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AdvaTab® Temazepam ODT

Gastroenterology

A convenient orally disintegrating tablet (ODT) formulation of Temazepam, a common treatment for insomnia.


Temazepam has been successfully prescribed to treat sleep disorders for more than two decades.1 Eurand’s Temazepam formulation uses their proprietary AdvaTab® ODT technology to create an easy-to-swallow dosage form that can be taken as needed, with or without water.

Eurand’s proprietary Temazepam ODT formulation has been demonstrated to be clinically bioequivalent to Restoril (temazepam) Capsules USP, marketed in the U.S. by Mallinckrodt Pharmaceuticals.

Eurand’s AdvaTab technology produces an ODT with the following key properties: pleasant taste, smooth mouthfeel, and disintegration in less than 30 seconds. This is due to our proprietary microencapsulation technique that ensures a uniform and complete taste-masking for a superior-tasting ODT.

Therapeutic Category

Sleep Aid

Indication

Short-term treatment of insomnia

Development Status

Phase II

Available Dosage Strength(s)

  • 7.5 mg
  • 15 mg
  • 22.5 mg
  • 30 mg

Product Description

ODT formulation of temazepam, a benzodiazepine hypnotic agent

Eurand Technology

AdvaTab® - Orally Disintegrating Tablet (ODT) technology

Licensing Opportunities

Eurand is seeking partners to register, market, and sell the product in countries around the world.

AdvaTab® Temazepam has been clinically demonstrated as bioequivalent to the currently marketed U.S. brand, Restoril (temazepam) Capsules USP.


Temazepam

This information is provided solely for the purpose of the evaluation of business opportunities by potential collaboration partners. The information is based on currently existing data and marketing authorizations in a number of jurisdictions and should not be assumed to be approved by regulatory authorities in any individual country. Consumers should consult with their individual physician for product information and should not rely upon any information provided here.

For more information on this product, please contact Eurand.

1www.restoril.com
Restoril™ is a registered trademark of Mallinckrodt, Inc.

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Taste-masking and ODTs

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