KLEPTOSE® HPB / KLEPTOSE® HP

Betacyclodextrins and modified Hydroxypropyl & Methyl Betacyclodextrins

Molecular encapsulation with betacyclodextrins has become an accepted and useful tool for pharmaceutical developers, with several pharmaceutical products containing cyclodextrin complexes now 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. Together with different substituted Hydroxypropyl or CRYSMEB* Methyl Betacyclodextrins, KLEPTOSE® caters for the specific needs of the pharmaceutical and cosmetic industry.

 

* under development

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 Pharmacopoeia conformity - European Pharmacopoeia - Draft USP monograph 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 Canadian DMF n° 2005-150 PROPERTIES KLEPTOSE® Hydroxypropyl betacyclodextrins (HPBCD) are highly soluble betacyclodextrin derivatives suitable for pharmaceutical as well as cosmetic applications. A Pyrogen Free pharmaceutical grade can be produced under cGMP conditions for parental use. Roquette has been manufacturing    pharmaceutical grade HPBCD for several years. This pharmaceutical grade HPBCD is now directly available to the R & D community  under the trade name KLEPTOSE® HPB**.

RANGE KLEPTOSE® HP high molecular substitution  KLEPTOSE® HP Parenteral Grade high molecular substitution endotoxin controlled KLEPTOSE® HPB Oral Grade medium molecular substitution KLEPTOSE® HPB Parenteral Grade medium molecular substitution endotoxin controlled APPLICATIONS Pharmaceutical: 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.   Cosmetics: Suitable for encapsulation of volatile compounds. To increase shelf life of expensive flavours.

** The use of HPBCD in pharmaceutical compositions containing drugs which are instable or sparingly soluble in water is now free of any broad use patent except for the US territory. 

TYPICAL FORMULATION

At present there are no typical formulations available in our database for this product.

However Roquette has long offered an integrated customer service for formulation assistance (see here presentation of Applications Laboratory Services & Support).

Roquette continuously develops new formulations to serve as basic guidelines for optimum performance of its products. To know more about our typical formulations, please contact us or fill in our Formulation Assistance Request.

 

 

CURRENT PACKAGING FOR THIS FAMILY OF PRODUCTS:

• 25 kg fiber drum

To check the immediate availability of these packaging formats or other special packaging, please contact us or your local Roquette representative for  further information.

 

QUALITY-RELATED DOCUMENTATION

• Group quality policy
• Group safety policy
  
• Group environmental policy / S.M.E.
• ISO certificate
• GMO certificate

TECHNICAL BROCHURES

• KLEPTOSE® betacyclodextrins and Hydroxypropyl betacyclodextrins - 40 pages
• KLEPTOSE® HP/KLEPTOSE® HPB - multifunctional excipients for molecular encapsulation - 38 pages
• KLEPTOSE® HPB - An attractive excipient in oral drug delivery - 8 pages
• KLEPTOSE® HPB - A safe solubilizing excipient for dermal drug delivery - 8 pages
• KLEPTOSE® HPB - A safe solubilizing excipient in injectable dosage forms - 8 pages
• KLEPTOSE® HPB - A safe solubilizing excipient for nasal and pulmonary drug delivery - 8 pages
• KLEPTOSE® HPB - A safe solubilizing excipient for ocular drug delivery - 8 pages
• Personal Care Products - 16 pages

 

SAMPLE REQUEST

Early formulation is important and we recognize the need for formulators to have representative material for initial testing. We can provide small non-commercial samples wherever you are in the world, with both the corresponding certificate of analysis and conformity and the material safety data sheet.

To obtain access to this service, please log in with your personal password and submit your sample or other request here.

More information

 

SAMPLE REQUEST

Early formulation is important and we recognize the need for formulators to have representative material for initial testing. We can provide small non-commercial samples wherever you are in the world, with both the corresponding certificate of analysis and conformity and the material safety data sheet.

To obtain access to this service, please log in with your personal password and submit your sample or other request here.

Sample request form