Review ArticleReview

Analysis of Particulate Matter in Liquid-Finished Dosage Forms

Jan Duchek and Balazs Havasi
PDA Journal of Pharmaceutical Science and Technology November 2018, 72 (6) 608-625; DOI: https://doi.org/10.5731/pdajpst.2017.008292

Reference

  1. 1.↵
    1. Tawde S. A.
    Particulate Matter in Injectables: Main Cause for Recalls. J. Pharmacovigil. 2014, 3 (1).
  2. 2.↵
    Drug Recalls. U.S. Food and Drug Administration. http://www.fda.gov/Drugs/drugsafety/DrugRecalls/default.htm (accessed October 2018).
  3. 3.↵
    1. Madsen R. E.,
    2. Cherris R. T.,
    3. Shabushnig J. G.,
    4. Hunt D. G.
    Visible Particulates in Injections—A History and a Proposal to Revise USP General Chapter Injections <1> Pharmacopeial Forum. 2009, 35 (5), 1383–1387.
    OpenUrl
  4. 4.↵
    1. Langille S. E.
    Particulate Matter in Injectable Drug Products. PDA J. Pharm. Sci. Technol. 2016, 67 (3), 186–200.
    OpenUrl
  5. 5.↵
    1. Doessegger L.,
    2. Mahler H. C.,
    3. Szczesny P.,
    4. Rockstroh H.,
    5. Kallmeyer G.,
    6. Langenkamp A.,
    7. Herrmann J.,
    8. Famulare J.
    The Potential Clinical Relevance of Visible Particles in Parenteral Drugs. PDA J. Pharm. Sci. And Technol. 2012, 101 (8), 2635–2644.
    OpenUrl
  6. 6.↵
    1. Bukofzer S.,
    2. Ayres J.,
    3. Chavez A.,
    4. Devera M.,
    5. Miller J.,
    6. Ross D.,
    7. Shabushnig J.,
    8. Vargo S.,
    9. Watson H.,
    10. Watson R.
    Industry Perspective on the Medical Risk of Visible Particles in Injectable Drugs. PDA J. Pharm. Sci. and Technol. 2015, 69 (1), 123–139.
    OpenUrl
  7. 7.
    USP 37/NF number, General chapter <1> Injections – Foreign and particulate matter. www.usp.org.
  8. 8.
    Ph. Eur. 7.0 Parenteral preparations – Injections.
  9. 9.
    JP 16: 6.06. Foreign insoluble matter test.
  10. 10.↵
    USP <1790> Visual Inspection of Injections.
  11. 11.↵
    Selected reviews: (a) Ripple, D. C.; Dimitrova, M. N. Protein Particles: What We Know and What We Do Not Know PDA J. Pharm. Sci. and Technol. 2012, 101 (10), 3568–3579. (b) Zölls, S.; Tantipolphan, R.; Wiggenhorn, M.; Winter, G.; Jiskoot, W.; Friess, W.; Hawe, A. Particles in Therapeutic Protein Formulations, Part 1: Overview of Analytical Methods PDA J. Pharm. Sci. and Technol. 2012, 101 (3), 914–935. (c) Narhi, L. O.; Jiang, Y.; Cao, S.; Bedenek, K.; Shnek, D. A Critical Review of Analytical Methods for Subvisible and Visible Particles. Curr. Pharm. Biotechnol. 2009, 10 (4), 373–381.
  12. 12.↵
    1. Borchert S. J.,
    2. Abe A.,
    3. Aldrich D. S.,
    4. Fox L. E.,
    5. Freeman J.
    E; White, R. D. Particulate Matter in Parenteral Products: A Review. J. Parent. Sci Technol. 1986, 40 (5), 212–241.
    OpenUrl
  13. 13.↵
    1. Sandell E.
    1. Ernerot L
    Particulate matter in parenteral products, in Industrial Aspects of Pharmaceutics, Ed. Sandell E., Swedish Pharmaceutical Press 1993;227–235.
  14. 14.↵
  15. 15.↵
    1. Aldrich D. S.,
    2. Smith M. A.
    Pharmaceutical Applications of Infrared Microspectroscopy. Applied Spectroscopy Reviews. 1999, 34 (4), 275–327.
    OpenUrl
  16. 16.↵
    1. Barber T. A.
    Control of Particulate Matter Contamination in Healthcare Manufacturing, CRC Press: Boca Raton, 1999.
  17. 17.↵
    EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Annex 1, Manufacture of Sterile Medicinal Products.
  18. 18.↵
    ISO 14644-1:2015. Cleanrooms and associated controlled environments—Part 1: Classification of air cleanliness by particle concentration.
  19. 19.↵
    1. Yu L. X.,
    2. Amidon G.,
    3. Khan M. A.,
    4. Hoag S. W.,
    5. Polli J.,
    6. Raju G. K.,
    7. Woodcock J.
    (a) Quality by Design (QbD): An Example Pharmaceutical Development Report for an Immediate Release (IR) Dosage Form, April 2012, retrieved from www.fda.gov. (b) Yu L. X., Amidon G., Khan M. A., Hoag S. W., Polli J., Raju G. K., Woodcock J. Understanding Pharmaceutical Quality by Design. The AAPS Journal. 2014, 16 (4), 771–783.
    OpenUrl
  20. 20.↵
    1. Box G. E.
    P. Science and Statistics J. Am. Stat. Assoc. 1976, 71 (356), 791–799.
    OpenUrlCrossRefWeb of Science
  21. 21.↵
    1. Krishna A.,
    2. Rice M.,
    3. Kester T.,
    4. Waters M.,
    5. Wilson T.
    Particulate Study on NeoProfen, a Neonatal Injectable Product. PDA J. Pharm. Sci. and Technol. 2016, 70 (1), 76–92.
    OpenUrl
  22. 22.↵
    Pharm. Eur. 2.9.20. Prarticulate Contamination: Visible Particles.
  23. 23.↵
    1. Lye S. T.,
    2. Hwang N. C.
    Glass Particle Contamination: Is It Here to Stay? Anaesthesia. 2003, 58 (1), 84–105.
    OpenUrlPubMed
  24. 24.↵
    1. Bratoš I.
    Unpublished results, Sandoz Development Center, Unterach am Attersee, Austria.
  25. 25.↵
    1. Adar F.,
    2. Geiger R.,
    3. Noonan J.
    Raman Spectroscopy for Process/Quality Control. Appl. Spect. Rev. 1997, 32 (1-2), 45–101.
    OpenUrl
  26. 26.↵
    1. Cao X.,
    2. Wen Z. Q.,
    3. Vance A.,
    4. Torraca G.
    Raman Microscopic Applications in the Biopharmaceutical Industry: In Situ Identification of Foreign Particulates Inside Glass Containers with Aqueous Formulated Solutions. Appl. Spectrosc. 2009, 63 (7), 830–834.
    OpenUrlCrossRefPubMed
  27. 27.↵
    1. Stuart B. H.
    Infrared Spectroscopy: Fundamentals and Applications; John Wiley & Sons, Ltd: Chichester, 2004.
  28. 28.↵
    1. Chalmers J. M.,
    2. Griffiths P. R.
    Handbook of Vibrational Spectroscopy; Chalmers J. M., Griffiths P. R., Eds.; John Wiley & Sons Ltd: Chichester, 2002; Vol. 3, pp 2327–2347.
    OpenUrl
  29. 29.↵
    1. Ban K,
    2. Sonohara R.,
    3. Yoshida M.,
    4. Sako K.,
    5. Uchida S.,
    6. Namiki N.
    Pharmaceutical Development of a Parenteral Formulation of Conivaptan Hydrochloride. PDA J. Pharm. Sci. and Technol. 2013, 67 (4), 336–353.
    OpenUrl
  30. 30.↵
    1. Cremers D. A.,
    2. Chinni R. C.
    Laser-Induced Breakdown Spectroscopy—Capabilities and Limitations. Appl. Spect. Rev. 2009, 44 (6), 457–506.
    OpenUrl
  31. 31.↵
    1. Cremers D. A.,
    2. Radziemski L. J.
    Handbook of Laser-Induced Breakdown Spectroscopy; John Wiley & Sons, Ltd.: Chichester, 2013.
  32. 32.↵
    1. Goldstein J.,
    2. Newbury D. E,
    3. Joy D. C.,
    4. Lyman C. E.,
    5. Echlin P.,
    6. Lifshin E.,
    7. Sawyer L.,
    8. Michael J. R.
    Scanning Electron Microscopy and X-ray Microanalysis; Springer: New York, 2003.
  33. 33.↵
    1. Thomas R.
    Practical Guide to ICP-MS; Marcel Dekker, Inc.: New York, 2004.
  34. 34.↵
    1. Zuccarello D. J.,
    2. Murphy M. P.,
    3. Meyer R. F.,
    4. Winslow P. A.
    A Comprehensive Approach for the Determination of Extractable and Leachable Metals in Pharmaceutical Products by Inductively-Coupled Plasma. PDA J. Pharm. Sci. and Technol. 2009, 63 (4), 339–352.
    OpenUrl
  35. 35.↵
    1. Shearer G.
    Using Misroscopical Analysis Methods. Contract Pharma. 2014, 96–99.
  36. 36.↵
    1. Borchert S. J.,
    2. Ryan M. M.,
    3. Davison R. L.,
    4. Speed W.
    Accelerated Extractable Studies of Borosilicate Glass Containers. J. Parent. Sci. Tech. 1989, 43 (2), 67–79.
    OpenUrl
  37. 37.↵
    1. Sacha G. A.,
    2. Saffell-Clemmer W.,
    3. Abram K.,
    4. Akers M. J.
    Practical Fundamentals of Glass, Rubber, and Plastic Sterile Packaging Systems. Pharm. Dev. Technol. 2010, 15 (1), 6–34.
    OpenUrlPubMed
Back to top

In This Issue

Print
Download PDF
Article Alerts
Email Article
Citation Tools
Analysis of Particulate Matter in Liquid-Finished Dosage Forms
Jan Duchek, Balazs Havasi
PDA Journal of Pharmaceutical Science and Technology Nov 2018, 72 (6) 608-625; DOI: 10.5731/pdajpst.2017.008292
Twitter logo Facebook logo Mendeley logo

Jump to section

Keywords