Controlled Extraction Studies Applied to Polyvinyl Chloride and Polyethylene Materials: Conclusions from the ELSIE Controlled Extraction Pilot Study

详细信息    查看全文

• 作者：Andrew Teasdale ; Michael Jahn ; Simon Bailey ; Andrew Feilden…
• 关键词：extractables ; extraction technique ; polyethylene ; polyvinyl chloride
• 刊名：AAPS PharmSciTech
• 出版年：2015
• 出版时间：June 2015
• 年：2015
• 卷：16
• 期：3
• 页码：664-674
• 全文大小：544 KB
• 参考文献：1.Norwood DL, Ball DJ, Nagao LM. Overview of leachables and extractables in orally inhaled and nasal drug products. In: Ball DJ, Norwood DL, Stults CLM, Nagao LM, editors. Leachables and extractables handbook: safety evaluation, qualification, and best practices applied to inhalation drug products. Hoboken: Wiley; 2012. p. 6.
  2.Health Canada. Guidance for industry. Pharmaceutical quality of inhalation and nasal products. 2006. Available from: http://鈥媤ww.鈥媓c-sc.鈥媑c.鈥媍a/鈥媎hp-mps/鈥媝rodpharma/鈥媋pplic-demande/鈥媑uide-ld/鈥媍hem/鈥媔nhalationnas-eng.鈥媝hp
  3.European Medicines Agency. Guideline on the pharmaceutical quality of inhalation and nasal products. 2006. Available from: http://鈥媤ww.鈥媏ma.鈥媏uropa.鈥媏u/鈥媎ocs/鈥媏n_鈥婫B/鈥媎ocument_鈥媗ibrary/鈥婼cientific_鈥媑uideline/鈥?009/鈥?9/鈥媁C500003568.鈥媝df
  4.Product Quality Research Institute Leachables and Extractables Working Group. Safety thresholds and best practices for extractables and leachables in orally inhaled and nasal drug products. 2006. Available from: http://鈥媤ww.鈥媝qri.鈥媜rg/鈥媝dfs/鈥婰E_鈥婻ecommendations_鈥媡o_鈥婩DA_鈥?9-29-06.鈥媝df
  5.U.S. Food and Drug Administration Center for Drug Evaluation and Research. Draft guidance for industry. Metered dose inhaler (MDI) and dry powder inhaler (DPI) drug products. Chemistry manufacturing and controls documentation. 1998. Available from: http://鈥媤ww.鈥媐da.鈥媑ov/鈥媎ownloads/鈥婦rugs/鈥婫uidanceComplian鈥媍eRegulatoryInfo鈥媟mation/鈥婫uidances/鈥媢cm070573.鈥媝df
  6.U.S. Food and Drug Administration Center for Drug Evaluation and Research. guidance for industry. Container closure Systems for packaging human Drugs and biologics. Chemistry, manufacturing, and controls documentation. 1999. Available from: http://鈥媤ww.鈥媐da.鈥媑ov/鈥媎ownloads/鈥婦rugs/鈥婫uidanceComplian鈥媍eRegulatoryInfo鈥媟mation/鈥婫uidances/鈥媢cm070551.鈥媝df
  7.Schroeder AC. Leachables and extractables in OINDP: an FDA perspective. PQRI Leachables and Extractables Workshop. 2005. http://鈥媝qri.鈥媜rg/鈥媤orkshops/鈥媗each_鈥媏xt/鈥媔magespdfs/鈥媝resentations/鈥婣lanSchroederDay鈥?.鈥媝df
  8.Markovic I. Challenges associated with extractable and/or leachable substances in therapeutic biologic protein products. Am Pharm Rev. 2006;9(6):20鈥?.
  9.Ball D, Paskiet D, et al. PQRI research project proposal: reporting and qualification thresholds for leachables in parenteral and ophthalmic drug products. 2007. http://鈥媤ww.鈥媝qri.鈥媜rg/鈥媍ommworking/鈥媘inutes/鈥媝dfs/鈥媎ptc/鈥媝odpwg/鈥婣ddl/鈥婸QRI_鈥婸ODP_鈥媝roposal_鈥?4072.鈥媝df
  10.U.S. Food and Drag Administration Office of Combination Products. Guidance for industry and FDA staff: technical considerations for pen, jet, and related injectors intended for use with drugs and biological products. 2013. Available from: http://鈥媤ww.鈥媐da.鈥媑ov/鈥媎ownloads/鈥婻egulatoryInform鈥媋tion/鈥婫uidances/鈥婾CM147095.鈥媝df
  11.China Food and Drug Administration. Technical guideline for compatibility studies between chemical drug injections and plastic packaging materials. 2012.
  12.U.S. Food and Drug Administration Center for Drug Evaluation and Research. Guidance for industry nasal spray and inhalation solution, suspension, and spray drug products鈥攃hemistry, manufacturing, and controls documentation. 2002. Available from: http://鈥媤ww.鈥媐da.鈥媑ov/鈥媎ownloads/鈥婦rugs/鈥婫uidanceComplian鈥媍eRegulatoryInfo鈥媟mation/鈥婫uidances/鈥媢cm070575.鈥媝df
  13.International Organization for Standardization. ISO 10993-1 Biological evaluation of medical devices鈥擯art 1: evaluation and testing within a risk management process. 2009.
  14.Dohmeier DM, Norwood DL, et al. Use of polymeric materials in orally inhaled and nasal drug products. Med Device Technol. 2009;20(2):32鈥?.PubMed
  15.Ball DJ, Beierschmitt WP, Shaw AJ. Pharmaceutical container closure systems: selection and qualification of materials. In: Ball DJ, Norwood DL, Stults CLM, Nagao LM, editors. Leachables and extractables handbook: safety evaluation, qualification, and best practices applied to inhalation drug products. Hoboken: Wiley; 2012. p. 217.View Article
  16.Tougas T, Roan S, Falco B. Critical component quality control and specification strategies. In: Ball DJ, Norwood DL, Stults CLM, Nagao LM, editors. Leachables and extractables handbook: safety evaluation, qualification, and best practices applied to inhalation drug products. Hoboken: Wiley; 2012. p. 523.
  17.Extractables and Leachables Safety Information Exchange. Controlled extraction studies on materials for ELSIE database: qualitative and semi-quantitative studies. 2010. http://鈥媤ww.鈥媏lsiedata.鈥媜rg/鈥?/span>
  18.Norwood DL, Paskiet D, Ruberto M, Feinberg T, Schroeder A, Poochikian G, et al. Best practices for extractables and leachables in orally inhaled and nasal drug products: an overview of the PQRI recommendations. Pharm Res. 2008;25(4):727鈥?9.View Article PubMed
  19.Stults CLM, Ansell J, Shaw AJ, Nagao LM. Evaluation of extractables in processed and unprocessed polymer materials used for pharmaceutical applications. AAPS PharmSciTech. 2014. doi:10.鈥?208/鈥媠12249-014-0188-6 .
  20.International Conference on Harmonization (ICH). Draft consensus guideline. Guideline for elemental impurities, Q3D. Current step 2b version. 26 July 2013. http://鈥媤ww.鈥媔ch.鈥媜rg/鈥媐ileadmin/鈥婸ublic_鈥媁eb_鈥婼ite/鈥婭CH_鈥婸roducts/鈥婫uidelines/鈥婹uality/鈥婹3D/鈥婹3D_鈥婼tep2b.鈥媝df
  21.Jenke D, Castner J, Egert T, et al. Extractables characterization of five materials of construction representative of packaging systems used for parenteral and ophthalmic drug products. PDA J Pharm Sci Tech. 2013;67:448鈥?11. doi:10.鈥?731/鈥媝dajpst.鈥?013.鈥?0933 .View Article
  22.Stults CLM, Mikl J, Whelehan O, Morrical B, Duffield W, Nagao LM. A risk-based approach to management of leachables utilizing statistical analysis of extractables. AAPS PharmSciTech. 2014. doi:10.鈥?208/鈥媠12249-014-0221-9 .
  23.European Pharmacopoeia. Chapter 3.1. Materials used for the manufacture of containers. 7th ed 7.8 July 2013.
  24.Japanese Pharmacopoeia. General test 7.02. Test methods for plastic containers. 16th ed, 2011.
  25.United States Pharmacopeia. <661> Containers鈥攑lastics. United States Pharmacopeia. 36; National Formulary 31. 2013
  
• 作者单位：Andrew Teasdale (1)
  Michael Jahn (2)
  Simon Bailey (3)
  Andrew Feilden (4)
  Graham Taylor (1)
  Marta L. Corcoran (5)
  Robert Malick (6)
  Dennis Jenke (7)
  Cheryl L. M. Stults (9)
  Lee M. Nagao (8)
  
  1. AstraZeneca R&D, Macclesfield, Cheshire, UK
  2. Novartis Pharma AG, Basel, Switzerland
  3. Sanofi Aventis, Holmes Chapel, Cheshire, UK
  4. Smithers Rapra, Shawbury, Shrewsbury, Shropshire, UK
  5. MedImmune, LLC, Gaithersburg, Maryland, USA
  6. AbbVie, Inc, Waukegan, Illinois, USA
  7. Baxter Healthcare, Round Lake, Illinois, USA
  9. Extractables Leachables Safety Information Exchange (ELSIE), Washington, DC, 20005, USA
  8. Drinker Biddle and Reath, LLP, 1500 K Street, NW, Suite 1100, Washington, District of Columbia, 20005, USA
  
• 刊物主题：Pharmacology/Toxicology; Biotechnology; Biochemistry, general; Pharmacy;
• 出版者：Springer US
• ISSN：1530-9932

文摘

The effective management of leachables in pharmaceutical products is a critical aspect of their development. This can be facilitated if extractables information on the materials used in a packaging or delivery system is available to assist companies in selecting materials that will be compatible with the drug product formulation and suitable for the intended use. The Extractables and Leachables Safety Information Exchange (ELSIE) materials working group developed and executed a comprehensive extraction study protocol that included a number of extraction solvents, extraction techniques, and a variety of analytical techniques. This was performed on two test materials, polyethylene (PE) and polyvinyl chloride (PVC), that were selected due to their common use in pharmaceutical packaging. The purpose of the study was to investigate if the protocol could be simplified such that (i) a reduced number or even a single extraction technique could be used and (ii) a reduced number of solvents could be used to obtain information that is useful for material selection regardless of product type. Results indicate that, at least for the PVC, such reductions are feasible. Additionally, the studies indicate that levels of extractable elemental impurities in the two test materials were low and further confirm the importance of using orthogonal analytical detection techniques to gain adequate understanding of extraction profiles.