Solid nanocrystalline dispersions of ziprasidone with enhanced bioavailability in the fasted state

Molecular Pharmaceutics

Volumn 9, Issue 12, 2012, Pages 3526-3534

  Thombre, Avinash G ^a   Caldwell, W Brett ^b   Friesen, Dwayne T ^b   McCray, Scott B ^b   Sutton, Steven C ^a  

^a PFIZER INC   (United States)

^b Bend Research Incorporated   (United States)

Author keywords

food effect; oral bioavailability; solubilization; ziprasidone

Indexed keywords

HYDROXYPROPYLMETHYLCELLULOSE ACETATE SUCCINATE; NANOCRYSTAL; ZIPRASIDONE;

ARTICLE; CRYSTAL STRUCTURE; DIET RESTRICTION; DISPERSION; DRUG BIOAVAILABILITY; DRUG SOLUBILITY; HUMIDITY; IN VITRO STUDY; MEMBRANE TRANSPORT; PARTICLE SIZE; PRIORITY JOURNAL; SCANNING TRANSMISSION ELECTRON MICROSCOPY; SOLID; SPRAY DRYING; TEMPERATURE; THERMAL ANALYSIS; TRANSMISSION ELECTRON MICROSCOPY; X RAY POWDER DIFFRACTION;

ABSORPTION; ADMINISTRATION, ORAL; ANIMALS; ANTIPSYCHOTIC AGENTS; BIOLOGICAL AVAILABILITY; CALORIMETRY, DIFFERENTIAL SCANNING; CAPSULES; CRYSTALLIZATION; DOGS; FASTING; METHYLCELLULOSE; PIPERAZINES; SOLUBILITY; THIAZOLES; TISSUE DISTRIBUTION; X-RAY DIFFRACTION;

EID: 84870517504     PISSN: 15438384     EISSN: 15438392     Source Type: Journal    
DOI: 10.1021/mp3003607     Document Type: Article

References (30)

1. Harvey, P. D.; Bowie, C. R. Ziprasidone: efficacy, tolerability, and emerging data on wide-ranging effectiveness Expert Opin. Pharmacother. 2005, 6 (2) 337-346 (Pubitemid 40305345)
2. Patel, N. C.; Keck, P. E., Jr. Ziprasidone: efficacy and safety in patients with bipolar disorder Expert Rev. Neurother. 2006, 6 (8) 1129-1138 (Pubitemid 44231971)
3. Greenberg, W. M.; Citrome, L. Ziprasidone for schizophrenia and bipolar disorder: a review of the Clinical trials CNS Drug Rev. 2007, 13 (2) 137-177 (Pubitemid 47052346)
4. Miceli, J. J.; Wilner, K. D.; Hansen, R. A.; Johnson, A. C.; Apseloff, G.; Gerber, N. Single- and multiple-dose pharmacokinetics of ziprasidone under nonfasting conditions in healthy male volunteers Br. J. Clin. Pharmacol. 2000, 49 (Suppl. 1) 5S-13S (Pubitemid 30151047)
5. Lincoln, J.; Stewart, M. E.; Preskorn, S. H. How sequential studies inform drug development: evaluating the effect of food intake on optimal bioavailability of ziprasidone J. Psychiatr. Pract. 2010, 16 (2) 103-114
6. Miceli Jeffrey, J.; Glue, P.; Alderman, J.; Wilner, K. The effect of food on the absorption of oral ziprasidone Psychopharmac. Bull. 2007, 40 (3) 58-68
7. Gandelman, K.; Alderman, J. A.; Glue, P.; Lombardo, I.; La Badie, R. R.; Versavel, M.; Preskorn, S. H. The impact of calories and fat content of meals on oral ziprasidone absorption: a randomized, open-label, crossover trial J. Clin. Psychiatry (Memphis, TN, U.S.) 2009, 70 (1) 58-62
8. Hamelin, B. A.; Allard, S.; Laplante, L.; Miceli, J.; Wilner, K. D.; Tremblay, J.; Lebel, M. The effect of timing of a standard meal on the pharmacokinetics and pharmacodynamics of the novel atypical antipsychotic agent ziprasidone Pharmacotherapy 1998, 18 (1) 9-15 (Pubitemid 28058997)
9. Citrome, L. Using oral ziprasidone effectively: the food effect and dose-response Adv. Ther. 2009, 26 (8) 739-748
10. Fagiolini, A.; Canas, F.; Gallhofer, B.; Larmo, I.; Levy, P.; Montes, J. M.; Papageorgiou, G.; Zink, M.; Rossi, A. Strategies for successful clinical management of schizophrenia with ziprasidone Expert Opin. Pharmacother. 2010, 11 (13) 2199-2220
11. Thombre, A. G.; Herbig, S. M.; Alderman, J. A. Improved Ziprasidone Formulations with Enhanced Bioavailability in the Fasted State and a Reduced Food Effect Pharm. Res. 2011, 28 (12) 3159-3170
12. Friesen, D. T.; Shanker, R.; Crew, M.; Smithey, D. T.; Curatolo, W. J.; Nightingale, J. A. S. Hydroxypropyl Methylcellulose Acetate Succinate-Based Spray-Dried Dispersions: An Overview Mol. Pharmaceutics 2008, 5 (6) 1003-1019
13. Leuner, C.; Dressman, J. Improving drug solubility for oral delivery using solid dispersions Eur. J. Pharm. Biopharm. 2000, 50 (1) 47-60 (Pubitemid 30326688)
14. Yu, L. Amorphous pharmaceutical solids: preparation, characterization and stabilization Adv. Drug Delivery Rev. 2001, 48 (1) 27-42 (Pubitemid 32454482)
15. Sinha, S.; Baboota, S.; Ali, M.; Kumar, A.; Ali, J. Solid Dispersion: An Alternative Technique for Bioavailability Enhancement of Poorly Soluble Drugs J. Dispersion Sci. Technol. 2009, 30 (10) 1458-1473
16. Curatolo, W.; Nightingale, J. A.; Herbig, S. M. Utility of Hydroxypropylmethylcellulose Acetate Succinate (HPMCAS) for Initiation and Maintenance of Drug Supersaturation in the GI Milieu Pharm. Res. 2009, 26 (6) 1419-1431
17. Vasconcelos, T.; Sarmento, B.; Costa, P. Solid dispersions as strategy to improve oral bioavailability of poor water soluble drugs Drug Discovery Today 2007, 12 (23 and 24) 1068-1075 (Pubitemid 350186132)
18. 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 (1) 64-75
19. Kesisoglou, F.; Panmai, S.; Wu, Y. Nanosizing-Oral formulation development and biopharmaceutical evaluation Adv. Drug Delivery Rev. 2007, 59 (7) 631-644 (Pubitemid 47285408)
20. Merisko-Liversidge, E.; Liversidge, G. G.; Cooper, E. R. Nanosizing: a formulation approach for poorly-water-soluble compounds Eur. J. Pharm. Sci. 2003, 18 (2) 113-120 (Pubitemid 36184748)
21. Stella, V. J.; Nti-Addae, K. W. Prodrug strategies to overcome poor water solubility Adv. Drug Delivery Rev. 2007, 59 (7) 677-694 (Pubitemid 47285410)
22. Porter, C. J. H.; Pouton, C. W.; Cuine, J. F.; Charman, W. N. Enhancing intestinal drug solubilization using lipid-based delivery systems Adv. Drug Delivery Rev. 2008, 60 (6) 673-691
23. Gursoy, R. N.; Benita, S. Self-emulsifying drug delivery systems (SEDDS) for improved oral delivery of lipophilic drugs Biomed. Pharmacother. 2004, 58 (3) 173-182 (Pubitemid 38479922)
24. Brewster, M. E.; Loftsson, T. Cyclodextrins as pharmaceutical solubilizers Adv. Drug Delivery Rev. 2007, 59 (7) 645-666 (Pubitemid 47299263)
25. Alonzo David, E.; Zhang Geoff, G. Z.; Zhou, D.; Gao, Y.; Taylor Lynne, S. Understanding the behavior of amorphous pharmaceutical systems during dissolution Pharm. Res. 2010, 27 (4) 608-618
26. Newman, A.; Knipp, G.; Zografi, G. Assessing the performance of amorphous solid dispersions J. Pharm. Sci. 2012, 101 (4) 1355-1377
27. Kesisoglou, F.; Panmai, S.; Wu, Y. Application of nanoparticles in oral delivery of immediate release formulations Curr. Nanosci. 2007, 3 (2) 183-190 (Pubitemid 46845725)
28. Junghanns, J.-U. A. H.; Mueller, R. H. Nanocrystal technology, drug delivery and clinical applications Int. J. Nanomed. 2008, 3 (3) 295-309
29. Babcock, W. C.; Caldwell, W. B.; Crew, M. D.; Friesen, D. T.; Smithey, D. T.; Shanker, R. M. Pharmaceutical compositions of semi-ordered drugs and polymers. PCT Application No. WO2003IB03465; PCT Publication No. WO2004014342A1; EP Patent EP1530457B1 (granted 2009); US Patent is US 8,257,739 B2 (granted 2012).
30. Jenkins, R.; Snyder, R., Eds. Introduction to X-Ray Powder Diffractometry; 1996; 544 pp (approximately).