Importance of evaluating the consolidation of granules manufactured by high shear mixer

International Journal of Pharmaceutics

Volumn 338, Issue 1-2, 2007, Pages 79-86

  Ohno, Ikumasa ^a   Hasegawa, Susumu ^a   Yada, Shuichi ^a   Kusai, Akira ^a   Moribe, Kunikazu ^b   Yamamoto, Keiji ^b  

^a DAIICHI SANKYO CO   (Japan)

^b CHIBA UNIVERSITY   (Japan)

Author keywords

dataNESIA; Dissolution; High shear granulation; Pore size; Process parameter; X ray computed tomography

Indexed keywords

MEFENAMIC ACID;

ARTICLE; DRUG GRANULE; DRUG MANUFACTURE; DRUG SOLUBILITY; IMPELLER; PARTICLE SIZE; PRIORITY JOURNAL; ROTATION; TABLET;

MEFENAMIC ACID; PARTICLE SIZE; POWDERS; SOLUBILITY; TABLETS; TECHNOLOGY, PHARMACEUTICAL;

EID: 34248667556     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2007.01.030     Document Type: Article

References (25)

1. Ameye D., Keleb E., Vervaet C., Remon J.P., Adams E., and Massart D.L. Scaling-up of a lactose wet granulation process in Mi-Pro high shear mixers. Eur. J. Pharm. Sci. 17 (2002) 247-251
2. Badawy S.I.F., Menning M.M., Gorko M.A., and Gilbert D.L. Effect of process parameters on compressibility of granulation manufactured in a high-shear mixer. Int. J. Pharm. 198 (2000) 51-61
3. Badawy S.I.F., Gray D.B., and Hussain M.A. A study on the effect of wet granulation on microcrystalline cellulose particle structure and performance. Pharm. Res. 23 (2006) 634-640
4. Bouwmann A.M., Henstra M.J., Westerman D., Chung J.T., Zhang Z., Ingram A., Seville J.P.K., and Frijlink H.W. The effect of the amount of binder liquid on the granulation mechanisms and structure of microcrystalline cellulose granules prepared by high shear granulation. Int. J. Pharm. 290 (2005) 129-136
5. Farbera L., Tardos G., and Michaels J.N. Use of X-ray tomography to study the porosity and morphology of granules. Powder Technol. 132 (2003) 57-63
6. Faure A., Grimsey I.M., Rowe R.C., York P., and Cliff M.J. Applicability of a scale-up methodology for wet granulation process in Collette Gral high shear mixer granulators. Eur. J. Pharm. Sci. 8 (1999) 85-93
7. Hancock B.C., and Mullarney M.P. X-ray microtomography of solid dosage forms. Pharm. Technol. 2 (2005) 92-100
8. Horsthuis G.J.B., van Laarhoven J.A.H., van Rooij R.C.B.M., and Vromans H. Studies on upscaling parameters of the Gral high shear granulation process. Int. J. Pharm. 92 (1993) 143-150
9. Johansen A., and Schæfer T. Effects of interactions between powder particles size and binder viscosity on agglomerate growth mechanisms in a high shear mixer. Eur. J. Pharm. Sci. 12 (2001) 297-309
10. Johansen A., and Schæfer T. Effects of physical properties of powder particles on binder liquid requirement and agglomerate growth mechanisms in a high shear mixer. Eur. J. Pharm. Sci. 14 (2001) 135-147
11. Knight P.C., lnstone T., Pearson J.M.K., and Hounslow M.J. An investigation into the kinetics of liquid distribution and growth in high shear mixer agglomeration. Powder Technol. 97 (1998) 246-257
12. Mackaplow M.B., Rosen L.A., and Michaelis J.N. Effect of primary particle size on granule growth and endpoint determination in high-shear wet granulation. Powder Technol. 108 (2000) 32-45
13. Mehta K.A., Kislalioglu M.S., Phuapradit W., Malick A.W., and Shah N.H. Effect of formulation and process variables on porosity parameters and release rates from a multiunit erosion matrix of a poorly soluble drug. J. Control. Release 63 (2000) 201-211
14. Onuki Y.M., Morishita M., and Takayama K. Formulation optimization of water-in-oil-water multiple emulsion for intestinal insulin delivery. J. Control. Release 97 (2004) 91-99
15. Onuki Y., Hoshi M., Okabe H., Fujikawa M., Morishita M., and Takayama K. Formulation optimization of photocrosslinked polyacrylic acid modified with 2-hydroxyethyl methacrylate hydrogel as an adhesive for a dermatological patch. J. Control. Release 108 (2005) 331-340
16. Schæfer T. Growth mechanisms in melt agglomeration in high shear mixers. Powder Technol. 117 (2001) 68-82
17. Sinka I.C., Burch S.F., Tweed J.H., and Cunningham J.C. Measurement of density variations in tablets using X-ray computed tomography. Int. J. Pharm. 271 (2004) 215-224
18. Sirois P.J., and Craig D. Scaleup of a high-shear granulation process using a normalized impeller work parameter. Pharm. Dev. Technol. 5 (2000) 365-374
19. Surini S., Akiyama H.Y., Morishita M., Nagai T., and Takayama K. Release phenomena of insulin from an implantable device composed of a polyion complex of chitosan and sodium hyaluronate. J. Control. Release 90 (2003) 291-301
20. Takayama K. Formulation design and optimization of solid dosage forms based on a multivariate spline interpolation. Pharm. Tech. Jpn. 18 (2002) 1687-1694
21. Takayama K., Fujikawa M., Obata Y., Morishita M., and Nagai T. Optimization of pharmaceutical formulation based on artificial neural networks. Yakuzaigaku 64 (2004) 2-12
22. Takayama K. Development of DDS based on supporting systems for design of experiments. Pharm. Tech. Jpn. 21 (2005) 2076-2078
23. van den Dries K., and Vromans H. Relationship between inhomogeneity phenomena and granule growth mechanisms in a high-shear mixer. Int. J. Pharm. 247 (2002) 167-177
24. van den Dries K., de Vegt O.M., Girard V., and Vromans H. Granule breakage phenomena in a high shear mixer; influence of process and formulation variables and consequences on granule homogeneity. Powder Technol. 133 (2003) 228-236
25. Vonk P., Guillaume C.P.F., Ramaker J.S., Vromans H., and Kossen N.W.F. Growth mechanisms of high-shear pelletisation. Int. J. Pharm. 157 (1997) 93-102