In vivo-in vitro correlation for amoxicillin trihydrate 1000 mg dispersible tablet

Drug Dev Ind Pharm. 2009 Aug;35(8):981-5. doi: 10.1080/03639040902737492.

Abstract

Objectives: An in vivo-in vitro correlation (IVIVC) for amoxicillin dispersible tablet was established.

Methods: The model of absorption was constructed with type 2 dissolution apparatus and with the use of variable hydrodynamic conditions simulating passage through upper part of gastrointestinal tract. The in vivo test was performed on 24 volunteers.

Summary of results: The predicted errors for AUC and C(max) were calculated. Conditions of the in vitro test were discriminative to capsules, which were claimed to have lower bioavailability. The zero-order process of amoxicillin absorption enabled to establish the IVIVC more easily.

Overall conclusions: The described model showed features of level A correlation for immediate release dosage form and the zero-order process of amoxicillin absorption is an advantage for establishing IVIVC.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Amoxicillin / administration & dosage
  • Amoxicillin / pharmacokinetics*
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / pharmacokinetics*
  • Area Under Curve
  • Biological Availability
  • Female
  • Humans
  • Male
  • Models, Biological*
  • Solubility
  • Tablets
  • Young Adult

Substances

  • Anti-Bacterial Agents
  • Tablets
  • Amoxicillin