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(2-Hydroxypropyl)-γ-cyclodextrin (HP-γ-CD), CAS NO128446-34-4, is a chemically modified derivative of γ-cyclodextrin, a cyclic oligosaccharide composed of eight glucose units linked by α-1,4-glycosidic bonds. The modification involves the substitution of hydroxypropyl groups onto the hydroxyl groups of the glucose units, enhancing the solubility and functional properties of the parent cyclodextrin. This article delves into the characteristics, pharmaceutical applications, and advantages of HP-γ-CD, with a particular focus on its role as a pharmaceutical excipient.
Characteristics
HP-γ-CD is a white, amorphous powder that is highly soluble in water and various organic solvents. The degree of substitution (DS) of hydroxypropyl groups can vary, typically ranging from 0.5 to 1.5 per glucose unit, which influences its solubility and interaction with guest molecules. The molecular weight of HP-γ-CD is approximately 1297 g/mol, though this can vary slightly depending on the degree of substitution.
The unique structure of HP-γ-CD, characterized by a hydrophobic cavity and a hydrophilic exterior, allows it to form inclusion complexes with a wide range of guest molecules. This property is pivotal in enhancing the solubility, stability, and bioavailability of poorly soluble compounds.
Pharmaceutical Applications
Solubility Enhancement
One of the primary applications of HP-γ-CD in the pharmaceutical industry is to enhance the solubility of poorly water-soluble drugs. Many active pharmaceutical ingredients (APIs) suffer from low aqueous solubility, which can limit their bioavailability and therapeutic efficacy. HP-γ-CD can form inclusion complexes with these APIs, significantly increasing their solubility and making them more readily absorbable in the gastrointestinal tract.
Stability Improvement
HP-γ-CD also plays a crucial role in improving the stability of pharmaceutical compounds. Many drugs are prone to degradation due to environmental factors such as light, heat, and moisture. By forming inclusion complexes with these drugs, HP-γ-CD can protect them from degradation, thereby extending their shelf life and maintaining their therapeutic potency.
Taste Masking
The unpleasant taste of certain drugs can be a significant barrier to patient compliance, especially in pediatric and geriatric populations. HP-γ-CD can encapsulate the bitter-tasting molecules, effectively masking their taste and making the medication more palatable. This is particularly useful in the formulation of oral suspensions, chewable tablets, and other dosage forms intended for direct consumption.
Controlled Release
HP-γ-CD can be used to develop controlled-release formulations, where the drug is released slowly over time. This is achieved by encapsulating the drug within the cyclodextrin cavity, which controls the rate at which the drug is released into the body. Controlled-release formulations can improve therapeutic outcomes by maintaining consistent drug levels in the bloodstream, reducing the frequency of dosing, and minimizing side effects.
Drug Delivery Systems
HP-γ-CD is also employed in advanced drug delivery systems, such as liposomes, nanoparticles, and micelles. Its ability to enhance the solubility and stability of drugs makes it an ideal component in these systems, which are designed to deliver drugs more effectively to specific target sites within the body.
Advantages as a Pharmaceutical Excipient
Enhanced Solubility and Bioavailability
The primary advantage of HP-γ-CD as a pharmaceutical excipient is its ability to significantly enhance the solubility and bioavailability of poorly water-soluble drugs. This is particularly important for oral and injectable formulations, where improved solubility can lead to better absorption and therapeutic efficacy.
Biocompatibility and Safety
HP-γ-CD is biocompatible and exhibits low toxicity, making it suitable for use in pharmaceutical formulations. Its safety profile is well-documented, and it is generally recognized as safe (GRAS) by regulatory authorities. This ensures that HP-γ-CD can be used in a wide range of pharmaceutical products without posing significant risks to patients.
Versatility
The versatility of HP-γ-CD is another significant advantage. It can form inclusion complexes with a wide range of molecules, from small organic compounds to large biomolecules. This broad compatibility makes it a valuable tool in the formulation of various types of pharmaceutical products, including tablets, capsules, injectables, and topical preparations.
Improved Patient Compliance
By masking the unpleasant taste of certain drugs and enabling the development of controlled-release formulations, HP-γ-CD can improve patient compliance. This is particularly important in populations that may have difficulty adhering to medication regimens, such as children and the elderly.
Conclusion
(2-Hydroxypropyl)-γ-cyclodextrin is a versatile and valuable compound with a wide range of applications in the pharmaceutical industry. Its unique ability to enhance the solubility, stability, and bioavailability of poorly soluble drugs, coupled with its biocompatibility and safety, makes it an indispensable pharmaceutical excipient. As research and development continue, the potential applications and benefits of HP-γ-CD are likely to expand, further solidifying its importance in modern pharmaceutical science.
Specifications(COA) of (2-Hydroxypropyl)-γ-cyclodextrin CAS NO128446-34-4
Items | Specifications | Results |
Appearance | White powder | Conform |
Loss on drying | ≤5.0% | 3.4% |
Heavy Metal | ≤10ppm | Conform |
Assay | ≥98% | 99.8% |
Conclusion | The product conforms to the standard of CP2010. | |
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