Download Leachables and Extractables Handbook: Safety Evaluation, by Douglas J. Ball, Daniel L. Norwood, Cheryl L. M. Stults, Lee PDF
By Douglas J. Ball, Daniel L. Norwood, Cheryl L. M. Stults, Lee M. Nagao
A sensible and science-based process for addressing toxicological matters relating to leachables and extractables linked to inhalation drug products
Packaging and equipment parts of Orally Inhaled and Nasal Drug items (OINDP)?such as metered dose inhalers, dry powder inhalers, and nasal sprays?pose capability security hazards from leachables and extractables, chemical substances that may be published or migrate from those parts into the drug product. Addressing the recommendations, history, ancient use, and improvement of protection thresholds and their application for qualifying leachables and extractables in OINDP, the Leachables and Extractables guide takes a realistic method of familiarize readers with the hot innovations for safeguard and possibility evaluate proven via a joint attempt of scientists from the FDA, academia, and undefined. assurance contains top practices for the chemical review and administration of leachables and extractables in the course of the pharmaceutical product existence cycle, in addition to:
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Guidance for pharmaceutical execs to qualify and risk-assess box closure method leachables and extractables in drug products
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Principles for outlining toxicological security thresholds which are acceptable to OINDP and most likely acceptable to different drug products
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Regulatory views, in addition to an appendix of keywords and definitions, case reports, and pattern protocols
Analytical chemists, packaging and machine engineers, formula improvement scientists, part providers, regulatory affairs experts, and toxicologists will all enjoy the wealth of data provided during this very important text.Content:
Chapter 1 evaluation of Leachables and Extractables in Orally Inhaled and Nasal Drug items (pages 1–19): Douglas J. Ball, Daniel L. Norwood and Lee M. Nagao
Chapter 2 A basic evaluate of the Suitability for meant Use specifications for fabrics utilized in Pharmaceutical platforms (pages 21–36): Dennis Jenke
Chapter three idea and alertness of protection Thresholds in Drug improvement (pages 37–44): David Jacobson?Kram and Ronald D. Snyder
Chapter four the improvement of safeguard Thresholds for Leachables in Orally Inhaled and Nasal Drug items (pages 45–58): W. Mark Vogel
Chapter five The Analytical review Threshold (AET) and its dating to protection Thresholds (pages 59–78): Daniel L. Norwood, James O. Mullis and Scott J. Pennino
Chapter 6 protection Thresholds within the Pharmaceutical improvement approach for OINDP: An viewpoint (pages 79–92): David Alexander and James Blanchard
Chapter 7 The Chemistry and Toxicology Partnership: Extractables and Leachables details Sharing one of the Chemists and Toxicologists (pages 93–115): Cheryl L. M. Stults, Ronald Wolff and Douglas J. Ball
Chapter eight Use of safeguard Thresholds within the Pharmaceutical improvement procedure for OINDP: U.S. Regulatory views (pages 117–127): Timothy J. McGovern
Chapter nine the applying of the security Thresholds to Qualify Leachables from Plastic box Closure structures meant for Pharmaceutical items: A Regulatory viewpoint (pages 129–152): Kumudini Nicholas
Chapter 10 Analytical top Practices for the overview and administration of Extractables and Leachables in Orally Inhaled and Nasal Drug items (pages 153–183): Daniel L. Norwood, Cheryl L. M. Stults and Lee M. Nagao
Chapter eleven Chemical and actual Attributes of Plastics and Elastomers: influence at the Extractables Profile of box Closure structures (pages 185–215): Michael A. Ruberto, Diane Paskiet and Kimberly Miller
Chapter 12 Pharmaceutical box Closure platforms: choice and Qualification of fabrics (pages 217–240): Douglas J. Ball, William P. Beierschmitt and Arthur J. Shaw
Chapter thirteen Analytical options for id and Quantitation of Extractables and Leachables (pages 241–287): Daniel L. Norwood, Thomas N. Feinberg, James O. Mullis and Scott J. Pennino
Chapter 14 Extractables: The managed Extraction research (pages 289–329): Thomas N. Feinberg, Daniel L. Norwood, Alice T. Granger and Dennis Jenke
Chapter 15 Extractables: Case learn of a Sulfur?Cured Elastomer (pages 331–386): Daniel L. Norwood, Fenghe Qiu, James R. Coleman, James O. Mullis, Alice T. Granger, Keith McKellop, Michelle Raikes and John A. Robson
Chapter sixteen Case research of a Polypropylene: Extractables Characterization, Quantitation, and keep watch over (pages 387–415): Diane Paskiet, Laura Stubbs and Alan D. Hendricker
Chapter 17 Analytical Leachables experiences (pages 417–447): Andrew D. Feilden and Andy Rignall
Chapter 18 improvement, Optimization, and Validation of equipment for regimen checking out (pages 449–506): Cheryl L. M. Stults and Jason M. Creasey
Chapter 19 serious part qc and Specification concepts (pages 507–548): Terrence Tougas, Suzette Roan and Barbara Falco
Chapter 20 Inorganic Leachables (pages 549–571): Diane Paskiet, Ernest L. Lippert, Brian D. Mitchell and Diego Zurbriggen
Chapter 21 international Particulate topic: Characterization and keep an eye on in a Quality?By?Design setting (pages 573–615): James R. Coleman, John A. Robson, John A. Smoliga and Cornelia B. box
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Additional resources for Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products
Example text
And Allain, L. Profiling of metal ions leached from pharmaceutical packaging materials. PDA J Pharm Sci Technol 2006, 60, p. 337. , and Perpall, H. Leachable study on solid dosage form. Am Pharm Rev 2006, 9(7), p. 58. W. Determination of “extractables” on polymer materials by means of HPLC-MS. PDA J Pharm Sci Technol 2006, 60, p. 291. , and Nakazawa, H. High-throughput determination of mono- and di(20-ethylhexyl)phthalate migration from PVC tubing to drugs using liquid chromatography-tandem mass spectrometry.
3 Possible means of performing a suitability for use assessment for additive interactions. , directly measure the effect that the contact has on the product or its user) or (2) test the potentially affected product directly for added substances and assess the outcome based on the probable impact of the added substances (Fig. 3). Many suitability for use dimensions and aspects are well suited for the “monitor outcomes” approach. Thus, for example, incompatibilities, such as pH change, discoloration, precipitate formation, and issues with protection and performance can readily be assessed by the “contact the product and system, and monitor the effect” approach.
Part 21, Sec. 39, amended September 2000. Anderson, P. History of aerosol therapy: Liquid nebulization to MDIs to DPIs. Respir Care [Online] 2005, 50, pp. 1139–1150. United States Food, Drug and Cosmetic Act, Section 501(a)(3). United States Congress, amended through December 31, 2004. ITFG/IPAC-RS CMC Leachables and Extractables Technical Team. Leachables and extractables testing: Points to consider, 2001. Product Quality Research Institute Leachables and Extractables Working Group. Development of scientifically justifiable thresholds for leachables and extractables, 2002.