KLEPTOSE® - Betacyclodextrin

Solubility improvement | Solubility and stability improvement | Taste-masking

KLEPTOSE® (cyclodextrins) are efficient solubilisation, stabilization enhancers and taste-masking agents. A full range is available for use in many dosage forms, from solid to liquid.

Introduction

Molecular encapsulation with betacyclodextrins is an accepted and useful tool for pharmaceutical formulators, with many pharmaceutical products containing cyclodextrin complexes on the market.

Cyclodextrins can improve the solubility of poorly soluble compounds and can be used for taste masking of bitter or unpleasant active ingredients.

Roquette has pioneered the industrial development of cyclodextrins with its KLEPTOSE® range of betacyclodextrins.

MONOGRAPH

KLEPTOSE® - Betacyclodextrin

® Registered trademark(s) of Roquette Freres

Description

 Crystalline powder

  • White
  • Almost odourless
  • Slightly sweet tasting

Betadex (beta-cyclodextrin)

Compliance

  • European Pharmacopoeia
  • USP / NF / JPE (Certain grades only)

Regulatory Documentation

  • US DMF Type IV n° 9155
Registrations vary depending on local regulations.
Properties

Properties

  • Ring shaped amphiphilic molecule
  • Its non-polar cavity allows the formation of complexes with actives in the solvent or dry phase.
  • Water solubility* at 20°C = 1.85g / 100ml

A variety of particle sizes

  • KLEPTOSE® Standard
  • KLETPOSE® 200 F - for improved mouthfeel (fine particle size)
  • KLEPTOSE® 10 - for aerosol use and improved mouthfeel (very fine particle size)
  • KLEPTOSE® DC - for direct compression
  • KLEPTOSE® 4% and 7% - for inclusion of moisture sensitive actives (low moisture content)
Applications
  • Solubility improvement
  • Stability improvement
  • Taste masking

Dosage Forms

  • Tablets, capsules, sachets
  • Oral suspensions (due to limited aqueous solubility)

 

Current packaging for this family of products

KLEPTOSE®

  • Bag 25.00 kg
  • Drum 50.00 kg

KLEPTOSE® 4%

  • Cardboard box 25.00 kg

KLEPTOSE® 7%

  • Cardboard box 25.00 kg
Other packagings might be offered upon request.

KLEPTOSE® 10

  • Drum 45.00 kg

KLEPTOSE® 200 F

  • Drum 50.00 kg

KLEPTOSE® DC

  • Drum 20.00 kg
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