Principles for Management of Extractables and Leachables in Ophthalmic Drug Products

  • Houston C
  • Rodrigues A
  • Smith B
  • et al.
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Abstract

Ophthalmic solutions and suspensions have long been classified into a high risk category with respect to concerns over extractables and leachables (E&L), though specific guidance on the management of leachables in these products is generally absent from regulatory authorities or the scientific literature. As a result, ophthalmic drug products (ODP) were originally included in the scope of the Product Quality Research Institute Leachables and Extractables Working Group for Parenteral and Ophthalmic Drug Products (PQRI-PODP). Relative to other high concern dosage forms such as metered dose inhalers or injectables, ODP possess unique challenges with respect to the nature of impactful E&L as well as the safety assessment of leachables. For example, extensive use of semipermeable low density polyethylene primary packaging for ODP necessitates a strong focus on E&L from secondary packaging sources. For safety assessment, a key challenge is the lack of a sufficient database developed on all relevant ophthalmic toxicity endpoints. As result, the working group is unable to recommend a Safety Concern Threshold (SCT) for ODP at this time. Nevertheless, the ophthalmic industry has developed a number of time-tested practices to manage E&L for ODP. This article describes those science-based practices and key considerations in the analysis, management, and safety assessment of E&L in ODP.

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APA

Houston, C. T., Rodrigues, A. D., Smith, B. B., Wang, T., & Richardson, M. (2022). Principles for Management of Extractables and Leachables in Ophthalmic Drug Products. PDA Journal of Pharmaceutical Science and Technology, 76(3), 278–294. https://doi.org/10.5731/pdajpst.2022.012744

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