PMC:7554011 / 4698-6476
Annnotations
{"target":"http://pubannotation.org/docs/sourcedb/PMC/sourceid/7554011","sourcedb":"PMC","sourceid":"7554011","source_url":"https://www.ncbi.nlm.nih.gov/pmc/7554011","text":"Development of a physiologically relevant in vitro dissolution setup would be crucial for the prediction of the in vivo performance after the administration of a formulation to a paediatric patient. Moreover, it would be beneficial for the investigation of formulation sensitivity to different foods and drinks, so that the risks associated with its co-administration can be predicted. In 2018, the FDA issued a draft guidance addressing the recommended approaches for determination of the suitability of the vehicles intended for co-administration of paediatric medicines. In this guidance, standardised in vitro methods for evaluating possible vehicle effects on in vivo product performance were described (9). These tests could help reduce the number of in vivo studies required for paediatric formulation development, and ultimately help tackle ethical issues related to paediatric clinical research (10). To this extent, in vitro test conditions should address the parameters relevant to drug release and dissolution in the paediatric gastrointestinal (GI) tract, including media composition, prandial state, hydrodynamics and current administration practices. The possible effect of these parameters on the in vivo drug behaviour should be considered during paediatric drug development (6,11). Recently, in vitro dissolution studies, performed with a mini-paddle apparatus and a two-stage approach, showed that this setup could be a useful biopharmaceutical tool for estimating drug release/dissolution in paediatric conditions (12,13). With this setup, it is possible to address pH, fluid volumes and transit times representative of the GI tract of infants, as well as different paediatric administration practices such as medicine co-administration with food and drinks.","tracks":[{"project":"2_test","denotations":[{"id":"33051713-17725846-26780","span":{"begin":905,"end":907},"obj":"17725846"},{"id":"33051713-24189013-26781","span":{"begin":1293,"end":1294},"obj":"24189013"},{"id":"33051713-28495584-26782","span":{"begin":1295,"end":1297},"obj":"28495584"}],"attributes":[{"subj":"33051713-17725846-26780","pred":"source","obj":"2_test"},{"subj":"33051713-24189013-26781","pred":"source","obj":"2_test"},{"subj":"33051713-28495584-26782","pred":"source","obj":"2_test"}]}],"config":{"attribute types":[{"pred":"source","value type":"selection","values":[{"id":"2_test","color":"#93a1ec","default":true}]}]}}