A study of the physical stability of wet media-milled fenofibrate suspensions using dynamic equilibrium curves

Chemical Engineering Research and Design

Volumn 91, Issue 7, 2013, Pages 1245-1258

  Knieke, C ^a   Azad, M A ^a   Dave R N ^a   Bilgili, E ^a  

^a NEW JERSEY INSTITUTE OF TECHNOLOGY   (United States)

Author keywords

Dynamic equilibrium; Fenofibrate; Nanoparticles; Stabilization; Wet media milling

Indexed keywords

DYNAMIC EQUILIBRIA; FENOFIBRATE; GUIDING PRINCIPLES; HYDROXYPROPYL METHYL CELLULOSE; PHYSICAL STABILITY; STABILIZER CONCENTRATION; WET-MEDIA MILLINGS;

EXPERIMENTS; MILLING (MACHINING); NANOPARTICLES; OPTIMIZATION; OSTWALD RIPENING; PARTICLE SIZE; SODIUM DODECYL SULFATE; STABILIZATION; SUSPENSIONS (COMPONENTS);

DYNAMICS;

EID: 84878963245     PISSN: 02638762     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cherd.2013.02.008     Document Type: Article

References (51)

1. Ain-Ai A., Gupta P.K. Effect of arginine hydrochloride and hydroxypropyl cellulose as stabilizers on the physical stability of high drug loading nanosuspensions of a poorly soluble compound. Int. J. Pharm. 2008, 351:282-288.
2. Aubouy M., Raphaël E. Scaling description of a colloidal particle clothed with polymers. Macromolecules 1998, 31:4357-4363.
3. Barthelmes G., Pratsinis S.E., Buggisch H. Particle size distributions and viscosity of suspensions undergoing shear-induced coagulation and fragmentation. Chem. Eng. Sci. 2003, 58:2893-2902.
4. Berglund K.D., Przybycien T.M., Tilton R.D. Coadsorption of sodium dodecyl sulfate with hydrophobically modified nonionic cellulose polymers. 1. Role of polymer hydrophobic modification. Langmuir 2003, 19:2705-2713.
5. Bhakay A., Merwade M., Bilgili E., Davé R.N. Novel aspects of wet milling for the production of microsuspensions and nanosuspensions of poorly water-soluble drugs. Drug Dev. Ind. Pharm. 2011, 37:963-976.
6. Bhakay A., Dave R., Bilgili E. Recovery of BCS class II drugs during aqueous redispersion of core-shell type nanocomposite particles produced via fluidized bed coating. Powder Technol. 2013, 236:221-234.
7. Bilgili E., Hamey R., Scarlett B. Production of pigment nanoparticles using a wet stirred media mill with polymeric media. China Particuol. 2004, 2:93-100.
8. Bilgili E., Hamey R., Scarlett B. Nano-milling of pigment agglomerates using a wet stirred media mill: elucidation of the kinetics and breakage mechanisms. Chem. Eng. Sci. 2006, 61:149-157.
9. Bilgili E., Afolabi A. A combined microhydrodynamics-polymer adsorption analysis for elucidation of the roles of stabilizers in wet stirred media milling. Int. J. Pharm. 2012, 439:193-206.
10. Bruno, J.A., Doty, B.D., Gustow, E., Illig, K.J., Rajagopalan, N., Sarpotdar, P., 1996. Method of grinding pharmaceutical substances. US Patent 5,518,187.
11. Cerdeira A.M., Mazzotti M., Gander B. Miconazole nanosuspensions: influence of formulation variables on particle size reduction and physical stability. Int. J. Pharm. 2010, 396:210-218.
12. Evertsson H., Nilsson S. Microviscosity in clusters of ethylhydroxyethyl cellulose and sodium dodecyl sulfate formed in dilute aqueous solutions as determined with fluorescence probe techniques. Macromolecules 1997, 30:2377-2385.
13. Ghosh I., Bose S., Vippagunta R., Harmon F. Nanosuspension for improving the bioavailability of a poorly soluble drug and screening of stabilizing agents to inhibit crystal growth. Int. J. Pharm. 2011, 409(1-2):260-268.
14. Henry R.F., Zhang G.Z., Gao Y., Buckner I.S. Fenofibrate. Acta Crystallogr. 2003, E59:o699-o700.
15. Huttig G.F. Zermahlungsvorgahge als chemisches problem 1952, Dechema Monograph, Band 245-268.
16. Jamzad S., Fassihi R. Role of surfactant and pH on dissolution properties of fenofibrate and glipizide - a technical note. AAPS Pharm. Sci. Technol. 2006, 7(2):E1-E6.
17. Keck C.M., Muller R.H. Drug nanocrystals of poorly soluble drugs produced by high pressure homogenisation. Eur. J. Pharm. Biopharm. 2006, 62(1):3-16.
18. Kim C.-J. Surface Chemistry and Colloids, Advanced Pharmaceutics: Physicochemical Principles 2004, CRC Press, pp. 193-256.
19. Kissa E. Dispersions: Characterization, Testing, and Measurement 1999, Marcel Dekker, New York, pp. 240-241.
20. Knieke C., Sommer M., Peukert W. Identifying the apparent and true grinding limit. Powder Technol. 2009, 195(1):25-30.
21. Lee J. Drug nano- and microparticles processed into solid dosage forms: physical properties. J. Pharm. Sci. 2003, 92:2057-2068.
22. Lee J., Lee S.-J., Choi J.-Y., Yoo J.Y., Ahn C.-H. Amphiphilic amino acid copolymers as stabilizers for the preparation of nanocrystal dispersion. Eur. J. Pharm. Sci. 2005, 24:441-449.
23. Lee J., Choi J.-Y., Park C.H. Characteristics of polymers enabling nano-comminution of water insoluble drugs. Int. J. Pharm. 2008, 355:328-336.
24. Lifshitz I.M., V.V.Slyozov V.V. The kinetics of precipitation from supersaturated solid solutions. J. Phys. Chem. Solids 1961, 19(1-2):35-50.
25. Liu P., Rong X., Laru J., van Veen B., Kiesvaara J., Hirvonen J., Laaksonen T., Peltonen L. Nanosuspensions of poorly soluble drugs: preparation and development by wet milling. Int. J. Pharm. 2011, 411(1-2):215-222.
26. Liversidge G.G., Cundy K.C. Particle size reduction for improvement of oral bioavailability of hydrophobic drugs: I. Absolute oral bioavailability of nanocrystalline danazol in beagle dogs. Int. J. Pharm. 1995, 125:91-97.
27. Mende S., Stenger F., Peukert W., Schwedes J. Mechanical production and stabilization of submicron particles in stirred media mills. Powder Technol. 2003, 132(1):64-73.
28. Merisko-Liversidge E., Liversidge G.G., Cooper E.R. Nanosizing: a formulation approach for poorly-water soluble compounds. Eur. J. Pharm. Sci. 2003, 18:113-120.
29. Monteiro A., Afolabi A., Bilgili E. Continuous production of drug nanoparticle suspensions via wet stirred media milling: a fresh look at the Rehbinder effect. Drug Dev. Ind. Pharm. 2013, 39:266-283.
30. Napper D.H. Colloid stability. Ind. Eng. Chem. Prod. Res. Dev. 1970, 9(4):467-477.
31. Ng J.D., Lorber B., Witz J., Théobald-Dietrich A., Kern D., Giegé R. The crystallization of biological macromolecules from precipitates: evidence for Ostwald ripening. J. Cryst. Growth 1996, 168:50-62.
32. Noyes A., Whitney W. The rate of solution of solid substances in their own solutions. J. Am. Chem. Soc. 1897, 19:930-934.
33. Opoczky L., Farnady F. Fine grinding and states of equilibrium. Powder Technol. 1984, 4:27-31.
34. Panmai S., Deshpande S. Development of nanoformulations: selection of polymeric stabilizers based on adsorption isotherm. PMSE Prepr. 2003, 89:808-809.
35. Petrović L.B., Sovilj V.J., Katona J.M., Milanovic J.L. Influence of polymer-surfactant interactions on o/w emulsion properties and microcapsule formation. J. Colloid Interface Sci. 2010, 342:333-339.
36. Peukert W., Schwarzer H.-C., Stenger F. Control of aggregation in production and handling of nanoparticles. Chem. Eng. Process. 2005, 44(2):245-252.
37. Richetti P., Kekicheff P. Direct measurement of depletion and structural forces in a micellar system. Phys. Rev. Lett. 1992, 68(12):1951-1954.
38. Seader J.D., Henley E.J. Separation Process Principles 2006, John Wiley & Sons, Hobeken, NJ, p. 578. 2nd ed.
39. Sepassi S., Goodwin D.J., Drake A.F., Holland S., Leonard G., Martini L., Lawrence M.J. Effect of polymer molecular weight on the production of drug nanoparticles. J. Pharm. Sci. 2007, 96(10):2655-2666.
40. Sievens-Figueroa L., Bhakay A., Jerez-Rozo J.I., Pandya N., Romanach R., Michniak-Kohn B., Iqbal Z., Bilgili E., Davé R.N. Preparation and characterization of hydroxypropyl methyl cellulose films containing stable BCS class II drug nanoparticles for pharmaceutical applications. Int. J. Pharm. 2012, 423:496-508.
41. Singh S.K., Srinivasan K.K., Gowthamaranjan K., Singare D.S., Prakash D., Gaikwad N.B. Investigation of preparation parameters of nanosuspension by top-down media milling to improve the dissolution of poorly water-soluble glyburide. Eur. J. Pharm. Biopharm. 2011, 78(3):441-446.
42. Sommer M., Stenger F., Peukert W., Wagner N.J. Agglomeration and breakage of nanoparticles in stirred media mills - a comparison of different methods and models. Chem. Eng. Sci. 2006, 61(1):135-148.
43. Sovilj V., Petrović L.B. Influence of hydroxypropylmethyl cellulose-sodium dodecylsulfate interaction on the solution conductivity and viscosity and emulsion stability. Carbohydr. Polym. 2006, 64(1):41-49.
44. ® SP1) is a superior carrier for solid dispersions with a high drug load. J. Pharm. Sci. 2011, 100(6):2333-2342.
45. Stenger F., Mende S., Schwedes J., Peukert W. Nanomilling in stirred media mills. Chem. Eng. Sci. 2005, 60(16):4557-4565.
46. Su J.C., Liang S.Y., Liu W.L., Jan T.C. Ceramic micro/nanoparticle size evolution in wet grinding in stirred ball mill. J. Manuf. Sci. Eng. 2004, 126(4):779-786.
47. Van Eerdenbrugh B., Van den Mooter G., Augustijns P. Top-down production of drug nanocrystals: nanosuspension stabilization, miniaturization and transformation into solid products. Int. J. Pharm. 2008, 364:64-75.
48. Van Eerdenbrugh B., Froyen L., van Humbeeck J., Martens J.A., Augustijns P., Van den Mooter G. Drying of crystalline drug nanosuspensions - the importance of surface hydrophobicity on dissolution behavior upon redispersion. Eur. J. Pharm. Sci. 2008, 35:127-135.
49. Verma S., Kumar S., Gokhale R., Burgess D.J. Physical stability of nanosuspensions: investigation of the role of stabilizers on Ostwald ripening. Int. J. Pharm. 2011, 406:145-152.
50. Wagner C. Theorie der alterung von niederschlagen durch umlosen (Ostwald-reifung). Z. Elektrochem. 1961, 65(7):581-591.
51. Zhu W., Romanski F.S., Meng X., Mitra S., Tomassone M.S. Atomistic simulation study of surfactant and polymer interactions on the surface of a fenofibrate crystal. Eur. J. Pharm. Sci. 2011, 42:452-461.