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From Drug Delivery Systems to Drug Release, Dissolution, IVIVC, BCS, BDDCS, Bioequivalence and Biowaivers

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ABSTRACT

This is a summary report of the conference on drug absorption and bioequivalence issues held in Titania Hotel in Athens (Greece) from the 28th to the 30th of May 2009. The conference included presentations which were mainly divided into three sections. The first section focused on modern drug delivery systems such as polymer nanotechnology, cell immobilization techniques to deliver drugs into the brain, nanosized liposomes used in drug eluting stents, encapsulation of drug implants in biocompatible polymers, and application of differential scanning calorimetry as a tool to study liposomal stability. The importance of drug release and dissolution were also discussed by placing special emphasis on camptothecins and oral prolonged release formulations. The complexity of the luminal environment and the value of dissolution in lyophilized products were also highlighted. The second session of the conference included presentations on the Biopharmaceutics Classification Scheme (BCS), the Biopharmaceutics Drug Disposition Classification System (BDDCS), and the role of transporters in the classification of drugs. The current status of biowaivers and a modern view on non-linear in vitro–in vivo (IVIVC) correlations were also addressed. Finally, this section ended with a special topic on biorelevant dissolution media and methods. The third day of the conference was dedicated to bioequivalence. Emphasis was placed on high within-subject variability and its impact on study design. Two unresolved issues of bioequivalence were also discussed: the use of generic antiepileptic drugs and the role of metabolites in bioequivalence assessment. Finally, the conference closed with a presentation of the current regulatory status of WHO and EMEA.

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Authors and Affiliations

  1. Thriassio General Hospital, Elefsina, Greece

    Vangelis Karalis

  2. KLEVA Pharmaceuticals SA, Acharnae, Greece

    Eleni Magklara

  3. International Pharmaceutical Federation, North Potomac, Maryland, USA

    Vinod P. Shah

  4. Faculty of Pharmacy, National and Kapodistrian University of Athens, Athens, Greece

    Panos Macheras

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  1. Vangelis Karalis
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  2. Eleni Magklara
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  3. Vinod P. Shah
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  4. Panos Macheras
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Correspondence to Vinod P. Shah.

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Ick Chan Kwon (Biomedical Research Center, Korea Institute of Science and Technology), Gorka Orive (Faculty of Pharmacy, University of the Basque Country, Spain), Sophia Antimisiaris (Faculty of Pharmacy, University of Patras, Greece), Dimitri Hatziavramidis (School of Chemical Engineering, National Technical University of Athens, Greece), Costas Demetzos (Faculty of Pharmacy, National and Kapodistrian University of Athens, Greece), Michalakis Savva (Arnold & Marie Schwartz College of Pharmacy and Health Science, Long Island, NY, USA), Evangelos Karavas (Pharmathen SA, Athens, Greece), Christos Reppas (Faculty of Pharmacy, National and Kapodistrian University of Athens, Greece), George Digenis (US World Meds and University of Kentucky, Lexington, USA), Vinod P. Shah (Scientific Secretary of FIP), Leslie Z. Benet (University of California, San Francisco, CA, USA), Panos Macheras (Faculty of Pharmacy, National and Kapodistrian University of Athens, Greece), Maria Vertzoni (Faculty of Pharmacy, National and Kapodistrian University of Athens, Greece), Kamal K. Midha (President of FIP), Achiel Van Peer (Johnson and Johnson, Beerse, Belgium), Meir Bialer (School of Pharmacy, The Hebrew University of Jerusalem, Israel), Vangelis Karalis (Thriassio General Hospital of Elefsina, Greece, Jose A. Morais (University of Lisbon, Lisbon, Portugal)

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Karalis, V., Magklara, E., Shah, V.P. et al. From Drug Delivery Systems to Drug Release, Dissolution, IVIVC, BCS, BDDCS, Bioequivalence and Biowaivers. Pharm Res 27, 2018–2029 (2010). https://doi.org/10.1007/s11095-010-0220-9

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