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Volumn 101, Issue 6, 2012, Pages 2109-2122

Forced degradation studies of corticosteroids with an alumina-steroid-ethanol model for predicting chemical stability and degradation products of pressurized metered-dose inhaler formulations

Author keywords

Corticosteroid; Degradation pathway; Degradation reaction; Drug excipient interaction; Drug delivery; Forced degradation; Metered dose inhaler

Indexed keywords

ALCOHOL; ALUMINUM OXIDE; BECLOMETASONE DIPROPIONATE; BUDESONIDE; EXCIPIENT; STEROID; TRIAMCINOLONE ACETONIDE;

EID: 84859744261     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23111     Document Type: Article
Times cited : (9)

References (27)
  • 1
    • 84859747478 scopus 로고    scopus 로고
    • FDA. Guidance for industry Q1A (R2) stability testing of new drug substances and products. Federal Register 68(225) (November 21)
    • FDA. 2003. Guidance for industry Q1A (R2) stability testing of new drug substances and products. Federal Register 68(225) (November 21) 65717.
    • (2003) , pp. 65717
  • 4
    • 34447287756 scopus 로고    scopus 로고
    • Stress testing: A predictive tool. In Drugs and the pharmaceutical sciences
    • Baertschi SW, Ed. New York: Taylor & Francis.
    • Baertschi SW, Jansen PJ. 2005. Stress testing: A predictive tool. In Drugs and the pharmaceutical sciences. Vol. 153. Pharmaceutical stress testing: Predicting drug degradation; Baertschi SW, Ed. New York: Taylor & Francis, pp 13-49.
    • (2005) 153. Pharmaceutical stress testing: Predicting drug degradation , pp. 13-49
    • Baertschi, S.W.1    Jansen, P.J.2
  • 5
    • 84859760479 scopus 로고
    • Montreal protocol on substances that deplete the ozone layer. New York: Liaisons Office of the United Nations Environmental Program.
    • Montreal protocol on substances that deplete the ozone layer. 1989. New York: Liaisons Office of the United Nations Environmental Program.
    • (1989)
  • 6
    • 0032790248 scopus 로고    scopus 로고
    • Drug-surfactant-propellant interactions in HFA-formulations
    • Vervaet C, Byron PR. 1999. Drug-surfactant-propellant interactions in HFA-formulations. Int J Pharm 186:13-30.
    • (1999) Int J Pharm , vol.186 , pp. 13-30
    • Vervaet, C.1    Byron, P.R.2
  • 7
    • 0034658554 scopus 로고    scopus 로고
    • Transition to CFC-free metered dose inhalers-Into the new millennium
    • McDonald KJ, Martin GP. 2000. Transition to CFC-free metered dose inhalers-Into the new millennium. Int J Pharm 201:89-102.
    • (2000) Int J Pharm , vol.201 , pp. 89-102
    • McDonald, K.J.1    Martin, G.P.2
  • 8
    • 0038433196 scopus 로고    scopus 로고
    • The influence of formulation variables on the performance of alternative propellant-driven metered dose inhalers
    • Smyth HDC. 2003. The influence of formulation variables on the performance of alternative propellant-driven metered dose inhalers. Adv Drug Del Rev 55:807-828.
    • (2003) Adv Drug Del Rev , vol.55 , pp. 807-828
    • Smyth, H.D.C.1
  • 9
    • 0032438394 scopus 로고    scopus 로고
    • Improved airway targeting with CFC-free HFA-beclomethasone dipropionate metered-dose inhaler compared with CFC-beclomethasone
    • Leach CL, Davidson PJ, Boudreau RJ. 1998. Improved airway targeting with CFC-free HFA-beclomethasone dipropionate metered-dose inhaler compared with CFC-beclomethasone. Eur Respir J 12:1346-1353.
    • (1998) Eur Respir J , vol.12 , pp. 1346-1353
    • Leach, C.L.1    Davidson, P.J.2    Boudreau, R.J.3
  • 10
    • 0006099669 scopus 로고
    • Chemical stability in pressurized inhalers formulated as solutions
    • Soine WH, Blondino FE, Byron PR. 1992. Chemical stability in pressurized inhalers formulated as solutions. J Biopharm Sci 3:41-47.
    • (1992) J Biopharm Sci , vol.3 , pp. 41-47
    • Soine, W.H.1    Blondino, F.E.2    Byron, P.R.3
  • 11
    • 0001337425 scopus 로고
    • Organic reactions at alumina surfaces
    • Posner GH. 1978. Organic reactions at alumina surfaces. Angew Chem Int Ed Engl 17:487-496.
    • (1978) Angew Chem Int Ed Engl , vol.17 , pp. 487-496
    • Posner, G.H.1
  • 12
    • 85030493866 scopus 로고    scopus 로고
    • C-17/21 OH 20-ketosteroid solution aerosol products with enhanced chemical stability. Patent US6315985.
    • Wu ZZ, Govind N, Johnson PR. 2001. C-17/21 OH 20-ketosteroid solution aerosol products with enhanced chemical stability. Patent US6315985.
    • (2001)
    • Wu, Z.Z.1    Govind, N.2    Johnson, P.R.3
  • 13
    • 0348085798 scopus 로고
    • Studies on the stability of corticosteroids. III. Separation and quantitation of hydrocortisone and its degradation products by high-performance liquid chromatography
    • Hansen J, Bundgard H. 1980. Studies on the stability of corticosteroids. III. Separation and quantitation of hydrocortisone and its degradation products by high-performance liquid chromatography. Arch Pharm Chem Sci Ed 8:91-99.
    • (1980) Arch Pharm Chem Sci Ed , vol.8 , pp. 91-99
    • Hansen, J.1    Bundgard, H.2
  • 14
    • 34250256538 scopus 로고
    • Stability of corticosteroids under anaerobic conditions. VI. Kinetics of the decomposition of prednisolone and the appearance of some decomposition products in aqueous solution under anaerobic conditions
    • Dekker D, Beunen JH. 1980. Stability of corticosteroids under anaerobic conditions. VI. Kinetics of the decomposition of prednisolone and the appearance of some decomposition products in aqueous solution under anaerobic conditions. Pharm Weekbl 2:1116-1120.
    • (1980) Pharm Weekbl , vol.2 , pp. 1116-1120
    • Dekker, D.1    Beunen, J.H.2
  • 15
    • 85030492777 scopus 로고    scopus 로고
    • Stabilized steroid composition. International Publication Number WO9640042.
    • Won CM, Strohbeck CL, Tang SY, Hsu BH. 1996. Stabilized steroid composition. International Publication Number WO9640042.
    • (1996)
    • Won, C.M.1    Strohbeck, C.L.2    Tang, S.Y.3    Hsu, B.H.4
  • 16
    • 0028970008 scopus 로고
    • New steroidal antiinflammatory antedrugs: Steroidal [16α,17 α-d]-3′-carbethoxyisoxazolines
    • Kwon T, Heiman AS, Oriaku ET, Yoon K, Lee HJ. 1995. New steroidal antiinflammatory antedrugs: Steroidal [16α, 17 α-d]-3′-carbethoxyisoxazolines. J Med Chem 38:1048-1051.
    • (1995) J Med Chem , vol.38 , pp. 1048-1051
    • Kwon, T.1    Heiman, A.S.2    Oriaku, E.T.3    Yoon, K.4    Lee, H.J.5
  • 17
    • 0008590343 scopus 로고
    • Conversion of steroid-17-yl glyoxals to epimeric glycolic esters
    • Lewbart ML, Mattox VR. 1963. Conversion of steroid-17-yl glyoxals to epimeric glycolic esters. J Org Chem 28:1779-1785.
    • (1963) J Org Chem , vol.28 , pp. 1779-1785
    • Lewbart, M.L.1    Mattox, V.R.2
  • 18
    • 84859738038 scopus 로고    scopus 로고
    • Formulation of budesonide in a HFA pMDI propellant system
    • 3 mixture has been reported as a poster presented to the 2000 AAPS Conference.]
    • 3 mixture has been reported as a poster presented to the 2000 AAPS Conference].
    • (2000) AAPS Pharm Sci , vol.2 , Issue.SUPPL. , pp. 2111
    • Alband, T.1    Schultz, D.2    McIntyre, D.3    Wu, Z.Z.4
  • 19
    • 84859768430 scopus 로고    scopus 로고
    • Alumina-catalyzed degradation of triamcinolone acetonide in ethanol solution
    • [A part of the results has been reported as a poster presented to the 2000 AAPS Conference.]
    • Wu ZZ, Bui G, Thatcher M. 2000. Alumina-catalyzed degradation of triamcinolone acetonide in ethanol solution. AAPS Pharm Sci 2 (Suppl):2128. [A part of the results has been reported as a poster presented to the 2000 AAPS Conference].
    • (2000) AAPS Pharm Sci , Issue.2 SUPPL. , pp. 2128
    • Wu, Z.Z.1    Bui, G.2    Thatcher, M.3
  • 20
    • 85030488309 scopus 로고    scopus 로고
    • Flunisolide aerosol formulations. Patent US5980867.
    • Tzou TZ, Schultz RK, Ross DL. 1999. Flunisolide aerosol formulations. Patent US5980867.
    • (1999)
    • Tzou, T.Z.1    Schultz, R.K.2    Ross, D.L.3
  • 21
    • 84859755675 scopus 로고
    • Preparation and purity assessment of a reference standard: The major degradation product of chemically stressed triamcinolone acetonide
    • Holder NL, Gopal D, Hsu B. 1994. Preparation and purity assessment of a reference standard: The major degradation product of chemically stressed triamcinolone acetonide. Proc NOBCChE 21:127-139.
    • (1994) Proc NOBCChE , vol.21 , pp. 127-139
    • Holder, N.L.1    Gopal, D.2    Hsu, B.3
  • 22
    • 0003520774 scopus 로고
    • Silverstein RM, Bassler GC, Morrill TC, Eds. 5th ed. New York: John Wiley & Sons, Inc.
    • Silverstein RM, Bassler GC, Morrill TC, Eds. 1991. Spectrometric identification of organic compounds. 5th ed. New York: John Wiley & Sons, Inc., pp 246.
    • (1991) Spectrometric identification of organic compounds , pp. 246
  • 23
    • 62849108423 scopus 로고    scopus 로고
    • Forced degradation of betamethasone sodium phosphate under solid state: Formation, characterization, and mechanistic study of all four 17, 20-diastereomers of betamethasone 17-deoxy-20-hydroxy-21-oic acid
    • Li M, Wang X, Chen B, Chan TM, Rustum A. 2009. Forced degradation of betamethasone sodium phosphate under solid state: Formation, characterization, and mechanistic study of all four 17, 20-diastereomers of betamethasone 17-deoxy-20-hydroxy-21-oic acid. J Pharm Sci 98:894-904.
    • (2009) J Pharm Sci , vol.98 , pp. 894-904
    • Li, M.1    Wang, X.2    Chen, B.3    Chan, T.M.4    Rustum, A.5
  • 24
    • 0001277503 scopus 로고
    • Efficient oxidative coupling of 2-naphthols catalyzed by alumina-supported copper (II) sulfate using dioxygen as oxidant
    • Sakamoto T, Yonehara H, Pac C. 1994. Efficient oxidative coupling of 2-naphthols catalyzed by alumina-supported copper (II) sulfate using dioxygen as oxidant. J Org Chem 59:6859-6861.
    • (1994) J Org Chem , vol.59 , pp. 6859-6861
    • Sakamoto, T.1    Yonehara, H.2    Pac, C.3
  • 25
    • 0008763412 scopus 로고
    • Oxidation-reduction of 9-(p-methoxyphenyl)-9-fluorenylacetaldehyde on activated alumina
    • Lamb FA, Cote PN, Slutsky B, Vittimberga BM. 1974. Oxidation-reduction of 9-(p-methoxyphenyl)-9-fluorenylacetaldehyde on activated alumina. J Org Chem 39:2796-2797.
    • (1974) J Org Chem , vol.39 , pp. 2796-2797
    • Lamb, F.A.1    Cote, P.N.2    Slutsky, B.3    Vittimberga, B.M.4
  • 26
    • 0002401473 scopus 로고
    • Organic reactions at alumina surfaces. V. Highly selective alcohol and diol oxidation reactions on alumina
    • Posner GH, Perfetti RB, Runquist AW. 1976. Organic reactions at alumina surfaces. V. Highly selective alcohol and diol oxidation reactions on alumina. Tetrahedron Lett 39:3499-3502.
    • (1976) Tetrahedron Lett , vol.39 , pp. 3499-3502
    • Posner, G.H.1    Perfetti, R.B.2    Runquist, A.W.3
  • 27
    • 35348900505 scopus 로고
    • Stereospecific reductions of isoilludin S and M on alumina chromatography
    • Ichihara A, Matsumoto T. 1974. Stereospecific reductions of isoilludin S and M on alumina chromatography. Bull Chem Soc Jap 47:1030-1031.
    • (1974) Bull Chem Soc Jap , vol.47 , pp. 1030-1031
    • Ichihara, A.1    Matsumoto, T.2


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