The effect of different administration scenarios and testing conditions was investigated by varying the dissolution test parameters, as described in Table II. These were as follows: (1) effect of co-administration of formulation with selected vehicles in comparison to direct administration of formulation; (2) effect of different mixing patterns (i.e. time between preparation and administration/testing of the formulation-vehicle mixture); and (3) effect of hydrodynamics (50 vs 100 rpm, in selected studies of Pentasa® and Singulair® granules).
Table II Dosing Scenarios and Testing Conditions Investigated
Setup Agitation speed (rpm) Scenario: direct introduction Scenario: mixing with vehicles Formulations Mixing pattern (h)
1 50 ✓ M, OJ, BLS, PY, APSUK, F, OS, GY, APSDE All 0
2 50 N/A M, OJ, BLS, PY, APSUK All 4
3 100 ✓ M, OJ, BLS, PY, APSUK Singulair®, Pentasa® 0
BLS, blackcurrant squash; OS, orange squash; M, milk; F, formula; OJ, orange juice; PY, plain yoghurt; GY, Greek yoghurt; APSUK, applesauce UK; APSDE, applesauce DE; N/A, not applicable