Lactose contaminant as steroid degradation enhancer

Pharmaceutical Research

Volumn 25, Issue 11, 2008, Pages 2666-2673

  Nieuwmeyer, Florentine ^a   Van Der Voort Maarschalk, Kees ^a,b   Vromans, Herman ^a,c  

^a MERCK RESEARCH LABORATORIES   (United States)

^b UNIVERSITY OF GRONINGEN   (Netherlands)

^c UTRECHT UNIVERSITY   (Netherlands)

Author keywords

Degradation; Lactose; Particle surface; Phosphate; Steroid

Indexed keywords

17ALPHA HYDROXY 11 METHYLENE 19 NORPREGNA 4,15 DIEN 20 YN 3 ONE; LACTOSE; PHOSPHATE;

ARTICLE; CHEMICAL COMPOSITION; DRUG CONTAMINATION; DRUG DEGRADATION; DRUG STABILITY; HUMIDITY; PRIORITY JOURNAL;

DRUG CONTAMINATION; DRUG STABILITY; EXCIPIENTS; HYDROGEN-ION CONCENTRATION; LACTOSE; NORETHINDRONE; PARTICLE SIZE;

EID: 53849145301     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-008-9687-z     Document Type: Article

References (37)

1. Z. Li L. K. Jacobus W. P. Wuelfing M. Golden G. P. Martin R. R. Reed 2006 Detection and quantification of low-molecular-weight aldehydes in pharmaceutical excipients by headspace gas chromatography J. Chrom. A. 1104 1 10
2. F. J. S. Nieuwmeyer K. van der Voort Maarschalk H. Vromans 2007 Granule breakage during drying processes Int. J. Pharm. 329 81 87
3. K. C. Waterman R. C. Adami 2005 Accelerated aging: prediction of chemical stability of pharmaceuticals Int. J. Pharm. 293 101 125
4. K. C. Waterman, R. C. Adami, and J. Hong. Impurities in drug products. In S. Ahuja, and K. M. Alsante (eds.), Handbook of isolation and characterization of impurities in pharmaceuticals, Academic, Boston, 2005.
5. G. Zografi 1988 States of water associated with solids Drug Develop. Ind. Pharm. 14 1905 1926
6. J. T. Carstensen 1988 Effect of moisture on the stability of solid dosage forms Drug Develop. Ind. Pharm. 14 1927 1969
7. C. Ahlneck G. Zografi 1990 The molecular basis of moisture effects on the physical and chemical stability of drugs in the solid state Int. J. Pharm. 62 87 95
8. F. J. S. Nieuwmeyer, K. van der Voort Maarschalk, and H. Vromans. Consequences of granule heterogeneity for breakage and attrition during fluid bed drying. Eur. J. Pharm. Biopharm. (2008) doi: 10.1016/j.ejpb.2008.03.003.
9. J. T. Carstensen. Drug Stability; Principles and Practices. Marcel Dekker, New York, 1990.
10. E. G. Prout F. C. Tompkins 1944 The thermal decomposition of potassium permanganate Trans. Faraday. Soc. 40 448 498
11. L. Leeson A. Mattocks 1958 Decomposition of aspirin in the solid state J. Am. Pharm. Assoc. Sc. Ed. 49 329 333
12. C. Ahlneck G. Alderborn 1988 Solid state stability of acetylsalicylic acid in binary mixtures with microcrystalline and microfine cellulose Acta Pharm Suecica 25 41 52
13. C. Ahlneck P. Lundgren 1985 Methods for the evaluation of solid state stability and compatibility between drug and excipient Acta Pharm Suecica 22 6 305 313
14. J. T. Carstensen P. Pothisiri 1975 Decomposition of p-aminosalicylic acid in the solid state J. Pharm. Sc. 64 1 37 44
15. J. T. Carstensen F. Attarchi 1988 Decomposition of aspirin in the solid state in the presence of limited amounts of moisture III: Effect of temperature and a possible mechanism J. Pharm. Sci. 77 4 318 321
16. G. Buckton 1997 Characterisation of small changes of in the physical properties of powders of significance for dry powder inhalation Adv. Drug. Del. Rev. 26 17 27
17. A. Saleki-Gerhardt C. Ahlneck G. Zografi 1994 Assessment of disorder in crystalline solids Int. J. Pharm. 101 237 247
18. E. V. Lifran T. T. L. Vu R. J. Durham J. A. Hourigan R. W. Sleigh 2006 Lactose-phosphate and its origin in cheese-making: a case study Austr. J. Dairy Techn. 61 2 163 166
19. FIL-International Dairy Federation Milk. Determination of total phosphorus content, Spectrometric method. International Standard 1990, 42B: (1990).
20. R. Mahajan A. Templeton A. Harman R. Reed R. Chern 2005 The effect of inert atmospheric packaging on oxidative degradation in formulated granules Pharm. Res. 22 128 140
21. J. Bronlund T. Paterson 2004 Moisture sorption isotherms for crystalline, amorphous and predominantly crystalline lactose powders Int. Dairy J. 14 247 254
22. J. T. Carstensen C. Ertell 1990 Physical and chemical properties of calcium phosphates for solid state pharmaceutical formulations Drug Dev. Ind. Pharm. 16 1121 1133
23. C. Scheef D. Oelkrug P. C. Smidt 1998 Surface acidity of solid pharmaceutical excipients III: Excipients for solid dosage forms Eur. J. Pharm. Biopharm. 46 209 213
24. I. Bernabe P. di Martino E. Joiris C. Berneron A. M. Guyot-Hermann P. Conflant M. Drache 1995 Compression ability improvement of lactose by recrystallization influence of lactose phosphate content Il Farmaco. 50 801 809
25. R. A Visser. Crystal growth kinetics of alpha-lactose monohydrate. Ph.D. thesis 1983
26. European Pharmacopeia 6.1, monograph 01/2008:0187, 2233-2234.
27. P. Thornalley S. Wolff J. Crabbe A. Stern 1984 The autoxidation of glyceraldehyde and other simple monosaccharides under physiological conditions catalysed by buffer ions Biochimica et Biophysica Acta 797 276 287
28. A. J. Stein J. H. Geiger 1999 The crystal structure and mechanism of 1-l-myo-inositol-1-phospahte synthase J. Biol Chem. 277 11 9484 9491
29. E. V. Lifran T. T. L. Vu R. J. Durham J. A. Hourigan R. W. Sleigh 2007 Crystallisation kinetics of lactose in the presence of lactose phosphate Powder Techn. 179 43 54
30. W. R. Wasylaschuk P. A. Harmon G. Wagner A. B. Harman A. C. Templeton H. Xui R. A. Reed 2007 Evaluation of hydroperoxides in common pharmaceutical excipients J. Pharm. Sc. 96 1 106 116
31. M. G. McGeown F. H. Malpress 1952 Studies on the synthesis of lactose by the mammary gland; the sugar-phosphates in milk Biochem. J. 52 606 611
32. K. van den Dries H. Vromans 2002 Relationship between inhomogeneity phenomena and granule growth mechanisms in a high-shear mixer Int. J. Pharm. 247 167 177
33. H. Vromans H. G. M. Poels-Janssen H. Egermann 1999 Effects of high shear granulation on granule homogeneity Pharm. Dev. Technol. 4 297 303
34. A. C. Scott M. J. Hounslow T. Instone 2000 Direct evidence of heterogeneity during high shear granulation Powder Techn. 113 205 213
35. K. van den Dries O. M. de Vegt V. Girard H. Vromans 2003 Granule breakage phenomena in a high shear mixer; influence of process and formulation variables and consequences on granule homogeneity Powder Technol. 133 228 236
36. M. D. Jones R. Price 2006 The influence of fine excipient particles on the performance of carrier based dry powder inhalation formulations Pharm. Res. 23 1665 1674
37. X. Zeng G. P. Martine C. Marriot J. Pritchard 2001 Lactose as a carrier in dry powder formulations: the influence of surface characteristics on drug delivery J. Pharm. Sc. 90 1424 1434