Disproportionation of the calcium salt of atorvastatin in the presence of acidic excipients

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 82, Issue 2, 2012, Pages 410-416

  Christensen, Niels Peter Aae ^a   Rantanen, Jukka ^a   Cornett, Claus ^a   Taylor, Lynne S ^b  

^a UNIVERSITY OF COPENHAGEN   (Denmark)

^b PURDUE UNIVERSITY   (United States)

Author keywords

Chemometrics; Disproportionation; Excipients; Processing; Raman spectroscopy; Salt

Indexed keywords

ASCORBIC ACID; ATORVASTATIN; CALCIUM SALT; CITRIC ACID; EXCIPIENT; LACTOSE; MANNITOL; POLYACRYLIC ACID; SORBITOL; STARCH GLYCOLATE SODIUM;

ARTICLE; CHEMOMETRIC ANALYSIS; CHEMOMETRICS; DRUG FORMULATION; DRUG MANUFACTURE; HUMIDITY; POWDER; SPECTROSCOPY; STORAGE; STRESS; TEMPERATURE;

ACIDS; ACRYLIC RESINS; CALCIUM; CALIBRATION; CHEMISTRY, PHARMACEUTICAL; CITRIC ACID; EXCIPIENTS; HEPTANOIC ACIDS; HUMIDITY; HYDROGEN-ION CONCENTRATION; POWDERS; PYRROLES; SOLUTIONS; TEMPERATURE;

EID: 84867863966     PISSN: 09396411     EISSN: 18733441     Source Type: Journal    
DOI: 10.1016/j.ejpb.2012.07.003     Document Type: Article

References (29)

1. C.G. Wermuth, and P.H. Stahl Introduction P.H. Stahl, C.G. Wermuth, Handbook of Pharmaceutical Salts - Properties, Selection, and Use 2008 Wiley-VCH 1 8
2. A.T. Serajuddin Salt formation to improve drug solubility Adv. Drug Deliv. Rev. 59 2007 603 616 (Pubitemid 47285406)
3. C.R. Gardner, C.T. Walsh, and O. Almarsson Drugs as materials: valuing physical form in drug discovery Nat. Rev. Drug Discov. 3 2004 926 934 (Pubitemid 39529930)
4. G.G. Zhang, D. Law, E.A. Schmitt, and Y. Qiu Phase transformation considerations during process development and manufacture of solid oral dosage forms Adv. Drug Deliv. Rev. 56 2004 371 390 (Pubitemid 38202329)
5. M. Pudipeddi, A.T.M. Serajuddin, D.J.W. Grant, and P.H. Stahl Solubility and dissolution of weak acids, bases, and salts P.H. Stahl, C.G. Wermuth, Handbook of Pharmaceutical Salts - Properties, Selection, and Use 2008 Wiley-VCH Zürich 19 40
6. P. Guerrieri, A.C. Rumondor, T. Li, and L.S. Taylor Analysis of relationships between solid-state properties, counterion, and developability of pharmaceutical salts AAPS. PharmSciTech. 11 2010 1212 1222
7. P. Guerrieri, K. Jarring, and L.S. Taylor Impact of counterion on the chemical stability of crystalline salts of procaine J. Pharm. Sci. 99 2010 3719 3730
8. B.M. Maurin, D.J.W. Grant, and P.H. Stahl The physicochemical background: fundamentals of ionic equilibria P.H. Stahl, C.G. Wermuth, Handbook of Pharmaceutical Salts - Properties, Selection, and Use 2008 Wiley-VCH Zürich 9 18
9. G.A. Stephenson, A. Aburub, and T.A. Woods Physical stability of salts of weak bases in the solid-state J. Pharm. Sci. 100 2011 1607 1617
10. M.B. Maurin, W.J. Addicks, S.M. Rowe, and R. Hogan Physical chemical properties of alpha styryl carbinol antifungal agents Pharm. Res. 10 1993 309 312 (Pubitemid 23041750)
11. P. Guerrieri, and L.S. Taylor Role of salt and excipient properties on disproportionation in the solid-state Pharm. Res. 26 2009 2015 2026
12. E.A. Zannou, Q. Ji, Y.M. Joshi, and A.T. Serajuddin Stabilization of the maleate salt of a basic drug by adjustment of microenvironmental pH in solid dosage form Int. J. Pharm. 337 2007 210 218 (Pubitemid 46756053)
13. B.R. Rohrs, T.J. Thamann, P. Gao, D.J. Stelzer, M.S. Bergren, and R.S. Chao Tablet dissolution affected by a moisture mediated solid-state interaction between drug and disintegrant Pharm. Res. 16 1999 1850 1856 (Pubitemid 30040701)
14. V.M. Sonje, L. Kumar, C.L. Meena, G. Kohli, V. Puri, R. Jain, A.K. Bansal, and H. Brittain Atorvastatin calcium Profiles Drug Subst., Excipients, Relat. Methodol. 35 2010 1 70
15. L.B. Rockland Saturated salt solutions for static control of relative humidity between 5°C and 40°C Anal. Chem. 32 1960 1375 1376
16. S. Wold, M. Sjöström, and L. Eriksson PLS-regression: a basic tool of chemometrics Chemom. Intell. Lab. Syst. 58 2001 109 130 (Pubitemid 33033283)
17. L. Norgaard, A. Saudland, J. Wagner, J.P. Nielsen, L. Munck, and S.B. Engelsen Interval partial least-squares regression (iPLS): a comparative chemometric study with an example from near-infrared spectroscopy Appl. Spectrosc. 54 2000 413 419 (Pubitemid 30585546)
18. M. Bassompierre, L. Munck, R. Bro, and S.B. Engelsen Rapid dioxin assessment in fish products by fatty acid pattern recognition Analyst 129 2004 553 558 (Pubitemid 38813521)
19. L. Norgaard, M.T. Hahn, L.B. Knudsen, I.A. Farhat, and S.B. Engelsen Multivariate near-infrared and Raman spectroscopic quantifications of the crystallinity of lactose in whey permeate powder Int. Dairy. J. 15 2005 1261 1270 (Pubitemid 41219221)
20. Å. Rinnan, F. van den Berg, and S.B. Engelsen Review of the most common pre-processing techniques for near-infrared spectra Trends Anal. Chem. 28 2009 1201 1222
21. J.A. Dean Correlation of Infrared Spectra with Molecular Structure in the Mid-Infrared Region 1995 Analytical Chemistry Handbook McGraw-Hill, Inc. New York pp. 18-45
22. N.P.A. Christensen, C. Cornett, and J. Rantanen Role of excipients on solid-state properties of piroxicam during processing J. Pharm. Sci. 101 2012 1202 1211
23. C.M. Andersen, and R. Bro Variable selection in regression - a tutorial J. Chemom. 24 2010 728 737
24. R.C. Rowe, P.J. Sheskey, and S.C. Owen Handbook of Pharmaceutical Excipients 2006 Pharmaceutical Press London and Chicago
25. H. Shindo, M. Ohashi, O. Tateishi, and A. Seo Atomic force microscopic observation of step movements on NaCl(0 0 1) and NaF(0 0 1) with the help of adsorbed water J. Chem. Soc. Faraday Trans. 93 1997 1169 1174 (Pubitemid 127820853)
26. M. Luna, F. Rieutord, N.A. Melma, Q. Dai, and M. Salmeron Adsorption of water on alkali halide surfaces studied by scanning polarization force microscopy J. Phys. Chem. A 102 1998 6793 6800 (Pubitemid 128604939)
27. B.C. Hancock, and C.R. Dalton The effect of temperature on water vapor sorption by some amorphous pharmaceutical sugars Pharm. Dev. Technol. 4 1999 125 131 (Pubitemid 29072356)
28. E.F. Unger Weighing benefits and risks - the FDA's review of prasugrel N. Engl. J. Med. 361 2009 942 945
29. D.A. Shah, K.K. Bhatt, R.S. Mehta, S.L. Baldania, and T.R. Gandhi Stability indicating RP-HPLC estimation of atorvastatin calcium and amlodipine besylate in pharmaceutical formulations Indian J. Pharm. Sci. 70 2008 754 760