smartCrystals - Review of the second generation of drug nanocrystals

Handbook of Materials for Nanomedicine

Volumn , Issue , 2010, Pages 555-579

  Keck, Cornelia M ^a   Müller, Rainer H ^a  

^a FREIE UNIVERSITÄT BERLIN   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 79953160816     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.4032/9789814267588     Document Type: Chapter

References (74)

1. E. Merisko-Liversidge et al., Formulation and antitumor activity evaluation of nanocrystalline suspensions of poorly soluble anticancer drugs. Pharm Res., 13(2), 272-278 (1996).
2. M. Mehta, in AAPS/FDA Workshop on Biopharmaceutics Classification System. September, 25-27 (2002).
3. European Pharmacopoeia, 5.07 : 5.11. Characters Section in Monographs 'Solubility', (2007).
4. FDA, Guidance to industry: Waiver of in vivo BA and BE studies for immediate release solid oral dosage forms based on a biopharmaceutical classification system. (2000).
5. S. Stegemann et al., When poor solubility becomes an issue: From early stage to proof of concept. European Journal of Pharmaceutical Sciences 31(5), 249-261 (2007).
6. G. G. Liversidge, K. C. Cundy, J. F. Bishop and D. A. Czekai, Surface modified drug nanoparticles. United States Patent 5, 145, 684, Sterling Drug Inc. (New York, NY) (1992).
7. R. H. Müller, R. Becker, B. Kruss and K. Peters. Pharmaceutical nanosuspensions for medicament administration as systems with increased saturation solubility and rate of solution. United States Patent, 5, 858, 410, (1999).
8. R. H. Muller and C. M. Keck, Challenges and solutions for the delivery of biotech drugs - A review of drug nanocrystal technology and lipid nanoparticles. J. Biotechnol, 113(1-3), 151-170 (2004).
9. C. M. Keck and R. H. Muller, Drug nanocrystals of poorly soluble drugs produced by high pressure homogenisation. Eur. J. Pharm. Biopharm, 62(1), 3-16 (2006).
10. P. Gassmann, M. List, A. Schweitzer and H. Sucker, Hydrosols - Alternatives for the parenteral applikation of poorly water soluble drugs. European Journal of Pharmaceutics & Biopharmaceutics, 40, 64-72 (1994).
11. M. List and H. Sucker, Pharmaceutical colloidal hydrosols for injection. GB Patent 2200048, Sandoz LTD. CH (1988).
12. H. Auweter et al., Precipitated water-insoluble colorants in colloid disperse form. United States Patent 6494924, BASF Aktiengesellschaft (2002).
13. M. Mosharraf and C. Nystrom, Apparent solubility of drugs in partially crystalline systems. Drug Dev. Ind. Pharm., 29(6), 603-622 (2003).
14. W. J. Curatolo, S. M. Herbig and J. A. S. Nightingale. Spray dried solid dispersions comprising a sparingly soluble drug and hydroxypropylmethylcellulose acetate succinate (HPMCAS) provide increased aqueous solubility and/or bioavailability in a use environment. EP20060019790, Pfizer Products Inc., (2007).
15. R. H. Müller, K. Mäder and K. Krause, Verfahren zur schonenden Herstellung von hochfeinen Micro-/Nanopartikeln. PCT Application PCT/EP00/06535, (2000).
16. J. E. Kipp et al., Method for preparing submicron particle suspensions. 6,884,436, Baxter International Inc. (2005).
17. J. E. Kipp, J. C. T. Wong, M. J. Doty and C. L. Rebbeck, Microprecipitation method for preparing submicron suspensions. United States Patent 6,607,784, Baxter International Inc. (Deerfield, IL) (2003).
18. R. H. Müller, B. H. L. Böhm and M. J. Grau, Nanosuspensions - Formulations for poorly soluble drugs with poor bioavailability / Ist communication: Production and properties. Pharm. Ind., 61(1), 74 (1999).
19. R. H. Müller, B.H. L. Böhmand M. J. Grau, Nanosuspensions-Formulations for Poorly Soluble Drugs with Poor Bioavailability /2nd Communication: Stability, biopharmaceutical aspects, possible drug forms and registration aspects. Pharm. Ind., 61(2), 175 (1999).
20. R. H. Müller, C. Jacobs and O. Kayser, Nanosuspensions for the formulation of poorly soluble drugs, Pharmaceutical Emulsions and Suspensions F. Nielloud and G. Marti-Mestres, Marcel Dekker, S. 383-407 (2000).
21. M. Bisrat and C. Nyström, Physicochemical aspects of drug release. VIII. The relation between particle size and surface specific dissolution rate in agitated suspensions. International Journal of Pharmaceutics, 47(1-3), 223-231 (1988).
22. E. Arzt, S. Gorb and R. Spolenak, From micro to nano contacts in biological attachment devices. Proc. Nat. Acad. Sciences, 100(19), 10603-10606 (2003).
23. G. G. Liversidge and K. C. Cundy, Particle size reduction for improvement of oral bioavailability of hydrophobic drugs: I. Absolute oral bioavailability of nanocrystalline danazol in beagle dogs. International Journal of Pharmaceutics, 125(1), 91-97 (1995).
24. M. V. Chaubal, Application of drug delivery technologies in lead candidate selection and optimization. Drug Discov. Today, 9(14), 603-609 (2004).
25. E. Acosta, Bioavailability of nanoparticles in nutrient and nutraceutical delivery. Current Opinion in Colloid & Interface Science, in press (2008).
26. Physicians' Desk Reference (54). PDR at Montvale, 1460 (2004).
27. B. E. Rabinow, Nanosuspensions in drug delivery. Nat. Rev. Drug Discov., 3(9), 785-796 (2004).
28. B. Rabinow et al., Itraconazole IV nanosuspension enhances efficacy through altered pharmacokinetics in the rat. Int. J. Pharm, 339(1-2), 251-260 (2007).
29. R. H. Müller, J. Möschwitzer and F. N. Bushrab, Manufacturing of nanoparticles by milling and homogenisation techniques, in Nanoparticle Technology for Drug Delivery (159. Aufl.), R. B. Gupta and U. B. Kompella, Taylor & Francis Group, New York, S., 21-52 (2006).
30. FDA, Guidance for Industry Q3A Impurities in New Drug Substances. (2008).
31. S. Buchmann, W. Fischli, F. P. Thiel and R. Alex, Aqueous microsuspension, an alternative intravenous formulation for animal studies. in 42nd Annual Congress of the International Association for Pharmaceutical Technology (APV), Mainz (1996).
32. K. P. Krause et al., Heavy metal contamination of nanosuspensions produced by high-pressure homogenisation. Int. J. Pharm., 196(2), 169-172 (2000).
33. M. A. Fichera, S. A. Wissing and R. H. Müller, Effect of 4000 bar homogenisation pressure on particle diminution in drug suspensions. in APV. Nürnberg (2004).
34. H. Sucker, Hydrosole, eine Alternative für die parenterale Anwendung von schwer wasserl ̈ oslichen Wirkstoffen, in Pharmazeutische Technologie: Moderne Arzneiformen Aufl.), R. H. Müller, G. E. Hildebrand, Wissenschaftliche Verlagsgesellschaft mbH. Stuttgart. S. 383-391 (1998).
35. Moneret-Vautrin, D. A., M. C. Laxenaire and F. Viry-Babel, Anaphylaxis caused by anti-cremophor EL IgG STS antibodies in a case of reaction to althesin. Br. J. Anaesth., 55(5), 469-471 (1983).
36. D. Dye and J. Watkins, Suspected anaphylactic reaction to Cremophor EL. Br. Med. J., 280(6228), 1353 (1980).
37. H. Gelderblom et al., Cremophor EL: The drawbacks and advantages of vehicle selection for drug formulation. Eur. J. Cancer, 37(13), 1590-1598 (2001).
38. E. D. Hugger et al., A comparison of commonly used polyethoxylated pharmaceutical excipients on their ability to inhibit Pglycoprotein activity in vitro. Journal of Pharmaceutical Sciences, 91(9), 1991-2002 (2002).
39. A. K. Singla, A. Garg and D. Aggarwal, Paclitaxel and its formulations. International Journal of Pharmaceutics, 235(1-2), 179-192 (2002).
40. A. J. ten Tije et al., Pharmacological effects of formulation vehicles: implications for cancer chemotherapy. Clin. Pharmacokinet., 42(7), 665-685 (2003).
41. R. H. Müller and C. Olbrich, Medicament vehicle for the controlled administration of an active agent, produced from lipid Matrix - Medicament conjugates. European Patent EP1176984, PharmaSol GmbH (2000).
42. R. H. Müller, Colloidal carriers for controlled drug delivery and targeting Aufl), Wissenschaftliche Verlagsgesellschaft mbH, CRC Press, Stuttgart, Boston (1991).
43. J. P. Möschwitzer, Method for the production of ultra-fine submicron suspensions. DE, 10 2005 011 786.4, ABBOTT GmbH & Co. KG (2005).
44. J. Möschwitzer Drug nanocrystals prepared by high pressure homogenisation - the universal formulation approach for poorly soluble drugs, Freie Universität Berlin (2006).
45. R. H. Müller and C. M. Keck, Improvement of delivery & solubility of poorly soluble drugs by nanonisation. In LTS Academy. Petersberg,: Konferenzdokumentation, 12-17 (2007).
46. J. Möschwitzer and A. Lemke, Method for carefully producing ultrafine particle suspensions and ultrafine particles and use thereof. PCT/EP2006/003377, ABBOTT GmbH & CO.KG (2007).
47. J. Möschwitzer and R. H. Müller, New method for the effective production of ultrafine drug nanocrystals. Journal of Nanoscience and Nanotechnology, 6, 6, 3145-3153 (2006).
48. B. H. L. Böhm, Herstellung und Charakterisierung von Nanosuspensionen als neue Arzneiform für Arzneistoffe mit geringer Bioverf ügbarkeit. PhD-thesis, Freie Universität Berlin (1999).
49. R. H. Müller and J. Möschwitzer, Method and device for producing very fine particles and coating such particles. PCT/EP2006/009930, ABBOTT GmbH & CO. KG (2007).
50. G. Molema, Drug targeting: Basic concepts and novel advances, in Drug Targeting G. Molema and D. K. F. Meijer, Wiley-VCH Verlag GmbH. Weinheim. S., 1-22 (2001).
51. M. Hashida et al., Cell-specific delivery of genes with glycosylated carriers. Adv. Drug Deliv. Rev., 52(3), 187-196 (2001).
52. M. A. Dobrovolskaia and S. E. McNeil, Immunological properties of engineered nanomaterials. 2(8), 469-478 (2007).
53. Choon K. Tang, J. L. Gabriela Minigo, Dodie S. Pouniotis, Magdalena Plebanski, Anja Scholzen, Ian F. C. McKenzie, Geoffrey A. Pietersz and Vasso Apostolopoulos, Mannan-mediated gene delivery for cancer immunotherapy. Immunology, 120(3), 325-335 (2007).
54. C. Bies, C. M. Lehr and J. F. Woodley, Lectin-mediated drug targeting: History and applications. Adv. Drug Deliv. Rev., 56(4), 425-435 (2004).
55. R. H. Müller, M. Lück and J. Kreuter. Medicament excipient particles for tissue-specific application of a medicament. United States Patent 6,288,040, PharmaSol GmbH (2001).
56. A. Ambruosi et al., Influence of surfactants, polymer and doxorubicin loading on the anti-tumour effect of poly(butyl cyanoacrylate) nanoparticles in a rat glioma model. J. Microencapsul, 23(5), 582-592 (2006).
57. C. M. Keck, Drug nanocrystals - Advanced performace and applications therereof. Habilitation, in preparation. Freie Universität Berlin.
58. R. H. Müller and S. Heinemann, Surface modelling of microparticles as parenteral systems with high tissue affinity, in Bioadhesion - Possibilities and Future Trends Aufl.), R.A.J. Gurny, H. E., Wissenschaftliche Verlagsgesellschaft Stuttgart. S., 202-214 (1989).
59. N. Schöler, Solid lipid nanoparticles (SLN) and nanosuspensions: In vitro cytotoxicity and therapeutic use in the model of reactivating toxoplasmosis in mice. Dissertation, PhD thesis, Freie Universität Berlin (2001).
60. N. Schöler et al., Atovaquone nanosuspensions show excellent therapeutic effect in a new murine model of reactivated toxoplasmosis. Antimicrobial Agents & Chemotherapy, 45(6), 1771-1779 (2001).
61. N. Scholer et al., Preserved solid lipid nanoparticles (SLN) at low concentrations do cause neither direct nor indirect cytotoxic effects in peritoneal macrophages. Int. J. Pharm., 196(2), 235-239 (2000).
62. S. E. Gelperina, Z. S. Smirnova, A. S. Khalanskiy, I. N. Skidan, A. I. Bobruskin and J. Kreuter, Chemotherapy of brain tumours using doxorubicin bound to polysorbate 80-coated nanoparticles, in 3rd World Meeting APV/APGI, Berlin (2000).
63. A. E. Gulyaev, S. E. Gelperina, I. N. Skidan, A. S. Antropov G. Ya. Kivman and J. Kreuter, Significant transport of doxorubicin into the brain with polysorbate 80-coated nanoparticles. Pharm. Res., 16, 1564-1569 (1999).
64. J. Kreuter et al., Direct evidence that polysorbate-80-coated poly (butylcyanoacrylate) nanoparticles deliver drugs to the CNS via specificmechanisms requiring prior binding of drug to the nanoparticles. Pharmaceutical Research, 20(3), 409-416 (2003).
65. R. H. Müller and S. Schmidt, PathFinder technology for the delivery of drugs to the brain. NewDrugs, 2, 38-42 (2002).
66. R. H. Muller and C. M. Keck, Drug delivery to the brain-realization by novel drug carriers. J. Nanosci. Nanotechnol., 4(5), 471-483 (2004).
67. R. N. Alyautdin, V. E. Petrov, K. Langer, A. Berthold, D. A. Kharkevich and J. Kreuter, Delivery of loperamide across the bloodbrain barrier with poly-sorbate 80-coated polybutylcyanoacrylate nanoparticles. Pharm. Res., 14, 325-328 (1997).
68. R. N. Aliautdin, J. Kreuter and D. A. Kharkevich, Drug delivery to the brain with nanoparticles. Eksp Klin Farmakol, 66(2), 65-68 (2003).
69. J. A. Kreuter, R. N., Alyautdin, D. A. Karkevich and B. A. Sabel, Drug targeting to the nervous system by nanoparticles. United States Patent: 6,117,454, Medinova Medical Consulting GmbH (DE) (1997).
70. J. Kreuter, Nanoparticulate systems for brain delivery of drugs. Advanced Drug Delivery Reviews, 47(1), 65-81 (2001).
71. M. K. Pratten and J. B. Lloyd, Pinocytosis and phagocytosis: the effect of size of a particulate substrate on its mode of capture by rat peritoneal macrophages cultured in vitro. Biochim. Biophys. Acta., 881(3), 307-313 (1986).
72. C. M. Keck, Cyclosporine nanosuspensions: optimised size characterisation & oral formulations. Dissertation, Freie Universität Berlin (2006).
73. S. Nobili et al., Pharmacological strategies for overcomingmultidrug resistance. Curr. Drug Targets, 7(7), 861-879 (2006).
74. G. Lehne, P-glycoprotein as a drug target in the treatment of multidrug resistant cancer. Curr. Drug Targets, 1(1), 85-99 (2000).