Supercritical antisolvent processing of γ-Indomethacin: Effects of solvent, concentration, pressure and temperature on SAS processed Indomethacin

Powder Technology

Volumn 201, Issue 1, 2010, Pages 64-69

  Varughese, Princy ^a   Li, Jing ^a   Wang, Wayne ^b   Winstead, Denita ^b  

^a RUTGERS UNIVERSITY   (United States)

^b JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

Author keywords

Amorphous; Indomethacin; Micronization; Poor water solubility; Supercritical antisolvent processing

Indexed keywords

INDOMETHACIN; MICRONIZATIONS; POOR WATER SOLUBILITY; SUPERCRITICAL ANTISOLVENTS; WATER SOLUBILITIES;

DISSOLUTION; SOLUBILITY;

SEMICONDUCTING INTERMETALLICS;

GAMMA INDOMETACIN; INDOMETACIN; SOLVENT; UNCLASSIFIED DRUG;

ARTICLE; CHEMICAL REACTION; CONCENTRATION (PARAMETERS); CRYSTALLIZATION; DISSOLUTION; PARTICLE SIZE; POWDER; PRESSURE; PURIFICATION; SOLUBILITY; SUPERCRITICAL ANTISOLVENT; TEMPERATURE;

EID: 77952320688     PISSN: 00325910     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.powtec.2010.03.008     Document Type: Article

References (37)

1. Keck C.M., Muller R.H. Drug nanocrystals of poorly soluble drugs produced by high pressure homogenisation. European Journal of Pharmaceutics and Biopharmaceutics 2006, 62(1):3.
2. Cavallari C., Luppi B., Di Pietra A.M., Rodriguez L., Fini A. Enhanced release of indomethacin from PVP/stearic acid microcapsules prepared coupling co-freeze-drying and ultrasound assisted spray-congealing process. Pharmaceutical Research 2007, 24(3):521-529.
3. Liu R. Water-insoluble drug formulation 2000, CRC Press.
4. Ghaderi R. A supercritical fluids extraction process for the production of drug loaded biodegradable microparticles. PhD Thesis, Acta Universitatis Upasaliensis, Uppsala, 2000 2000.
5. Debenedetti P.G., Tom J.W. Particle formation with supercritical fluids-a review. Journal of Aerosol Science 1991, 22:555-584.
6. Rantakyla, M. J., Particle Production by Supercritical Antisolvent Processing Techniques [thesis]. Helsinki, Finland: University of Technology, Helsinki (Espoo), Finland 2004.
7. York P., Kompella U.B., Shekunov B.Y. Supercritical fluid technology for drug product development. Informa Healthcare 2004.
8. Elvassore, N.; Parton, T.; Bertucco, A.; Di Noto, V., Kinetics of particle formation in the gas antisolvent precipitation process. In 2003; Vol. 49, pp 859-868.
9. Jung J., Perrut M. Particle design using supercritical fluids: literature and patent survey. Journal of Supercritical Fluids 2001, 20(3):179-219.
10. Yeo S.D., Kiran E. Formation of polymer particles with supercritical fluids: a review. Journal of Supercritical Fluids 2005, 34(3):287-308.
11. Bodmeier R., Wang H., Dixon D.J., Mawson S., Johnston K.P. Polymeric microspheres prepared by spraying into compressed carbon dioxide. Pharmaceutical Research 1995, 12(8):1211-1217.
12. Bleich J., Müller B.W. Production of drug loaded microparticles by the use of supercritical gases with the aerosol solvent extraction system (ASES) process. Journal of microencapsulation 1996, 13(2):131-139.
13. Gong K., Rehman I.U., Darr J.A. Synthesis of poly (sebacic anhydride)-indomethacin controlled release composites via supercritical carbon dioxide assisted impregnation. International Journal of Pharmaceutics 2007, 338(1-2):191-197.
14. Warwick B., Dehghani F., Foster N.R., Biffin J.R., Regtop H.L. Micronization of copper indomethacin using gas antisolvent processes. Industrial and Engineering Chemistry Research 2002, 41(8):1993-2004.
15. Bandi N., W.W., Roberts C.B., Kotra L.P., Kompella U.B. Preparation of budesonide- and indomethacin-hydroxypropyl-ß-cyclodextrin (HPBCD) complexes using a single-step, organic-solvent-free supercritical fluid process. European Journal of Pharmaceutical Sciences 2004, 23(2):159-168.
16. Backensfeld T. M. B. W., Wiese, M., Seydel J. K., Effect of cyclodextrin derivatives on indomethacin stability in aqueous solution. Pharmaceutical Research 1990, 7(5):484-490.
17. Rusu D., Cimpoiu C., Hodisan T. The control over the new obtaining procedeum of indomethacin. Journal of Pharmaceutical and Biomedical Analysis 1998, 17(3):409-413.
18. Yazdanian M., Briggs K., Jankovsky C., Hawi A. The "high solubility" definition of the current FDA Guidance on Biopharmaceutical Classification System may be too strict for acidic drugs. Pharmaceutical Research 2004, 21(2):293-299.
19. Jain A.K. Solubilization of indomethacin using hydrotropes for aqueous injection. European Journal of Pharmaceutics and Biopharmaceutics 2008, 68(3):701-714.
20. Van De Waterbeemd H., Testa B. Drug bioavailability: estimation of solubility, permeability, absorption and bioavailability 2008, Vch Pub.
21. 2 system for nanoparticle preparation of indomethacin. International Journal of Pharmaceutics 2009, 386(1-2):243-248.
22. Imaizumi H., Nambu N., Nagai T. Stability and several physical properties of amorphous and crystalline form of indomethacin. Chemical and Pharmaceutical Bulletin (Tokyo) 1980, 28(9):2565-2569.
23. Okumura T., Ishida M., Takayama K., Otsuka M. Polymorphic transformation of indomethacin under high pressures. Journal of Pharmaceutical Sciences 2006, 95(3):689-700.
24. Kaneniwa N., Otuska M., Hayashi T. Physicochemical characterization of indomethacin polymorphs and the transformation kinetics in ethanol. Chem. Pharm. Bull. 1985, 33:3447-3455.
25. Wu, K.; Li, J., Precipitation of a biodegradable polymer using compressed carbon dioxide as antisolvent, Journal of Supercritical Fluids 46 (2) (2008) 211-216.
26. Banakar U.V. Pharmaceutical dissolution testing. Informa Healthcare 1991.
27. Schmitt W.J., Salada M.C., Shook G.G., Speaker S.M. Finely-divided powders by carrier solution injection into a near or supercritical fluid. AIChE Journal 1995, 41(11):2476-2486.
28. Reverchon E., Della Porta G. Production of antibiotic micro- and nano-particles by supercritical antisolvent precipitation. Powder Technology 1999, 106(1-2):23-29.
29. Gokhale A., Khusid B., Dave R.N., Pfeffer R. Effect of solvent strength and operating pressure on the formation of submicrometer polymer particles in supercritical microjets. Journal of Supercritical Fluids 2007, 43(2):341-356.
30. Andreatta A.E., Florusse L.J., Bottini S.B., Peters C.J. Phase equilibria of dimethyl sulfoxide (DMSO)+carbon dioxide, and DMSO+carbon dioxide+water mixtures. The Journal of supercritical fluids 2007, 42(1):60-68.
31. Reverchon E., Caputo G., De Marco I. Role of phase behavior and atomization in the supercritical antisolvent precipitation. ACS American Chemical Society 2003, vol. 42:6406-6414.
32. Reverchon E., Adami R., Marco I.D., Laudani C.G., Spada A. Pigment Red 60 micronization using supercritical fluids based techniques. Journal of Supercritical Fluids 2005, 35(1):76-82.
33. Sauceau M., Letourneau J.J., Freiss B., Richon D., Fages J. Solubility of eflucimibe in supercritical carbon dioxide with or without a co-solvent. Journal of Supercritical Fluids 2004, 31(2):133-140.
34. Reverchon E., Della Porta G., Di Trolio A., Pace S. Supercritical antisolvent precipitation of nanoparticles of superconductor precursors. Industrial and Engineering Chemistry Research 1998, 37(3):952-958.
35. Dixon D.J., Johnston K.P., Bodmeier R.A. Polymeric materials formed by precipitation with a compressed fluid antisolvent. AIChE Journal 1993, 39(1):127-139.
36. Henczka M., Baldyga J., Shekunov B.Y. Particle formation by turbulent mixing with supercritical antisolvent. Chemical Engineering Science 2005, 60(8-9):2193-2201.
37. Miguel F., Martin A., Gamseb T. Supercritical anti solvent precipitation of lycopene: effect of the operating parameters. Journal of Supercritical Fluids 2006, 36:225-235.