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:
These components have been carefully selected for their distinctive properties, and when co-processed physically they provide ideal attributes for ODT formulations.
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
The below diagrams give an insight into each grade’s specifications:
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).
Tablets with SmartEx® Plus showed improved stability in terms of disintegration and hardness compared to other co-processed excipients.
Formulating with SmartEx® Plus
Looking to improve your ODT formulations with this exciting new co-processed excipient? Fill out the contact form below and a member of our technical team will be in touch with more information and recommendations regarding this novel ingredient. You can also find out further details by visiting the Shin-Etsu website. Samples of SmartEx® Plus are available too, so be sure to let us know if you’d like one!