TESTS ON FORMULATIONS: Content Uniformity, Hardness, Dissolution.

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TESTS ON FORMULATIONS: Content Uniformity, Hardness, Dissolution.

  1. 1. TESTS ON FORMULATIONS: Content Uniformity, Hardness, Dissolution.
  2. 2.  Different chemical substances, including the active drug, are combined to produce a final medicinal product.
  3. 3.  To ensure that every tablet contains the amount of drug substance intended with little variation among tablets within a batch.
  4. 4.  Used for testing the consistencyBulk powdersLiquid oralsAlso during filling of powders into capsules or liquids into vials or ampoulesAmount of active pharmaceutical ingredient within individual units of tablets or capsules.
  5. 5.  Measures crushing strength property defined as compressional force applied diametrically to a tablet which just fracture it.
  6. 6. Limits:4 kg is considered to be the minimum for satisfactory tablets. Oral tablets: 4 to 10 kgHypodermic and chewable tablets: 3 kg.Sustained release tablets: 10 to 20 kg.
  7. 7.  Why do we measure Hardness:Need for pressure adjustment on the tableting machine.Affects the disintegration and dissolutionFactors affecting Hardness:Compression of the tablet and compressive force.Amount of binder. (More binder a more hardness)Method of granulation in preparing the tablet
  8. 8. Predict in vivo drug release profiles.Test is intended for a capsule or Tablet.Condition maintained: Temperature: 37 ± 0.5°C Speed: 25-150 rpm
  9. 9.  BASKET TYPE:Vessel is cylindricalHight: 100-210mmInside diameter: 98-106mmBasket position: the distance between the inside of bottom vessel & basket maintained at 25 ± 2mm.
  10. 10. PADDLE TYPE:Vessel is cylindricalHight: 160-210mmInside diameter: 98-160mm.Blade position: distance between the inside bottom of vessel & the blade is maintained at 25 ± 2mm.
  11. 11. Apparatus should be chemically inert.Do not adsorb, react or interfere with dissolution medium.All metal parts of the apparatus must be made from stainless steel.
  12. 12. VolumeDeaerationExamples Of Typical Media
  13. 13. Above mentioned tests are very essential in order to ensure,• Constant dose of drug• Sufficient mechanical strength• Released in controlled and reproducible way.
  14. 14. Bibliography:Indian Pharmacopoeia.Webliography:www.pharmainfo.net

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