Oral osmotically driven systems: 30 years of development and clinical use.
The number of marketed oral osmotically driven systems (OODS) has doubled in the last 10 years. The main clinical benefits of OODS are their ability to improve treatment tolerability and patient compliance. These advantages are mainly driven by the capacity to deliver drugs in a sustained manner, independent of the drug chemical properties, of the patient's physiological factors or concomitant food intake. However, access to these technologies has been restricted by the crowded patent landscape and manufacturing challenges. In this review article, we intend to give an overview of the OODS development in the last 30 years, detailing the technologies, specific products and their clinical use. General guidance on technology selection is described in light of the recent advances in the field. The clinical performance of these technologies is also discussed, with a focus on food effects and the in vivo-in vitro correlation. Special attention is paid to safety given the controversial case study of Osmosin. Overall, oral osmotically driven systems appear to be a promising technology for product life-cycle strategies.
Malaterre
Vincent
V
Novartis Pharma AG, Technical R&D, Basel, Switzerland; School of Pharmaceutical Sciences, University of Geneva-Lausanne, Geneva, Switzerland.
Ogorka
Joerg
J
Loggia
Nicoletta
N
Gurny
Robert
R
D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical; D003692:Delayed-Action Preparations; D016503:Drug Delivery Systems / Q000379:methods* / Q000639:trends; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007213:Indomethacin / Q000008:administration & dosage; D007260:Infusion Pumps / Q000639:trends; D009997:Osmotic Pressure; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000639:trends
D003692:Delayed-Action Preparations; D004364:Pharmaceutical Preparations; D007213:Indomethacin