Preparation of stable nitrendipine nanosuspensions using the precipitation-ultrasonication method for enhancement of dissolution and oral bioavailability

European Journal of Pharmaceutical Sciences

Volumn 40, Issue 4, 2010, Pages 325-334

  Xia, Dengning ^a   Quan, Peng ^a   Piao, Hongze ^a   Piao, Hongyu ^a   Sun, Shaoping ^a,b   Yin, Yongmei ^c   Cui, Fude ^a  

^a SHENYANG PHARMACEUTICAL UNIVERSITY   (China)

^b HEILONGJIANG UNIVERSITY   (China)

^c NANKAI UNIVERSITY   (China)

Author keywords

Dissolution rate; Nanocrystals; Nanosuspensions; Nitrendipine; Oral bioavailability; Precipitation; Ultrasonication

Indexed keywords

NANOCRYSTAL; NANOPARTICLE; NITRENDIPINE; POLYVINYL ALCOHOL; CALCIUM CHANNEL BLOCKING AGENT; EXCIPIENT; SUSPENSION;

ANIMAL EXPERIMENT; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; DRUG BIOAVAILABILITY; DRUG SOLUBILITY; DRUG STABILITY; DRUG SYNTHESIS; MALE; MAXIMUM PLASMA CONCENTRATION; NANOPHARMACEUTICS; NONHUMAN; PRECIPITATION; PRIORITY JOURNAL; RAT; SUSPENSION; TABLET FORMULATION; TEMPERATURE; TIME TO MAXIMUM PLASMA CONCENTRATION; ULTRASOUND; ZETA POTENTIAL; ANIMAL; BIOAVAILABILITY; BLOOD; CHEMISTRY; COMPARATIVE STUDY; DRUG FORMULATION; NANOTECHNOLOGY; OSMOLARITY; PARTICLE SIZE; PROCEDURES; RANDOMIZATION; SOLUBILITY; TIME; ULTRASTRUCTURE; WISTAR RAT;

ANIMALS; BIOLOGICAL AVAILABILITY; CALCIUM CHANNEL BLOCKERS; CHEMICAL PRECIPITATION; DRUG COMPOUNDING; DRUG STABILITY; EXCIPIENTS; MALE; NANOPARTICLES; NANOTECHNOLOGY; NITRENDIPINE; OSMOLAR CONCENTRATION; PARTICLE SIZE; POLYVINYL ALCOHOL; RANDOM ALLOCATION; RATS; RATS, WISTAR; SOLUBILITY; SUSPENSIONS; TEMPERATURE; TIME FACTORS; ULTRASONICS;

EID: 77953543307     PISSN: 09280987     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejps.2010.04.006     Document Type: Article

References (35)

1. Absorption and Drug Development: Solubility, Permeability, and Charge state 2003, John Wiley & Sons, Inc., Hoboken, NJ. A. Avdeef (Ed.).
2. Dhumal R.S., Biradar S.V., Paradkar A.R., York P. Particle engineering using sonocrystallization: salbutamol sulphate for pulmonary delivery. Int. J. Pharm. 2009, 368:129-137.
3. 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, 63:173-175.
4. Douroumis D., Fahr A. Stable carbamazepine colloidal systems using the cosolvent technique. Eur. J. Pharm. Sci. 2007, 30:367-374.
5. Gao L., Zhang D., Chen M. Drug nanocrystals for the formulation of poorly soluble drugs and its application as a potential drug delivery system. J. Nanopart. Res. 2008, 10:845-862.
6. Guo Z., Zhang M., Li H., Wang J., Kougoulos E. Effect of ultrasound on anti-solvent crystallization process. J. Cryst. Growth. 2005, 273:555-563.
7. Hintz R.J., Johnson K.C. The effect of particle size distribution on dissolution rate and oral absorption. Int. J. Pharm. 1989, 51:9-17.
8. Ji J.-b., Lu X.-h., Xu Z.-c. Effect of ultrasound on adsorption of Geniposide on polymeric resin. Ultrason. Sonochem. 2006, 13:463-470.
9. Jia L., Wong H., Cerna C., Weitman S.D. Effect of nanonization on absorption of 301029: ex vivo and in vivo pharmacokinetic correlations determined by liquid chromatography/mass spectrometry. Pharm. Res. 2002, 19:1091-1096.
10. Crystallization Process Systems 2002, Butterworth-Heinemann, Oxford. A.G. Jones (Ed.).
11. Kesisoglou F., Panmai S., Wu Y. Nanosizing-oral formulation development and biopharmaceutical evaluation. Adv. Drug Deliv. Rev. 2007, 59:631-644.
12. Kipp, J.E., Wong, T., Chung, J., Doty, M.J., Werling, J., Rebbeck, C.L., Brynjelsen, S., 2005. Method for preparing submicron particle suspensions. U.S Patent: 6884436.
13. Krause K.P., Kayser O., Mader K., Gust R., Muller R.H. Heavy metal contamination of nanosuspensions produced by high-pressure homogenisation. Int. J. Pharm. 2000, 196:169-172.
14. Li H., Wang J., Bao Y., Guo Z., Zhang M. Rapid sonocrystallization in the salting-out process. J. Cryst. Growth 2003, 247:192-198.
15. Li X.S., Wang J.X., Shen Z.G., Zhang P.Y., Chen J.F., Yun J. Preparation of uniform prednisolone microcrystals by a controlled microprecipitation method. Int. J. Pharm. 2007, 342:26-32.
16. Lince F., Marchisio D.L., Barresi A.A. Strategies to control the particle size distribution of poly-e{open}-caprolactone nanoparticles for pharmaceutical applications. J. Colloid Interface Sci. 2008, 322:505-515.
17. Lindfors L., Forssén S., Westergren J., Olsson U. Nucleation and crystal growth in supersaturated solutions of a model drug. J. Colloid Interface Sci. 2008, 325:404-413.
18. Lindfors L., Forssn S., Skantze P., Skantze U., Zackrisson A., Olsson U. Amorphous drug nanosuspensions. 2. Experimental determination of bulk monomer concentrations. Langmuir 2006, 22:911-916.
19. Lindfors L., Skantze P., Skantze U., Rasmusson M., Zackrisson A., Olsson U. Amorphous drug nanosuspensions. 1. Inhibition of Ostwald ripening. Langmuir 2006, 22:906-910.
20. Louhi-Kultanen M., Karjalainen M., Rantanen J., Huhtanen M., Kallas J. Crystallization of glycine with ultrasound. Int. J. Pharm. 2006, 320:23-29.
21. Luque de Castro M.D., Priego-Capote F. Ultrasound-assisted crystallization (sonocrystallization). Ultrason. Sonochem. 2007, 14:717-724.
22. Möschwitzer J., Achleitner G., Pomper H., Muller R.H. Development of an intravenously injectable chemically stable aqueous omeprazole formulation using nanosuspension technology. Eur. J. Pharm. Biopharm. 2004, 58:615-619.
23. Matteucci M.E., Hotze M.A., Johnston K.P., Williams R.O. Drug nanoparticles by antisolvent precipitation: mixing energy versus surfactant stabilization. Langmuir 2006, 22:8951-8959.
24. Pathak P., Meziani M.J., Desai T., Sun Y.-P. Formation and stabilization of ibuprofen nanoparticles in supercritical fluid processing. J. Supercrit. Fluids 2006, 37:279-286.
25. Rabinow B.E. Nanosuspensions in drug delivery. Nature 2004, 3:785-796.
26. Raghavan S.L., Trividic A., Davis A.F., Hadgraft J. Crystallization of hydrocortisone acetate: influence of polymers. Int. J. Pharm. 2001, 212:213-221.
27. Reverchon E. Supercritical antisolvent precipitation of micro- and nano-particles. J. Supercrit. Fluids 1999, 15:1-21.
28. Soons P.A., Breimer D.D. Stereoselective pharmacokinetics of oral and intravenous nitrendipine in healthy male subjects. Br. J. Clin. Pharmacol. 1991, 32:11-16.
29. Sugimoto T. Underlying mechanisms in size control of uniform nanoparticles. J. Colloid Interface Sci. 2007, 309:106-118.
30. Martindale: The Complete Drug Reference (Thirty-sixth edition) 2009, Pharmaceutical Press, London, Chicago. S.C. Sweetman, P.S. Blake (Eds.).
31. Van Eerdenbrugh B., Froyen L., Martens J.A., Blaton N., Augustijns P., Brewster M., Van den Mooter G. Characterization of physico-chemical properties and pharmaceutical performance of sucrose co-freeze-dried solid nanoparticulate powders of the anti-HIV agent loviride prepared by media milling. Int. J. Pharm. 2007, 338:198-206.
32. 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.
33. Werling, J., Doty, M.J., Rebbeck, C.L., Wong, J.C.T., Kipp, J.E., 2007. Polymorphic form of itraconazole U.S Patent: 7193084.
34. Xiong R., Lu W., Li J., Wang P., Xu R., Chen T. Preparation and characterization of intravenously injectable nimodipine nanosuspension. Int. J. Pharm. 2008, 350:338-343.
35. Zimmermann A., Millqvist-Fureby A., Elema M.R., Hansen T., Müllertz A., Hovgaard L. Adsorption of pharmaceutical excipients onto microcrystals of siramesine hydrochloride: effects on physicochemical properties. Eur. J. Pharm. Biopharm. 2009, 71:109-116.