PMDA posts Japanese Pharmacopoeia technical note on mini-tablet classification and quality
The note distinguishes count-based tablets from weighed granules and discusses units for dosage uniformity and dissolution assessment.
On 5 November 2026, Japan's PMDA posted the Japanese Pharmacopoeia Formulation Committee's September 2026 technical note, 'Handling of Mini-tablets and Similar Products as Dosage Forms'. It concerns mini-tablets and granular tablets, including pediatric formulations in Japan. The committee considers a separate new Pharmacopoeia dosage-form category unnecessary at present. This is technical information, not an enacted amendment to the Pharmacopoeia; it sets no effective date or transition period.
The note considers products dispensed or taken by a specified count to be tablets and products dispensed by a specified weighed amount to be granules. For count-based products, dosage uniformity is normally assessed on individual tablets; a group of tablets may be the unit when the minimum approved dose comprises several tablets. For weighed products, packaged granules are subject to dosage-uniformity testing, while unpackaged granules are outside that test's scope.
Development and quality-control teams should check the dosing unit and approved product information, then consider content variation and dissolution assessment at the smallest dose when setting specifications and control strategies. The note does not prescribe a universal numerical limit or a new test method; product-specific decisions require the current Pharmacopoeia text and approval particulars.