Radial tensile strength prediction of relaxing and relaxed compacts by near-infrared chemical imaging

International Journal of Pharmaceutics

Volumn 418, Issue 2, 2011, Pages 297-303

  Igne, Benoît ^a   Anderson, Carl A ^a   Drennen III, James K ^a  

^a DUQUESNE UNIVERSITY   (United States)

Author keywords

Near infrared chemical imaging; Quality attributes; Radial tensile strength; Viscoelastic relaxation

Indexed keywords

LACTOSE; MICROCRYSTALLINE CELLULOSE; STARCH; THEOPHYLLINE;

ARTICLE; COMPRESSION; CORRELATION COEFFICIENT; DENSITY; DRUG DOSAGE FORM; INFRARED RADIATION; MOLECULAR IMAGING; PARTIAL LEAST SQUARES REGRESSION; PREDICTION; PRIORITY JOURNAL; PROCESS DEVELOPMENT; SPECTROSCOPY; TENSILE STRENGTH; VALIDATION PROCESS; VISCOELASTICITY;

CALIBRATION; COMPUTER SIMULATION; DRUG COMPOUNDING; EXCIPIENTS; MODELS, CHEMICAL; PHARMACEUTICAL PREPARATIONS; REPRODUCIBILITY OF RESULTS; SPECTROSCOPY, NEAR-INFRARED; TENSILE STRENGTH;

EID: 80052965856     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2011.05.038     Document Type: Article

References (36)

1. A.S. Alam, and E.L. Parrott Effect of aging on some physical properties of hydrochlorothiazide tablets J. Pharm. Sci. 60 1971 263 266
2. K.A. Bakeev Process Analytical Technology 2005 Blackwell Publishing Oxford
3. M. Blanco, and M. Alcalá 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 (Pubitemid 43097317)
4. M. Blanco, M. Alcalá, J.M. González, and E. Torras A process analytical technology approach based on near infrared spectroscopy: tablet hardness, content uniformity, and dissolution test measurements of intact tablets J. Pharm. Sci. 95 2006 2137 2142
5. X. Cao, M. Morganti, B.C. Hancock, and V.M. Masterson Correlating particle hardness with powder compaction performance J. Pharm. Sci. 99 2010 4309 4316
6. J.H. Cho, P.J. Gemperline, P.K. Aldridge, and S.S. Sekulic Effective mass sampled by NIR fiber-optic reflectance probes in blending process Anal. Chim. Acta 348 1997 303 310 (Pubitemid 27397439)
7. F.C. Clarke, S.V. Hammond, R.D. Jee, and A.C. Moffat Determination of the information depth and sample size for the analysis of pharmaceutical materials using reflectance near-infrared microscopy Appl. Spectrosc. 56 2002 1475 1483
8. R.P. Cogdill, C.A. Anderson, and J.K. Drennen Using NIR spectroscopy as an integrated PAT tool Spectroscopy 19 2004 104 109 (Pubitemid 41100941)
9. S.T. David, and L.L. Augsburger Plastic flow during compression of directly compressible fillers and its effect on tablet strength J. Pharm. Sci. 66 1977 155 159 (Pubitemid 8040007)
10. M. Donoso, D.O. Kildsig, and E.S. Ghaly Prediction of tablet hardness and porosity using near-infrared diffuse reflectance spectroscopy as a nondestructive method Pharm. Dev. Technol. 8 2003 357 366 (Pubitemid 37296719)
11. N.K. Ebube, S.S. Thosar, R.A. Roberts, M.S. Kemper, R. Rubinovitz, D.L. Martin, G.E. Reier, T.A. Wheatley, and A.J. Shukla Application of near-infrared spectroscopy for nondestructive analysis of Avicel powders and tablets Pharm. Dev. Technol. 4 1999 19 26 (Pubitemid 29072344)
12. C.D. Ellison, B.J. Ennis, M.L. Hamad, and R.C. Lyon Measuring the distribution of density and tableting force in pharmaceutical tablets by chemical imaging J. Pharm. Biomed. Anal. 48 2008 1 7
13. J.T. Fell, and J.M. Newton Determination of tablet strength by diametral compression test J. Pharm. Sci. 59 1970 688 691
14. C. Gendrina, Y. Roggoa, and C. Collet Pharmaceutical applications of vibrational chemical imaging and chemometrics: a review J. Pharm. Biomed. Anal. 48 2008 533 553
15. M.S. Gordon, V.S. Rudraraju, J.K. Rhie, and Z.T. Chowhan Effect of aging on the dissolution of wet granulated tablets containing super disintegrants Int. J. Pharm. 97 1993 119 131 (Pubitemid 23242373)
16. A.A. Gowen, C.P. O'Donnell, P.J. Cullen, and S.E.J. Bell Recent applications of chemical imaging to pharmaceutical process monitoring and quality control Eur. J. Pharm. Biopharm. 69 2008 10 22
17. J.H. Guo, G.W. Skinner, W.W. Harcum, J.P. Malone, and L.G. Weyer Application of near-infrared spectroscopy in the pharmaceutical solid dosage form Drug Dev. Ind. Pharm. 25 1999 1267 1270
18. C. Gustafsson, C. Nystrom, H. Lennholm, M.C. Bonferoni, and C.M. Caramella Characteristics of hydroxypropyl methylcellulose influencing compatibility and prediction of particle and tablet properties by infrared spectroscopy J. Pharm. Sci. 92 2003 494 504 (Pubitemid 36258964)
19. J. Parris, C. Airiau, R. Escott, J. Rydzak, and R. Crocombe Monitoring API drying operations by NIR Spectroscopy 20 2005 34 42 (Pubitemid 41647293)
20. P.G. Karehill, and C. Nystrom Studies on direct compression of tablets. Part 2. Investigation of strength increase upon aging and bonding mechanisms for some plastically deforming materials Int. J. Pharm. 64 1990 27 34
21. J.D. Kirsch, and J.K. Drennen Nondestructive tablet hardness testing by near-infrared spectroscopy: a new and robust spectral best-fit algorithm J. Pharm. Biomed. Anal. 19 1999 351 362 (Pubitemid 29073493)
22. N. Lordi, and P. Shiromani Mechanism of hardness of aged compacts Drug Dev. Ind. Pharm. 10 1984 729 752 (Pubitemid 14122112)
23. W. Lowenthal Disintegration of tablets J. Pharm. Sci. 61 1972 1695 1711
24. K.M. Morisseau, and C.T. Rhodes Near-infrared spectroscopy as a nondestructive alternative to conventional tablet hardness testing Pharm. Res. 14 1997 108 111 (Pubitemid 27113324)
25. M. Otsuka, and I. Yamane Prediction of tablet hardness based on near infrared spectra of raw mixed powders by chemometrics J. Pharm. Sci. 95 2006 1425 1433 (Pubitemid 44049112)
26. E. Rees, and E. Shotton Some observations on the aging of sodium chloride compacts J. Pharm. Sci. 22 1970 17S 23S
27. G. Reich Near-infrared spectroscopy and imaging: basic principles and pharmaceutical applications Adv. Drug Deliv. Rev. 57 2005 1109 1143 (Pubitemid 40797572)
28. Y. Roggo, P. Chalus, L. Maurer, C. Lema-Martinez, A. Edmond, and N. Jent A review of near infrared spectroscopy and chemometrics in pharmaceutical technologies J. Pharm. Biomed. Anal. 44 2007 683 700 (Pubitemid 47030775)
29. Y. Roggo, C. Roeseler, and M. Ulmschneider Near infrared spectroscopy for qualitative comparison of pharmaceutical batches J. Pharm. Biomed. Anal. 36 2004 777 786 (Pubitemid 39469417)
30. M.C. Sarraguca, and J.A. Lopes Quality control of pharmaceuticals with NIR: from lab to process line Vibr. Spectrosc. 49 2009 204 210
31. Z. Shi, and C.A. Anderson Application of Monte Carlo simulation-based photon migration for enhanced understanding of near-infrared (NIR) diffuse reflectance. Part I. Depth of penetration in pharmaceutical materials J. Pharm. Sci. 99 2010 2399 2412
32. Z. Shi, R.P. Cogdill, S.M. Short, and C.A. Anderson Process characterization of powder blending by near-infrared spectroscopy: blend end-points and beyond J. Pharm. Biomed. Anal. 47 2008 738 745
33. S.M. Short, R.P. Cogdill, P.L.D. Wildfong, J.K. Drennen, and C.A. Anderson A near-infrared spectroscopic investigation of relative density and crushing strength in four-component compacts J. Pharm. Sci. 98 2009 1095 1109
34. B. Swarbrick, B. Grouta, and J. Noss The rapid, at-line determination of starch content in sucrose-starch blends using near-infrared reflectance spectroscopy; a process analytical technology initiative J. Near Infrared Spectrosc. 13 2005 1 8 (Pubitemid 40874730)
35. A.S. Tatavarti, R. Fahmy, H. Wu, A.S. Hussain, W. Marnane, D. Bensley, G. Hollenbeck, and S.W. Hoag Assessment of NIR spectroscopy for nondestructive analysis of physical and chemical attributes of sulfamethazine bolus dosage forms AAPS PharmSciTech. 6 2005 E91 E99
36. C.Y. Wu, S.M. Best, A.C. Bentham, B.C. Hancock, and W. Bonfield Predicting the tensile strength of compacted multi-component mixtures of pharmaceutical powders Pharm. Res. 23 2006 1898 1905 (Pubitemid 44200554)