The use of inverse gas chromatography for the study of lactose and pharmaceutical materials used in dry powder inhalers

Advanced Drug Delivery Reviews

Volumn 64, Issue 3, 2012, Pages 285-293

  Jones, Matthew D ^a   Young, Paul ^b   Traini, Daniela ^b  

^a Royal United Hospital   (United Kingdom)

^b UNIVERSITY OF SYDNEY   (Australia)

Author keywords

Batch to batch variation; Blending; Dry powder inhalers; Fine particle fraction; Free energy of adsorption; Inverse gas chromatography; Milling; Surface energy; Surface properties

Indexed keywords

BATCH-TO-BATCH VARIATION; DRY POWDER INHALER; FINE PARTICLE FRACTIONS; FREE ENERGY OF ADSORPTION; INVERSE GAS CHROMATOGRAPHY;

ADSORPTION; ATOMIZERS; BLENDING; FREE ENERGY; INTERFACIAL ENERGY; MILLING (MACHINING); SUGARS; SURFACE CHEMISTRY; SURFACE PROPERTIES;

GAS CHROMATOGRAPHY;

BUDESONIDE; CYCLOHEXANE; HEXANE; LACTOSE; MAGNESIUM STEARATE; SALBUTAMOL SULFATE; SALMETEROL XINAFOATE;

ADSORPTION; ATOMIC FORCE MICROSCOPY; BATCH PROCESS; CALORIMETRY; DISPERSION; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRY POWDER; ENTHALPY; INVERSE GAS CHROMATOGRAPHY; MATHEMATICAL ANALYSIS; MATHEMATICAL COMPUTING; MEDICAL RESEARCH; METHODOLOGY; PARTICLE SIZE; POWDER INHALER; PREDICTION; PRIORITY JOURNAL; PROCESS MONITORING; PROCESS OPTIMIZATION; RAMAN SPECTROMETRY; REVIEW; SENSITIVITY ANALYSIS; SURFACE PROPERTY; X RAY POWDER DIFFRACTION;

CHROMATOGRAPHY, GAS; DRUG CARRIERS; DRY POWDER INHALERS; LACTOSE; PHARMACEUTICAL PREPARATIONS;

EID: 84858616022     PISSN: 0169409X     EISSN: 18728294     Source Type: Journal    
DOI: 10.1016/j.addr.2011.12.015     Document Type: Review

References (77)

1. Buckton G., Gill H. The importance of surface energetics of powders for drug delivery and the establishment of inverse gas chromatography. Adv. Drug Delivery Rev. 2007, 59:1474-1479.
2. Grimsey I.M., Feeley J.C., York P. Analysis of the surface energy of pharmaceutical powders by inverse gas chromatography. J. Pharm. Sci. 2002, 91:571-583.
3. Tong H.H.Y., Shekunov B.Y., York P., Chow A.H.L. Influence of polymorphism on the surface energetics of salmeterol xinafoate crystallized from supercritical fluids. Pharm. Res. 2002, 19:640-648.
4. Donnet J.B., Park S.J., Balard H. Evaluation of specific interactions of solid surfaces by inverse gas chromatography - a new approach based on polarizability of the probes. Chromatographia 1991, 31:434-440.
5. Schultz J., Lavielle L., Martin C. The role of the interface in carbon-fiber epoxy composites. J. Adhes. 1987, 23:45-60.
6. Dorris G.M., Gray D.G. Adsorption of n-alkanes at zero surface coverage on cellulose paper and wood fibers. J. Colloid Interface Sci. 1980, 77:353-362.
7. Guttmann V. The Donor-Acceptor Approach to Molecular Interactions 1978, Plenum Press, New York.
8. Riddle F.L., Fowkes F.M. Spectral shifts in acid-base chemistry. 1. van der Waals contributions to acceptor numbers. J. Am. Chem. Soc. 1990, 112:3259-3264.
9. Gutierrez M.C., Rubio J., Rubio F., Oteo J.L. Inverse gas chromatography: a new approach to the estimation of specific interactions. J. Chromatogr. A 1999, 845:53-66.
10. van Oss J. Interfacial Forces in Aqueous Media 1994, Marcel Dekker, New York.
11. Traini D., Young P.M., Thielmann F., Acharya M. The influence of lactose pseudopolymorphic form on salbutamol sulfate-lactose interactions in DPI formulations. Drug Dev. Ind. Pharm. 2008, 34:992-1001.
12. Tong H.H.Y., Shekunov B.Y., York P., Chow A.H.L. Surface characterization of salmeterol xinafoate powders by inverse gas chromatography at finite coverage. J. Pharm. Sci. 2005, 94:695-700.
13. Das S., Larson I., Young P., Stewart P. Understanding lactose behaviour during storage by monitoring surface energy change using inverse gas chromatography. Dairy Sci. Technol. 2010, 90:271-285.
14. Timsina M.P., Martin G.P., Marriott C., Ganderton D., Yianneskis M. Drug delivery to the respiratory tract using dry powder inhalers. Int. J. Pharm. 1994, 101:1-13.
15. Podczeck F. Particle-Particle Adhesion in Pharmaceutical Powder Handling 1998, Imperial College Press, London.
16. Zeng X.M., Martin G.P., Marriott C. Particulate Interactions in Dry Powder Formulations for Inhalation 2001, Taylor and Francis, London.
17. Johnson K.L., Kendall K., Roberts A.D. Surface energy and contact of elastic solids. Proc. R. Soc. Lond. A Math. Phys. Sci. 1971, 324:301-313.
18. Dupré A. Theorie mechanique de la Chaleur 1869, Gauthier-Villars, Paris.
19. Newell H.E., Buckton G., Butler D.A., Thielmann F., Williams D.R. The use of inverse phase gas chromatography to measure the surface energy of crystalline, amorphous, and recently milled lactose. Pharm. Res. 2001, 18:662-666.
20. Thielmann F., Burnett D.J., Heng J.Y.Y. Determination of the surface energy distributions of different processed lactose. Drug Dev. Ind. Pharm. 2007, 33:1240-1253.
21. Feeley J.C., York P., Sumby B.S., Dicks H. Processing effects on the surface properties of α-lactose monohydrate assessed by inverse gas chromatography (IGC). J. Mater. Sci. 2002, 37:217-222.
22. Shekunov B.Y., Feeley J.C., Chow A.H.L., Tong H.H.Y., York P. Physical properties of supercritically-processed and micronised powders for respiratory drug delivery. KONA. 2002, 20:178-187.
23. Tong H.H.Y., Shekunov B.Y., York P., Chow A.H.L. Characterization of two polymorphs of salmeterol xinafoate crystallized from supercritical fluids. Pharm. Res. 2001, 18:852-858.
24. Schiavone H., Palakodaty S., Clark A., York P., Tzannis S.T. Evaluation of SCF-engineered particle-based lactose blends in passive dry powder inhalers. Int. J. Pharm. 2004, 281:55-66.
25. Feeley J.C., York P., Sumby B.S., Dicks H. Determination of surface properties and flow characteristics of salbutamol sulphate, before and after micronisation. Int. J. Pharm. 1998, 172:89-96.
26. Ohta M., Buckton G. Determination of the changes in surface energetics of cefditoren pivoxil as a consequence of processing induced disorder and equilibration to different relative humidities. Int. J. Pharm. 2004, 269:81-88.
27. York P., Ticehurst M.D., Osborn J.C., Roberts R.J., Rowe R.C. Characterisation of the surface energetics of milled dl-propranolol hydrochloride using inverse gas chromatography and molecular modelling. Int. J. Pharm. 1998, 174:179-186.
28. Gaisford S., Dennison M., Tawfik M., Jones M.D. Following mechanical activation of salbutamol sulphate during ball-milling with isothermal calorimetry. Int. J. Pharm. 2010, 393:74-78.
29. Tang P., Chan H.K., Chiou H., Ogawa K., Jones M.D., Adi H., Buckton G., Prud'homme R.K., Raper J.A. Characterisation and aerosolisation of mannitol particles produced via confined liquid impinging jets. Int. J. Pharm. 2008, 367:51-57.
30. Grimsey I.M., Sunkersett M., Osborn J.C., York P., Rowe R.C. Interpretation of the differences in the surface energetics of two optical forms of mannitol by inverse gas chromatography and molecular modelling. Int. J. Pharm. 1999, 191:43-50.
31. Heng J., Thielmann F., Williams D. The effects of milling on the surface properties of form I paracetamol crystals. Pharm. Res. 2006, 23:1918-1927.
32. Young P.M., Chan H.K., Chiou H., Edge S., Tee T.H.S., Traini D. The influence of mechanical processing of dry powder inhaler carriers on drug aerosolization performance. J. Pharm. Sci. 2007, 96:1331-1341.
33. Ticehurst M.D., Rowe R.C., York P. Determination of the surface-properties of 2 batches of salbutamol sulfate by inverse gas-chromatography. Int. J. Pharm. 1994, 111:241-249.
34. Ticehurst M.D., York P., Rowe R.C., Dwivedi S.K. Characterisation of the surface properties of α-lactose monohydrate with inverse gas chromatography, used to detect batch variation. Int. J. Pharm. 1996, 141:93-99.
35. Hickey A.J., Mansour H.M., Telko M.J., Xu Z., Smyth H.D.C., Mulder T., McLean R., Langridge J., Papadopoulos D. Physical characterization of component particles included in dry powder inhalers. I. Strategy review and static characteristics. J. Pharm. Sci. 2007, 96:1282-1301.
36. Oliveira A.C., Buckton G., Collins E., Clarke J. In vitro deposition from a dry powder inhaler and its correlation with surface energy of amorphous fine particle surfaces. J. Pharm. Pharmacol. 2006, 58:A23.
37. Jones M.D., Buckton G. Comparison of atomic force microscopy and inverse gas chromatography for the prediction of dry powder inhalation performance. Proc. Drug Delivery Lungs 2008, 19.
38. Tong H.H.Y., Shekunov B.Y., York P., Chow A.H.L. Predicting the aerosol performance of dry powder inhalation formulations by interparticulate interaction analysis using inverse gas chromatography. J. Pharm. Sci. 2006, 95:228-233.
39. Cline D., Dalby R. Predicting the quality of powders for inhalation from surface energy and area. Pharm. Res. 2002, 19:1274-1277.
40. Saleem I., Smyth H., Telko M. Prediction of dry powder inhaler formulation performance from surface energetics and blending dynamics. Drug Dev. Ind. Pharm. 2008, 34:1002-1010.
41. Kumon M., Machida S., Suzuki M., Kusai A., Yonemochi E., Terada K. Application and mechanism of inhalation profile improvement of DPI formulations by mechanofusion with magnesium stearate. Chem. Pharm. Bull. 2008, 56:617-625.
42. Sethuraman V.V., Hickey A.J. Powder properties and their influence on dry powder inhaler delivery of an antitubercular drug. AAPS PharmSciTech 2002, 3:28.
43. Jiang R.G., Pan W.S., Wang C.L., Liu H. Use of recrystallized lactose as carrier for inhalation powder of interferon α2b. Pharmazie 2005, 60:632-633.
44. Bernhard F., Steckel H. Proposing a model that correlates surface energy values to aerosol data. Proc. Drug Delivery Lungs 2005, 16:97.
45. Kumon M., Suzuki M., Kusai A., Yonemochi E., Terada K. Novel approach to DPI carrier lactose with mechanofusion process with additives and evaluation by IGC. Chem. Pharm. Bull. 2006, 54:1508-1514.
46. Chow A.H.L., Tong H.H.Y., Shekunov B.Y., York P. Use of inverse gas chromatography (IGC) to determine the surface energy and surface area of powdered materials. Pharm. Res. 2004, 21:1718-1719.
47. Smyth H.D.C., Hickey A.J. Carriers in drug powder delivery: implications for inhalation system design. Am. J. Drug Del. 2005, 3:117-132.
48. Jones M.D., Hooton J.C., Dawson M.L., Ferrie A.R., Price R. An investigation into the dispersion mechanisms of ternary dry powder inhaler formulations by the quantification of interparticulate forces. Pharm. Res. 2008, 25:337-348.
49. Jones M.D., Harris H., Hooton J.C., Shur J., King G.S., Mathoulin C.A., Nichol K., Smith T.L., Dawson M.L., Ferrie A.R., Price R. An investigation into the relationship between carrier-based dry powder inhalation performance and formulation cohesive-adhesive force balances. Eur. J. Pharm. Biopharm. 2008, 69:496-507.
50. Hooton J.C., Jones M.D., Harris H., Shur J., Price R. The influence of crystal habit on the prediction of dry powder inhalation formulation performance using the cohesive-adhesive force balance approach. Drug Dev. Ind. Pharm. 2008, 34:974-983.
51. Telko M.J., Hickey A.J. Critical assessment of inverse gas chromatography as means of assessing surface free energy and acid-base interaction of pharmaceutical powders. J. Pharm. Sci. 2007, 96:2647-2654.
52. Brookman D.J., Sawyer D.T. Specific interactions affecting gas chromatographic retention for modified alumina columns. Anal. Chem. 1968, 40:106-110.
53. Saint Flour C., Papirer E. Gas-solid chromatography: a quick method of estimating surface free energy variations induced by the treatment of short glass fibers. J. Colloid Interface Sci. 1983, 91:69-75.
54. Nardin M., Papirer E. Relationship between vapor pressure and surface energy of liquids: application to inverse gas chromatography. J. Colloid Interface Sci. 1990, 137:534-545.
55. London F. The general theory of molecular forces. Trans. Faraday Soc. 1937, 33:8-26.
56. Dong S., Brendle M., Donnet J.B. Study of solid surface polarity by inverse gas chromatography at infinite dilution. Chromatographia 1989, 28:469-472.
57. CRC Handbook of Chemistry and Physics 2006, CRC Press, Boca Raton. D.R. Lide (Ed.).
58. Chehimi M.M., Pigoislandureau E. Determination of acid-base properties of solid materials by inverse gas chromatography at infinite dilution - a novel empirical method based on the dispersive contribution to the heat of vaporization of probes. J. Mater. Chem. 1994, 4:741-745.
59. Fowkes F.M. Quantitative characterization of the acid-base properties of solvents, polymers, and inorganic surfaces. J. Adhes. Sci. Technol. 1990, 4:669-691.
60. Christensen J.J., Hanks R.W., Izaat R.M. Handbook of Heats of Mixing 1982, John Wiley and Sons, New York.
61. Christensen C., Gmehling J., Rasmussen P., Weidlich U. Heats of Mixing Data Collection - Binary Systems 1984, Dechema, Frankfurt.
62. Christensen J.J., Rowley R.L., Izaat R.M. Handbook of Heats of Mixing: Supplementary Volume 1988, John Wiley and Sons, New York.
63. Brendlé E., Papirer E. A new topological index for molecular probes used in inverse gas chromatography. 2. Application for the evaluation of the solid surface specific interaction potential. J. Colloid Interface Sci. 1997, 194:217-224.
64. Brendlé E., Papirer E. A new topological index for molecular probes used in inverse gas chromatography for the surface nanorugosity evaluation. 1. Method of evaluation. J. Colloid Interface Sci. 1997, 194:207-216.
65. Barysz M., Jashari G., Lall R.S., Srivastava V.K., Trinajstic N. On the distance matrix of molecules containing heteroatoms. Stud. Phys. Theor. Chem. 1983, 28:222-230.
66. Hamieh T., Schultz J. New approach to characterise physicochemical properties of solid substrates by inverse gas chromatography at infinite dilution. I. Some new methods to determine the surface areas of some molecules adsorbed on solid surfaces. J. Chromatogr. A 2002, 969:17-25.
67. Mukhopadhyay P., Schreiber H.P. Aspects of acid-base interactions and use of inverse gas chromatography. Colloids Surf. A. 1995, 100:47-71.
68. Panzer U., Schreiber H.P. On the evaluation of surface interactions by inverse gas chromatography. Macromolecules 1992, 25:3631-3633.
69. Kamdem D.P., Bose S.K., Luner P. Inverse gas chromatography characterization of birch wood meal. Langmuir 1993, 9:3039-3044.
70. Dutschk V., Mäder E., Rudoy V. Determination of polarity parameters for glass fibres by inverse gas chromatography: some results and remarks. J. Adhes. Sci. Technol. 2001, 15:1373-1389.
71. Fekete E., Móczó J., Pukánszky B. Determination of the surface characteristics of particulate fillers by inverse gas chromatography at infinite dilution: a critical approach. J. Colloid Interface Sci. 2004, 269:143-152.
72. Thielmann F. Introduction into the characterisation of porous materials by inverse gas chromatography. J. Chromatogr. A 2004, 1037:115-123.
73. Planinsek O., Trojak A., Srcic S. The dispersive component of the surface free energy of powders assessed using inverse gas chromatography and contact angle measurements. Int. J. Pharm. 2001, 221:211-217.
74. Ahfat N.M., Buckton G., Burrows R., Ticehurst M.D. An exploration of inter-relationships between contact angle, inverse phase gas chromatography and triboelectric charging data. Eur. J. Pharm. Sci. 2000, 9:271-276.
75. Dove J.W., Buckton G., Doherty C. A comparison of two contact angle measurement methods and inverse gas chromatography to assess the surface energies of theophylline and caffeine. Int. J. Pharm. 1996, 138:199-206.
76. Traini D., Rogueda P., Young P.M., Price R. Surface energy and interparticle force correlation in model pMDI formulations. Pharm. Res. 2005, 22:816-825.
77. Järn M., Tåg C.-M., Järnström J., Granqvist B., Rosenholm J.B. Alternative models for determining the surface energy components in offset printing. J. Colloid Interface Sci. 2006, 301:668-676.