Development of a new method to assess nanocrystal dissolution based on light scattering

Pharmaceutical Research

Volumn 29, Issue 10, 2012, Pages 2887-2901

  Anhalt, Katharina ^a,b   Geissler, Simon ^a   Harms, Meike ^a,b   Weigandt, Markus ^a   Fricker, Gert ^b  

^a Research Pharmaceutics and Drug Product Development   (Germany)

^b UNIVERSITY OF HEIDELBERG   (Germany)

Author keywords

Dissolution; Light scattering; Nanocrystal; Nanosuspension; Noyes Whitney equation

Indexed keywords

FENOFIBRATE; NANOCRYSTAL;

ANALYTIC METHOD; ARTICLE; CONTROLLED STUDY; DISSOLUTION; DRUG SOLUBILITY; LIGHT SCATTERING; MATHEMATICAL MODEL; PARTICLE SIZE; PRIORITY JOURNAL; SUSPENSION;

BIOLOGICAL AVAILABILITY; FENOFIBRATE; LIGHT; NANOPARTICLES; PARTICLE SIZE; SCATTERING, RADIATION; SOLUBILITY; SUSPENSIONS; TECHNOLOGY, PHARMACEUTICAL; WATER;

EID: 84866728200     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-012-0795-4     Document Type: Article

References (54)

1. Lipinski CA. Poor aqueous solubility -an industry wide problem in drug discovery. Am Pharm Rev. 2002;5:82-5.
2. Rabinow BE. Nanosuspensions in drug delivery. Nat Rev Drug Discov. 2004;3(9):785-96.
3. Kesisoglou F, Panmai S, Wu Y. Nanosizing-oral formulation development and biopharmaceutical evaluation. Adv Drug Deliv Rev. 2007;59(7):631-44.
4. Muller RH, Gohla S, Keck CM. State of the art of nanocrystals-special features, production, nanotoxicology aspects and intracellular delivery. Eur J Pharm Biopharm. 2011;78(1):1-9.
5. Van Eerdenbrugh B, Vermant J, Martens JA, Froyen L, Humbeeck JV, Van den Mooter G, et al. Solubility increases associated with crystalline drug nanoparticles: methodologies and significance. Mol Pharm. 2010;7(5):1858-70.
6. Brunner E. Reaktionsgeschwindigkeit in Heterogenen Systemen. Z Physik Chem. 1904;47(1):56-102.
7. Nernst W. Theorie der Reaktionsgeschwindigkeit in Heterogenen Systemen. Z Physik Chem. 1904;47(1):52-5.
8. Noyes A, Whitney WR. The rate of solution of solid substances in their own solutions. J Am Chem Soc. 1897;19:930-4.
9. Costa P, Sousa Lobo JM. Modeling and comparison of dissolution profiles. Eur J Pharm Sci. 2001;13(2):123-33.
10. Freundlich H. Colloid and capillary chemistry. New York: E. P. Dutton and Company; 1923.
11. Ostwald W. Über die vermeintliche Isomerie des roten und gelben Quecksilberoxyds und die Oberflächenspannung fester Körper. Z Physik Chem. 1900;34:495-503.
12. Kesisoglou F, Wu Y. Understanding the effect of API properties on bioavailability through absorption modeling. AAPS J. 2008;10 (4):516-25.
13. Heng D, Cutler DJ, Chan HK, Yun J, Raper JA. What is a suitable dissolution method for drug nanoparticles? Pharm Res. 2008;25 (7):1696-701.
14. Xia D, Cui F, Piao H, Cun D, Jiang Y, Ouyang M, et al. Effect of crystal size on the in vitro dissolution and oral absorption of nitrendipine in rats. Pharm Res. 2010;27(9):1965-76.
15. Shono Y, Jantratid E, Kesisoglou F, Reppas C, Dressman JB. Forecasting in vivo oral absorption and food effect of micronized and nanosized aprepitant formulations in humans. Eur J Pharm Biopharm. 2010;76(1):95-104.
16. Jinno J, Kamada N, Miyake M, Yamada K, Mukai T, Odomi M, et al. In vitro-in vivo correlation for wet-milled tablet of poorly watersoluble cilostazol. J Control Release. 2008;130(1):29-37.
17. Laaksonen T, Liu P, Rahikkala A, Peltonen L, Kauppinen EI, Hirvonen J, et al. Intact nanoparticulate indomethacin in fastdissolving carrier particles by combined wet milling and aerosol flow reactor methods. Pharm Res. 2011;28(10):2403-11.
18. Li W, Yang Y, Tian Y, Xu X, Chen Y, Mu L, et al. Preparation and in vitro/in vivo evaluation of revaprazan hydrochloride nanosuspension. Int J Pharm. 2011;408(1-2):157-62.
19. Juenemann D, Jantratid E, Wagner C, Reppas C, Vertzoni M, Dressman JB. Biorelevant in vitro dissolution testing of products containing micronized or nanosized fenofibrate with a view to predicting plasma profiles. Eur J Pharm Biopharm. 2011;77 (2):257-64.
20. Magenheim B, Levy MY, Benita S. A new in vitro technique for the evaluation of drug release profile from colloidal carriers -ultrafiltration technique at low pressure. Int J Pharm. 1993;94(1-3):115-23.
21. Helle A, Hirsjarvi S, Peltonen L, Hirvonen J, Wiedmer SK, Hyotylainen T. Novel, dynamic on-line analytical separation system for dissolution of drugs from poly(lactic acid) nanoparticles. J Pharm Biomed Anal. 2010;51(1):125-30.
22. Bhardwaj U, Burgess DJ. A novel USP apparatus 4 based release testing method for dispersed systems. Int J Pharm. 2010;388(1-2):287-94.
23. Abdel-Mottaleb MM, Lamprecht A. Standardized in vitro drug release test for colloidal drug carriers using modified USP dissolution apparatus I. Drug Dev Ind Pharm. 2011;37(2):178-84.
24. Aldridge PK, Melvin DW, Williams BA, Bratin K, Kostek LJ, Sekulic SS. A robotic dissolution system with on-line fiber-optic UV analysis. J Pharm Sci. 1995;84(8):909-14.
25. Chen CS, Brown CW. A drug dissolution monitor employing multiple fiber optic probes and a UV/visible diode array spectrophotometer. Pharm Res. 1994;11(7):979-83.
26. Tsinman K, Avdeef A, Tsinman O, Voloboy D. Powder dissolution method for estimating rotating disk intrinsic dissolution rates of low solubility drugs. Pharm Res. 2009;26(9):2093-100.
27. Alonzo DE, Zhang GG, Zhou D, Gao Y, Taylor LS. Understanding the behavior of amorphous pharmaceutical systems during dissolution. Pharm Res. 2010;27(4):608-18.
28. Galli C. Experimental determination of the diffusion boundary layer width of micron and submicron particles. Int J Pharm. 2006;313(1-2):114-22.
29. Van Eerdenbrugh B, Alonzo DE, Taylor LS. Influence of particle size on the ultraviolet spectrum of particulate-containing solutions: implications for in-situ concentration monitoring using UV/Vis fiber-optic probes. Pharm Res. 2011;28(7):1643-52.
30. Mora L, Chumbimuni-Torres KY, Clawson C, Hernandez L, Zhang L, Wang J. Real-time electrochemical monitoring of drug release from therapeutic nanoparticles. J Control Release. 2009;140(1):69-73.
31. Rosenblatt KM, Douroumis D, Bunjes H. Drug release from differently structured monoolein/poloxamer nanodispersions studied with differential pulse polarography and ultrafiltration at low pressure. J Pharm Sci. 2007;96(6):1564-75.
32. Charalampopoulos N, Avgoustakis K, Kontoyannis CG. Differential pulse polarography: a suitable technique for monitoring drug release from polymeric nanoparticle dispersions. Anal Chim Acta. 2003;491:57-62.
33. Kayaert P, Li B, Jimidar I, Rombaut P, Ahssini F, Van den Mooter G. Solution calorimetry as an alternative approach for dissolution testing of nanosuspensions. Eur J Pharm Biopharm. 2010;76 (3):507-13.
34. Tucker CJ, inventor. Real time monitoring of small particle dissolution by way of light scattering. United States patent US6750966. 2002.
35. Crisp MT, Tucker CJ, Rogers TL, Williams 3rd RO, Johnston KP. Turbidimetric measurement and prediction of dissolution rates of poorly soluble drug nanocrystals. J Control Release. 2007;117(3):351-9.
36. Chaubal MV, Popescu C. Conversion of nanosuspensions into dry powders by spray drying: a case study. Pharm Res. 2008;25 (10):2302-8.
37. van de Hulst HC. Light scattering by small particles. New York: Wiley; 1957.
38. Elsayed MM, Cevc G. Turbidity spectroscopy for characterization of submicroscopic drug carriers, such as nanoparticles and lipid vesicles: size determination. Pharm Res. 28(9):2204-22
39. Hanafy A, Spahn-Langguth H, Vergnault G, Grenier P, Tubic Grozdanis M, Lenhardt T, et al. Pharmacokinetic evaluation of oral fenofibrate nanosuspensions and SLN in comparison to conventional suspensions of micronized drug. Adv Drug Deliv Rev. 2007;59(6):419-26.
40. Brittain HG. Particle-size distribution IV. Determination by laserlight scattering. Pharm Technol. 2003;27(10):102-14.
41. Saveyn H, Mermuys D, Thas O, van der Meeren P. Determination of the refractive index of water-dispersible granules for use in laser diffraction experiments. Part Part Syst Char. 2002;19(6):426-32.
42. Lindfors L, Forssen S, Skantze P, Skantze U, Zackrisson A, Olsson U. Amorphous drug nanosuspensions. 2. Experimental determination of bulk monomer concentrations. Langmuir. 2006;22(3):911-6.
43. Chatterjee A, Moulik SP, Sanyal SK, Mishra BK, Puri PM. Thermodynamics of micelle formation of ionic surfactants: a critical assessment for sodium dodecyl sulfate, cetyl pyridinium chloride and dioctyl sulfosuccinate (Na Salt) by microcalorimetric, conductometric, and tensiometric measurements. J Phys Chem B. 2001;105 (51):12823-31.
44. Langguth P, Fricker G, Wunderli-Allenspach H. Biopharmazie. Weinheim: WILEY-VCH Verlag GmbH & Co. KGaA; 2004.
45. Laakso R, Kristoffersson E, Marvola M. Bi-exponential first-order release kinetics of indomethacin from tablets containing polysorbate 80. Int J Pharm. 1984;19(1):35-42.
46. Tinke AP, Vanhoutte K, De Maesschalck R, Verheyen S, De Winter H. A new approach in the prediction of the dissolution behavior of suspended particles by means of their particle size distribution. J Pharm Biomed Anal. 2005;39 (5):900-7.
47. Tay T, Allahham A, Morton DA, Stewart PJ. Understanding improved dissolution of indomethacin through the use of cohesive poorly water-soluble aluminium hydroxide: effects of concentration and particle size distribution. J Pharm Sci. 2011;100(10):4269-80.
48. Sugano K, Okazaki A, Sugimoto S, Tavornvipas S, Omura A, Mano T. Solubility and dissolution profile assessment in drug discovery. Drug Metab Pharmacokinet. 2007;22(4):225-54.
49. Dressman JB, Amidon GL, Reppas C, Shah VP. Dissolution testing as a prognostic tool for oral drug absorption: immediate release dosage forms. Pharm Res. 1998;15(1):11-22. Review.
50. Jamzad S, Fassihi R. Role of surfactant and pH on dissolution properties of fenofibrate and glipizide-a technical note. AAPS PharmSciTech. 2006;7(2):E33.
51. Gao Z. Mathematical modeling of variables involved in dissolution testing. J Pharm Sci. 2011;100(11):4934-42.
52. Dokoumetzidis A, Papadopoulou V, Macheras P. Analysis of dissolution data using modified versions of Noyes-Whitney equation and the Weibull function. Pharm Res. 2006;23(2):256-61.
53. Judefeind A, de Villiers MM. Drug loading into and in vitro release from nanosized drug delivery systems. Biotechnol: Pharm Aspects. 2009; 10(Nanotechnology in Drug Delivery):129-62.
54. Johnson KC. Comparison of methods for predicting dissolution and the theoretical implications of particle-size-dependent solubility. J Pharm Sci. 2012;101(2):681-9.