NCIt definition : Solid preparation consisting of granules showing a rate and/or place of release different
from that of conventional-release granules. This deliberate modification is achieved
by a special formulation design and/or manufacturing method. Modified-release granules
are usually single-dose preparations intended for oral use, and include prolonged-release,
delayed release and pulsatile-release granules.;
Alternative definition : EDQM-HC: Solid preparation consisting of granules showing a rate and/or place of release
different from that of conventional-release granules. This deliberate modification
is achieved by a special formulation design and/or manufacturing method. Modified-release
granules are usually single-dose preparations intended for oral use, and include prolonged-release,
delayed release and pulsatile-release granules. The generic term 'modified-release
granules' is used only when the more specific terms 'gastro-resistant granules' or
'prolonged-release granules' do not apply.;