SmartEx® Plus

Description

 

Co-processed excipient for ODTs

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.

 

If you have any questions, please contact Shin-Etsu directly here