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Article CommentaryCommentary

Biocompatibility Considerations for Orally Inhaled and Nasal Drug Products and Other Drug-–Device Combination Products

Cheryl L. M. Stults, Christine L. Lanning, Lee M. Nagao and James Conners
PDA Journal of Pharmaceutical Science and Technology January 2024, 78 (1) 125-139; DOI: https://doi.org/10.5731/pdajpst.2023.012852
Cheryl L. M. Stults
1C & M Technical Consulting, LLC, San Mateo, CA;
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Christine L. Lanning
2Merck & Co., Inc., West Point, PA;
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Lee M. Nagao
3Faegre Drinker Biddle & Reath, LLP, Washington DC; and
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  • For correspondence: lee.nagao@faegredrinker.com
James Conners
4Sumitomo Pharma America, Marlborough, MA
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References

  1. 1.↵
    U.S. Food and Drug Administration. Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, “Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing within a Risk Management Process”, 2020. FDA Web site. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and (accessed January 17, 2023).
    Google Scholar
  2. 2.↵
    U.S. Pharmacopeial Convention, General Chapter <87> Biological Reactivity Tests In Vitro. In USP 42—NF 37; USP: Rockville, MD, 2019.
    Google Scholar
  3. 3.↵
    U.S. Pharmacopeial Convention, General Chapter <88> Biological Reactivity Tests In Vivo. In USP 42—NF 37; USP: Rockville, MD, 2019.
    Google Scholar
  4. 4.↵
    U.S. Pharmacopeial Convention, General Chapter <1031> The Biocompatibility of Materials Used in Drug Containers, Medical Devices and Implants. In USP 42—NF 37; USP: Rockville, MD, 2019.
    Google Scholar
  5. 5.↵
    U.S. Food and Drug Administration. Title 21, Part 4, Subchapter A. Current Good Manufacturing Practice Requirements for Combination Products, 2023. eCFR Web site. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-4?toc=1 (accessed January 17, 2023).
    Google Scholar
  6. 6.↵
    Office of Regulatory Affairs, Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, and Center for Biologics Evaluation and Research, United States Food and Drug Administration. Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products, 2017. FDA Web site. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/current-good-manufacturing-practice-requirements-combination-products (accessed January 17, 2023).
    Google Scholar
  7. 7.↵
    U.S. Food and Drug Administration. Frequently Asked Questions about Combination Products. How Are Combination Products Assigned for Review? FDA Web site. https://www.fda.gov/combination-products/about-combination-products/frequently-asked-questions-about-combination-products#review (accessed January 17, 2023).
    Google Scholar
  8. 8.↵
    Center for Drug Evaluation and Research, U.S. Food and Drug Administration. Metered Dose Inhaler (MDI) and Drug Powder Inhaler (DPI) Products—Quality Considerations, Draft Guidance for Industry, 2018. FDA Web site. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/metered-dose-inhaler-mdi-and-dry-powder-inhaler-dpi-drug-products-quality-considerations (accessed January 17, 2023).
    Google Scholar
  9. 9.↵
    Center for Devices and Radiological Health, U.S. Food and Drug Administration. Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators, 1993. FDA Web site. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reviewer-guidance-nebulizers-metered-dose-inhalers-spacers-and-actuators (accessed January 17, 2023).
    Google Scholar
  10. 10.↵
    International Organization for Standardization. ISO 18562-1:2017 Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications—Part 1: Evaluation and Testing within a Risk Management Process. ISO: Geneva, 2017.
    Google Scholar
  11. 11.↵
    U.S. Food and Drug Administration. Title 21, Chapter 1, Subchapter C, Part 211, Subpart E Control of Components and Drug Product Containers and Closures, 2023. eCFR Web site. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-E (accessed January 17, 2023).
    Google Scholar
  12. 12.↵
    U.S. Food and Drug Administration. Title 21, Chapter 1, Subchapter F, Subpart B, Section 600.11 Physical Establishment, Equipment, Animals, and Care, 2023. eCFR Web site. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-600/subpart-B/section-600.11 (accessed 2023-01-17).
    Google Scholar
  13. 13.↵
    U.S. Food and Drug Administration. Title 21, Chapter 1, Subchapter H, Part 820, Subpart A, Section 820.1 Quality System Regulation, Scope, 2023. eCFR Web site. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-A/section-820.1 (accessed January 18, 2023).
    Google Scholar
  14. 14.↵
    Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration. Container Closure Systems for Packaging Human Drugs and Biologics, 1999. FDA Web site. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/container-closure-systems-packaging-human-drugs-and-biologics (accessed January 17, 2023).
    Google Scholar
  15. 15.↵
    Center for Drug Evaluation and Research, U.S. Food and Drug Administration. Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products–Chemistry, Manufacturing, and Controls Documentation, 2002. FDA Web site. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/nasal-spray-and-inhalation-solution-suspension-and-spray-drug-products-chemistry-manufacturing-and (accessed January 17, 2023).
    Google Scholar
  16. 16.↵
    Center for Devices and Radiological Health, U.S. Food and Drug Administration. Office of Device Evaluation (ODE) Blue Book Memorandum #G95-1, Use of International Standard ISO-10993, Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing, 1995.
    Google Scholar
  17. 17.↵
    ASTM International. ASTM F748-16 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices, 2016. ANSI Webstore. https://webstore.ansi.org/standards/astm/astmf74816 (accessed January 17, 2023).
    Google Scholar
  18. 18.↵
    U.S. Pharmacopeial Convention. USP <87>, Biological Reactivity Tests in Vitro; USP <88>, Biological Reactivity Tests in Vivo; USP <1031> The Biocompatibility of Materials Used in Drug Containers, Medical Devices and Implants. Pharmacopeial Forum 2021, 47 (4).
    Google Scholar
  19. 19.↵
    International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS). Recommended Baseline Requirements for Materials Used in Orally Inhaled and Nasal Drug Products (OINDP), 2017. IPACRS Web site. https://www.ipacrs.org/_files/ugd/932589_4ddd4088c47d472c866194b64ddafa82.pdf (accessed January 18, 2023).
    Google Scholar
  20. 20.↵
    Verein Deutscher Ingenieure. Medical Grade Plastics (MGP), 2019. VDI Web site. https://www.vdi.de/richtlinien/details/vdi-2017-medical-grade-plastics-mgp (accessed January 17, 2023).
    Google Scholar
  21. 21.↵
    Committee for Medicinal Products for Human Use, Committee for Medicinal Products for Veterinary Use, European Medicines Agency. Guideline on Plastic Immediate Packaging Materials, 2005. EMA Web site. https://www.ema.europa.eu/en/plastic-primary-packaging-materials-scientific-guideline (accessed January 17, 2023).
    Google Scholar
  22. 22.↵
    European Parliament, European Council, European Union. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, Annex I, General safety and performance requirements, 2017. EUR-Lex Web site https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745 (accessed January 17, 2023).
    Google Scholar
  23. 23.↵
    European Parliament. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
    Google Scholar
  24. 24.↵
    International Organization for Standardization. ISO 10993-1:2018 Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing within a Risk Management Process. ISO: Geneva, 2018.
    Google Scholar
  25. 25.↵
    1. Oktem B.
    Chemical Analysis for Medical Devices: Strategies for Reducing Scientific Questions, 2020. Society of Toxicology Web site. https://www.toxicology.org/groups/ss/MDCPSS/docs/MDCPSS_Webinar-092520-Oktem.pdf (accessed January 17, 2023).
    Google Scholar
  26. 26.↵
    1. Oktem B.,
    2. Hood A.,
    3. Goode J.,
    4. Sussman E.,
    5. Wickramasekara S.
    CDRH Scientific Perspective on Chemical Analysis and Toxicological Risk Assessment for Medical Devices, 2019. Society of Toxicology Web site. https://www.toxicology.org/groups/ss/MDCPSS/docs/Webinar-SOT-MDCPSS-May22-2019-Slides-final.pdf (accessed January 17, 2023).
    Google Scholar
  27. 27.↵
    International Organization for Standardization. ISO/TS 21726:2019 Biological Evaluation of Medical Devices—Application of the Threshold of Toxicological Concern (TTC) for Assessing Biocompatibility of Medical Device Constituents. ISO Web site. https://www.iso.org/standard/71514.html (accessed January 17, 2023)
    Google Scholar
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PDA Journal of Pharmaceutical Science and Technology: 78 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 78, Issue 1
January/February 2024
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Biocompatibility Considerations for Orally Inhaled and Nasal Drug Products and Other Drug-–Device Combination Products
Cheryl L. M. Stults, Christine L. Lanning, Lee M. Nagao, James Conners
PDA Journal of Pharmaceutical Science and Technology Jan 2024, 78 (1) 125-139; DOI: 10.5731/pdajpst.2023.012852
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  • Article
    • Abstract
    • 1. Introduction
    • 2. Background
    • 3. Current Regulatory Landscape
    • 4. Industry Experiences with Biocompatibility Evaluation for OINDPs
    • 5. Discussion
    • 6. Summary Points
    • Conflict of Interest Statement
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Keywords

  • Orally inhaled drug products
  • Nasal drug products
  • Biocompatibility
  • Drug–device combination products
  • Regulatory

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Biocompatibility Considerations for Orally Inhaled and Nasal Drug Products and Other Drug-–Device Combination Products
Cheryl L. M. Stults, Christine L. Lanning, Lee M. Nagao, James Conners
PDA Journal of Pharmaceutical Science and Technology Jan 2024, 78 (1) 125-139; DOI: 10.5731/pdajpst.2023.012852

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