Product >> Pharmaceutical >> Excipients >> Hydropropyl Betadex
Cyclodextrins are natural cyclic oligosaccharides that were discovered just over 100 years ago, but only recently highly purified cyclodextrins became available as pharmaceutical excipients. Worldwide about 30 different pharmaceutical products containing hydroxypropyl beta cyclodextrin (HPBCD) are commercially available. Complexol-HP® has mainly been used as complexing agent to increase aqueous solubility of poorly soluble drugs, and to increase their bioavailability and stability. In addition, Complexol-HP® can be used to reduce gastrointestinal drug irritation, it converts liquid drugs into microcrystalline or amorphous powder, and prevents drug-drug and drug-excipient interactions. A number of books and review articles have been published on pharmaceutical applications of HPBCD. Complexol-HP® is used in the formulation development of tablets, aqueous parenteral solutions, rectal, topical, nasal sprays and eye drop solutions.
Advantages of Complexol-HP®:
- Stabilization of light- or oxygen-sensitive substances.
- Modification of the chemical reactivity of guest molecules.
- Fixation of very volatile substances.
- Improvement of solubility of substances.
- Modification of liquid substances to powders.
- Protection against degradation of substances by micro-organisms.
- Masking of malodour and taste.
- Masking pigments or the color of substances.
Applications of Complexol-HP®:
• Improves the solubility of compounds with low water solubility, facilitating higher bioavailability of drugs (when the solubility or the rate of dissolution are the limiting factors of bioavailability)
• Increases shelf-life of expensive flavors and fragrances through encapsulation of volatile compounds
• Controls release of drugs, fragrances or flavors
• Improves organoleptic properties of drugs and obtain more palatable preparations
• Avoids incompatibilities between actives in the same formulation
• Stabilizes reactive ingredients against oxidation, hydrolysis
• Stabilizes against temperature degradation, hydrolysis, oxidation, photolysis
• Improves Flowability and compression behavior of active compounds
• Transforms liquid actives into easily manipulated solid complexes
Regulatory status of Complexol-HP® :
- The American FDA has given market approval for solid oral, liquid oral, ophathalmic and intravenous formulations containing HPBCD derivatives
- Our manufacturing unit is approved by WHO-GMP and ISO 9001 : 2008
- Complexol-HP® is having registered Type IV US DMF No. 23816
- Pharmacopoeia conformity: the USP and EP have published draft monographs for hydroxypropyl betacyclodextrin
- HPBCD is also included in Inactive Ingredient database (IIG) of USFDA
- HPBCD is introduced into Generally Regarded As a Safe (GRAS) list of the USFDA