Guidelines for the practical stability studies of anticancer drugs: A European consensus conference

Annales Pharmaceutiques Francaises

Volumn 69, Issue 4, 2011, Pages 221-231

  Bardin, C ^a   Astier, A ^b   Vulto, A ^c   Sewell, G ^d   Vigneron, J ^e   Trittler, R ^f   Daouphars, M ^g   Paul, M ^b   Trojniak, M ^h   Pinguet, F ⁱ  

^a HÔTEL DIEU   (France)

^b FACULTÉ DE MÉDECINE   (France)

^c ERASMUS MEDICAL CENTER   (Netherlands)

^d UNIVERSITY OF PLYMOUTH   (United Kingdom)

^e INFOSTAB   (France)

^f UNIVERSITY OF FREIBURG   (Germany)

^g CENTRE HENRI BECQUEREL   (France)

^h VENETO INSTITUTE OF ONCOLOGY IOV IRCCS   (Italy)

ⁱ CENTRE VAL D AURELLE   (France)

Author keywords

Anticancer drugs; Consensus conference; Europe; Guidelines; Practical stability

Indexed keywords

ANTINEOPLASTIC AGENT; PROTEIN;

ARTICLE; BIOLOGICAL ACTIVITY; CLINICAL PRACTICE; CONSENSUS; DEVICE; DRUG DEGRADATION; DRUG INFUSION; DRUG STABILITY; ENVIRONMENTAL TEMPERATURE; EUROPE; HEALTH CARE ORGANIZATION; LIGHT; MECHANICAL STRESS; METHODOLOGY; OUTPATIENT; PH; PHARMACY; PRACTICE GUIDELINE; RISK; STORAGE TEMPERATURE;

ANTINEOPLASTIC AGENTS; DRUG INDUSTRY; DRUG STABILITY; DRUG STORAGE; EUROPE; FRANCE; LIGHT; REPRODUCIBILITY OF RESULTS; STERILIZATION; TEMPERATURE;

EID: 80051578699     PISSN: 00034509     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.pharma.2011.07.002     Document Type: Article

References (55)

1. De Lemos M.L., Hamata L. Stability issues of parenteral chemotherapy drugs. J Oncol Pharm Pract 2007, 13:27-31.
2. Astier A. The stability of anticancer drugs. EJHP Pract 2007, 13:90-93.
3. Herceptin. Information professionnelle du Compendium Suisse des Médicaments® Acceded June, 10, 2011. http://www.kompendium.ch/MonographieTxt.aspx%3Flang=fr%26MonType=fi.
4. Plumridge R., Sewell G. Dose-banding of cytotoxic drugs: a new concept in cancer chemotherapy. Am J Health Syst Pharm 2001, 58:1760-1764.
5. Kaestner S., Walker V., Perren T., Sewell G.J. Clinical and pharmacokinetic study on dose-banded and individual chemotherapy. J Oncol Pharm Pract 2004, 10:100.
6. Sewell G.J., Priston M.J. Stability of intravesical epirubicin infusion. A sequential temperature study. J Clin Pharmacy Ther 2003, 28:349-353.
7. Sewell G.J., Rigby-Jones A.E., Priston M.J. Stability of intravesical epirubicin infusion: a sequential temperature study. J Clin Pharm Ther 2003, 28:349-353.
8. Kaestner S., Sewell G. A sequential temperature cycling study for the investigation of carboplatin infusion stability to facilitate dose-banding. J Oncol Pharm Pract 2007, 13:109-117.
9. Manning M.C., Chou D.K., Murphy B.M., Payne R.W., Katayama D.S. Stability of proteins pharmaceuticals: an update. Pharm Res 2010, 27:544-575.
10. Wang W. Instability, stabilization and formulation of liquid protein pharmaceuticals. Int J Pharm 1999, 185:129-188.
11. Lalou A., Blanchet B., Carvalho M., Paul M., Astier A. Mechanically-induced aggregation of the monoclonal antibody cetuximab. Ann Pharm Fr 2009, 67:340-352.
12. Bolognese A, Esposito A, Manfra M, Catalano L, Petruziello F, Martorelli MC, et al. An NMR study of the bortezomib degradation under clinical use conditions. Adv Hematol 2009 [art. no. 704928].
13. Andre P., Cisternino S., Chiadmi F., Toledano A., Schlatter J., Fain O., et al. Stability of bortezomib 1mg/mL solution in plastic syringe and glass vial. Ann Pharmacother 2005, 39:1462-1466.
14. Friess D., Nguyen H.C., Lipp H.P. HPLC-stabilitätuntersuchungen zu rekonstituierten Bortezomib-Lösungen. Krankenhauspharmazie 2005, 26(6):206-210.
15. Walker S.E., Milliken D., Law S. Stability of bortezomib reconstituted with 0.9% sodium chloride at 4°C and room temperature (23°C). Can J Hosp Pharm 2008, 61(1):14-20.
16. International Conference of Harmonization (ICH). Guidelines for stability 2011. http://www.ich.org/products/guidelines.html.
17. Bakshi M., Singh S. Development of stability-indicating assay methods - critical review. J Pharm Biomed Anal 2002, 28:1011-1040.
18. Williams L.A., Hastings M.B. Identifying the criteria of a valid stability study. Int J Pharm Compound 2009, 13:32-36.
19. Trissel L.A. Trissel's stability of compounded formulations 2005, APhA, 512 pp. 3th ed.
20. Vigneron J. Stability studies of drugs used in oncology: the role of the hospital pharmacist. EJHP Pract 2006, 12:75-76.
21. Vigneron J. Stability studies: ten pieces of advice. EJHP Sci 2008, 14:2.
22. Prankerd R. Compounded products - stability studies in hospital pharmacy department. J Pharm Pract Res 2009, 39:5-7.
23. Dolan J.W. Stability-indicating assays. LC-GC North America 2004, 25:346-348.
24. Hong D.D., Shah M. Development and validation of HPLC stability indicating assays. Drug stability: principles and practices 2000, 329-384. Marcel Dekker, New York. J.T. Carstensen, C.T. Rhodes (Eds.).
25. Magari R.T. Uncertainty of measurement and error in stability studies. J Pharm Biomed Anal 2007, 45:171-175.
26. Xu Q.A., Trissel L.A. Stability indicating HPLC methods for drug analysis 1999, McGraw-Hill, New York.
27. Gamelin E., Boisdron-Celle M., Delva R., et al. Long-term weekly treatment of colorectal metastatic cancer with fluorouracil and leucovorin: results of a multicentric prospective trial of fluorouracil dosage optimization by pharmacokinetic monitoring in 152 patients. J Clin Oncol 1998, 16:1470-1478.
28. Fournet A., Gilard V., Malet-Martino M., Martino R., Canal P., De Forni M. Stability of commercial solutions of 5-fluorouracil. Cancer Chemother Pharmacol 2000, 46:501-506.
29. Martel P., Petit I., Pinguet F., Poujol S., Astre C., Fabbro M. Long term stability of 5-fluorouracil. J Pharm Biomed Anal 1996, 14:395-399.
30. Whelan J.S. Fatal radiation myelopathy after high dose busulfan and melphalan chemotherapy and radiotherapy for Ewing's sarcoma: a review of the litterature and implications for practice. Clin Oncol 2005, 17:385-390.
31. Karstens A., Krämer I. Chemical and physical stability of diluted busulfan infusion solutions. Eur J Hosp Pharm Sci 2007, 13:40-47.
32. Zhou X.J., Rahmani R. Preclinical and clinical pharmacology of vinca alkaloids. Drugs 1992, 44:1-16.
33. Chatelut E., Canal P., Bugat R. Pharmacokinetics and individual dose adjustment of carboplatin. Bull Cancer 2000, 87:17-23.
34. Zhang Y., Trissel L. Physical instability of frozen pemetrexed solutions in PVC bags. Ann Pharmacother 2006, 40:1289-1292.
35. Chi E.Y., Krishnan S., Randolph T.W., Carpenter J.F. Physical stability of proteins in aqueous solution; mechanism and driving forces in non-native protein aggregation. Pharm Res 2003, 20:1325-1336.
36. Bee S.J., Chiu D., Sawicki S., Stevenson J.L., Chatterjee K., Freund E., et al. Monoclonal antibody interactions with micro-and nanoparticles: adsorption, aggregation, and accelerated stress studies. J Pharm Sci 2009, 98:3218-3238.
37. Bee S.J., Melson S.A., Freund E., Carpenter J.F., Randolph T.W. Precipitation of monoclonal antibody by soluble tungsten. J Pharm Sci 2009, 98:3290-3301.
38. Philo J.S., Arakawa T. Mechanisms of protein aggregation. Curr Pharm Biotechnol 2009, 10:348-351.
39. Mahler H.C., Friess W., Grauschopf U., Kiese S. Protein aggregation: pathways, induction factors, and analysis. J Pharma Sci 2009, 98:2909-2934.
40. Paul M., Lalou A., Carvalho M., Blanchet B., Astier A. Thermal stability of two monoclonal antibodies: cetuximab and bevacizumab. Eur J Oncol Pharm 2008, 2:37.
41. Malher H.C., Müller R., Frie W., Dellile A., Matheus S. Induction and analysis of aggregates in a liquid IgG1-antibody formulation. Eur J Pharm Biopharm 2005, 59:407-417.
42. Lebitasy M., Hecq J.D., Athanassopoulos A., Vanbeckbergen D., Jamart J., Galanti L. Effect of freeze-thawing on the long term stability of calcium levofolinate in 5% dextrose stored on polyolefin infusion bags. J Clin Pharm Ther 2009, 34:423-428.
43. Hecq J.D. Ten years of European hospital pharmacy history: centralized intravenous additives services. Eur J Hosp Pharm 2004, 10:47.
44. Cohen V., Jellinek S.P., Teperikidis L., Berkovits E., Goldman W.M. Room temperature storage of medications labeled for refrigeration. Am J Health Syst Pharm 2007, 64:1711-1715.
45. Kim H.H., Lee Y.M., Suh J.K., Song N.W. Photodegradation mechanism and reaction kinetics of recombinant human interferon α-2. Photochem Photobio Sci 2007, 6:171-180.
46. Karstens A., Krämer I. Viability of micro-organisms in novel chemical and biopharmaceutical drug solutions for cancer treatment. Eur J Hosp Pharm Sci 2007, 11:27-32.
47. Astier A., Pinguet F., Vigneron J. The practical stability of anticancer drugs: SFPO and ESOP recommendations. Eur J Oncol Pharm 2010, 4(3):4-10. The SFPO stability group members.
48. Staub A., Guillarme D., Schappler J., Veuthey J.L., Rudaz S. Intact protein analysis in the biopharmaceutical field. J Pharm Biopharm Anal 2011, 55:810-822.
49. Ikesue H., Vermeulen L.C., Hoke R., Kolesar J.M. Stability of cetuximab and panitumumab in glass vials and polivinyl chloride bags. Am J Health Syst Pharm 2010, 67:223-226.
50. Schellekens H. Bioequivalence and the immunogenicity of biopharmaceuticals. Nature Rev 2002, 1:457-462.
51. Wang W., Singh S., Zeng D.L., King K., Nema S. Antibody structure, instability, and formulation. J. Pharm. Sci. 2007, 96:1-26.
52. Fradkin A.H., Carpenter J.F., Randolph T.W. Immunogenicity of aggregates of recombinant human growth hormone in mouse models. J Pharm Sci 2009, 98:3247-3264.
53. Gøtzsche P.C., Jørgensen A.W. Opening up data at the European Medicines Agency. Br Med J 2011, 342:1-4.
54. King Guide to parenteral admixtures: http://www.kingguide.com/.
55. Vigneron J. Stabilis Infostab. http://www.infostab.com/.