Polymeric nanoparticles for increased oral bioavailability and rapid absorption using celecoxib as a model of a low-solubility, high-permeability drug

Pharmaceutical Research

Volumn 29, Issue 2, 2012, Pages 427-440

  Morgen, Michael ^a   Bloom, Corey ^a   Beyerinck, Ron ^a   Bello, Akintunde ^b   Song, Wei ^b   Wilkinson, Karen ^b   Steenwyk, Rick ^b   Shamblin, Sheri ^b  

^a Bend Research Incorporated   (United States)

^b PFIZER INC   (United States)

Author keywords

Bioavailability; Celecoxib; Ethyl cellulose; Nanoparticles; Rapid absorption

Indexed keywords

BILE SALT; CASEIN; CELECOXIB; ETHYL CELLULOSE; NANOPARTICLE; POLYMER; CELLULOSE; CYCLOOXYGENASE 2 INHIBITOR; DRUG DERIVATIVE; PYRAZOLE DERIVATIVE; SULFONAMIDE;

ADULT; ANIMAL EXPERIMENT; AQUEOUS SOLUTION; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIFFERENTIAL SCANNING CALORIMETRY; DOG; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG CAPSULE; DRUG RELEASE; DRUG SOLUBILITY; DRY POWDER; DYNAMIC LIGHT SCATTERING; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; LIGHT SCATTERING; MALE; MAXIMUM PLASMA CONCENTRATION; NONHUMAN; NORMAL HUMAN; PARTICLE SIZE; PHASE 1 CLINICAL TRIAL; PHYSICAL MODEL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCANNING ELECTRON MICROSCOPY; SPRAY DRYING; SUSPENSION; TIME TO MAXIMUM PLASMA CONCENTRATION; TRANSMISSION ELECTRON MICROSCOPY; ANIMAL; BIOAVAILABILITY; CHEMISTRY; PERMEABILITY; SOLUBILITY; ULTRASTRUCTURE;

ADULT; ANIMALS; BIOLOGICAL AVAILABILITY; CELLULOSE; CYCLOOXYGENASE 2 INHIBITORS; DOGS; HUMANS; MALE; NANOPARTICLES; PERMEABILITY; PYRAZOLES; SOLUBILITY; SULFONAMIDES;

EID: 84860876423     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-011-0558-7     Document Type: Article

References (28)

1. Lipinski CA. Drug-like properties and the causes of poor solubility and poor permeability. J Pharmacol Toxicol Methods. 2000;44:235-49. (Pubitemid 32239479)
2. Gursoy RN, Benita S. Self-emulsifying drug delivery systems (SEDDS) for improved oral delivery of lipophilic drugs. Biomed Pharmacother. 2004;58:173-82. (Pubitemid 38479922)
3. Hauss DJ. Oral lipid based formulations. Adv Drug Deliv Rev. 2007;59:667-76.
4. Amidon GL, Lennernas H, Shaw VP, Crison JR. A theoretical basis for a biopharmaceutic drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res. 1995;12:413-20.
5. Butler JM, Dressman JM. The developability classification system: application of biopharmaceutics concepts to formulation development. J Pharm Sci. 2010;99:4940-54.
6. Muller RH, Keck CM. Challenges and solutions for the delivery of biotech drugs-a review of drug nanocrystal technology and lipid nanoparticles. J Biotech. 2004;113:151-70. (Pubitemid 39237077)
7. Van Eerdenbrugh B, Van den Mooter G, Augustijns P. Topdown production of drug nanocrystals: nanosuspension stabilization, miniaturization and transformation into solid products. Int J Pharm. 2008;364:64-75.
8. Connors KA. Population characteristics of cyclodextrin complex stabilities in aqueous solution. J Pharm Sci. 1995;84(7):843-8.
9. Porter CJH, Pouton CW, Cuine JF, Charman WN. Enhancing intestinal drug solubilisation using lipid-based delivery systems. Adv Drug Deliv Rev. 2008;60:673-91.
10. Wu Y, Loper A, Landis E, Hettrick L, Novak L, Lynn K, et al. The role of biopharmaceutics in the development of a clinical nanoparticle formulation of MK-0869: a beagle dog model predicts improved bioavailability and diminished food effect on absorption in human. Intl J Pharm. 2004;285:135-46. (Pubitemid 39361543)
11. Hu J, Johnson KP, Williams RO III. Nanoparticle engineering processes for enhancing the dissolution rates of poorly water soluble drugs. Drug Dev Ind Pharm. 2004;30:233-45. (Pubitemid 38451748)
12. Leuner C, Dressman J. Improving drug solubility for oral delivery using solid dispersions. Eur J Pharm Biopharm. 2000;50:47-60. (Pubitemid 30326688)
13. Yu L. Amorphous pharmaceutical solids: preparation, characterization and stabilization. Adv Drug Deliv Rev. 2001;48:27-42. (Pubitemid 32454482)
14. Friesen DT, Shanker RM, Crew MD, Smithey DT, Curatolo WJ, Nightingale JAS. Hydroxypropyl methyl cellulose acetate succinate-based spray-dried dispersions: An overview. Mol Pharm. 2008;5:1003-19.
15. Yang W, Tam J, Miller DA, Zhou J, McConville JT, Johnston KP, et al. High bioavailability from nebulized itraconazole nanoparticle dispersions with biocompatible stabilizers. Int J Pharm. 2008;361:177-88.
16. Hancock BC, Parks M. What is the true solubility advantage for amorphous pharmaceuticals? Pharm Res. 2000;17:397-404. (Pubitemid 30395293)
17. Paulson SK, Vaughn MB, Jessen SM, Lawal Y, Gresk CJ, Yan B, et al. Pharmacokinetics of celecoxib after oral administration in dogs and humans: effect of food and site of absorption. J Pharmacol Exp Ther. 2001;297:638-45. (Pubitemid 32377995)
18. van Wijngaarden J, van Beek E, van Rossum G, van der Bent C, Hoekman K, van der Pluijm G, et al. Celecoxib enhances doxorubicin-induced cytotoxicity in MDA-MB231 cells by NF-κB-mediated increase of intracellular doxorubicin accumulation. Eur J Cancer. 2007;43:433-42. (Pubitemid 46123984)
19. Chawla G, Gupta P, Thilagavathi R, Chakraborti AK, Bansal AK. Characterization of solid-state forms of celecoxib. Eur J Pharm Sci. 2003;20:305-17. (Pubitemid 37338536)
20. Dolenc A, Kristl J, Baumgartner S, Planinšek O. Advantages of celecoxib nanosuspension formulation and transformation into tablets. Int J Pharm. 2009;376:204-12.
21. Nasr M. In vitro and in vivo evaluation of proniosomes containing celecoxib for oral administration. AAPS Pharm Sci Tech. 2010;11:85-9.
22. Abdelwahed W, Degobert G, Stainmesse S, Fessi H. Freezedrying of nanoparticles: formulation, process and storage considerations. Adv Drug Del Rev. 2006;58:1688-713. (Pubitemid 44827432)
23. Beyerinck RA, Bloom CJ, Crew MD, Friesen DT, Morgen MM, Smithey DT. Pharmaceutical compositions based on a) nanoparticles comprising enteric polymers and b) casein. World International Patent Office Application WO/2008/065502. 2008a.
24. Beyerinck RA, Smithey DT, Miller WK, Morgen MM, Bloom CJ. Pharmaceutical compositions comprising nanoparticles and casein. World International Patent Office Application WO/2008/135852. 2008b.
25. Miller WK, Smithey DT, Tadday R, Frankamp BL. Pharmaceutical compositions comprising nanoparticles and a resuspending material. World International Patent Office Application WO/2009/073215. 2009.
26. Vehring R. Pharmaceutical particle engineering via spray-drying. Pharm Res. 2007;25:999-1022.
27. Dobry DE, Settell DM, Baumann JM, Ray RJ, Graham LJ, Beyerinck RA. A model-based methodology for spraydrying process development. J Pharm Innov. 2009;4:133-42.
28. Curatolo WJ, Nightingale JAS, Herbig SM. Utility of hydroxypropylmethyl cellulose acetate succinate (HPMCAS) for initiation and maintenance of drug supersaturation in the GI milieu. Pharm Res. 2009;26:1419-31.