERIC DRUG; METOPROLOL SUCCINATE;

ARTICLE; CONTROLLED RELEASE FORMULATION; DRUG DETERMINATION; DRUG QUALITY; DRUG SOLUBILITY; PRIORITY JOURNAL; QUALITY CONTROL; TABLET COMPRESSION; TABLET PROPERTY; WEIGHT;

ADRENERGIC BETA-ANTAGONISTS; CHEMISTRY, PHARMACEUTICAL; DELAYED-ACTION PREPARATIONS; METOPROLOL; QUALITY CONTROL; SPECTROSCOPY, NEAR-INFRARED; TABLETS;

EID: 78049263321     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2010.09.004     Document Type: Article

References (29)

1. Amigo J.M., Ravn C. Direct quantification and distribution assessment of major and minor components in pharmaceutical tablets by NIR-chemical imaging. Eur. J. Pharm. Sci. 2009, 37:76-82.
2. Barnes R.J., Dhanoa M.S., Lister S.J. Standard normal variate transformation and de-trending of near-infrared diffuse reflectance spectra. Appl. Spectrosc. 1989, 43:772-777.
3. Borer M.W., Zhou X., Hays D.M., Hofer J.D., White K.C. Evaluation of key sources of variability in the measurement of pharmaceutical drug products by near infrared reflectance spectroscopy. J. Pharm. Biomed. Anal. 1998, 17:641-650.
4. Burger J., Geladi P. Spectral pre-treatments of hyperspectral near infrared images: analysis of diffuse reflectance scattering. J. Near Infrared Spectrosc. 2007, 15:29-37.
5. Candolfi A., Maesschalck D.R., Massart D.L., Hailey P.A., Harrington A.C.E. Identification of pharmaceutical excipients using NIR spectroscopy and SIMCA. J. Pharm. Biomed. Anal. 1999, 19:923-935.
6. Cruz J., Bautista M., Amigo J.M., Blanco M. NIR-chemical imaging study of acetylsalicylic acid in commercial tablets. Talanta 2009, 80(2):473-480.
7. Dou Y., Qu N., Wang B., Chi Y.Z., Ren Y.L. Simultaneous determination of two active components in compound aspirin tablets using principal component artificial neural networks (PC-ANNs) on NIR spectroscopy. Eur. J. Pharm. Sci. 2007, 32:193-199.
8. Dubois J., Lewis N.E., Fry J., Calvey E.M. Bacterial identification by near-infrared chemical imaging of food-specific cards. Food Microbiol. 2005, 22:577-583.
9. Ellison C.D., Ennis B.J., Hamad M.L., Lyon R.C. Measuring the distribution of density and tabletting force in pharmaceutical tablets by chemical imaging. J. Pharm. Biomed. Anal. 2008, 48:1-7.
10. Geladi P., MacDougall D., Martens H. Linearization and scatter-correction for near-infrared reflectance spectra of meat. Appl. Spectrosc. 1985, 39:491-500.
11. Gendrin C., Roggo Y., Collet C. Pharmaceutical applications of vibrational chemical imaging and chemometrics: a review. J. Pharm. Biomed. Anal. 2008, 48:533-553.
12. Gupta A., Hunt R.L., Khan M.A. Influence of tablet characteristics on weight variability and weight loss in split tablets. Am. J. Health-Syst. Pharm. 2008, 65:2326-2332.
13. Habib Y.S., Augsburger L.L., Shangraw R.F. Production of inert cushioning beads: effect of excipients on the physicomechanical properties of freeze-dried beads containing microcrystalline cellulose produced by extrusion-spheronization. Int. J. Pharm. 2002, 233:67-83.
14. Hill S.W., Varker A.S., Karlage K., Myrdal P.B. Analysis of Drug Content and Weight Uniformity for Half-Tablets of 6 Commonly Split Medications. J. Manage. Care Pharm. 2009, 15:253-261.
15. Li W., Bashai-Woldu A., Ballard J., Johnson M., Agresta M., Rasmussen H., Hu S., Cunningham J., Winstead D. Applications of NIR in early stage formulation development: Part I Semi-quantitative blend uniformity and content uniformity analyses by reflectance NIR without calibration models. Int. J. Pharm. 2007, 340:97-103.
16. Luypaert J., Massart D.L., Heyden V.Y. Near-infrared spectroscopy applications in pharmaceutical analysis. Talanta 2007, 72:865-883.
17. MacDonald B.F., Prebble K.A. Some applications of near-infrared reflectance analysis in the pharmaceutical industry. J. Pharm. Biomed. Anal. 1993, 11:1077-1085.
18. McDevitt J.T., Gurst A.H., Chen Y. Accuracy of tablet splitting. Pharmacotherapy 1998, 18:193-197.
19. Moes J.J., Ruijken M.M., Gout E., Frijlink H.W., Ugwoke M.I. Application of process analytical technology in tablet process development using NIR spectroscopy: Blend uniformity, content uniformity and coating thickness measurements. Int. J. Pharm. 2008, 357:108-118.
20. Nicolaï B.M., Lötze E., Peirs A., Scheerlinck N., Theron K.I. Non-destructive measurement of bitter pit in apple fruit using NIR hyperspectral imaging. Postharvest Biol. Technol. 2006, 40:1-6.
21. Polli J.E., Kim S., Martin B.R. Weight uniformity of split tablets required by a Veterans Affairs policy. J. Manage. Care Pharm. 2003, 9:401-407.
22. Quinzler R., Gasse C., Schneider A., Kaufmann-Kolle P., Szecsenyi J., Haefeli W.E. The frequency of inappropriate tablet splitting in primary care. Eur. J. Clin. Pharmacol. 2006, 62:1065-1073.
23. Ravn C., Skibsted E., Bro R. Near-infrared chemical imaging (NIR-CI) on pharmaceutical solid dosage forms-comparing common calibration approaches. J. Pharm. Biomed. Anal. 2008, 48:554-561.
24. Reich G. Near-infrared spectroscopy and imaging: basic principles and pharmaceutical applications. Adv. Drug Deliv. Rev. 2005, 57:1109-1143.
25. Roggo Y., Chalus P., Maurer L., Lema-Martinez C., Edmond A., Jent N. A review of near infrared spectroscopy and chemometrics in pharmaceutical technologies. J. Pharm. Biomed. Anal. 2007, 44:683-700.
26. Rosenberg J.M., Nathan J.P., Plakogiannis F. Weight variability of pharmacist-dispensed split tablets. J. Am. Pharm. Assoc. (Wash.) 2002, 42:200-205.
27. Sandberg A., Regardh C.G., Wieselgren I., Bergstrand R. Pharmacokinetic and biopharmaceutic aspects of once daily treatment with metoprolol CR/ZOK: a review article. J. Clin. Pharmacol. 1990, 30:S2-16.
28. Savitzky A., Golay M.J.E. Smoothing and differentiation of data by simplified least-squares procedures. Anal. Chem. 1964, 36:1627-1639.
29. Wagner K.G., Krumme M., Schmidt P.C. Investigation of the pellet-distribution in single tablets via image analysis. Eur. J. Pharm. Biopharm. 1999, 47:79-85.