Assessment of the critical factors affecting the porosity of roller compacted ribbons and the feasibility of using NIR chemical imaging to evaluate the porosity distribution

International Journal of Pharmaceutics

Volumn 410, Issue 1-2, 2011, Pages 1-8

  Lim, Hanpin ^a   Dave, Vivek S ^b   Kidder, Linda ^c   Neil Lewis, E ^c   Fahmy, Raafat ^d   Hoag, Stephen W ^a  

^a UNIVERSITY OF MARYLAND SCHOOL OF PHARMACY   (United States)

^b Lubrizol Advanced Materials Inc   (United States)

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

^d Malvern Instruments Inc   (United States)

Author keywords

Density; Feed screw speed; NIR chemical imaging; NIR CI; Porosity; Quality by design; Roller compacted ribbon; Roller compaction; Roller pressure; Roller speed

Indexed keywords

MICROCRYSTALLINE CELLULOSE; NANORIBBON;

ARTICLE; COMPRESSION; FEED SCREW SPEED; IMAGING; NEAR INFRARED CHEMICAL IMAGING; POROSITY; PRIORITY JOURNAL; ROLL PRESSURE; ROLL SPEED; YOUNG MODULUS;

CELLULOSE; CHEMISTRY, PHARMACEUTICAL; EXCIPIENTS; FEASIBILITY STUDIES; LINEAR MODELS; POROSITY; SPECTROSCOPY, NEAR-INFRARED;

EID: 79955593101     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2011.02.028     Document Type: Article

References (24)

1. Bacher, C., Olsen, P.M., Bertelsen, P., Kristensen, J., Sonnergaard, J.M., 2007. Improving the compaction properties of roller compacted calcium carbonate. Int. J. Pharm. 342, 115-123.
2. Bacher, C., Olsen, P.M., Bertelsen, P., Sonnergaard, J.M., 2008. Granule fraction inhomogeneity of calcium carbonate/sorbitol in roller compacted granules. Int. J. Pharm. 349, 19-23.
3. Cantor, S., Hoag, S.W., Augsburger, L.L., D. Ellison, C., Khan, M.A., Lyon, R.C., 2011. NIR spectroscopy applications in the development of a compacted multiparticulate system for modified release. Pharm. Sci. Technol., doi:10.1208/s12249-010-9580-z.
4. Daugherity, P.D., Chu, J.H., 2007. Investigation of serrated roll surface differences on ribbon thickness during roller compaction. Pharm. Dev. Technol. 12, 603-608.
5. Ende, M.T.A., Moses, S.K., Carella, A.J., Gadkari, R.A., Graul, T.W., Otano, A.L., Timpano, R.J., 2007. Improving the content uniformity of a low-dose tablet formulation through roller compaction optimization. Pharm. Dev. Technol. 12, 391-404.
6. FDA, 2006. ICH Harmonised Tripartite Guideline: Quality Risk Management Q9., http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory- Information/Guidances/ucm073511.pdf.
7. Feng, T., Wang, F., Pinal, R., Wassgren, C., Carvajal, M.T., 2008. Investigation of the variability of NIR in-line monitoring of roller compaction process by using Fast Fourier transform (FFT) analysis. AAPS Pharm. Sci. Technol. 9, 419-424.
8. Gamble, J.F., Tobyn, M., Dennis, A.B., Shah, T., 2010. Roller compaction: application of an in-gap ribbon porosity calculation for the optimization of downstream granule flow and compactability characteristics. Pharm. Dev. Technol. 15, 223-229.
9. Ghorab, M.K., Chatlapalli, R., Hasan, S., Nagi, A., 2007. Application of thermal effusivity as a process analytical technology tool for monitoring and control of the roller compaction process. AAPS Pharm. Sci. Technol. 8, 7.
10. Guigon, P., Simon, O., 2003. Roll press design - influence of force feed systems on compaction. Powder Technology. 130, 41-48. (Pubitemid 36293170)
11. Gupta, A., Peck, G.E., Miller, R.W., Morris, K.R., 2004. Nondestructive measurements of the compact strength and the particle-size distribution after milling of roller compacted powders by near-infrared spectroscopy. J. Pharm. Sci. 93, 1047-1053.
12. Gupta, A., Peck, G.E., Miller, R.W., Morris, K.R., 2005a. Effect of the variation in the ambient moisture on the compaction behavior of powder undergoing rollercompaction and on the characteristics of tablets produced from the post-milled granules. J. Pharm. Sci. 94, 2314-2326.
13. Gupta, A., Peck, G.E., Miller, R.W., Morris, K.R., 2005b. Influence of ambient moisture on the compaction behavior of microcrystalline cellulose powder undergoing uni-axial compression and roller-compaction: a comparative study using near-infrared spectroscopy. J. Pharm. Sci. 94, 2301-2313.
14. Gupta, A., Peck, G.E., Miller, R.W., Morris, K.R., 2005c. Real-time near-infrared monitoring of content uniformity, moisture content, compact density, tensile strength, and Young's modulus of roller compacted powder blends. J. Pharm. Sci. 94, 1589-1597.
15. Lewis, E.N., Kidder, L.H., Lee, E., 2006. NIR chemical imaging as process analytical tool. Innovations Pharm. Technol., 107-111.
16. Miguelez-Moran, A.M., Wu, C.Y., Dong, H.S., Seville, J.P.K., 2009. Characterisation of density distributions in roller-compacted ribbons using micro-indentation and X-ray micro-computed tomography. Eur. J. Pharm. Biopharm. 72, 173-182.
17. Miguelez-Moran, A.M., Wu, C.Y., Seville, J.P.K., 2008. The effect of lubrication on density distributions of roller compacted ribbons. Int. J. Pharm. 362, 52-59.
18. Peck, G.E., Soh, J.L.P., Morris, K., 2008. Dry granulation. In: Augsburger, L.L., Hoag, S.W. (Eds.), Pharmaceutical Dosage Forms: Tablets. Informa Healthcare USA, Inc., New York, pp. 303-336.
19. Sheskey, P.J., Hendren, J., 1999. The effects of roll compaction equipment variables, granulation technique, and HPMC polymer level on a controlled-release matrix model drug formulation. Pharm. Technol. 23, 90-106.
20. Simon, O., Guigon, P., 2003. Correlation between powder-packing properties and roll press compact heterogeneity. Powder Technology. 130, 257-264. (Pubitemid 36293201)
21. Tabasi, S.H., Fahmy, R., Bensley, D., O'Brien, C., Hoag, S.W., 2008. Quality by design. Part I. Application of NIR spectroscopy to monitor tablet manufacturing process. J. Pharm. Sci. 97, 4040-4051.
22. Tatavarti, A.S., Fahmy, R., Wu, H., Hussain, A.S., Marnane, W., Bensley, D., Hollenbeck, G., Hoag, S.W., 2005. Assessment of NIR spectroscopy for nondestructive analysis of physical and chemical attributes of sulfamethazine bolus dosage forms. AAPS Pharm. Sci. Technol. 06, E91-E99.
23. Tye, C.K., Sun, C.C., Amidon, G.E., 2005. Evaluation of the effects of tableting speed on the relationships between compaction pressure, tablet tensile strength, and tablet solid fraction. J. Pharm. Sci. 94, 465-472.
24. Wu, C.Y., Best, S.M., Bentham, A.C., Hancock, B.C., Bonfield, W., 2006. Predicting the tensile strength of compacted multi-component mixtures of pharmaceutical powders. Pharm. Res. 23, 1898-1905.