{"id":1192,"date":"2025-07-08T18:01:41","date_gmt":"2025-07-08T18:01:41","guid":{"rendered":"https:\/\/pharmacoguide.com\/?p=1192"},"modified":"2025-07-09T05:27:53","modified_gmt":"2025-07-09T05:27:53","slug":"topic-dissolution","status":"publish","type":"post","link":"https:\/\/pharmacoguide.com\/?p=1192","title":{"rendered":"TOPIC- DISSOLUTION"},"content":{"rendered":"

TOPIC- DISSOLUTION<\/span><\/em><\/span><\/h2>\n

Definition:<\/span><\/span><\/em><\/h3>\n

Dissolution is a process in which a solid substance solubilizes in a given solvent i.e. mass transfer from the solid surface to the liquid phase.<\/span><\/h3>\n

Dissolution is the rate determining step for hydrophobic,<\/span><\/h3>\n

poorly aqueous soluble drugs.<\/span><\/h3>\n

Why dissolution studies?<\/u><\/h3>\n
    \n
  1. \n

    To show that the release of drug from the tablet is close to 100%.<\/span><\/h3>\n<\/li>\n
  2. \n

    To show that the rate of drug release is uniform batch to batch.<\/span><\/h3>\n<\/li>\n
  3. \n

    And to show that release is equivalent to those batches proven to be bioavailable and clinically effective.<\/span><\/h3>\n<\/li>\n<\/ol>\n

    <\/h3>\n

    Apparatus Classification in USP:<\/u><\/span><\/em><\/h3>\n
      \n
    1. \n

      Apparatus 1 (rotating basket)<\/span><\/h3>\n<\/li>\n
    2. \n

      Apparatus 2 (paddle assembly)<\/span><\/h3>\n<\/li>\n
    3. \n

      Apparatus 3 (reciprocating cylinder)<\/span><\/h3>\n<\/li>\n
    4. \n

      Apparatus 4 (flow-through cell)<\/span><\/h3>\n<\/li>\n
    5. \n

      Apparatus 5 (paddle over disk)<\/span><\/h3>\n<\/li>\n
    6. \n

      Apparatus 6 (cylinder)<\/span><\/h3>\n<\/li>\n
    7. \n

      Apparatus 7 (reciprocating holder)<\/span><\/h3>\n<\/li>\n<\/ol>\n

      <\/h3>\n

      A drug product is considered rapidly dissolving when;<\/span><\/h3>\n

      no less than 85% of the labeled amount of the drug substance dissolves within 30 minutes, using USP Apparatus I at 100 rpm (or Apparatus II at 50 rpm) in a volume of 900 ml or less in each of the following media:<\/em><\/span><\/h3>\n
        \n
      • \n

        1 N HCl or Simulated Gastric Fluid USP without enzymes;<\/span><\/h3>\n<\/li>\n
      • \n

        a pH 5 buffer; and<\/span><\/h3>\n<\/li>\n
      • \n

        a pH 8 buffer.<\/span><\/h3>\n<\/li>\n<\/ul>\n

        \u00a0<\/em><\/h3>\n

        Biopharmaceutical Classification System;<\/u><\/span><\/em><\/strong><\/h4>\n

        Class I: <\/span><\/h4>\n

        High solubility\u2014High permeability<\/span><\/h4>\n

        Class II: <\/span><\/h4>\n

        Low solubility\u2014High permeability <\/span><\/h4>\n

        Class III: <\/span><\/h4>\n

        High solubility\u2014Low permeability <\/span><\/h4>\n

        Class IV: <\/span><\/h4>\n

        Low solubility\u2014Low permeability<\/span><\/h4>\n

        <\/h4>\n

        Why Qualification & Validation of the Apparatus?<\/u><\/strong><\/span><\/em><\/h3>\n

        -To maintain \u201cquality by design\u201d.<\/span><\/h3>\n

        -Physical & chemical calibrations\u2014for geometrical & dimensional accuracy & precision.<\/span><\/h3>\n

        -Vibration or undesired agitation to be avoided.<\/span><\/h3>\n

        -Temperature, rotation speed\/flow rate, volume, sampling probe, procedures, etc. need to be monitored periodically.<\/span><\/h3>\n

        Use of USP calibrator tablets for App. 1 & 2 (to be performed not less than twice a year)<\/span><\/h3>\n

        <\/h3>\n

        Solubility of solid in dissolution medium;<\/u><\/span><\/em><\/h3>\n
          \n
        • \n

          Temperature of dissolution medium.<\/span><\/h3>\n<\/li>\n
        • \n

          pH of the medium.<\/span><\/h3>\n<\/li>\n
        • \n

          Solubility of the drug in dissolution medium.<\/span><\/h3>\n<\/li>\n
        • \n

          Presence of co-solvents.<\/span><\/h3>\n<\/li>\n<\/ul>\n

          <\/h3>\n

          Dissolution rate constant<\/span><\/em><\/span><\/h3>\n

          Depend upon;<\/span><\/em><\/span><\/h3>\n
            \n
          • \n

            Thickness of boundary layer<\/span><\/h3>\n<\/li>\n
          • \n

            Degree of agitation<\/span><\/h3>\n<\/li>\n
          • \n

            Speed of stirring<\/span><\/h3>\n<\/li>\n
          • \n

            Shape, size & position of stirrer<\/span><\/h3>\n<\/li>\n
          • \n

            volume of dissolution medium<\/span><\/h3>\n<\/li>\n
          • \n

            Shape & size of container<\/span><\/h3>\n<\/li>\n
          • \n

            Viscosity of dissolution medium<\/span><\/h3>\n<\/li>\n
          • \n

            Dissolution Acceptance Criteria in case of Failure;<\/span><\/h2>\n<\/li>\n
          • \"\"<\/li>\n<\/ul>\n\n\n\n\n
            <\/td>\n<\/tr>\n
            <\/td>\n <\/p>\n

             <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

            THANK<\/u><\/strong> YOU<\/u><\/strong><\/span><\/em><\/h2>\n","protected":false},"excerpt":{"rendered":"

            TOPIC- DISSOLUTION Definition: Dissolution is a process in which a solid substance solubilizes in a given solvent i.e. mass transfer from the solid surface to the liquid phase. Dissolution is the rate determining step for hydrophobic, poorly aqueous soluble drugs. Why dissolution studies? To show that the release of drug from the tablet is close […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"templates\/template-full-width.php","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[],"class_list":["post-1192","post","type-post","status-publish","format-standard","hentry","category-training"],"_links":{"self":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/1192","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1192"}],"version-history":[{"count":5,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/1192\/revisions"}],"predecessor-version":[{"id":1200,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/1192\/revisions\/1200"}],"wp:attachment":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1192"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1192"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1192"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}