Nanocrystals for enhancement of oral bioavailability of poorly water-soluble drugs

Asian Journal of Pharmaceutical Sciences

Volumn 10, Issue 1, 2015, Pages 13-23

  Junyaprasert, Varaporn Buraphacheep ^a   Morakul, Boontida ^a  

^a MAHIDOL UNIVERSITY   (Thailand)

Author keywords

Bioavailability; Nanocrystals; Poorly water soluble drugs

Indexed keywords

APREPITANT; CILOSTAZOL; CYCLOSPORIN; DANAZOL; DRUG NANOCRYSTAL; FENOFIBRATE; GRISEOFULVIN; ITRACONAZOLE; KETOPROFEN; MEGESTROL ACETATE; NABILONE; NANOCRYSTAL; NAPROXEN; RAPAMYCIN; SPIRONOLACTONE; UNCLASSIFIED DRUG;

CELL ADHESION; CELL MEMBRANE; CELL SURFACE; DRUG BIOAVAILABILITY; DRUG DELIVERY SYSTEM; DRUG SOLUBILITY; HUMAN; IN VIVO STUDY; NONHUMAN; PARTICLE SIZE; PRESSURE; REVIEW; TEMPERATURE;

EID: 84923036353     PISSN: 18180876     EISSN: 2221285X     Source Type: Journal    
DOI: 10.1016/j.ajps.2014.08.005     Document Type: Review

References (59)

1. Magdalene R. Pure drug nanoparticles for the formulation of poorly soluble drugs. NewDrugs 2001, 3:62-68.
2. Möschwitzer J., Müller R.H. Drug nanocrystals - the universal formulation approach for poorly soluble drugs. Nanoparticulate drug delivery systems 2007, 71-88. Informa Healthcare, New York. D. Thassu, M. Deleers, Y. Pathak (Eds.).
3. Gao L., Zhang D., Chen M. Drug nanocrystals for the formulation of poorly soluble drugs and its application as a potential drug delivery system. J Nanopart Res 2008, 10:845-862.
4. Junghanns J.U.A.H., Müller R.H. Nanocrystal technology, drug delivery and clinical appications. Int J Nanomedicine 2008, 3(3):295-309.
5. Chen H., Khemtong C., Yang X., et al. Nanonization strategies for poorly water-soluble drugs. Drug Discov Today 2011, 16(7/8):354-360.
6. Müller R.H., Gohla S., Keck C.M. State of the art of nanocrystals - special features, production, nanotoxicology aspects and intracellular delivery. Eur J Pharm Biopharm 2011, 78:1-9.
7. Kocbek P., Baumgartner S., Kristl J. Preparation and evaluation of nanosuspensions for enhancing the dissolution of poorly soluble drugs. Int J Pharm 2006, 312:179-186.
8. Buckton G., Beezer A.E. The relationship between particle size and solubility. Int J Pharm 1992, 82:R7-R10.
9. Möschwitzer J., Müller R.H. New method for the effective production of ultrafine drug nanocrystals. J Nanosci Nanotech 2006, 6:3145-3153.
10. Gulsun T., Gursoy R.N., Oner L. Nanocrystal technology for oral delivery of poorly water-soluble drugs. FABAD J Pharm Sci 2009, 34:55-65.
11. Keck C.M., Müller R.H. SmartCrystals - review of the second generation of drug nanocrystal. Handbook of materials for nanomedicine 2010, 555-580. Pan Stanford, Singapore. V.P. Torchilin, M.M. Amiji (Eds.).
12. Kesisoglou F., Panmai S., Wu Y. Nanosizing - oral formulation development and biopharmaceutical evaluation. Adv Drug Deliv Rev 2007, 59(7):631-644.
13. Jacobs C., Kayser O., Müller R.H. Nanosuspensions as a new approach for the formulation of the poorly soluble drug tarazepide. Int J Pharm 2000, 196:161-164.
14. Merisko-Liversidge E, Wei L. Stabilization of chemical compounds using nanoparticulate formulations. US 2001; 952032 20010914. CAN 138:243327, US 2003054042 A1. 2003.
15. Möschwitzer J., Achleitner G., Pomper H., et al. Development of an intravenously injectable chemically stable aqueous omeprazole formulation using nanosuspension technology. Eur J Pharm Biopharm 2004, 58(3):615-619.
16. Teeranachaideekul V., Junyaprasert V.B., Souto E.B., et al. Development of ascorbyl palmitate nanocrystals applying the nanosuspension technology. Int J Pharm 2008, 354:227-234.
17. Mauludin R., Müller R.H., Keck C.M. Development of an oral rutin nanocrystal formulation. Int J Pharm 2009, 370:202-209.
18. Dolenc A., Kristl J., Baumgartner S., et al. Advantages of celecoxib nanosuspension formulation and transformation into tablets. Int J Pharm 2009, 376:204-212.
19. Sinha B., Müller R.H., Möschwitzer J.P. Bottom-up approaches for preparing drug nanocrystals: formulations and factors affecting particle size. Int J Pharm 2013, 453:126-141.
20. Möschwitzer J.P. Drug nanocrystals in the commercial pharmaceutical development process. Int J Pharm 2013, 453:142-156.
21. Keck C.M., Müller R.H. Drug nanocrystals of poorly soluble drugs produced by high pressure homogenisation. Eur J Pharm Biopharm 2006, 62:3-16.
22. Merisko-Liversidge E., Liversidge G.G. Nanosizing for oral and parenteral drug delivery: a perspective on formulating poorly-water soluble compounds using wet mediamilling technology. Adv Drug Deliv Rev 2011, 30:427-440.
23. Eerdenbrugh B.V., den Mooter G.V., Augustijns P. Top-down production of drug nanocrystals: nanosuspension stabilization, miniaturization and transformation into solid products. Int J Pharm 2008, 364:64-75.
24. Niwa T., Miura S., Danjo K. Universal wet-milling technique to prepare oral nanosuspension focused on discovery and preclinical animal studies - development of particle design method. Int J Pharm 2011, 405:218-227.
25. Merisko-Liversidge E., Liversidge G.G. Drug nanoparticles: formulating poorly water-soluble compounds. Toxicol Pathol 2008, 36(1):43-48.
26. Bushrab F.N., Müller R.H. Nanocrystals of poorly soluble drugs for oral administration. NewDrugs 2003, 5:20-22.
27. Morakul B., Suksiriworapong J., Leanpolchareanchai J., et al. Precipitation-lyophilization-homogenization (PLH) for preparation of clarithromycin nanocrystals: influencing factors on physicochemical properties and stability. Int J Pharm 2013, 457:187-196.
28. Liversidge G.G., Cundy K.C. Particle size reduction for improvement of oral bioavailability of hydrophobic drugs: I. Absolute oral bioavailability of nanocrystalline danazol in beagle dogs. Int J Pharm 1995, 125(1):91-97.
29. Kesisoglou F., Mitra A. Crystalline nanosuspensions as potential toxicology and clinical oral formulations for BCS II/IV compounds. AAPS J 2012, 14:677-687.
30. Peters K., Leitzke S., Diederichs J.E., et al. Preparation of a clofazimine nanosuspension for intravenous use and evaluation of its therapeutic efficacy in murine Mycobacterium avium infection. J Antimicrob Chemother 2000, 45(1):77-83.
31. Ganta S., Paxton J.W., Baguley B.C., et al. Formulation and pharmacokinetic evaluation of an asulacrine nanocrystalline suspension for intravenous delivery. Int J Pharm 2009, 367:179-186.
32. Rosario P., Claudio B., Ferrara P., et al. Eudragit RS100 nanosuspensions for the ophthalmic controlled delivery of ibuprofen. Eur J Pharm Sci 2002, 16:53-61.
33. Kassem M.A., Abdel Rahman A.A., Ghorab M.M., et al. Nanosuspension as an ophthalmic delivery system for certain glucocorticoid drugs. Int J Pharm 2007, 340:126-133.
34. Ali H.S.M., York P., Ali A.M.A., et al. Hydrocortisone nanosuspensions for ophthalmic delivery: a comparative study between microfluidic nanoprecipitation and wet milling. J Control Release 2011, 149:175-181.
35. Jacobs C., Müller R.H. Production and characterization of a budesonide nanosuspension for pulmonary administration. Pharm Res 2002, 19(2):189-194.
36. Sultana S., Talegaonkar S., Ali R., et al. Inhalation of alendronate nanoparticles as dry powder inhaler for the treatment of osteoporosis. J Microencapsul 2012, 29(5):445-454.
37. Zhang J., Lv H., Jiang K., et al. Enhanced bioavaiability after oral and pulmonary administration of baicalein nanocrystal. Int J Pharm 2011, 420:180-188.
38. Shaal L.A., Shegokar R., Müller R.H. Production and characterization of antioxidant apigenin nanocrystals as a novel UV skin protective formulation. Int J Pharm 2011, 420:133-140.
39. Mitri K., Shegokar R., Gohla S., et al. Lutein nanocrystals as antioxidant formulation for oral and dermal delivery. Int J Pharm 2011, 420:141-146.
40. Zhai X., Lademann J., Keck C.M., et al. Nanocrystals of medium soluble actives - novel concept for improved dermal delivery and production strategy. Int J Pharm 2014, 470:141-150.
41. Mishra P.R., Shaal L.A., Müller R.H., et al. Production and characterization of hesperetin nanosuspensions for dermal delivery. Int J Pharm 2009, 371:182-189.
42. Kayser O., Olbrich C., Yardley V., et al. Formulation of amphotericin B as nanosuspension for oral administration. Int J Pharm 2003, 254:73-75.
43. Liversidge G.G., Conzentino P. Drug particle size reduction for decreasing gastric irritancy and enhancing absorption of naproxen in rats. Int J Pharm 1995, 125:309-313.
44. Li W., Yang Y., Tian Y., et al. Preparation and invitro/invivo evaluation of revaprazan hydrochloride nanosuspension. Int J Pharm 2011, 408:157-162.
45. Xia D., Quan P., Piao H., et al. Preparation of stable nitrendipine nanosuspensions using the precipitation-ultrasonication method for enhancement of dissolution and oral bioavailability. Eur J Pharm Sci 2010, 40:325-334.
46. Kayser O. A new approach for targeting to Cryptosporidium parvum using mucoadhesive nanosuspensions: research and applications. Int J Pharm 2001, 214:83-85.
47. Jinno J., Kamada N., Miyake M., et al. Effect of particle size reduction on dissolution and oral absorption of a poorly water-soluble drug, cilostazol, in beagle dogs. J Control Release 2006, 111:56-64.
48. Wu Y., Loper A., Landis E., 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. Int J Pharm 2004, 285:135-146.
49. Sauron R., Wilkins M., Jessent V., et al. Absence of a food effect with a 145 mg nanoparticle fenofibrate tablet formulation. Int J Clin Pharmacol Ther 2006, 44(2):64-70.
50. Kirkof N. Creation and characterization of nanoparticles. 32nd annual meeting and exposition of the controlled release society Miami 2005.
51. Möschwitzer J., Müller R.H. From the drug nanocrystals to the final mucoadhesive oral dosage form 2004.
52. Möschwitzer J., Müller R.H. Spray coated pellets as carrier system for mucoadhesive drug nanocrystals. Eur J Pharm Biopharm 2006, 62(3):282-287.
53. Möschwitzer J., Müller R.H. Controlled drug delivery system for oral application of drug nanocrystals. 2004 AAPS annual meeting and exposition 2004, Baltimore: MD.
54. Food and drug administration, Center for drug evaluation and research. Orange book: approved drug products with therapeutics equivalence evaluations. 29th ed Rockville: MD. [Updated May 17, 2013. Accessed May 23, 2014]. http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm.
55. de Waard H., Frijlink H.W., Hinrichs W.L. Bottom up preparation techniques for nanocrystals of lipophilic drugs. Pharm Res 2011, 28:1220-1223.
56. Vergote G.J., Vervaet C., Driessche I.V., et al. Invivo evaluation of matrix pellets containing nanocrystalline ketoprofen. Int J Pharm 2002, 240:79-84.
57. Müller R.H., Runge S., Revelli V., et al. Oral bioavailability of cyclosporine: solid lipid nanoparticles (SLN) versus drug nanocrystals. Int J Pharm 2006, 317:82-89.
58. Lungguth P., Hanafy A., Frenzel D., et al. Nanosuspension formulations for low-soluble drugs: pharmacokinetic evaluation using spironolactone as model compound. Drug Dev Ind Pharm 2005, 31:319-329.
59. Mou D., Chen H., Wan J., et al. Potent dried drug nanosuspensions for oral bioavailability enhancement of poorly soluble drugs with pH-dependent solubility. Int J Pharm 2011, 413:237-244.