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Dissolution and drug release testing

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Dissolution and drug release testin

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Dissolution and drug release testing

  1. 1. 1 Dissolution and drug release testin g Mr:Roshan G Bodhe Research Scholar, M. Pharm (Pha rmaceutics) RCPIPER, Shirpur
  2. 2. 2 Why do we study dissolution? Disintegration Dissolution Absorption Drug in the blo od and the bod y
  3. 3. 3 Dissolution and drug release tests  Dissolution and drug release tests are in-vitro test s that measure the rate and extent of dissolution or release of the drug substance from a drug prod uct, usually in an aqueous medium under specifie d conditions  The dissolution test is an important quality control procedure for the drug product and is often linked to product performance in vivo.  In-vitro drug dissolution studies are most often us ed for monitoring drug product stability and manu facturing process
  4. 4. 4 Conditions that May Affect Drug Dissolution and Release: Drug and formulation related  Drug substance  Particle size  Polymorph  Surface area  Chemical stability in dissolution media  Formulation of drug product  Excipients (lubricants, suspending agents, etc)
  5. 5. 5 Conditions that May Affect Drug Dissolution and Release: methodology related  Medium  Volume  pH  Molarity  Co-solvents, added enzymes/surfactants  Temperature of medium  Apparatus  Hydrodynamics  Agitation rate  Shape of dissolution vessel  Placement of tablet in vessel  Sinkers (for floating products and products th at stick to side of vessel)
  6. 6. 6 Dissolution Apparatus
  7. 7. 7 Apparatusa Name Drug Product Apparatus 1 Rotating basket Tablets Apparatus 2 Paddle Tablets, capsules, modified drug products, suspensions Apparatus 3 Reciprocating cylinder Extended-release drug products Apparatus 4 Flow cell Drug products containing low-water-soluble drugs Apparatus 5 Paddle over disk Transdermal drug products Apparatus 6 Cylinder Transdermal drug products Apparatus 7 Reciprocating disk Transdermal drug products Rotating bottle (Non-USP-NF) Extended-release drug products (beads) Diffusion cell (Franz) (Non-USP-NF) Ointments, creams, transdermal drug products Dissolution Apparatus aApparatus 1–7 refer to compendial dissolution apparatus in USP-NF (Unite d States Pharmacopeia)
  8. 8. 8 Rotating basket (Apparatus 1)
  9. 9. 9 Rotating basket (Apparatus 1)  In case of none-disintegrating dosa ge forms this apparatus is superior t o apparatus 2 since it constraints t he dosage form in a steady state flu id flow  It is inferior for testing dosage form s which contains gums due to cloggi ng of screen matrix
  10. 10. 10 Rotating basket (Apparatus 1)  In the case of floating dosage forms this method performs well, but care should be taken that excepients do not clog the basket mesh
  11. 11. 11 Rotating Paddle (Apparatus 2)
  12. 12. 12 Rotating Paddle (Apparatus 2)  This apparatus is identical to appara tus 1 except that the paddle is subs tituted for the rotating basket  Frequently used for both disintegrati ng and non-disintegrating dosage fo rms
  13. 13. 13 Reciprocating cylinder (Apparatus 3)
  14. 14. 14 Reciprocating cylinder (Apparatus 3)  One advantage of the reciprocating cylinder is that the gastrointestinal t ract conditions can be easily simulat ed, as it is easy to make time depen dent pH changes  This apparatus is most suitable for n ondisintegrating (extended release) or delayed release (enteric coated) dosage forms
  15. 15. 15 Flow cell (Apparatus 4)
  16. 16. 16 Flow cell (Apparatus 4)  The advantage of flow through cell apparatus is the ability to test drugs of very low aqueous solubility and t he ability to change the pH convenie ntly during the test
  17. 17. 17 Paddle over disk (Apparatus 5)
  18. 18. 18 Cylinder (Apparatus 6)  The cylinder method (Appar atus 6) for testing transder mal preparation is modified from the basket method (A pparatus 1). In place of the basket, a stainless steel cyli nder is used to hold the sa mple.
  19. 19. 19 Reciprocating Disk Method (Apparatus 7)  In the reciprocating disk me thod for testing transderma l products, a motor drive as sembly (Apparatus 7) is use d to reciprocate the system vertically, and the samples a re placed on disk-shaped ho lders using cuprophan supp orts

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