Injection grade hydroxypropyl betacyclodextrin

The introduction of hydroxypropyl (2-hydroxypropyl) destroys the hydrogen bonds within the ring of β-cyclodextrin, which not only retains the cyclodextrin cavity, but also overcomes the main shortcoming of poor water solubility of β-cyclodextrin.

Basic information

Name:Hydroxypropyl betacyclodextrin

CAS No.:128446-35-5

DMF No.:030168

CEP No.:CEP 2022-219 - Rev 00

Qaulity : Injection grade/Oral grade/Technical grade

Package: 500g/bag , 1kg/bag,  10kg/drum , 20kg/drum or customized

Product features

1. Solubilize and help dissolve poorly soluble drugs, improve the solubility of active ingredients in oily drugs, target drug delivery and protect the effectiveness of drug ingredients.

2. Improve drug bioavailability, increase the efficacy of the drug or reduce the dosage.

3. Adjust or control the release rate of drugs to reduce drug side effects.

4. Cover up bad smells.

Scope of application

Hydroxypropyl betacyclodextrin can be used in oral preparations, injection preparations, mucosal drug delivery systems (including nasal mucosa, rectum, cornea, etc.), transdermal absorption drug delivery systems, carriers for lipophilic targeted drugs, and can also be used as protein protectants and stabilizers.

From a safety perspective, injection grade hydroxypropyl betacyclodextrin has a favorable toxicological profile. The hydroxypropyl modification significantly reduces the nephrotoxicity associated with native beta-cyclodextrin by enhancing water solubility and facilitating renal clearance. This makes it a safer choice for intravenous, intramuscular, and subcutaneous drug delivery. Rigorous quality control ensures that the excipient meets international standards for heavy metals, residual solvents, and microbial limits, making it reliable for sensitive injectable formulations.

In manufacturing, the production of injection grade hydroxypropyl betacyclodextrin involves precise control of substitution degree and molecular structure to optimize performance in pharmaceutical systems. This ensures consistent inclusion complex formation and predictable interaction with active pharmaceutical ingredients (APIs). It is available in powder form, easily dissolvable in water for injection (WFI), and can be sterilized by filtration, making it practical for large-scale pharmaceutical manufacturing.

In conclusion, injection grade hydroxypropyl betacyclodextrin plays a vital role in modern injectable drug formulation. Its combination of excellent solubilizing ability, stability enhancement, biocompatibility, and safety profile makes it indispensable for addressing solubility and stability challenges in parenteral pharmaceuticals. With ongoing advancements in drug delivery technology, this excipient is expected to become even more important, enabling innovative treatments and improving patient outcomes across multiple therapeutic areas.