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USP and Dissolution Testing

USP and Dissolution Testing. Advisory Committee for Pharmaceutical Sciences 2 May 2005 Will Brown Staff Liaison to the Biopharmaceutics Expert Committee Department of Standards Development. Biopharmaceutics Expert Committee 2005-2010. Thomas Foster, chair Diane Burgess Bryan Crist

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USP and Dissolution Testing

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  1. USP and Dissolution Testing Advisory Committee for Pharmaceutical Sciences 2 May 2005 Will Brown Staff Liaison to the Biopharmaceutics Expert Committee Department of Standards Development

  2. Biopharmaceutics Expert Committee2005-2010 • Thomas Foster, chair • Diane Burgess • Bryan Crist • Mario Gonzalez • Vivian Gray • Johannes Krämer • Lewis Leeson • Alan Parr • James Polli • Leon Shargel • Eli Shefter • William Simon • Clarence Ueda • David Young

  3. The USP Performance Test • Dissolution or Disintegration • Tests within the specification for a dosage form • Procedure • Acceptance Criteria • <711> Dissolution • General description of techniques • Modified case-by-case: monograph

  4. The USP Performance Test • Study design and analysis: S1, S2, S3 • Number of units tested fixed for each stage • Acceptance criteria determined by FDA working with Applicants (NDA’s and ANDA’s) • Details of the test communicated by sponsor (Applicant) • Testing by attribute: pass or fail • Some control over distribution: e.g., Q-25% at S3

  5. Biopharmaceutics Expert Committee • Workplan includes revising General Chapters to have a performance test by dosage form by route of administration • Intention of working with FDA and pharmaceutical manufacturers as appropriate • Advisory panels formed in 2000-2005 cycle

  6. Meetings can be productive • 1993 FDA Advisory Committee • Follow-on IR and ER Guidance documents • Pharmaceutical Discussion Group • Harmonization for Dissolution and Disintegration General Chapters

  7. Theoretical Approaches • W Hauck et al., Oral Dosage Form Performance Tests: New Dissolution Approaches Pharm Res 22(2):182-187, 2005 • Explicit hypothesis testing • Parametric tolerance intervals • Improved way to set dissolution acceptance criteria • More flexible protocol design to assess conformity

  8. Theoretical Approaches • Allow industry more control on study design • Tiers possible • Number of units within tiers • Can differ between manufacturers • Set P value (fraction of units in the reference batch that must conform) • Risk clearly assessed, managed and communicated • Corresponds to approaches for uniformity of metered dose inhalers (Wednesday session)

  9. Calibrators • GMP-related concept • Done occasionally (six month maximum) • Rule out test assemblies that do not perform, extremes • Inter-Laboratory variability is a major contributor to width of ranges but must be captured • Criteria derived from analysis of data collected in collaborative studies • Acceptable values fall in ranges representing performance by the “best of the best”

  10. Calibrators • Salicylic Acid Tablets • Unit packaging • Prednisone Tablets • Scale up from U of Md batches (reproduction of NCDA#2) • New batch in production • Theophylline Beads • Deleted from system suitability requirement for Apparatus 3 Reciprocating Cylinder

  11. Thank you for your attention

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