Antisolvent crystallisation is a potential technique to prepare engineered lactose with promising aerosolisation properties: Effect of saturation degree

International Journal of Pharmaceutics

Volumn 437, Issue 1-2, 2012, Pages 57-69

  Kaialy, Waseem ^a,b   Nokhodchi, Ali ^a,c  

^a MEDWAY SCHOOL OF PHARMACY   (United Kingdom)

^b DAMASCUS UNIVERSITY   (Syrian Arab Republic)

^c TABRIZ UNIVERSITY OF MEDICAL SCIENCES   (Iran)

Author keywords

Anomer form; Density; Dry powder inhaler; Engineered lactose; Fine particle fraction; Homogeneity; Porosity; Roughness; Saturation; Shape

Indexed keywords

ENGINEERED LACTOSE PARTICLE; LACTOSE; SALBUTAMOL SULFATE; UNCLASSIFIED DRUG;

AEROSOL; ANTISOLVENT CRYSTALLISATION TECHNIQUE; AQUEOUS SOLUTION; ARTICLE; BULK DENSITY; CRYSTALLIZATION; DIFFERENTIAL SCANNING CALORIMETRY; DRUG DELIVERY SYSTEM; DRUG FORMULATION; INFRARED SPECTROSCOPY; LOWER RESPIRATORY TRACT; MORPHOLOGY; PARTICLE SIZE; POROSITY; POWDER; POWDER INHALER; PRIORITY JOURNAL; SCANNING ELECTRON MICROSCOPY; SOLID STATE; SOLUBILITY; SURFACE PROPERTY; X RAY POWDER DIFFRACTION;

1-BUTANOL; AEROSOLS; ALBUTEROL; BRONCHODILATOR AGENTS; CRYSTALLIZATION; DRUG COMPOUNDING; DRY POWDER INHALERS; ETHANOL; LACTOSE; PARTICLE SIZE; SOLVENTS;

EID: 84865406808     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2012.07.064     Document Type: Article

References (52)

1. C. Bosquillon, C. Lombry, V. Preat, and R. Vanbever Comparison of particle sizing techniques in the case of inhalation dry powders J. Pharm. Sci. 90 2001 2032 2041
2. A.B.N. Brito, and M. Giulietti Study of lactose crystallization in water-acetone solutions Cryst. Res. Technol. 42 2007 583 588
3. N.Y.K. Chew, and H.K. Chan Effect of powder polydispersity on aerosol generation J. Pharm. Pharm. Sci. 5 2002 162 168
4. A.H.L. Chow, H.H.Y. Tong, P. Chattopadhyay, and B.Y. Shekunov Particle engineering for pulmonary drug delivery Pharm. Res. 24 2007 411 437
5. M.J. Donovan, and H.D.C. Smyth Influence of size and surface roughness of large lactose carrier particles in dry powder inhaler formulations Int. J. Pharm. 402 2010 1 9
6. 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 1872
7. N. El-Gendy, and C. Berkland Combination chemotherapeutic dry powder aerosols via controlled nanoparticle agglomeration Pharm. Res. 26 2009 1752 1763
8. M.P. Flament, P. Leterme, and A. Gayot The influence of carrier roughness on adhesion, content uniformity and the in vitro deposition of terbutaline sulphate from dry powder inhalers Int. J. Pharm. 275 2004 201 209
9. D. Ganderton The generation of respirable clouds from coarse powder aggregates J. Biopharm. Sci. 3 1992 101 105
10. I. Gonda Study of the effects of polydispersity of aerosols on regional deposition in the respiratory tract J. Pharm. Pharmacol. 33 1981 52P
11. S. Garnier, S. Petit, F. Mallet, M.N. Petit, D. Lemarchand, S. Coste, J. Lefebvre, and G. Coquerel Influence of ageing, grinding and preheating on the thermal behaviour of alphalactose monohydrate Int. J. Pharm. 361 2008 131 140
12. E. Guenette, A. Barrett, D. Kraus, R. Brody, L. Harding, and G. Magee Understanding the effect of lactose particle size on the properties of DPI formulations using experimental design Int. J. Pharm. 380 2009 80 88
13. M.S. Hassan, and R. Lau Inhalation performance of pollen-shape carrier in dry powder formulation: effect of size and surface morphology Int. J. Pharm. 413 2011 93 102
14. N. Islam, P. Stewart, I. Larson, and P. Hartley Lactose surface modification by decantation: are drug-fine lactose ratios the key to better dispersion of salmeterol xinafoate from lactose-interactive mixtures? Pharm. Res. 21 2004 492 499
15. K.K. Jain Drug delivery systems - an overview Methods Mol. Biol. 437 2008 1 50
16. W. Kaialy, and A. Nokhodchi The use of engineered lactose for improved pulmonary drug delivery Lactose as a Carrier for Inhalation Products 2010 TEFARCO Innova, BioPharmaNet Parma, Italy
17. W. Kaialy, M.D. Ticehurst, and A. Nokhodchi Dry powder inhalers: mechanistic evaluation of lactose formulations containing salbutamol sulphate Int. J. Pharm. 423 2012 184 194
18. W. Kaialy, H. Larhrib, and A. Nokhodchi The effect of carrier particle size on adhesion, content uniformity, and inhalation performane of budesonide using dry powder inhalers Y.C. Wu, G. Wei, Particulate Materials: Synthesis, characterisation, processing, and modelling 2011 The Royal Society of Chemistry Thomas Graham House, Science Park, Milton Road, Cambridge, UK 133 139
19. W. Kaialy, H. Larhrib, G.P. Martin, and A. Nokhodchi The effect of engineered mannitol-lactose mixture on dry powder inhaler performance Pharm. Res. 29 2012 74 85
20. W. Kaialy, H. Larhrib, M.D. Ticehurst, and A. Nokhodchi Influence of batch cooling crystallization on mannitol physical properties and drug dispersion from dry powder inhalers Cryst. Growth Des. 12 2012 3006 3017
21. W. Kaialy, A. Alhalaweh, S.P. Velaga, and A. Nokhodchi Influence of lactose carrier particle size on the aerosol performance of budesonide from a dry powder inhaler Powder Technol. 227 2012 74 85
22. W. Kaialy, A. Alhalaweh, S.P. Velaga, and A. Nokhodchi Effect of carrier particle shape on dry powder inhaler performance Int. J. Pharm. 421 2011 12 23
23. W. Kaialy, M.N. Momin, M.D. Ticehurst, J. Murphy, and A. Nokhodchi Engineered mannitol as an alternative carrier to enhance deep lung penetration of salbutamol sulphate from dry powder inhaler Colloids Surf. B 79 2010 345 356
24. W. Kaialy, G.P. Martin, M.D. Ticehurst, M.N. Momin, and A. Nokhodchi The enhanced aerosol performance of salbutamol from dry powders containing engineered mannitol as excipient Int. J. Pharm. 392 2010 178 188
25. W. Kaialy, G.P. Martin, H. Larhrib, M.D. Ticehurst, E. Kolosionek, and A. Nokhodchi The influence of physical properties and morphology of crystallised lactose on delivery of salbutamol sulphate from dry powder inhalers Colloids Surf. B 89 2012 29 39
26. W. Kaialy, G.P. Martin, M.D. Ticehurst, and A. Nokhodchi Engineered mannitol as potential carrier for enhanced DPI performance J. Pharm. Pharmacol. 26 2010 1432 1433
27. W. Kaialy, M.D. Ticehurst, J. Murphy, and A. Nokhodchi Improved aerosolization performance of salbutamol sulphate formulated with lactose crystallised from binary mixtures of ethanol-acetone J. Pharm. Sci. 100 2011 2665 2684
28. W. Kaialy, G.P. Martin, M.D. Ticehurst, P. Royall, M.A. Mohammad, J. Murphy, and A. Nokhodchi Characterisation and deposition studies of recrystallised lactose from binary mixtures of ethanol/butanol for improved drug delivery from dry powder inhalers AAPS J. 13 2011 30 43
29. J.H. Kirk, S.E. Dann, and C.G. Blatchford Lactose: a definitive guide to polymorph determination Int. J. Pharm. 334 2007 103 114
30. V.N.P. Le, T.H.H. Thi, E. Robins, and M. Flament Dry powder inhalers: study of the parameters influencing adhesion and dispersion of fluticasone propionate AAPS PharmSciTech 13 2012 477 484
31. V. Le, H. Bierend, E. Robins, H. Steckel, and M. Flament Influence of the lactose grade within dry powder formulations of fluticasone propionate and terbutaline sulphate Int. J. Pharm. 422 2012 75 82
32. Littringer, E., Mescher, A., Schroettner, H., Achelis, L., Walzel, P., Urbanetz, N. Spray dried mannitol carrier particles with tailored surface properties - the influence of carrier surface roughness and shape. Eur. J. Pharm. Biopharm.; http://dx.doi.org/10.1016/j.ejpb.2012.05.001, in press.
33. M.D. Louey, and P.J. Stewart Particle interactions involved in aerosol dispersion of ternary interactive mixtures Pharm. Res. 19 2002 1524 1531
34. T.B. Martonen, I. Katz, K. Fults, and A.J. Hickey Use of analytically defined estimates of aerosol respirable fraction to predict lung deposition patterns Pharm. Res. 9 1992 1634 1639
35. O. Monnier, J.P. Klein, B. Ratsimba, and C. Hoff Particle size determination by laser reflection: methodology and problems Part. Part. Syst. Charact. 13 1996 10 17
36. A. Nokhodchi, M.D. Ticehurst, M.A. Mohammad, and W. Kaialy Better aerosolisation performance of salbutamol formulated with lactose crystallised from binary mixtures of ethanol/butanol J. Pharm. Pharmacol. 26 2010 1407 1408
37. A. Nokhodchi, W. Kaialy, and M.D. Ticehurst The influence of particle physicochemical properties on delivery of drugs by dry powder inhalers to the lung M.A. Popescu, Drug Delivery 2011 Nova NY, Hauppauge 1 50
38. A. Nokhodchi, W. Kaialy, and M.D. Ticehurst The influence of using carriers with increasing elongation ratios on uniformity, adhesion and in vitro aerosolozation performance of salbutamol sulphate from dry powder inhalers CRS Annual Meeting Maryland, USA 2011
39. J. Ooi, D. Traini, S. Hoe, W. Wong, and P.M. Young Does carrier size matter? A fundamental study of drug aerosolisation from carrier based dry powder inhalation systems Int. J. Pharm. 413 2011 1 9
40. P. Pantaraks, and A.E. Flood Effect of growth rate history on current crystal growth: a second look at surface effects on crystal growth rates Cryst. Growth Des. 5 2005 365 371
41. G. Pilcer, N. Wauthoz, and K. Amighi Lactose characteristics and the generation of the aerosol Adv. Drug Deliv. Rev. 64 2011 233 256
42. F. Podczeck The relationship between physical properties of lactose monohydrate and the aerodynamic behaviour of adhered drug particles Int. J. Pharm. 160 1998 119 130
43. F. Podczeck, J.M. Newton, and M.B. James The adhesion force of micronized salmeterol xinafoate particles to pharmaceutically relevant surface materials J. Phys. D 29 1996 1878
44. H. Schulz Mechanisms and factors affecting intrapulmonary particle deposition: implications for efficient inhalation therapies holger schulz Pharm. Sci. Technol. Today 1 1998 326 344
45. H. Steckel, and B.W. Müller In vitro evaluation of dry powder inhalers II: influence of carrier particle size and concentration on in vitro deposition Int. J. Pharm. 154 1997 31 37
46. S. Suarez, and A.J. Hickey Drug properties affecting aerosol behavior Respir. Care 45 2000 652 666
47. R. Vanbever, J.D. Mintzes, J. Wang, J. Nice, D. Chen, R. Batycky, R. Langer, and D.A. Edwards Formulation and physical characterization of large porous particles for inhalation Pharm. Res. 16 1999 1735 1742
48. D.R. Yang, K.S. Lee, J.S. Lee, S.G. Kim, D.H. Kim, and Y.K. Bang Modeling of metastable zone width behavior with dynamic equation Ind. Eng. Chem. Res. 46 2007 8158 8165
49. P.M. Young, W. Owen, O. Jesslynn, and D. Traini The influence of drug loading on formulation structure and aerosol performance in carrier based dry powder inhalers Int. J. Pharm. 416 2011 129 135
50. P.M. Young, P. Kwok, H. Adi, H.K. Chan, and D. Traini Lactose composite carriers for respiratory delivery Pharm. Res. 26 2009 802 810
51. P.M. Young, H. Chan, H. Chiou, S. Edge, T.H.S. Tee, and D. Traini The influence of mechanical processing of dry powder inhaler carriers on drug aerosolization performance J. Pharm. Sci. 96 2007 1331 1341
52. X.M. Zeng, G.P. Martin, and C. Marriott Particulate Interactions in Dry Powder Formulations for Inhalation 2001 Taylor & Francis London