Hydroxypropyl Beta Cyclodextrin Powder

 

Hydroxypropyl beta cyclodextrin powder as a hydroxyalkylated derivative of β-cyclodextrin (β-CD, CAS 7585-39-9), HP-β-CD (CAS 128446-35-5) achieves a fundamental reconstruction of the molecular polarity through propoxy substitution of the C2/C6 hydroxyl group.

 

Its toxicological characteristics have been verified by the OECD 423 acute toxicity test, with an LD50>5000 mg/kg (oral administration to rats), and it is listed as a GRAS pharmaceutical excipient by USP-NF.

 

1. Solubility
With a hydrophobic cavity of 7.8-8.3 Å and a degree of substitution (MS) of 0.34-0.40, this molecule can increase the apparent solubility of poorly soluble drugs by 10²-10³ times.

 

2. Biopharmaceutical improvements
By forming 1:1 or 1:2 inclusion complexes (binding constant Ka=10³-10⁴ M⁻¹), it is achieved:

 

• Reduced first-pass effect: propranolol hepatic metabolism decreased by 42%.
• Sustained release characteristics: Ibuprofen Tmax is extended from 1.2h to 4.5h.
• Irritation control: Acyclovir increases corneal transmittance while reducing eye irritation scores by 78%.

 

 

1. HP─β─CD has high water solubility at room temperature, generally exceeding 50%, so it cannot crystallize in alcohol aqueous solution.

 

2. HP─β─CD and β─CD have different selectivities for enveloped substances, and the proportion of molecules enveloped by certain substances may change.

 

3. Hydroxypropyl beta cyclodextrin powder is basically neither catabolized nor accumulated in the human body. Most of the HP─β─CD taken orally administered is excreted with the feces. When administered parenterally, almost all HP─β─CD is excreted with the urine.

 

4. HP─β─CD can promote the rapid release of enveloped substances in the body.

 

5. HP─β─CD has lower surface activity and hemolytic activity than β─CD or other derivatives, making it safer to use.

 

 

Analysis		Specification	Result
Physical Description
Appearance		White or almost white, amorphous or crystalline powder. Freely soluble in water and in propylene glycol.	White powder
Clarity of solution		1.0g/2ml water solution is clear and transparent	Complies
Molar substitution		0.4~1.5	0.68
Chemical Tests
Identification	IR	Same absorption bands as USP Hydroxypropyl Betadex RS	Complies
	Clarity of solution	Positive	Positive
Betadex		1.5% Max	0.37%
Propylene glycol		2.5% Max	0.05%
Any other single impurity		0.25% Max	Not detected
Total impurity excluding Betadex and Propylene Glycol		1.0% Max	Not detected
Propylene Oxide		0.0001% Max	0.000012%
Conductivity		200µS/cm Max	70µS/cm
Loss on drying		10.0% Max	3.2%
Microbiology Control
Total aerobic microbial count		1000cfu/g Max	<10cfu/g
Total combined molds and yeasts		100cfu/g Max	<10cfu/g
Conclusion		Complies with the standards.
Packing and Storage
Packing: Pack in paper-carton and two plastic-bags inside.
Shelf life: 2 year when properly stored.
Storage: Store in a well-closed place with constant low temperature and no direct sun light.

 

 

1. Pharmaceutical Field:
Due to its low relative surface activity and hemolytic activity and no irritation to muscles, hydroxypropyl beta cyclodextrin powder is an ideal solubilizer and pharmaceutical excipient for injections.

 

It can improve the water solubility of poorly soluble drugs, increase drug stability, improve drug bioavailability, increase the efficacy of the drug or reduce the dosage, adjust or control the release rate of the drug, and reduce the toxic and side effects of the drug.

 

2. Food Field:
Hydroxypropyl beta-cyclodextrin can improve the stability and long-term effectiveness of nutritional molecules, mask or correct the bad smell and taste of food nutritional molecules, and improve production processes and product quality.

 

3. Cosmetics Field:
Hydroxypropyl beta cyclodextrin powder is used as a stabilizer, emulsifier, deodorant, etc. It can reduce the stimulation of skin and mucous membrane tissues by organic molecules in cosmetics, enhance the stability of active ingredients, and prevent the volatilization and oxidation of nutrients. It There is also a certain degree of relative hygroscopicity.

 

 

1. Basic information

 

Feature	Hydroxypropyl Beta Cyclodextrin	Hydroxypropyl Gamma Cyclodextrin
Structure	β-Cyclodextrin (7 glucose units)	γ-cyclodextrin (8 glucose units)
Hydroxypropyl substitution site	Mainly occurs at the C2 and C6 hydroxyl positions	Preferentially occupy C3 hydroxyl position
Cavity volume	262 ų	427 ų
Topological polarity	Electrostatic potential difference on the cavity surface ΔΨ=18.7 kV/m	ΔΨ=12.3 kV/m (more suitable for electrically neutral molecules)

 

2. Comparison of key performance parameters

1. Dissolution and stability
(1) Hydroxypropyl beta cyclodextrin powder:

• Water solubility reaches 60 g/100mL (25℃), but micelles are easily formed in high ionic strength solutions.
• The thermal decomposition temperature is increased to 315°C, while the original β-CD is 290°C.

 

(2) HP-γ-CD:

• The solubility exceeds 80 g/100mL, and it can tolerate pH 1-12 environment (gastric acid stability is improved by 300%).
• The oxidative stability index (OSI) reaches 42 hours, while HP-β-CD only reaches 28 hours.

 

 

1. Pharmaceutical field

 

(1) HP-β-CD:

• The main force in solubilizing small molecule drugs.
• Transdermal patch optimization: Increases estradiol transdermal rate by 220%.
• Limitations: Low renal clearance (CL=0.32 L/h/kg).

 

(2) HP-γ-CD:

• Macromolecule drug delivery: PD-1 antibody was successfully included, and the bioavailability for subcutaneous injection reached 81%.
• Cell therapy carrier: used in CAR-T cryopreservation solution to increase cell survival rate from 40% to 92%.
• Breakthrough application: The blood-brain barrier penetration efficiency is 7 times that of HP-β-CD.

 

2. Food and cosmetics

 

(1) Hydroxypropyl beta cyclodextrin powder:

• Sustained release of flavor substances: the retention rate of citrus essential oil is still 95% after 6 months.
• Sunscreen stabilization: Reduces avobenzone photodegradation rate by 78%.

 

(2) HP-γ-CD:

• Functional oil embedding: the oxidation induction period of omega-3 fatty acids is extended to 18 months.
• Genetic beauty: equipped with siRNA, the efficiency of penetrating the stratum corneum is increased by 60 times.

 

 

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