Sample requirements for a drug filter adsorption study

i. Sample requirement

  • To conduct a drug filter adsorption study, typically, a sample representing around 10% to 20% of drug release from the immediate-release dosage form in the dissolution vessel is needed

ii. Calculating drug concentration

*recommended volume is 900 mL

iii. Selection of the concentration to test

  • A value within the range between 10% to 20% is commonly chosen because, during a biorelevant dissolution experiment for an immediate release drug product, it is recommended to withdraw the first sample at around 5 minutes. This is typically the point when the drug product is at its lowest concentration in the dissolution medium
  • At this 5-minute time point, the drug formulation has usually disintegrated and started to dissolve in the dissolution medium

iv. Sample composition

  • The sample should contain the same amount of biorelevant medium as the actual dissolution sample taken from a vessel

Download our Biorelevant Dissolution Guides here.