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Guidelines for the Dissolution Testing of Drug Forms Using Specific Apparatus

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stephengraham
18 diapositives · 633 Views · Jan 06, 2020

This document outlines the dissolution testing procedures and apparatus as specified by the Bureau of Drug and Narcotic. It details the requirements for Apparatus 1 and Apparatus 2, including the design, materials, and operation conditions. Key aspects include the specifications for the basket and paddle assembly, stirring speeds, and the importance of thorough cleaning and maintenance. It emphasizes the need for regular checks on the physical condition of the equipment to ensure accurate and reproducible dissolution results. Proper calibration and handling of the apparatus are crucial for compliance with USP standards.

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  1. Dissolution Mrs. Witinee Kongsuk Bureau of Drug and Narcotic July 9, 2015 Bureau of Drug and Narcotic

  2. Dissolution Bureau of Drug and Narcotic

  3. Apparatus 1 Basket • Vessel • - Glass or other inert transparent material • - Cylindrical with hemispherical bottom • - 1L, 2L or 4L nominal capacity • Stirring shaft and basket • Basket • - 40 mesh • - Gold coating of 2.5 um is allowed. • Stirring • - rotating stirrer • - typical speeds: 50-100 rpm • Dosage form placed in the basket Bureau of Drug and Narcotic

  4. Apparatus 2 Paddle • Vessel • - same as for Apparatus 1 • Stirring blade and shaft • - metallic or suitably inert and rigid • - may be coated • Agitation • - rotating stirrer • - typical speeds: 50-75 rpm • Dosage form should remain • at the bottom center of the vessel Bureau of Drug and Narcotic

  5. Dissolution Assembly Water bath Bureau of Drug and Narcotic

  6. Visual Inspection Water bath • Check for leaks: tubing, joints • Circulation pump: check for leaks, trapped air, noise • Good practice to regularly change water • Use clean and clear water • Keep bath clean • Ensure adequate water level Bureau of Drug and Narcotic

  7. Dissolution Assembly Vessel Bureau of Drug and Narcotic

  8. Visual Inspection Vessel • Thorough cleaning is very important. • Sticky residues can build up on glass surface. • Always check the internal surface • Irregular curvature can affect hydrodynamics. • Check periodically during use looking for cracks, • scratches and build up of deposit or residue. Bureau of Drug and Narcotic

  9. Dissolution Assembly Bureau of Drug and Narcotic

  10. Dissolution Assembly Apparatus 1 Basket Bureau of Drug and Narcotic

  11. Dissolution Assembly Apparatus 2 Paddle Bureau of Drug and Narcotic

  12. Visual Inspection Baskets and Paddles • It is very important to carefully observe • the physical condition. • Shaft for both apparatus must be straight. • Loose basket clips will cause wobble. • Basket should be right cylinders (not bent). • Baskets that are old, distorted or frayed can give • non-reproducible results. • Baskets should be properly cleaned and stored. • Ensure vent hole in basket head is clear. • Baskets should be attached carefully to the shaft. • Paddles: smooth coating, if coated Bureau of Drug and Narcotic

  13. Dissolution Assembly Canular TheUSPdefines the sampling position as “A zone midway between the surface of the dissolution medium and the top of the rotating basket or blade, not less than 1 cm from the vessel wall" Bureau of Drug and Narcotic

  14. Other related tools • Calibrated thermometer • Calibrated stopwatch Bureau of Drug and Narcotic

  15. Calibration Bureau of Drug and Narcotic

  16. Mechanical Calibration • Conformance to USP specification • Position designation in the assembly • - Stirring elements • * Shafts • * Blade or baskets • - Vessels • Recommendation: • Maintain the same position for vessels / stirring • elements within the assembly throughout a PVT cycle Bureau of Drug and Narcotic

  17. Mechanical Calibration Shaft verticality Vessel verticality Bureau of Drug and Narcotic

  18. Mechanical Calibration Centering Wobble Bureau of Drug and Narcotic