Practical method for preparing nanosuspension formulations for toxicology studies in the discovery stage: Formulation optimization and in vitro/in vivo evaluation of nanosized poorly water-soluble compounds

Chemical and Pharmaceutical Bulletin

Volumn 62, Issue 11, 2014, Pages 1073-1082

  Komasaka, Takao ^a   Fujimura, Hisako ^a   Tagawa, Toshiaki ^b   Sugiyama, Akio ^a   Kitano, Yasunori ^a  

^a MITSUBISHI TANABE PHARMA CORPORATION   (Japan)

^b Advanced Medical Inc   (Japan)

Author keywords

Mixer mill; Nanosuspension; Oral absorption; Rotation revolution mixer; Toxicology study; Wet media milling

Indexed keywords

CELLULOSE; CILOSTAZOL; CINNARIZINE; CREMOPHOR; CURCUMIN; DANAZOL; FUROSEMIDE; HYDROXYPROPYLMETHYLCELLULOSE; INDOMETACIN; NAPROXEN; NIFEDIPINE; PHENYTOIN; PIROXICAM; POLOXAMER; POLYSORBATE 80; POVIDONE; SPIRONOLACTONE; TOCOFERSOLAN; ZIRCONIUM OXIDE; DRUG; NANOPARTICLE; SUSPENSION;

ANIMAL EXPERIMENT; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; CRYSTALLIZATION; DIFFERENTIAL SCANNING CALORIMETRY; DRUG ABSORPTION; DRUG FORMULATION; DRUG MEGADOSE; DRUG PENETRATION; DRUG SCREENING; DRUG SOLUBILITY; GASTROINTESTINAL IRRITATION; IN VITRO STUDY; IN VIVO STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MICROSCOPY; MOLECULAR WEIGHT; NANOSUSPENSION; NONHUMAN; PARTICLE SIZE; PHYSICAL CHEMISTRY; PLASMA CONCENTRATION-TIME CURVE; PROCESS OPTIMIZATION; RAT; SUSPENSION; TIME TO MAXIMUM PLASMA CONCENTRATION; ANIMAL; CHEMISTRY; ORAL DRUG ADMINISTRATION; PHARMACOKINETICS; PROCEDURES; SOLUBILITY; SPRAGUE DAWLEY RAT; TOXICITY TESTING;

ADMINISTRATION, ORAL; ANIMALS; DRUG COMPOUNDING; MALE; NANOPARTICLES; PARTICLE SIZE; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS; RATS; RATS, SPRAGUE-DAWLEY; SOLUBILITY; SUSPENSIONS; TOXICITY TESTS;

EID: 84909630769     PISSN: 00092363     EISSN: 13475223     Source Type: Journal    
DOI: 10.1248/cpb.c14-00232     Document Type: Article

References (50)

1. Lipinski C. A., J. Pharmacol. Toxicol. Methods, 44, 235-249 (2000).
2. Lipinski C. A., Am. Pharm. Rev., 5, 82-85 (2002).
3. Higgins J., Cartwright M. E., Templeton A. C., Drug Discov. Today, 17, 828-836 (2012).
4. Strickley R. G., Pharm. Res., 21, 201-230 (2004).
5. Vasconcelos T., Sarmento B., Costa P., Drug Discov. Today, 12, 1068-1075 (2007).
6. Van den Mooter G., Drug Discov. Today. Technol., 9, e79-e85 (2012).
7. Junghanns J. U., Müller R. H., Int. J. Nanomedicine, 3, 295-309 (2008).
8. Merisko-Liversidge E., Liversidge G. G., Adv. Drug Deliv. Rev., 63, 427-440 (2011).
9. Möschwitzer J. P., Int. J. Pharm., 453, 142-156 (2013).
10. Van Eerdenbrugh B., Stuyven B., Froyen L., Van Humbeeck J., Martens J. A., Augustijns P., Van den Mooter G., AAPS PharmSciTech, 10, 44-53 (2009).
11. Niwa T., Miura S., Danjo K., Int. J. Pharm., 405, 218-227 (2011).
12. Van Eerdenbrugh B., Froyen L., Martens J. A., Blaton N., Augustijns P., Brewster M., Van den Mooter G., Int. J. Pharm., 338, 198-206 (2007).
13. Niwa T., Miura S., Danjo K., Pharm. Res., 28, 2339-2349 (2011).
14. Van Eerdenbrugh B., Van den Mooter B., Augustijns P., Int. J. Pharm., 364, 64-75 (2008).
15. Wu L., Zhang J., Watanabe W., Adv. Drug Deliv. Rev., 63, 456-469 (2011).
16. Jacobs C., Kayser O., Müller R. H., Int. J. Pharm., 196, 161-164 (2000).
17. Ain-Ai A., Gupta P. K., Int. J. Pharm., 351, 282-288 (2008).
18. Pardeike J., Müller R. H., Int. J. Pharm., 391, 322-329 (2010).
19. Lee J., Choi J.-Y., Park C. H., Int. J. Pharm., 355, 328-336 (2008).
20. Van Eerdenbrugh B., Vermant J., Martens J. A., Froyen L., Van Humbeeck J., Augustijns P., Van Den Mooter G., J. Pharm. Sci., 98, 2091-2103 (2009).
21. George M., Ghosh I., Eur. J. Pharm. Sci., 48, 142-152 (2013).
22. Peltonen L., Hirvonen J., J. Pharm. Pharmacol., 62, 1569-1579 (2010).
23. Galia E., Nicolaides E., Horter D., Lobenberg R., Reppas C., Dressman J. B., Pharm. Res., 15, 698-705 (1998).
24. Juenemann D., Jantratid E., Wagner C., Reppas C., Vertzoni M., Dressman J. B., Eur. J. Pharm. Biopharm., 77, 257-264 (2011).
25. Neervannan S., Expert Opin. Drug Metab. Toxicol., 2, 715-731 (2006).
26. Li P., Zhao L., Int. J. Pharm., 341, 1-19 (2007).
27. Gad S. C., Cassidy C. D., Aubert N., Spainhour B., Robbe H., Int. J. Toxicol., 25, 494-521 (2006).
28. Enright B. P., McIntyre B. P., Thackaberry E. A., Treinen K. A., Kopytek S. J., Birth Defects Res. B. Dev. Reprod. Toxicol., 89, 504-516 (2010).
29. Pestei S., Martin H.-J., Maier G.-M., Guth B., J. Pharmacol. Toxicol. Methods, 54, 200-214 (2006).
30. Nissim J. A., Nature (London), 187, 305-307 (1960).
31. Nakamura J., Takada S., Ueda S., Hamaura T., Yamamoto A., Kimura T., Sezaki H., Chem. Pharm. Bull., 33, 3527-3529 (1985).
32. Verma S., Huey B. D., Burgess D. J., Langmuir, 25, 12481-12487 (2009).
33. Takatsuka T., Endo T., Jianguo Y., Yuminoki K., Hashimoto N., Chem. Pharm. Bull., 57, 1061-1067 (2009).
34. Toyobuku H., Tamai I., Ueno K., Tsuji A., J. Pharm. Sci., 92, 2249-2259 (2003).
35. Takano R., Sugano K., Higashida A., Hayashi Y., Machida M., Aso Y., Yamashita S., Pharm. Res., 23, 1144-1156 (2006).
36. Sun W., Mao S., Shi Y., Li L. C., Fang L., J. Pharm. Sci., 100, 3365-3373 (2011).
37. Hagio M., Matsumoto M., Fukushima M., Hara H., Ishizuka S., J. Lipid Res., 50, 173-180 (2009).
38. Duro R., Souto C., Gomez-Amoza J. L., Martinez-Pacheco R., Concheiro A., Drug Dev. Ind. Pharm., 25, 817-829 (1999).
39. Verma S., Kumar S., Gokhale R., Burgess D. J., Int. J. Pharm., 406, 145-152 (2011).
40. Kumar M. P., Rao Y. M., Apte S., Curr. Nanosci., 3, 191-194 (2007).
41. Lee J., Lee S.-J., Choi J.-Y., Yoo J. Y., Ahn C.-H., Eur. J. Pharm. Sci., 24, 441-449 (2005).
42. Butler J. M., Dressman J. B., J. Pharm. Sci., 99, 4940-4954 (2010).
43. Kesisoglou F., Panmai S., Wu Y., Adv. Drug Deliv. Rev., 59, 631-644 (2007).
44. Sigfridsson K., Nordmark A., Theilig S., Lindahl A., Drug Dev. Ind. Pharm., 37, 185-192 (2011).
45. Sigfridsson K., Lundqvist A. J., Strimfors M., Drug Dev. Ind. Pharm., 37, 243-251 (2011).
46. Kesisoglou F., Mitra A., AAPS J., 14, 677-687 (2012).
47. Sugano K., Int. J. Pharm., 387, 103-109 (2010).
48. Amidon G. E., Higuchi W. I., Ho N. F., J. Pharm. Sci., 71, 77-84 (1982).
49. Sugano K., Int. J. Pharm., 368, 116-122 (2009).
50. Tanaka Y., Hara T., Waki R., Nagata S., J. Pharm. Pharm. Sci., 15, 510-518 (2012).