Novel alternatives to reduce powder retention in the dry powder inhaler during aerosolization

International Journal of Pharmaceutics

Volumn 452, Issue 1-2, 2013, Pages 194-200

  Heng, Desmond ^a   Lee, Sie Huey ^a   Ng, Wai Kiong ^a   Chan, Hak Kim ^b   Kwek, Jin Wang ^a   Tan, Reginald B H ^a,c  

^a INSTITUTE OF CHEMICAL AND ENGINEERING SCIENCES   (Singapore)

^b UNIVERSITY OF SYDNEY   (Australia)

^c NATIONAL UNIVERSITY OF SINGAPORE   (Singapore)

Author keywords

Biomimicry; Capsule; Device; Dry powder inhaler; Force control agents; Powder retention; Surface coating

Indexed keywords

HYDROXYPROPYLMETHYLCELLULOSE; LYSOZYME; MAGNESIUM STEARATE;

ADHESION; AEROSOL; ARTICLE; DRUG CAPSULE; DRUG COATING; DRUG DELIVERY DEVICE; DRUG DELIVERY SYSTEM; DRUG RETENTION; DRY POWDER INHALER; PARTICLE SIZE; PRIORITY JOURNAL;

EID: 84884202159     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2013.05.006     Document Type: Article

References (62)

1. Abdul Bari, H.A., Kamarulizam, S.N., Rosli, M.Y., Gupta, A., 2012. Introducing slag powder as drag reduction agent in pipeline: an experimental approach. Sci. Res. Essays 7, 1768-1776.
2. Abdul Bari, H.A., Mohd Yunus, R.B., Mahmood, W.K., Hassan, Z.B., 2009. Sodium stearate as drag reducing agent in non-aqueous media. Int. J. Chem. Technol. 1, 11-18.
3. Begat, P., Morton, D.A.V., Shur, J., Kippax, P., Staniforth, J.N., Price, R., 2008. The role of force control agents in high-dose dry powder inhaler formulations. J. Pharm. Sci. 98, 2770-2783.
4. Behara, S.R.B., Kippax, P., Larson, I., Morton, D.A.V., Stewart, P., 2011. Kinetics of emitted mass - a study with three dry powder inhaler devices. Chem. Eng. Sci. 66, 5284-5292.
5. Bhushan, B., 2011. Biomimetics inspired surfaces for drag reduction and oleophobicity/philicity. Beilstein J. Nanotechnol. 2, 66-84.
6. Bolhuis, G.K., Lerk, C.F., Zijlstra, H.T., de Boer, A.H., 1975. Film formation by magnesium stearate during mixing and its effect on tabletting. Pharmaceutisch Weekblad 110 (16), 317-325.
7. Boraey, M.A., Hoe, S., Sharif, H., Miller, D.P., Lechuga-Ballesteros, D., Vehring, R., 2012. Improvement of the dispersibility of spray-dried budesonide powders using leucine in an ethanol-water cosolvent system. Powder Technol., http://dx.doi.org/10.1016/j.powtec.2012.02.047.
8. Brashier, B., Dhembare, P., Jantikar, A., Mahadik, P., Gokhale, P., Gogtay, J.A., et al., 2007. Tiotropium administered by a pressurized metered dose inhaler (pMDI) and spacer produces a similar bronchodilator response as that administered by a Rotahaler® in adult subjects with stable moderate-to-severe COPD. Respir. Med. 101, 2464-2471. (Pubitemid 350000963)
9. Bushnell, D.M., Moore, K.J., 1991. Drag reduction in nature. Annu. Rev. Fluid Mech. 23, 65-79.
10. Butters, M., Catterick, D., Craig, A., Curzons, A., Dale, D., Gillmore, A., et al., 2006. Critical assessment of pharmaceutical processes - a rationale for changing the synthetic route. Chem. Rev. 106, 3002-3027. (Pubitemid 44193054)
11. Chan, H.-K., Kwok, P.C.L., 2011. Production methods for nanodrug particles using the bottom-up approach. Adv. Drug Deliv. Rev. 63, 406-416.
12. Chan, J.G.Y., Chan, H.-K., Prestidge, C.A., Denman, J.A., Young, P.M., Traini, D., 2012. A novel dry powder inhalable formulation incorporating three first-line anti-tubercular antibiotics. Eur. J. Pharm. Biopharm., http://dx.doi.org/10.1016/j.ejpb.2012.08.007.
13. Chen, E.B., Morales, A.J., Chen, C.-C., Donatelli, A.A., Bannister, W.W., Cummings, B.T., 1998. Fluorescein and poly(ethylene oxide) hose stream additives for improved firefighting effectiveness. Fire Technol. 34, 291-306.
14. Chiou, H., Chan, H.-K., Heng, D., Prud'homme, R.K., Raper, J.A., 2008. A novel production method for inhalable cyclosporine A powders by confined liquid impinging jet precipitation. J. Aerosol Sci. 39, 500-509.
15. Chow, A.H.L., Tong, H.H.Y., Chattopadhyay, P., Shekunov, B.Y., 2007. Particle engineering for pulmonary drug delivery. Pharm. Res. 24, 411-437. (Pubitemid 46295160)
16. Clark, A.R., Hollingworth, A.M., 1993. The relationship between powder inhaler resistance and peak inspiratory conditions in healthy volunteers - implications for in vitro testing. J. Aerosol Med. 6, 99-110. (Pubitemid 23231366)
17. Coates, M., Fletcher, D.F., Chan, H.-K., Raper, J.A., 2004. A comparative study of two marketed pulmonary drug delivery devices using computational fluid dynamics. In: Paper presented at the Respiratory Drug Delivery IX.
18. Fasola, G., Aita, M., Marini, L., Follador, A., Tosolini, M., Mattioni, L., et al., 2008. Drug waste minimisation and cost-containment in medical oncology: two-year results of a feasibility study. BMC Health Serv. Res. 8, 1-8.
19. Fischer, F.X., Hess, H., Sucker, H., Byron, P.R., 1989. CFC propellant substitution: international perspectives. Pharm. Technol. Int. 1, 16.
20. Gillerman, R.G., Browning, R.A., 2000. Drug use inefficiency: a hidden source of wasted health care dollars. Econ. Health Syst. Res. 91, 921-924.
21. Guchardi, R., Frei, M., John, E., Kaerger, J.S., 2008. Influence of fine lactose and magnesium stearate on low dose dry powder inhaler formulations. Int. J. Pharm. 348, 10-17. (Pubitemid 350266232)
22. Heng, D., Cutler, D.J., Chan, H.-K., Yun, J., Raper, J.A., 2008a. Dissolution kinetic behavior of drug nanoparticles and their conformity to the diffusion model. Langmuir 24, 7538-7544.
23. Heng, D., Cutler, D.J., Chan, H.-K., Yun, J., Raper, J.A., 2008b. What is a suitable dissolution method for drug nanoparticles? Pharm. Res. 25, 1696-1701.
24. Heng, D., Lee, S.H., Kwek, J.W., Ng, W.K., Chan, H.-K., Tan, R.B.H., 2012. Assessing the combinatorial influence of climate formulation and device on powder aerosolization using the Taguchi experimental design. Powder Technol. 226, 253-260.
25. Heng, D., Lee, S.H., Ng, W.K., Tan, R.B.H., 2011. The nano spray dryer B-90. Expert Opin. Drug Deliv. 8, 965-972.
26. Heng, D., Ogawa, K., Cutler, D.J., Chan, H.-K., Raper, J.A., Ye, L., et al., 2009. Pure drug nanoparticles in tablets: what are the dissolution limitations? J. Nanopart. Res. 12, 1743-1754.
27. Herold, M., Hieke, K., 2003. Costs of drug delivery for CHOP, COP/CVP, and Fludarabine: an international assessment. Value Health 6, 167-174. (Pubitemid 36403134)
28. Hu, T.-T., Zhao, H., Jiang, L.-C., Le, Y., Chen, J.-F., Yun, J., 2008. Engineering pharmaceutical fine particles of budesonide for dry powder inhalation (DPI). Ind. Eng. Chem. Res. 47, 9623-9627.
29. Hussain, M.S.H., York, P., Timmins, P., 1988. A study of the formation of magnesium stearate film on sodium chloride using energy-dispersive X-ray analysis. International Journal of Pharmaceutics 42, 89-95. (Pubitemid 18092096)
30. Ibiapina, C., Cruz, A.A., Camargos, P.A.M., 2004. Hydrofluoroalkane as a propellant for pressurized metered-dose inhalers: history, pulmonary deposition, pharmacokinetics efficacy and safety. J. Pediatr. (Rio. J) 80, 441-446. (Pubitemid 44608509)
31. Janssens, W., VandenBrande, P., Hardeman, E., De Langhe, E., Philps, T., Troosters, T., et al., 2008. Inspiratory flow rates at different levels of resistance in elderly COPD patients. Eur. Respir. J. 31, 78-83.
32. Jimenez-Gonzalez, C., Poechlauer, P., Broxterman, Q.B., Yang, B.-S., Am Ende, D., Baird, J., et al., 2011. Key green engineering research areas for sustainable manufacturing: a perspective from pharmaceutical and fine chemicals manufacturers. Org. Process Res. Dev. 15, 900-911.
33. Kumon, M., Kwok, P.C.L., Adi, H., Heng, D., Chan, H.-K., 2010. Can low-dose combination products for inhalation be formulated in single crystalline particles? Eur. J. Pharm. Sci. 40, 16-24.
34. Kumon, M., Machida, S., Suzuki, M., Kusai, A., Yonemochi, E., Terada, K., 2008. Application and mechanism of inhalation profile improvement of DPI formulations by mechanofusion with magnesium stearate. Chem. Pharm. Bull. 56, 617-625. (Pubitemid 351669426)
35. Kumon, M., Suzuki, M., Kusai, A., Yonemochi, E., Terada, K., 2006. Novel approach to DPI carrier lactose with mechanofusion process with additives and evaluation by IGC. Chem. Pharm. Bull. 54, 1508-1514. (Pubitemid 44703976)
36. Kwok, P.C.L., Tunsirikongkon, A., Glover, W., Chan, H.-K., 2011. Formation of protein nano-matrix particles with controlled surface architecture for respiratory drug delivery. Pharm. Res. 28, 788-796.
37. Lahde, A., Raula, J., Kauppinen, E.I., 2008. Combined synthesis and in situ coating of nanoparticles in the gas phase. J. Nanopart. Res. 10, 121-130.
38. Leach, C.L., 2005. The CFC to HFA transition and its impact on pulmonary drug development. Respir. Care 50, 1201-1208.
39. Lee, S.H., Heng, D., Ng, W.K., Chan, H.-K., Tan, R.B.H., 2011. Nano spray drying: a novel method for preparing protein nanoparticles for protein therapy. Int. J. Pharm. 403, 192-200.
40. Lee, S.H., Teo, J., Heng, D., Ng, W.K., Chan, H.-K., Tan, R.B.H., 2012. Synergistic combination dry powders for inhaled antimicrobial therapy: formulation, characterization and in vitro evaluation. Eur. J. Pharm. Biopharm., http://dx.doi.org/10.1016/j.ejpb.2012.09.002.
41. Raula, J., Lahde, A., Kauppinen, E.I., 2008. A novel gas phase method for the combined synthesis and coating of pharmaceutical particles. Pharm. Res. 25, 242-245.
42. Raula, J., Lahde, A., Kauppinen, E.I., 2009. Aerosolization behavior of carrier-free L-leucine coated salbutamol sulphate powders. Int. J. Pharm. 365, 18-25.
43. Reddy, S.T., Chung, K.K., McDaniel, C.J., Darouiche, R.O., Landman, J., Brennan, A.B., 2011. Micropatterned surfaces for reducing the risk of catheter-associated urinary tract infection: an in vitro study on the effect of sharklet micropatterned surfaces to inhibit bacterial colonization and migration of uropathogenic Escherichia coli. J. Encourol. 25, 1547-1552.
44. Roy, A., Larson, R.G., 2005. A mean flow model for polymer and fiber turbulent drag reduction. Appl. Rheol. 15, 370-389. (Pubitemid 43025478)
45. Smith, I.J., Bell, J., Bowman, N., Everard, M., Stein, S., Weers, J.G., 2010. Inhaler devices: what remains to be done? J. Aerosol Med. Pulm. Drug Deliv. 23, S25-S37.
46. Steckel, H., Muller, B.W., 1997. In vitro evaluation of dry powder inhalers I: drug deposition of commonly used devices. Int. J. Pharm. 154, 19-29. (Pubitemid 27326816)
47. Swaminathan, V., Kildsig, D.O., 2002. Effect of magnesium stearate on the content uniformity of active ingredient in pharmaceutical powder mixtures. AAPS PharmSciTech 3, 1-5.
48. Tajber, L., Corrigan, O.I., Healy, A.M., 2009. Spray drying of budesonide, formoterol fumarate and their composites - II. Statistical factorial design and in vitro deposition properties. Int. J. Pharm. 367, 86-96.
49. Tay, T., Das, S., Stewart, P., 2010. Magnesium stearate increases salbutamol sulphate dispersion: what is the mechanism? Int. J. Pharm. 383, 62-69.
50. Tee, S.K., Marriott, C., Zeng, X.M., Martin, G.P., 2000. The use of different sugars as fine and coarse carriers for aerosolised salbutamol sulphate. Int. J. Pharm. 208, 111-123.
51. Timsina, M.P., Martin, G.P., Marriott, C., Ganderton, D., Yianneskis, M., 1994. Drug delivery to the respiratory tract using dry powder inhalers. Int. J. Pharm. 101, 1-13.
52. Traini, D., Adi, H., Valet, O.K., Young, P.M., 2012. Preparation and evaluation of single and co-engineered combination inhalation carrier formulations for the treatment of asthma. J. Pharm. Sci. 101, 4267-4276.
53. Tsapis, N., Bennet, D., Jackson, B., Weitz, D.A., Edwards, D.A., 2002. Trojan particles: large porous carriers of nanoparticles for drug delivery. PNAS 99, 12001-12005.
54. Uzunovic, A., Vranic, E., 2007. Effect of magnesium stearate concentration on dissolution properties of ranitidine hydrochloride coated tablets. Bosnian Journal of Basic Medical Sciences 7 (3), 279-283.
55. Vidgren, M., Karkkainen, A., Karjalainen, P., Paronen, P., Nuutinen, J., 1988. Effect of powder inhaler design on drug deposition in the respiratory tract. Int. J. Pharm. 42, 211-216. (Pubitemid 18092108)
56. Wang, J., Wen, H., Desai, D., 2010. Lubrication in tablet formulations. European Journal of Pharmaceutics and Biopharmaceutics 75, 1-15.
57. Weers, J.G., Bell, J., Chan, H.-K., Cipolla, D., Dunbar, C., Hickey, A.J., et al., 2010. Pulmonary formulations: what remains to be done? J. Aerosol Med. Pulm. Drug Deliv. 23, S5-S23.
58. Wertheimer, A.I., Morrison, A., 2002. Combination drugs: innovation in pharmacotherapy. Pharm. Ther. 27, 44-49. (Pubitemid 34112925)
59. Young, P.M., Cocconi, D., Colombo, P., Bettini, R., Price, R., Steele, D.F., et al., 2002. Characterization of a surface modified dry powder inhalation carrier prepared by 'particle smoothing'. J. Pharm. Pharmacol. 54, 1339-1344. (Pubitemid 35174178)
60. Zeng, X.M., Martin, G.P., Marriott, C., Pritchard, J., 2000. The effects of carrier size and morphology on the dispersion of salbutamol sulphate after aerosolization at different flow rates. J. Pharm. Pharmacol. 52, 1211-1221.
61. Zeng, X.M., Martin, G.P., Tee, S.K., Marriott, C., 1998. The role of fine particle lactose on the dispersion and deaggregation of salbutamol sulphate in an air stream in vitro. Int. J. Pharm. 176, 99-110. (Pubitemid 28544976)
62. Zhou, Q.T., Qu, L., Larson, I., Stewart, P.J., Morton, D.A.V., 2010. Improving aerosolization of drug powders by reducing powder intrinsic cohesion via a mechanical dry coating approach. Int. J. Pharm. 394, 50-59.