Tablet friability,harness and dissolution testing


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Tablet friability,harness and dissolution testing

  2. 2. Tablet Friability <ul><li>Tablets are constantly subjected to mechanical shocks & aberration during the manufacturing, packing and transportation process. </li></ul><ul><li>Such stress can lead to capping, aberration or eve breakage of the tablets </li></ul><ul><li>It is there fore important that the tablet is formulated to withstand such stress </li></ul>
  3. 3. Tablet Friability <ul><li>In order to monitor the resistance of tablets to such stress and to decide on their suitability for further processing such as coating, tablets are routinely subjected to friability test </li></ul>
  4. 4. Friability Test <ul><li>Friability is defined as the % of weight loss by tablets due to mechanical action during the test. Tablets are weighing before and after testing and friability is expressed as a percentage loss on pre test tablet weight. </li></ul><ul><li>Friability refers the ability of the compressed tablet to avoid fracture and breaking during transport </li></ul>
  5. 5. Friability Test <ul><li>Friability is closely related to tablet harness and is designed to evaluate the ability of the tablet to with stand aberration in packing, Handling and shipping. </li></ul><ul><li>Friability is usually measured by the use of Roche fibrilator or tumbler test. </li></ul>
  6. 6. Friability Test <ul><li>A number of tablets (20 Nos.) are weighed and placed in the apparatus where they are exposed to rolling and repeated shocks as they fall 6 inches in each turn within the apparatus. After 4 minutes of this treatment or 100 revolutions the tablets are weighed and the weight compared with initial weight. The loss due to abrasion is a measure of tablet friability. The value is expressed in percentage. </li></ul>
  7. 7. Friability Test <ul><li>Minimum weight loss of the tablet should not be NMT 1%. </li></ul><ul><li>There should not be any broken tablet. </li></ul>
  8. 8. <ul><li>Hardness </li></ul>
  9. 9. Hardness <ul><li>The resistance of tablets to capping,aberation or breakage under conditions of storage, transportation and handling before usage depends on its hardness. </li></ul><ul><li>Hardness is nothing but crushing strength </li></ul>
  10. 10. Hardness <ul><li>If tablet is too hard, it may not disintegrate in the required period of time and will fail dissolution test </li></ul><ul><li>If tablet is too soft it may not be able to withstand handling during subsequent processing such as coating or packaging and shipping operations. </li></ul>
  11. 11. Hardness <ul><li>The force required to break tablet is measured in kilograms and a crushing strength of 4 KG is usually considered to be the minimum for satisfactory tablets. </li></ul><ul><li>Oral tablets normally have a hardness of 4-10kg,However hypodermic and chewable tablets are usually much softer (3 kg) and some substained release tablets are much harder 10-20 kg. </li></ul>
  12. 12. Hardness <ul><li>Tablet hardness has been associated with tablet property such as density and porosity. </li></ul><ul><li>Hardness generally increase with normal storage of tablets & depends on the shape, chemical properties, binding agent & pressure applied during compression. </li></ul>
  13. 13. Hardness <ul><li>Hardness is expressed in Newton. </li></ul><ul><li>Hardness can also expressed in Kpa. </li></ul>
  14. 14. <ul><li>DISSOLUTION </li></ul>
  15. 15. Dissolution <ul><li>Active absorption of oral dosage forms depends on adequate release of the API from the product. Dissolution or solubility of the API play pivotal role in this aspect. </li></ul><ul><li>Dissolution testing is used as a tool to identify a crucial effect in the bioavailability of the API. </li></ul>