HPBCD Hydroxypropyl Beta Cyclodextrin Pharmaceutical Formulation Excipients

Hydroxypropyl-Beta-Cyclodextrin (HPBCD) is a modified cyclic oligosaccharide produced through the controlled reaction of propylene oxide with native beta-cyclodextrin. As an oral grade pharmaceutical excipient, HPBCD functions as a solubility enhancer and stability modifier for poorly water-soluble active pharmaceutical ingredients (APIs). With a water solubility exceeding 500 mg/mL at room temperature—compared to 18 mg/mL for unmodified beta-cyclodextrin—HPBCD enables formulation scientists to develop oral drug products with improved dissolution profiles. This excipient holds FDA DMF registration (#030168) and China CDE filing (F20209990366), and is manufactured in accordance with GMP standards by Shandong Binzhou Zhiyuan Biotechnology Co., Ltd. (FEI: 3011680310).

HPBCD Technical Specifications and Quality Parameters

HPBCD Mechanism of Action in Pharmaceutical Formulations

Molecular Encapsulation Principle

HPBCD features a truncated cone structure with a hydrophobic internal cavity and a hydrophilic external surface. This amphiphilic architecture allows HPBCD to form inclusion complexes with lipophilic drug molecules. The drug molecule resides within the cyclodextrin cavity, while the outer hydroxypropyl groups maintain aqueous solubility. This inclusion complex formation occurs through non-covalent interactions, preserving the chemical structure of the API.

Solubility Enhancement Mechanism

The hydroxypropyl substitution on the beta-cyclodextrin ring disrupts the intermolecular hydrogen bonding network that limits native beta-cyclodextrin solubility. This structural modification increases aqueous solubility from 18 mg/mL (beta-cyclodextrin) to greater than 500 mg/mL (HPBCD) at 25°C. At concentrations below 40% (w/v), HPBCD solutions exhibit low viscosity and good flow properties, facilitating manufacturing processes such as filtration and filling operations.

HPBCD Applications in Oral and Mucosal Drug Delivery

Solubility Improvement for Poorly Water-Soluble Drugs

HPBCD is utilized in oral solid and liquid formulations to increase the aqueous solubility of BCS Class II and IV drugs. The inclusion complex formation enhances dissolution rate and extent, potentially improving oral bioavailability. Unlike organic solvents or surfactants, HPBCD achieves solubilization through molecular encapsulation without altering the drug's chemical identity. Drug concentration increases linearly with HPBCD concentration within the complexation range, allowing predictable formulation development.

Stability Enhancement and Bioavailability Improvement

HPBCD inclusion complexes provide protection against environmental degradation factors. The cyclodextrin cavity shields encapsulated APIs from oxidation, photodegradation, and volatilization during storage and manufacturing. Additionally, the improved dissolution characteristics of HPBCD-drug complexes can lead to faster absorption and higher bioavailability compared to conventional formulations. HPBCD is applicable to oral, mucosal (nasal, rectal, ocular), and transdermal delivery systems.

Reduction of Drug Irritation

By forming inclusion complexes with irritant drug substances, HPBCD can reduce local irritation at administration sites. This property is particularly relevant for mucosal and transdermal formulations where direct tissue contact occurs. The controlled release profile achievable with cyclodextrin complexes also contributes to improved tolerability profiles.

HPBCD Packaging, Storage, and Supply Specifications

Available Packaging Configurations

HPBCD oral grade is supplied in multiple packaging options to accommodate different batch sizes: 1 kg, 2 kg, 10 kg, and 20 kg units. Packaging materials include fiber drums and cartons with inner polyethylene liners to maintain product integrity during transportation and storage.

Storage Conditions and Shelf Life

HPBCD should be stored in tightly sealed containers, protected from moisture and direct sunlight. Recommended storage conditions are cool, dry environments with controlled humidity. Properly stored material maintains specification compliance throughout the stated shelf life period.

FAQ About HPBCD Supply

What regulatory documentation is available for HPBCD oral grade?

This product holds FDA DMF registration (Number #030168) and China CDE filing (Number F20209990366). The manufacturer, Shandong Binzhou Zhiyuan Biotechnology Co., Ltd., operates under GMP conditions with FEI number 3011680310 and DUNS number 548171477. Full regulatory support documentation can be provided for commercial procurement and product registration purposes.

How is product quality verified during manufacturing?

Quality control procedures are implemented at all production stages: incoming raw material testing, in-process monitoring, and finished product release testing. Each batch undergoes complete analysis according to CP/USP/EP specifications before release. QA and QC departments oversee all manufacturing operations to ensure consistent compliance with established quality standards.

Can customers conduct on-site facility audits?

On-site audits are accepted as part of the supplier qualification process. Audit arrangements can be coordinated through the commercial procurement team. The manufacturing facility is located in Boxing Economic Development Zone, Binzhou, Shandong Province, China.

What is the typical lead time for commercial orders?

Standard production lead times vary based on order quantity and current production scheduling. Sample quantities are typically available for immediate shipment. For commercial scale orders, specific delivery timelines can be confirmed upon inquiry.