Particulate Matter in Injectable Drug Products

References

1. 1.↵
   1. Bartecchi C. E.

   Intravenous therapy: from humble beginnings through 150 years. South. Med. J. 1982, 75, 61–64.

   OpenUrlPubMed
2. 2.↵
   American Hospital Association Hospital Statistics, 2011.
3. 3.↵
   1. Pesko L. J.

   Physiological Consequences of Injected Particulates. In Liquid and Surface Borne Particle Measurement Handbook; Marcel Dekker, Inc.: New York, 1996; pp 661–686.
4. 4.↵
   USP <788> Particulate Matter in Injections. USP 35; U.S. Pharmacopeial Convention: Rockville, MD, 2012; pp 339–342.
5. 5.↵
   1. Groves M. J.

   Parenteral Products; Hindemann Medical Books, Ltd.: London, 1973.
6. 6.↵
   USP <1788> Methods for the Determination of Particulate Matter in Injections and Ophthalmic Solutions. 2102. USP 35. pp. 945–954.
7. 7.↵
   1. Nema S.,
   2. Ludwig J. D.

   1. Aldrich D. S.

   Chapter 5. Particulate Matter: Sub-Visible. In Pharmaceutical Dosage Forms: Parenteral Medications; Nema S., Ludwig J. D., Eds. Third ed. Volume 2, Informa Healthcare, New York NY 2010, 114–145.

   OpenUrl
8. 8.↵
   1. Barber Thomas.

   Chapter 7. Visual Inspection of Injectables and Devices. In Control of Particulate Matter: Contamination in Healthcare Manufacturing; Interpharm Press: Buffalo Grove, IL, 2000; pp 229–274.
9. 9.↵
   USP <1790> Visual Inspection of Injectable Products for Particulates. In preparation.
10. 10.↵
    1. Falchuk Kenneth H.,
    2. Peterson Lynn,
    3. McNeil Barbara J.

    . Macroparticle-Induced Phlebitis: Its Prevention by In-Line Filtration. New Engl. J. Med. 1985, 312 (2), 78–82.

    OpenUrlCrossRefPubMedWeb of Science
11. 11.↵
    1. Tran T.,
    2. Kupiec T. C.,
    3. Trissel L. A.

    Particulate matter in injections: What is it and what are the concerns? International Journal of Pharmaceutical Compounding 2006, 10 (3), 202–204.

    OpenUrl
12. 12.↵
    1. Gurgvich I.

    Letter to the Editor. New Engl. J. Med. 1985, 312 (22), 1453.

    OpenUrl
13. 13.↵
    1. Kirkpatrick C. J.,
    2. Rangoonwala R.

    Originator antibiotic or generic in clinical practice. J. Appl. Ther. Res. 2009, 7, 52–57.

    OpenUrl
14. 14.↵
    1. Hill S. E.,
    2. Heldman L. S.,
    3. Goo E. D.,
    4. Whippo P. E.,
    5. Perkinson J. C.

    Fatal microvascular pulmonary emboli from precipitation of a total nutrient admixture solution. J. Parenter. Enteral Nutr. 1996, 20 (1), 81–87.

    OpenUrlAbstract/FREE Full Text
15. 15.↵
    1. Schaefer S. C.,
    2. Bison P. A.,
    3. Rangoonwala R.,
    4. Kirckpatrick C. J.,
    5. Lehr H. A.

    0.2 um in-line filters prevent capillary obstruction by particulate contamination of generic antibiotic preparations in postischemic muscle. Chemother. J. 2008, 17, 172–178.

    OpenUrl
16. 16.↵
    1. Illum L.,
    2. Davis S. S.,
    3. Wilson C. G.,
    4. Thomas N. W.,
    5. Frier M.,
    6. Hardy J. G.

    Blood clearance and organ deposition of intravenously administered colloidal particles. The effects of particle size nature and shape. Int. J. Pharm. 1982, 12 (2-3), 135–146.

    OpenUrlCrossRef
17. 17.↵
    1. Malizia A. A. Jr..,
    2. Reiman H. M.,
    3. Myers R. P.,
    4. Sande J. R.,
    5. Barham S. S.,
    6. Benson R. C. Jr..,
    7. Dewanjee M. K.,
    8. Utz W. J.

    Migration and granulomatous reaction after periurethral injection of polytef (Teflon). J. Am. Med. Assoc. 1984, 251 (24), 3277–3281.

    OpenUrlCrossRefPubMed
18. 18.↵
    1. Jack T.,
    2. Brent B. E.,
    3. Boehne M.,
    4. Muller M.,
    5. Sewald K.,
    6. Braun A.,
    7. Wessel A.,
    8. Sasse M.

    Analysis of particulate contaminations of infusion solutions in a pediatric intensive care unit. Intensive Care Med. 2010, 36 (4), 707–711.

    OpenUrlPubMed
19. 19.↵
    1. Winding O.,
    2. Gronvall J.,
    3. Faarup P.,
    4. Hegedus V.

    Sequelae of intrinsic foreign-body contamination during selective renal angiography in rabbits. Radiology 1980, 134 (2), 321–326.

    OpenUrlPubMed
20. 20.↵
    1. Shay D. K.,
    2. Fann L. M.,
    3. Jarvis W. R.

    Respiratory distress and sudden death associated with receipt of a peripheral parenteral nutrition admixture. Infect. Control Hosp. Epidemiol. 1997, 18 (12), 814–817.

    OpenUrlPubMedWeb of Science
21. 21.↵
    1. Bradley J. S.,
    2. Wassel R. T.,
    3. Lee L.,
    4. Nambiar S.

    Intravenous ceftriaxone and calcium in the neonate: assessing the risk for cardiopulmonary adverse events. Pediatrics 2009, 123 (4), 609–613.

    OpenUrlCrossRef
22. 22.↵
    1. Cant A. J.,
    2. Lenney W.,
    3. Kirkham N.

    Plastic material from a syringe causing fatal bowel necrosis in a neonate. Br. Med. J. 1988, 296 (6627), 968–969.

    OpenUrlFREE Full Text
23. 23.↵
    1. Barber T.

    Chapter 1. Introduction and Overview. In Control of Particulate Matter: Contamination in Healthcare Manufacturing; Interpharm Press: Buffalo Grove, IL, 2000; pp 1–26.
24. 24.↵
    1. MacMahon P. J.,
    2. Eustace S. J.,
    3. Kavanagh E. C.

    Injectable corticosteroid and local anesthetic preparations: a review for radiologists. Radiology 2009, 252 (3), 647–661.

    OpenUrlCrossRefPubMedWeb of Science
25. 25.↵
    1. Okubadejo G. O.,
    2. Talcott M. R.,
    3. Schmidt R. E.,
    4. Sharma A.,
    5. Patel A. A.,
    6. Mackey R. B.,
    7. Guarino A. H.,
    8. Moran C. J.,
    9. Riew K. D.

    Perils of intravascular methylprednisolone injection into the vertebral srtery. J. Bone Joint Surg. Am. 2008, 90 (9), 1932–1938.

    OpenUrlCrossRef
26. 26.↵
    International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Pharmaceutical Development Q8(R2), 2009.
27. 27.↵
    1. Kanke M.,
    2. Simmons G. H.,
    3. Weiss D. L.,
    4. Bivins B. A.,
    5. DeLuca P. P.

    Clearance of 141C3-labeled microspheres from blood and distribution in specific organs following intravenous and intraarterial administration in beagle dogs. J. Pharm. Sci. 1980, 69 (7), 755–762.

    OpenUrlPubMedWeb of Science
28. 28.↵
    Intravenous ceftriaxone (marketed As Rocephin and generics) and calcium drug–drug interaction. FDA Drug Safety Newsletter 2009, 2 (3), 24–25.

    OpenUrl
29. 29.↵
    1. McKinnon B. T.

    FDA safety alert: hazards of precipitation associated with parenteral nutrition. Nutr. Clin. Pract. 1996, 11 (2), 1427–1428.

    OpenUrl
30. 30.↵
    1. Backhouse C. M.,
    2. Ball P. R.,
    3. Booth S.,
    4. Kelshaw M.,
    5. Potter S. R.,
    6. McCollum C. N.

    Particulate contaminants of intravenous medications and infuaions. J. Pharm. Pharmacol. 1987, 39:241–245.

    OpenUrlPubMedWeb of Science
31. 31.↵
    1. Puntis J. W.,
    2. Wilkins K. M.,
    3. Ball P. A.,
    4. Rushton D. I.,
    5. Booth I. W.

    Hazards of parenteral treatment: Do particles count? Arch. Dis. Child. 1992, 67 (12), 1475–1477.

    OpenUrlAbstract/FREE Full Text
32. 32.↵
    1. Van Lingen R. A.,
    2. Baerts W.,
    3. Marquering A. C. M.,
    4. Ruijs G. J. H. M.

    . The use of in-line intravenous filters in sick newborn infants. Acta Paediatr. 2004, 93 (5), 658–662.

    OpenUrlPubMedWeb of Science
33. 33.↵
    1. Niël-Weise B. S.,
    2. Stijnen T.,
    3. van den Broek P. J.

    Should in-line filters be used in peripheral intravenous catheters to prevent infusion-related phlebitis? A systematic review of randomized controlled trials. Anesth. Analg. 2010, 110 (6), 1624–1629.

    OpenUrlCrossRefPubMed
34. 34.↵
    1. Walpot H.,
    2. Franke R. P.,
    3. Burchard W. G.,
    4. Agternkamp C.,
    5. Müller F. G.,
    6. Mittermayer C.,
    7. Kalff G.

    Particulate contamination of intravenous solutions and drug additives during long-term Intensive therapy. 1. Energy dispersion electron images in the scanning electron microscope-REM/EDX. Anaesthesist 1989, 38 (10), 544–548.

    OpenUrlPubMedWeb of Science
35. 35.↵
    1. van den Hoogen A.,
    2. Krediet T. G.,
    3. Uiterwaal C. S.,
    4. Bolenius J. F.,
    5. Gerards L. J.,
    6. Fleer A.

    In-line filters in central venous catheters in a neonatal intensive care unit. J. Perinat. Med. 2006, 34 (1), 71–74.

    OpenUrlPubMed
36. 36.↵
    1. Oie S.,
    2. Kamiya A.

    Particulate and microbial contamination in in-use admixed parenteral nutrition solutions. Biol. Pharm. Bull. 2005, 28 (12), 2268–2270.

    OpenUrlPubMed
37. 37.↵
    1. Newton D. W.,
    2. Driscoll D. F.

    Calcium and phosphate compatibility: revisited again. Am. J. Health Syst. Pharm. 2008, 65 (1), 73–80.

    OpenUrlFREE Full Text
38. 38.↵
    1. Zabir A. F.,
    2. Choy C. Y.,
    3. Bushdan R.

    Glass particle contamination of parenteral preparations of intravenous drugs in anaesthetic practice. Southern African Journal of Anaesthesia and Analgesia 2008, 14 (3), 17–19.

    OpenUrl
39. 39.↵
    1. Lye S. T.,
    2. Hwang N. C.

    Glass particle contamination: Is it here to stay? Anesthesia 2003, 58 (1), 93–94.

    OpenUrlPubMed
40. 40.↵
    1. Diebold,
    2. Kristie J.

    Pre-testing for delamination in pharmaceutical vials. Healthcare Packaging 2009. Available at www.healthcare-packaging.com/archives/2009/09/pre-testing_for_delamination_i.php.
41. 41.↵
    FDA. Enforcement Reports. Available at http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm
42. 42.↵
    1. Yorioka K.,
    2. Oie S.,
    3. Oomaki M.,
    4. Imamura A.,
    5. Kamiya A.

    Particulate and microbial contamination in in-use admixed intravenous infusions. Biol. Pharm. Bull. 2006, 29 (11), 2321–2323.

    OpenUrlPubMed
43. 43.↵
    1. Stellmack M.,
    2. Rhodes K.

    Contamination control—metal particles. Meddling metals can contaminate biopharmaceuticals. December/January 2011. Available at www.pharmquality.com.
44. 44.↵
    1. Stellmack M.,
    2. Rhodes K.

    Metal contamination in bio-pharmaceutical drugs: solving a puzzle without all the pieces. October 2010. Available at www.contractpharma.com.
45. 45.↵
    1. Popińska K.,
    2. Kierkuś J.,
    3. Lyszkowska M.,
    4. Socha J.,
    5. Pietraszek E.,
    6. Kmiotek W.,
    7. Ksiazyk J.

    Aluminum contamination of parenteral nutrition additives, amino acid solutions, and lipid emulsions. Nutrition 1999, 15 (9), 683–686.

    OpenUrlCrossRefPubMedWeb of Science
46. 46.↵
    1. Sedman A. B.,
    2. Klein G. L.,
    3. Merritt R. J.,
    4. Miller N. L.,
    5. Weber K. O.,
    6. W. L.,
    7. Gill H.,
    8. Anand H.,
    9. Alfrey A. C.

    Evidence of aluminum loading in infants teceiving intravenous therapy. New Engl. J. Med. 1985, 312 (21), 1337–1343.

    OpenUrlPubMedWeb of Science
47. 47.↵
    FDA. Aluminum in large and small volume parenterals used in total parenteral nutrition. Federal Register 2000, 65 (17), 4103–4111.

    OpenUrl
48. 48.↵
    FDA Warning Letter 10-ATL-12. April 12, 2010.
49. 49.↵
    1. Carpenter J. F.,
    2. Randolph T. W.,
    3. Jiskoot W.,
    4. Crommelin D. J.,
    5. Middaugh C. R.,
    6. Winter G.,
    7. Fan Y. X.,
    8. Kirshner S.,
    9. Verthelyi D.,
    10. Kozlowski S.,
    11. Clouse K. A.,
    12. Swann P. G.,
    13. Rosenberg A.,
    14. Cherney B.

    Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality. J. Pharm. Sci. 2008, 98 (4), 1201–1205.

    OpenUrl
50. 50.↵
    1. Giezen T. J.,
    2. Mantel-Teeuwisse A. K.,
    3. Straus S. M.,
    4. Schellekens H.,
    5. Leufkens H. G.,
    6. Egberts A. C.

    Safety-related regulatory actions for biologicals approved in the United States and the European Union. J. Am. Med. Assoc. 2008, 300 (16), 1887–1895.

    OpenUrlCrossRefPubMed
51. 51.↵
    1. Singh S. K.,
    2. Afonina N.,
    3. Awwad M.,
    4. Bechtold-Peters K.,
    5. Blue J. T.,
    6. Chou D.,
    7. Cromwell M.,
    8. Krause H. J.,
    9. Mahler H. C.,
    10. Meyer B. K.,
    11. Narhi L.,
    12. Nesta D. P.,
    13. Spitznagel T.

    An industry perspective on the monitoring of subvisible particles as a quality attribute for protein therapeutics. J. Pharm. Sci. 2010, 99 (8), 3302–3321.

    OpenUrlCrossRefPubMed
52. 52.↵
    1. Das T.,
    2. Nema S.

    Protein particulate issues in biologics development. Am. Pharm. Rev. 2008, 11 (4), 52–57.

    OpenUrl
53. 53.↵
    1. Krebs M. R. H.,
    2. Devlin G. L.,
    3. Donald A. M.

    Protein particulates: another generic form of protein aggregation? Biophys. J. 2007, 92 (4), 1336–1342.

    OpenUrlCrossRefPubMedWeb of Science
54. 54.↵
    1. Driscoll D. F.

    Medical Impact on Particle Size. Presentation at the USP Workshop on Particle Size. Rockville, MD, December 8–10, 2010.
55. 55.↵
    1. Driscoll D. F.,
    2. Ling P. R.,
    3. Andersson C.,
    4. Bistrian B. R.

    Hepatic indicators of oxidative stress and tissue damage accompanied by systemic Inflammation in rats following a 24-hour infusion of an unstable lipid emulsion admixture. J. Parenter. Enteral Nutr. 2009, 33 (3), 327–335.

    OpenUrlAbstract/FREE Full Text
56. 56.↵
    1. Lehr H.-A.,
    2. Brunner J.,
    3. Rangoonwala R.,
    4. Kirkpatrick C. J.

    Particulate matter contamination of intravenous antibiotics aggravates loss of functional capillary density in postischemic striated muscle. Am. J. Respir. Crit. Care Med. 2002, 165 (4), 514–520.

    OpenUrlCrossRefPubMedWeb of Science
57. 57.↵
    1. Brauser,
    2. Deborah

    . Inline filtration may reduce SIRS mortality in the pediatric ICU. http://www.medscape.com/viewarticle/715108. January 14, 2010.
58. 58.↵
    1. Madsen R. E.,
    2. Cherris R.,
    3. Shabushnig J.,
    4. Hunt D.

    Visible particulates in injections—a history and a proposal to revise USP General Chapter Injections <1>. Pharmacop. Forum 2009, 35 (5), 1383–1387.

    OpenUrl
59. 59.↵
    USP <790> Visible particulates in injections. Pharmacop. Forum 2012, 38 (2). Online
60. 60.↵
    1. Nath N.,
    2. McNeal E.,
    3. Obenhuber D.,
    4. Pillari B.,
    5. Shelton L.,
    6. Stevens-Riley M.,
    7. Sweeney N.

    Particulate contaminants of intravenous medication and the limits set by USP General Chapter <788>. Pharmacop. Forum 2004, 30 (6), 2272–2280.

    OpenUrl
61. 61.↵
    USP <787> Subvisible particulate matter in therapeutic protein injections. Pharmacop. Forum 2012, 38 (3). Online.
62. 62.↵
    1. Gallelli J. F.,
    2. Groves M. J.

    USP perspectives on particle contamination of injectable products. J. Parenter. Sci. Technol. 1993, 47 (6), 289–292.

    OpenUrlPubMed