Products

KLEPTOSE HP/HPB
Hydroxypropyl Betadex USP/NF, EP

Kleptose HPB is a purified, polydisperse product resulting from controlled reaction of propylene oxide and native betadex under base catalysis. This product overcomes the low solubility and inadequate biological tolerance of the native betacyclodextrin molecule. Kleptose HPB is produced in a purpose built, state-of-the-art manufacturing plant following USFDA type GMP quality guidelines and is well supported by toxicology data.  

Roquette has introduced a new parenteral grade, Kleptose HPB–LB, which complies to USP/NF, EP as well as ChP requirement for ‘MS and Residual Betadex content’, thus facilitating faster registration of pharmaceutical products in China.

Grade

Molecular Substitution

Residual Betadex Content

Applications

Kleptose HPB

 0.58 – 0.68

1.5%

Suitable for parenteral use, syrups, solutions and oral suspensions as well as for dry formulations (with possibility of  in-situ encapsulation). Increases water solubility of poorly soluble drugs thereby improving bioavailability and enhances organoleptic properties of bitter or unpleasant actives

Kleptose HP

0.81 – 0.99

1.5%

KLEPTOSE HPB – LB PARENTERAL GRADE 0.50-0.71 0.3%

Low betadex content grade. Acts as stabilizer against light and oxidation and solubility enhancer for active substances in parenteral formulations. Also complies to ChP monograph

 

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