Formulation and in vivo evaluation of sodium alendronate spray-dried microparticles intended for lung delivery

Journal of Controlled Release

Volumn 152, Issue 3, 2011, Pages 370-375

  Cruz, Letícia ^a,e   Fattal, Elias ^b,c   Tasso, Leandro ^d   Freitas, Gabrielle C ^a   Carregaro, Adriano B ^a   Guterres, Sílvia S ^e   Pohlmann, Adriana R ^e   Tsapis, Nicolas ^b,c  

^a FEDERAL UNIVERSITY OF SANTA MARIA   (Brazil)

^b UNIVERSITÉ PARIS SACLAY   (France)

^c CNRS   (France)

^d UNIVERSITY OF CAXIAS DO SUL   (Brazil)

^e FEDERAL UNIVERSITY OF RIO GRANDE DO SUL   (Brazil)

Author keywords

Lung Toxicity; Sodium Alendronate; Spray Drying

Indexed keywords

AERODYNAMIC DIAMETERS; AERODYNAMIC EVALUATION; ALENDRONATE; AMMONIUM BICARBONATES; DRY POWDERS; FINE PARTICLE FRACTIONS; HOLLOW STRUCTURE; HYDROALCOHOLIC SOLUTION; IN-VITRO; IN-VIVO; INTRATRACHEAL; LUNG TOXICITY; MICRO-PARTICLES; POROUS PARTICLE; PULMONARY DELIVERY; PULMONARY TOXICITY; ROUGH SURFACES; SPHERICAL SHAPE; SPRAY-DRIED POWDERS; TAPPED DENSITY;

AERODYNAMICS; AMINO ACIDS; AMMONIUM COMPOUNDS; BIOCHEMISTRY; BIOLOGICAL ORGANS; POROUS MATERIALS; POWDERS; SPRAY DRYING; TOXICITY;

SODIUM;

ALENDRONIC ACID; BICARBONATE; LEUCINE;

ANIMAL EXPERIMENT; ARTICLE; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG DOSAGE FORM COMPARISON; DRUG FORMULATION; DRUG SCREENING; DRUG URINE LEVEL; DRY POWDER; IN VITRO STUDY; IN VIVO STUDY; INHALATIONAL DRUG ADMINISTRATION; LUNG ALVEOLUS; LUNG LAVAGE; LUNG TOXICITY; MALE; NONHUMAN; PARTICLE SIZE; POROSITY; PRIORITY JOURNAL; SPRAY DRYING; SURFACE PROPERTY;

ADMINISTRATION, INHALATION; AEROSOLS; ALENDRONATE; ANIMALS; BICARBONATES; BIOLOGICAL AVAILABILITY; BRONCHOALVEOLAR LAVAGE FLUID; CHEMISTRY, PHARMACEUTICAL; DOGS; ETHANOL; INSTILLATION, DRUG; INSUFFLATION; L-LACTATE DEHYDROGENASE; LEUCINE; LUNG; MALE; MICROSCOPY, ELECTRON, SCANNING; PARTICLE SIZE; PHARMACEUTIC AIDS; POWDERS; PROTEINS; RATS; RATS, WISTAR; SPECIFIC GRAVITY; SURFACE PROPERTIES;

EID: 79958236553     PISSN: 01683659     EISSN: 18734995     Source Type: Journal    
DOI: 10.1016/j.jconrel.2011.02.030     Document Type: Article

References (37)

1. J.H. Lin Bisphosphonates: A review of their pharmacokinetic properties Bone 18 1996 75 85 (Pubitemid 26092586)
2. F.R. Perez-Lopez Postmenopausal osteoporosis and alendronate Maturitas 48 2004 179 192 (Pubitemid 38781143)
3. R.G. Russell, P.I. Croucher, and M.J. Rogers Bisphosphonates: pharmacology, mechanisms of action and clinical uses Osteoporos. Int. 9 Suppl. 2 1999 S66 S80
4. I. Shinkai, and Y. Ohta New drugs - Reports of new drugs recently approved by the FDA - Alendronate Bioorg. Med. Chem. 4 1996 3 4
5. D.Y. Graham, and H.M. Malaty Alendronate gastric ulcers Aliment. Pharmacol. Ther. 13 1999 515 519 (Pubitemid 29176876)
6. J.K. Marshall, K.D. Rainsford, C. James, and R.H. Hunt A randomized controlled trial to assess alendronate-associated injury of the upper gastrointestinal tract Aliment. Pharmacol. Ther. 14 2000 1451 1457
7. F. Lanza Bisphosphonate mucosal injury-the end of the story? Dig. Liver Dis. 35 2003 67 70 (Pubitemid 41490313)
8. J.H. Lin, I.W. Chen, and D.E. Duggan Effects of dose, sex, and age on the disposition of alendronate, a potent antiosteolytic bisphosphonate, in rats Drug Metab. Dispos. 20 1992 473 478
9. S. Karie, V. Launay-Vacher, H. Izzedine, and G. Deray Drud-induced nephrotoxicity: Bibliography from January 2003 to December 2005 Néphrol. Thér. 2 2006 368 378 (Pubitemid 44647989)
10. J. Monkkonen, H.M. Koponen, and P. Ylitalo Comparison of the Distribution of 3 Bisphosphonates in Mice Pharmacol. Toxicol. 66 1990 294 298
11. S.C. Sutton, K. Engle, and J.A. Fix Intranasal Delivery of the Bisphosphonate Alendronate in the Rat and Dog Pharm. Res. 10 1993 924 926 (Pubitemid 23167579)
12. D.A. Edwards, J. Hanes, G. Caponetti, J. Hrkach, A. Ben-Jebria, M.L. Eskew, J. Mintzes, D. Deaver, N. Lotan, and R. Langer Large porous particles for pulmonary drug delivery Science 276 1997 1868 1871 (Pubitemid 27443665)
13. N. Tsapis, D. Bennett, K. O'Driscoll, K. Shea, M.M. Lipp, K. Fu, R.W. Clarke, D. Deaver, D. Yamins, J. Wright, C.A. Peloquin, D.A. Weitz, and D.A. Edwards Direct lung delivery of para-aminosalicylic acid by aerosol particles Tuberculosis 83 2003 379 385 (Pubitemid 37464043)
14. N.R. Labiris, and M.B. Dolovich Pulmonary drug delivery. Part I: physiological factors affecting therapeutic effectiveness of aerosolized medications Br. J. Clin. Pharmacol. 56 2003 588 599 (Pubitemid 37491710)
15. P. von Wichert, and C. Seifart The lung, an organ for absorption? Respiration 72 2005 552 558 (Pubitemid 41433576)
16. J.S. Patton, and P.R. Byron Inhaling medicines: delivering drugs to the body through the lungs Nat. Rev. Drug Discov. 6 2007 67 74 (Pubitemid 46020287)
17. L. He, Y. Gao, Y. Lin, and H. Katsumi Improvement of pulmonary absorption of insulin and other water-soluble compounds by polyamines in rats J. Control. Release 122 2007 94 101 (Pubitemid 47284558)
18. N. Tsapis, D. Bennett, B. Jackson, D.A. Weitz, and D.A. Edwards Trojan particles: large porous carriers of nanoparticles for drug delivery Proc. Natl Acad. Sci. U.S.A. 99 2002 12001 12005
19. S.K. Al Deeb, I.I. Hamdan, and S.M. Al Najjar Spectroscopic and HPLC methods for the determination of alendronate in tablets and urine Talanta 64 2004 695 702
20. H.S. Kang, S.J. Hwang, J.S. Park, and C.K. Kim HPLC method validation and pharmacokinetic study of alendronate sodium in human urine with fluorescence detection J. Liq. Chromatogr. Related Technol. 29 2006 1589 1600
21. P.C. Seville, H.Y. Li, and T.P. Learoyd Spray-dried powders for pulmonary drug delivery Crit. Rev. Ther. Drug Carrier Syst. 24 2007 307 360
22. P. Lucas, K. Anderson, U.J. Potter, and J.N. Staniforth Enhancement of small particle size dry powder aerosol formulations using an ultra low density additive Pharm. Res. 16 1999 1643 1647 (Pubitemid 29510566)
23. A.R. Najafabadi, K. Gilani, M. Barghi, and M. Rafiee-Tehrani The effect of vehicle on physical properties and aerosolisation behaviour of disodium cromoglycate microparticles spray dried alone or with L-leucine Int. J. Pharm. 285 2004 97 108 (Pubitemid 39361540)
24. N.Y.K. Chew, B.Y. Shekunov, H.H.Y. Tong, A.H.L. Chow, C. Savage, J. Wu, and H.K. Chan Effect of amino acids on the dispersion of disodium cromoglycate powders J. Pharm. Sci. US 94 2005 2289 2300 (Pubitemid 41665288)
25. N.R. Rabbani, and P.C. Seville The influence of formulation components on the aerosolisation properties of spray-dried powders J. Control. Release 110 2005 130 140 (Pubitemid 41713937)
26. C. Gervelas, A.L. Serandour, S. Geiger, G. Grillon, P. Fritsch, C. Taulelle, B. Le Gall, H. Benech, J.R. Deverre, E. Fattal, and N. Tsapis Direct lung delivery of a dry powder formulation of DTPA with improved aerosolization properties: Effect on lung and systemic decorporation of plutonium J. Control. Release 118 2007 78 86 (Pubitemid 46283100)
27. P.C. Seville, T.P. Learoyd, H.Y. Li, I.J. Williamson, and J.C. Birchall Amino acid-modified spray-dried powders with enhanced aerosolisation properties for pulmonary drug delivery Powder Technol. 178 2007 40 50 (Pubitemid 47247802)
28. R. Vehring Pharmaceutical particle engineering via spray drying Pharm. Res. 25 2008 999 1022
29. D. Lechuga-Ballesteros, C. Charan, C.L.M. Stults, C.L. Stevenson, D.P. Miller, R. Vehring, V. Tep, and M.C. Kuo Trileucine improves aerosol performance and stability of spray-dried powders for inhalation J. Pharm. Sci. US 97 2008 287 302
30. Y. Nozaki, and C. Tanford The solubility of amino acids and two glycine peptides in aqueous ethanol and dioxane solutions. Establishment of a hydrophobicity scale J. Biol. Chem. 246 1971 2211 2217
31. J. Glinski, G. Chavepeyer, and J.K. Platten Surface properties of aqueous solutions of L-leucine Biophys. Chem. 84 2000 99 103 (Pubitemid 30168951)
32. R. Vehring, W.R. Foss, and D. Lechuga-Ballesteros Particle formation in spray drying J. Aerosol Sci. 38 2007 728 746 (Pubitemid 47087809)
33. S. Aki, N. Eskiyurt, U. Akarirmak, F. Tuzun, M. Eryavuz, S. Alper, O. Arpacioglu, F. Atalay, V. Kavuncu, S. Kokino, O. Kuru, K. Nas, O. Ozerbil, G. Savas, O.F. Sendur, D. Soy, and G. Akyuz Gastrointestinal side effect profile due to the use of alendronate in the treatment of osteoporosis Yonsei Med. J. 44 2003 961 967 (Pubitemid 38081560)
34. R.F. Henderson Use of bronchoalveolar lavage to detect respiratory tract toxicity of inhaled material Exp. Toxicol. Pathol. 57 Suppl. 1 2005 155 159 (Pubitemid 40884488)
35. M. Drent, N.A. Cobben, R.F. Henderson, E.F. Wouters, and M. van Dieijen-Visser Usefulness of lactate dehydrogenase and its isoenzymes as indicators of lung damage or inflammation Eur. Respir. J. 9 1996 1736 1742 (Pubitemid 26271162)
36. J.H. Lin, D.E. Duggan, I.W. Chen, and R.L. Ellsworth Physiological Disposition of Alendronate, a Potent Anti-Osteolytic Bisphosphonate, in Laboratory-Animals Drug Metab. Dispos. 19 1991 926 932
37. E. Rytting, J. Nguyen, X.Y. Wang, and T. Kissel Biodegradable polymeric nanocarriers for pulmonary drug delivery Expert Opin. Drug Deliv. 5 2008 629 639 (Pubitemid 351998253)