241
Views
11
CrossRef citations to date
0
Altmetric
Research Article

Preparation of concentrated stable fenofibrate suspensions via liquid antisolvent precipitation

, , &
Pages 1693-1703 | Received 27 May 2013, Accepted 02 Sep 2013, Published online: 08 Oct 2013

References

  • Amidon GL, Lennernas H, Shah VP, Crison JR. A theoretical basis for a biopharmaceutical drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 1995;12:413–20
  • Lipinski C. Poor aqueous solubility-An industry wide problem in drug discovery. Am Pharm Rev 2002;53:82–5
  • Noyes AA, Whitney WR. The rate of solution of solid substances in their own solutions. J Am Chem Soc 1897;19:930–4
  • Hu J, Johnston KP, Williams III RO. Nanoparticle engineering processes for enhancing the dissolution rates of poorly water soluble drugs. Drug Dev Ind Pharm 2004;30:233–45
  • Verma S, Gokhale R, Burgess DJ. A comparative study of top-down and bottom-up approaches for the preparation of micro/nanosuspensions. Int J Pharm 2009;380:216–22
  • Zhao H, Wang JX, Wang QA, et al. Controlled liquid antisolvent precipitation of hydrophobic pharmaceutical nanoparticles in a microchannel reactor. Ind Eng Chem Res 2007;46:8229–35
  • Yinghui L, Changshan S, Yanru H, et al. Mechanism of dissolution enhancement and bioavailability of poorly water soluble celecoxib by preparing stable amorphous nanoparticles. J Pharm Pharmaceut Sci 2010;13:589–606
  • Rogers TL, Gillespie IB, Hitt JE, et al. Development and characterization of a scalable controlled precipitation process to enhance the dissolution of poorly water-soluble drugs. Pharm Res 2004;21:2048–57
  • Horn D, Rieger J. Organic nanoparticles in the aqueous phase – theory, experiment, and use. Angew Chem Int Ed 2001;40:4330–61
  • Myerson A. Handbook of industrial crystallization. 2nd ed. New York: John Wiley; 2002
  • Dalvi S, Dave RN. Controlling particle size of a poorly water-soluble drug using ultrasound and stabilizers in antisolvent precipitation. Ind Eng Chem Res 2009;48:7581–93
  • Zhang H, Wang J, Zhang Z, et al. Micronization of atorvastatin calcium by antisolvent precipitation process. Int J Pharm 2009;374:106–13
  • Choi Y, Chung S, Oh M, Kim H. Investigation of crystallization in a jet Y-mixer by a hybrid computational fluid dynamics and process simulation approach. Cryst Growth Des 2005;5:959–68
  • Kim KJ, Kim JY. Nucleation and supersaturation in drowning-out crystallization using a T-mixer. Chem Eng Technol 2006;29:951–6
  • Gassmann P, List M, Schweitzer A, Sucker H. Hydrosols-alternatives for the parenteral application of poorly water-soluble drugs. Eur J Pharm Biopharm 1994;40:64–72
  • Douroumis D, Fahr A. Nano and micro-particulate formulations of poorly water-soluble drugs by using a novel optimized technique. Eur J Pharm Biopharm 2006;63:173–5
  • Douroumis D, Scheler S, Fahr A. Using a modified shepards method for optimization of a nanoparticulate cyclosporin a formulation prepared by a static mixer technique. J Pharm Sci 2008;97:919–30
  • Chen JF, Zhang JY, Shen ZG, et al. Preparation and characterization of amorphous cefuroxime axetil drug nanoparticles with novel technology: high-gravity antisolvent precipitation. Ind Eng Chem Res 2006;45:8723–7
  • Beck C, Dalvi SV, Dave RN. Controlled liquid antisolvent precipitation using a rapid mixing device. Chem Eng Sci 2010;65:5669–75
  • Kumar V, Prud’homme R. Thermodynamic limits on drug loading in nanoparticle cores. J Pharm Sci 2008;97:4904–14
  • Rasenack N, Muller BW. Dissolution rate enhancement by in situ micronization of poorly water-soluble drugs. Pharm Res 2002;19:1894–900
  • Matteucci ME, Hotze MA, Johnston KP, Williams RO. Drug nanoparticles by antisolvent precipitation: mixing energy versus surfactant stabilization. Langmuir 2006;22:8951–9
  • de Waard H, Hinrichs WL, Frijlink HW. A novel bottom-up process to produce drug nanocrystals: controlled crystallization during freeze-drying. J Control Release 2008;128:179–83
  • Dong Y, Ng WK, Shen S, et al. Preparation and characterization of spironolactone nanoparticles by antisolvent precipitation. Int J Pharm 2009;375:84–8
  • Marchisio DL, Rivautella L, Barresi AA. Design and scale-up of chemical reactors for nanoparticle precipitation. AlChE J 2006;52:1877–87
  • Weber M, Russell LM, Debenedetti PG. Mathematical modeling of nucleation and growth of particles formed by the rapid expansion of a supercritical solution under subsonic conditions. J Supercrit Fluids 2002;23:65–80
  • Beck C, Sievens-Figueroa L, Gärtner K, et al. Effects of stabilizers on particle redispersion and dissolution from polymer strip films containing liquid antisolvent precipitated griseofulvin particles. Powder Technol 2013;236:37–51
  • Hu J, Ng WK, Dong Y, et al. Continuous and scalable process for water-redispersible nanoformulation of poorly aqueous soluble APIs by antisolvent precipitation and spray-drying. Int J Pharm 2011;404:198–204
  • Meng X, Chen Y, Chowdhury SR, et al. Stabilizing dispersions of hydrophobic drug molecules using cellulose ethers during antisolvent synthesis of microparticulates. Colloids Surf B 2009;70:7–14
  • Chiou H, Chan H, Heng D, et al. A novel production method for inhalable cyclosporine A powders by confined liquid impinging jet precipitation. J Aerosol Sci 2008;39:500–9
  • Kumar V, Prud’homme R. Nanoparticle stability: processing pathways for solvent removal. Chem Eng Sci 2009;64:1358–61
  • Kumar V, Wang L, Riebe M, et al. Formulation and stability of itraconazole and odanacatib nanoparticles: governing physical parameters. Mol Pharmaceutics 2009;6:1118–24
  • Munoz A, Guichard JP, Reginault E. Micronised fenofibrate. Atherosclerosis 1994;110:S45–8
  • Knieke C, Azad M, Dave R, Bilgili E. A study of the physical stability of wet media-milled fenofibrate suspensions using dynamic equilibrium curves. Chem Eng Res Des 2013;91:1245--58
  • D’Addio S, Prud’homme S. Controlling drug nanoparticle formation by rapid precipitation. Adv Drug Deliv Rev 2011;63:417–26
  • Kim Y, Lee M. Taxol-loaded block copolymer nanospheres composed of methoxy poly (ethylene glycol) and poly (ε-caprolactone) as novel anticancer drug carriers. J Biomaterials 2001;22:1697–704
  • Shuai X, Merdan T, Schaper K, et al. Core-cross-linked polymeric micelles as paclitaxel carriers. Bioconjugate Chem 2004;15:441–8
  • Vandervoort J, Ludwig A. Biocompatible stabilizers in the preparation of PLGA nanoparticles: a factorial design study. Int J Pharm 2002;238:77–92
  • Vauthier C, Cabane B, Labarre D. How to concentrate nanoparticles and avoid aggregation? Eur J Pharm Biopharm 2008;69:466–75
  • Dong Y, Ng WK, Shen S, et al. Controlled antisolvent precipitation of spironolactone nanoparticles by impingement mixing. Int J Pharm 2011;410:175–9
  • Xia D, Quan P, Piao H, et al. Preparation of stable nitrendipine nanosuspensions using the precipitation–ultrasonication method for enhancement of dissolution and oral bioavailability. Eur J Pharm Sci 2010;40:325–34
  • Chiou H, Chan H, Heng D, et al. Evaluation on the use of confined liquid impinging jets for the synthesis of nanodrug particles. Drug Dev Ind Pharm 2008;34:59–64
  • Jongen N, Bwoen P, Lemaitre J, et al. Precipitation of self-organized copper oxalate polycrystalline particles in the presence of hydroxyl propyl methyl cellulose (HPMC): control of morphology. J Colloid Interface Sci 2000;226:189–98
  • Chari K, Antalek B, Kowalczyk J, et al. Polymer-surfactant interaction and stability of amorphous colloidal particles. J Phys Chem B 1999;103:9867–72
  • Simons SJR, Rossetti D, Pagliai P, et al. The relationship between surface properties and binder performance in granulation. Chem Eng Sci 2005;60:4055–60
  • Raghavan SL, Trividic A, Davis AF, Hadgraft J. Crystallization of hydrocortisone acetate: influence of polymers. Int J Pharm 2001;212:213–21
  • Raghavan SL, Schuessel K, Davis AF, Hadgraft J. Formation and stabilization of triclosan colloidal suspensions using supersaturated systems. Int J Pharm 2003;261:153–8
  • Choi J, Park C, Lee J. Effect of polymer molecular weight on nano comminution of poorly water soluble drugs. Drug Deliv 2008;15:347–53
  • Dalvi S, Azad M, Dave RN. Precipitation and stabilization of ultrafine particles of fenofibrate in aqueous suspensions by RESOLV. Powder Technol 2013;236:75–84
  • Peng L, Xinyu R, Johanna L, et al. Nanosuspensions of poorly soluble drugs: preparation and development by wet milling. Int J Pharm 2011;411:215–22
  • Tadros T. Polymeric surfactants in disperse systems. Adv Colloid Interface Sci 2009;147–148:281–99
  • Choi Y, Yoo Y, Kwak S, et al. Role of polymeric stabilizers for drug nanocrystal dispersions. Curr Appl Phys 2005;5:472–4
  • Lee J, Choi YJ, Park CH. Characteristics of polymers enabling nano comminution of water insoluble drugs. Int J Pharm 2008;355:328–36
  • Wu L, Zhang J, Watanabe W. Physical and chemical stability of drug nanoparticles. Adv Drug Deliv Rev 2011;63:456–69
  • Terayama H, Inada K, Nakayama H, et al. Preparation of stable aqueous suspension of a hydrophobic drug with polymers. Colloids Surf B 2004;39:159–64
  • Zhu W, Romanskia F, Meng X, et al. Atomistic simulation study of surfactant and polymer interactions on the surface of a fenofibrate crystal. Eur J Pharm Sci 2011;42:452–61
  • Pongjanyakul T, Puttipipatkhachorn S. Polymer–magnesium aluminum silicate composite dispersions for improved physical stability of acetaminophen suspensions. AAPS Pharm SciTech 2009;10:346–54
  • Yang JH, Lin CW. Effects of various viscosity enhancers and pH on separating haem from porcine red blood cells. J Sci Food Agric 1996;70:364–8
  • George M, Ghosh I. Identifying the correlation between drug/stabilizer properties and critical quality attributes (CQAs) of nanosuspension formulation prepared by wet media milling technology. Eur J Pharm Sci 2013;48:142–52
  • Zhang J, Wu L, Chan H, Watanabe W. Formation, characterization, and fate of inhaled drug nanoparticles. Adv Drug Deliv Rev 2011;63:441–55
  • 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
  • Mersmann A. Crystallization and precipitation. Chem Eng Process 1999;38:345–53
  • Rana D, Neale GH, Hornof V. Surface tension of mixed surfactant systems: lignosulfonate and sodium dodecyl sulfate. Colloid Polym Sci 2002;280:775–8
  • Sane A, Thies M. The formation of fluorinated tetraphenylporphyrin nanoparticles via rapid expansion processes: RESS vs RESOLV. J Phys Chem B 2005;109:19688–95
  • Croy SR, Kwon GS. The effects of Pluronic block copolymers on the aggregation state of nystatin. J Control Release 2004;95:161–71
  • Thorat A, Dalvi S. Liquid antisolvent precipitation and stabilization of nanoparticles of poorly water soluble drugs in aqueous suspensions: recent developments and future perspective. Chem Eng J 2012;181–182:1–34
  • Chen X, Matteucci M, Lo C, et al. Flocculation of polymer stabilized nanocrystal suspensions to produce redispersible powders. Drug Dev Ind Pharm 2009;35:283–96

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.