SmartEx® Plus: a New Co-Processed Excipient for Oral Disintegration Tablets

SmartEx® Plus is an exciting new co-processed excipient that has been developed by Japanese chemical company Shin-Etsu to meet the increased demand for oral disintegration tablets (ODTs), with the added advantage that it offers excellent stability without compromising on disintegration time.

This unique type of co-processed excipient is based on three components: D-mannitol, low-substituted hydroxypropyl cellulose (L-HPC) and polyvinyl alcohol (PVA), with each one fulfilling the respective compendial requirements from the EP, NF and JP:

SmartEx® Plus_a New Co-Processed Excipient for Oral Disintegration Tablets_mannitol — SmartEx® Plus_a New Co-Processed Excipient for Oral Disintegration Tablets

These components have been carefully selected for their distinctive properties, and when co-processed physically they provide ideal attributes for ODT formulations.

Applications

SmartEx® Plus is suitable for use in the direct compression of immediate release tablets (IR), oral disintegration tablets (ODTs), dispersible tablets, and tablets produced by continuous manufacturing. It offers the following benefits:

Improved stability
High compressibility
Free flowing particles
Fast disintegration and good feeling in the mouth
Multi-compendial

The below diagrams give an insight into each grade’s specifications:

Particle Size Distribution

Particle Morphology

ODT formulation example

In this formulation example, acetaminophen ODTs (with a diameter of 8mm) were produced and the tensile strength and disintegration (USP disintegration test, water) were analysed.

A sufficient tensile strength was obtained, and the disintegration time complied with the USP (< 30 s) and EP (< 180 s) requirements for ODTs.

Stability of IR tablets example

In this IR tablet stability example, fast disintegrating ibuprofen tablets (with a diameter of 8mm) were produced and the tensile strength and disintegration (USP disintegration test, water) were analysed before and after one month storage (40°C/75% relative humidity).