KLEPTOSE® HP HPB - Hydroxypropyl betacyclodextrin

Molecular encapsulation | Solubility improvement | Taste masking
Kleptose HP and HPB for pharmaceutical applications: parenteral use, syrup oral suspensions. HPBCD increase water solubility and bioavailability.

Introduction

Molecular encapsulation with hydroxypropyl betacyclodextrins is an accepted and useful tool for 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 hydroxypropyl betacyclodextrins.

MONOGRAPH

KLEPTOSE® HP & HPB - Hydroxypropyl Betacyclodextrin

® Registered trademark(s) of Roquette Freres

Description - Compliance

Description

Hydroxypropyl betacyclodextrins are purified polydisperse products resulting from the controlled reaction of propylene oxide and native betacyclodextrin.

Roquette's pharmaceutical grade HPBCD is produced in a purpose build, state of the art manufacturing plant following US FDA and ICH Q7A GMP quality guidelines.

Compliance

  • European Pharmacopoeia
  • USP/NF

Compliance with GMP

  • Industrial sites: ISO 9001 certified
  • Manufacturing plant compliant with cGMP/FDA and GMP/ICH Q7A quality guidelines

Regulatory documentation

  • US DMF Type IV n° 9420
  • US DMF Type II n°XXXXX
  • Canadian DMF n° 2005-150

Registrations vary depending on local regulations.

Properties and range
  • KLEPTOSE® hydroxypropyl betacyclodextrins (HPBCD) are highly soluble betacyclodextrin derivatives suitable for all pharmaceutical applications.
  • A pyrogen-free pharmaceutical grade is produced under GMP conditions for parental use.
  • Roquette has been manufacturing pharmaceutical grade HPBCD for several decades.

A variety of grades

  • KLEPTOSE® HPB Oral Grade - medium molecular substitution
  • KLEPTOSE® HPB Parenteral Grade - medium molecular substitution endotoxin controlled
  • KLEPTOSE® HP oral grade - high molecular substitution
  • KLEPTOSE® HP Parenteral Grade - high molecular substitution endotoxin controlled
Applications

Suitable for parenteral use, syrups, solutions and oral suspensions as well as for dry formulations (with possibility of in-situ encapsulation).

  • To increase water solubility of poorly soluble drugs.
  • To increase bioavailability.
  • To improve organoleptic properties of bitter or unpleasant actives.
Current packaging for this family of products

KLEPTOSE® HPB Oral grade
KLEPTOSE® HP Oral grade

  • Drum 25 kg
  • Jerriplax 1 kg
Other packagings might be offered upon request.
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