Healthcare

SmartEx®

Co-processed excipient for ODTs

SmartEx®
SmartEx® Plus is a co-processed excipient

SmartEx® Plus was developed by Shin-Etsu to ease the developments of oral dispersible tablets (ODTs) or fast disintegrating tablets. SmartEx® Plus is a co-processed excipient based on mannitol, low-substituted hydroxypropyl cellulose (L-HPC) and polyvinyl alcohol (PVA). All the components fulfill the respective compendial requirements from the EP, NF and JP. Registration for an US-DMF number is ongoing.

ODTs are a step forward to improve the patient compliance and acceptance of medicines. Oral disintegrating tablets are defined by the pharmacopoeias as solid dosage form disintegrating in the mouth and they do not require water for swallowing. The tablets weight should be maximal 500 mg and the disintegration time should be less than 30 seconds (USP) or 180 seconds (EP) in 2 mL of saliva.

SmartEx® Marken

MarkenBeschreibungRegulatorischHerkunftKnowledge Base
PlusCo-processed excipientNF, EP, JPJapan Auswählen
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Guide to Applications
Pharmaceutical Excipients
SmartEx®Plus
Safety Data Sheets
Safety Data Sheet

The good mouthfeel is, besides the fast disintegration time, a key consideration when developing ODTs. That's why Shin-Etsu decided to combine mannitol, L-HPC and PVA. Mannitol is a water-soluble filler and it brings a good stability and a pleasant taste to the formulations. It has a sweet taste with a cooling effect once tablets disintegrate. L-HPC is a non-ionic disintegrant with defined small particle size, showing good compressible properties. PVA was chosen as a binder as it is not impacting the disintegration time. All three excipients are co-processed physically so that SmartEx® Plus provides ideal attributes for ODTs developments.
One of the major challenges faced by R&D is the stability of the developed tablets. In several cases, orally disintegrating tablets are either losing their tensile strength or their disintegration time is increased when put under accelerated stability conditions (40°C/75% relative humidity). With SmartEx® Plus excellent stability is achieved without compromising the disintegration time.

Further applications of SmartEx® Plus include the rapid development immediate release tablets or dispersible tablets by direct compression. Its excellent flow properties make SmartEx® Plus a key excipient in continuous manufacturing.
It was never as easy to develop a robust direct compression process as only three components are required: API, SmartEx® Plus, and magnesium stearate.

Please download the SmartEx® Plus information flyer here.

Marken und Anwendungen

Anwendungen
 
Tabletten und Pellets
Orally disintegrating tablets (ODT)
Dispersible tablets
Continuous Manufacturing (CM) for Oral Solid Dosage Form (OSD)
Direct compression (DC) immediate release (IR)
Capsule filling
SmartEx®
Plus
 
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