Pneumatic dry granulation: Potential to improve roller compaction technology in drug manufacture

Expert Opinion on Drug Delivery

Volumn 8, Issue 2, 2011, Pages 225-236

  Sandler, Niklas ^a   Lammens, Robert Frank ^b  

^a ÅBO AKADEMI UNIVERSITY   (Finland)

^b UNIVERSITY OF BONN   (Germany)

Author keywords

compactibility; flowability; granules; pneumatic dry granulation; powders; recompactibility; reducing fines; roller compaction; solid dosage forms

Indexed keywords

METFORMIN; MICROCRYSTALLINE CELLULOSE;

BULK DENSITY; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG GRANULATION; DRUG MANUFACTURE; PARTICLE SIZE; PNEUMATIC DRY GRANULATION; REVIEW; ROLLER COMPACTION; TABLET COMPRESSION;

DRUG COMPOUNDING; PHARMACEUTICAL PREPARATIONS; PHYSICOCHEMICAL PHENOMENA; POWDERS; TECHNOLOGY, PHARMACEUTICAL;

EID: 79251486017     PISSN: 17425247     EISSN: None     Source Type: Journal    
DOI: 10.1517/17425247.2011.548382     Document Type: Review

References (48)

1. Kristensen H, Schaefer T. Granulations. In: Swarbrick J, Boylan B, editors, Encyclopedia of pharmaceutical technology. Volume 7. Marcel Dekker; 1992. p. 121-60
2. Kleinebudde P. Roll compaction/dry granulation: pharmaceutical applications. Eur J Pharm Biopharm 2004;58:317-26
3. Miller R, Sheskey PJ. Roller compaction technology for the pharmaceutical industry. In: Parikh DM, editor, Handbook of pharmaceutical granulation technology. Marcel Dekker, New York; 2006. p. 3159-76
4. Miller RW, Sheskey PJ. A survey of current industrial practices and preferences of roller compaction technology and excipients. Am Pharm Rev 2001;4(1):24-35
5. Bindhumadhavan G, Seville JPK, Adams MJ, et al. Roll compaction of a pharmaceutical excipient-Experimental validation of rolling theory of granular solids. Chem Eng Sci 2005;60(14):3891-7
6. Ende MT, Moses SK, Carella AJ, et al. Improving the content uniformity of a low-dose tablet formulation through roller compaction optimization. Pharm Dev Technol 2007;12(4):391-404
7. Morris DG, Truitt BF, Kong A, et al. Influence of formulation composition and processing on the content uniformity of low-dose tablets manufactured at kilogram scale. Pharm Dev Technol 2009;14(5):451-60
8. Chang CK, Alvarez-Nunez FA, Rinella JV Jr, et al. Roller compaction, granulation and capsule product dissolution of drug formulations containing a lactose or mannitol filler, starch, and talc AAPS Pharm Sci Tech 2008;9(2):597-604
9. Bozic DZ, Dreu R, Vrecer F. Influence of dry granulation on compactibility and capping tendency of macrolide antibiotic formulation. Int J Pharm 2008;357(1-2):44-54
10. Endale A, Gebre-Mariam T, Schmidt PC Granulation by roller compaction and enteric coated tablet formulation of the extract of the seeds of Glinus lotoides loaded on Aeroperl 300 Pharma. AAPS Pharm Sci Tech 2008;9(1):31-8
11. Patel S, Kaushal AM, Bansal AK. Compaction behavior of roller compacted ibuprofen. Eur J Pharm Biopharm 62008;69(2):743-9
12. Vippagunta RR, Pan C, Vakil R, et al. Application of surface area measurement for identifying the source of batch-to-batch variation in processability. Pharm Dev Technol 2009;14(5):492-8
13. Wu CY, Hung WL, Miguelez-Moran AM, et al. Roller compaction of moist pharmaceutical powders. Int J Pharm 2010;391(1-2):90-7
14. Hadzovic E, Betz G, Hadzidedic S, et al. Roller compaction of different pseudopolymorphic forms of Theophylline: effect on compressibility and tablet properties. Int J Pharm 2010;396(1-2):53-62
15. Miguelez-Moran AM, Wu CY, Seville JP. The effect of lubrication on density distributions of roller compacted ribbons. Int J Pharm 2008;362(1-2):52-9
16. FDA. 2003 "PAT-A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance (Draft Guideline)". Available from: http://www. fda.gov/cder/OPS/PAT.htm
17. Lionberger RA, Lee SL, Lee LM, et al. Quality by design: concepts for ANDAs. AAPS J 2008;10(2):268-76
18. Feng T, Wang F, Pinal R, et al. Investigation of the variability of NIR in-line monitoring of roller compaction process by using Fast Fourier Transform (FFT) analysis. AAPS Pharm Sci Tech 2008;9(2):419-24
19. Gupta A, Peck GE, Miller RW, et al. 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 2005;94(10):2301-13
20. Gupta A, Peck GE, Miller RW, et al. Effect of the variation in the ambient moisture on the compaction behavior of powder undergoing roller-compaction and on the characteristics of tablets produced from the post-milled granules. J Pharm Sci 2005;94(10):2314-26
21. Gupta A, Peck GE, Miller RW, et al. 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 2005;94(7):1589-97
22. Gupta A, Peck GE, Miller RW, et al. Nondestructive measurements of the compact strength and the particle-size distribution after milling of roller compacted powders by near-infrared spectroscopy. J Pharm Sci 2004;93(4):1047-53
23. Salonen J, Salmi K, Hakanen A, et al. Monitoring the acoustic activity of a pharmaceutical powder during roller compaction. Int J Pharm 1997;153(2):257-61
24. Gamble JF, Tobyn M, Dennis AB, et al. Roller compaction: application of an in-gap ribbon porosity calculation for the optimization of downstream granule flow and compactability characteristics. Pharm Dev Technol 2009. [Epub ahead of print]
25. Lammens RF, Portner C. Control of production quality during dry granulation with roll compactors. Proc 3rd World Meeting APV/APGI; 3-6 April 2000, Berlin, Germany
26. Johanson JR. A rolling theory for granular solids. ASME J Appl Mech 1965;32:842-8
27. Johanson JR. Predicting limiting roll speeds for briquetting presses. Proc 13th Biennial Conf Inst Briquetting Agglomerat; 1973. p. 89-99
28. Reynolds G, Ingale R, Roberts R, et al. Practical application of roller compaction process modeling. Comp Chem Eng 2010;34(7):1049-57
29. Hsu S-H, Reklaitis GV, Venkatasubramanian V. Modeling and control of roller compaction for pharmaceutical manufacturing. Part I: process dynamics and control framework. J Pharm Innov 2010;5(1-2):14-22
30. Hsu S-H, Reklaitis GV, Venkatasubramanian V. Modeling and control of roller compaction for pharmaceutical manufacturing. Part II: control system design. J Pharm Innov 2010;5(1-2):24-36
31. ZinchukAV, Mullarney MP, Hancock BC. Simulation of roller compaction using a laboratory scale compaction simulator. Int J Pharm 2004;269(2):403-15
32. Peter S, Lammens RF, Steffens K-J. Roller compaction/Dry granulation: use of the thin layer model for predicting densities and forces during roller compaction. Powder Technol 2010;199(2):165-75
33. Soh JL, Wang F, Boersen N, et al. Utility of multivariate analysis in modeling the effects of raw material properties and operating parameters on granule and ribbon properties prepared in roller compaction. Drug Dev Ind Pharm 2008;34(10):1022-35
34. Cunningham JC, Winstead D, Zavaliangos A. Understanding variation in roller compaction through finite element-based process modeling. Comp Chem Eng 2010;34(7):1058-71
35. Turkoglu M, Aydin I, Murray M, et al. Modeling a roller compaction process using neural networks and genetic algorithms. Eur J Pharm Biopharm 1999;48:239-45
36. Hein S, Picker-Freyer KM, Langridge J. Simulation of roller compaction with subsequent tableting and characterization of lactose and microcrystalline cellulose. Pharm Dev Technol 2008;13(6):523-32
37. Miller RW. Using vacuum-deaeration feed system to minimize powder leakage during roll compaction. Powder Bulk Eng 1997;11(2):71-5
38. Shlieout G, Lammens RF, Kleinebudde P, et al. Dry granulation with a roller compactor. Part II: evaluating the operation modes. Pharm Tech Eur 2002;14(9):32-9
39. Busies H. Dichteverteilung in Schulpen, Dissertation 2006, Universitat Bonn, Germany
40. Heilakka E, Rahja P, Lammens RF, et al. Pneumatic Dry Granulation (PDG) in solid dosage form manufacture. AAPS Annual meeting; New Orleans; 2010
41. Hancock BC, Colvin JT, Mullarney MP, et al. The relative density of pharmaceutical powders, blends, dry granulations and immediate release tablets. Pharm Technol 2003;274:64-80
42. Davies N, Newton M. Mechanical strength. In: Alderborn G, Nystrom C, editors, Pharmaceutical powder compaction technology. Marcel Dekker, New York; 1996. p. 71, 165-92
43. Rowe RC, Roberts RJ. Mechanical properties. In: Alderborn G, Nystrom C, editors, Pharmaceutical powder compaction technology. Volume 71. Marcel Dekker, New York; 1996. p. 283-322
44. Miguelez-Moran AM, Wu CY, Dong H, et al. Characterisation of density distributions in roller-compacted ribbons using micro-indentation and X-ray micro-computed tomography. Eur J Pharm Biopharm 2009;72(1):173-82
45. Nkansah P, Wu SJ, Sobotka S, et al. A novel method for estimating solid fraction of roller-compacted ribbons. Drug Dev Ind Pharm 2008;34(2):142-48
46. Teng Y, Qiu Z, Wen H. Systematical approach of formulation and process development using roller compaction. Eur J Pharm Biopharm 2009;73(2):219-29
47. Wu SJ, Sun C. Insensitivity of compaction properties of brittle granules to size enlargement by roller compaction. J Pharm Sci 2007;96(5):1445-50
48. Sun CC, Himmelspach MW. Reduced tabletability of roller compacted granules as a result of granule size enlargement. J Pharm Sci 2006;95(1):200-6