| Size | Price | Stock | Qty |
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| 5g |
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| 10g |
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| 25g |
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| Other Sizes |
Purity: free macrogoly= 27.0-39.0%
| Targets |
Surfactant; emulsifier; solubilizer
Polyoxyl 15 hydroxystearate does not have a specific pharmacological target, as it is a pharmaceutical excipient rather than a therapeutic agent. Its primary function is as a nonionic surfactant and emulsifier that solubilizes poorly water-soluble compounds. By forming micelles, it enhances the solubility and bioavailability of hydrophobic drugs. It is used in pharmaceutical formulations to improve drug delivery and absorption. |
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| ln Vitro |
This work initially confirms surfactant-like behaviour of Solutol® HS15 in aqueous media, while subsequent experiments demonstrate that the effect of Solutol® HS15 on epithelial tight junctions is different from a 'classical' tight junction opening agent and illustrate the effect of Solutol® HS15 on the cell membrane (endocytosis rate) and F-actin cytoskeleton.
Conclusion: Solutol® HS15 is the principle component of CriticalSorb™ that has shown an enhancement in permeability of medium sized biological drugs across epithelia. This study suggests that its mechanism of action arises primarily from effects on the cell membrane and consequent impacts on the cell cytoskeleton in terms of actin organisation and tight junction opening[1].
In vitro, Polyoxyl 15 hydroxystearate is used as a solubilizing agent in formulation development. It enhances the solubility of poorly water-soluble compounds in aqueous media. The compound's surfactant properties are evaluated using critical micelle concentration (CMC) measurements and solubilization studies. It is tested for compatibility with various drugs and formulation components. These in vitro activities support its use in pharmaceutical formulation development. |
| ln Vivo |
In vivo, Polyoxyl 15 hydroxystearate is used as a pharmaceutical excipient in various drug formulations. It enhances the bioavailability of poorly soluble drugs by improving their solubilization and absorption. The compound is generally regarded as relatively nontoxic and nonirritant and is reported not to be mutagenic in bacteria, mammalian cell cultures, and mammals. Its safety and efficacy as an excipient have been established through extensive use in pharmaceutical products.
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| Enzyme Assay |
In vitro assays for Polyoxyl 15 hydroxystearate are primarily focused on its physicochemical properties rather than enzyme/receptor binding. Critical micelle concentration (CMC) is measured using surface tension or fluorescence methods. Solubilization capacity is assessed by measuring the solubility of model hydrophobic compounds. Compatibility studies are conducted with various drugs using HPLC or DSC. All assays include appropriate controls and reference standards.
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| Cell Assay |
Micelle size and CMC of Solutol® HS15 were determined in biologically relevant media. Polarised airway Calu-3 cell layers were used to measure the permeability of a panel of biological drugs, and to assess changes in TEER, tight junction and F-actin morphology. The rate of cell endocytosis was measured in vitro in the presence of Solutol® HS15 using a membrane probe, FM 2-10[1].
In vitro cell-based assays for Polyoxyl 15 hydroxystearate are conducted to assess its safety as an excipient. Cell lines are treated with compound concentrations ranging from 0.001-10% for 24-72 hours. Cell viability is assessed using MTT assays. Membrane integrity is assessed using LDH release assays. Permeability studies are conducted using Caco-2 cell monolayers. Experiments include vehicle controls and positive controls (e.g., known cytotoxic agents). |
| Animal Protocol |
In vivo animal studies with Polyoxyl 15 hydroxystearate are conducted as part of safety and toxicology evaluations for pharmaceutical excipients. The compound is administered via oral, intravenous, or topical routes at various doses. Toxicity, irritation, and sensitization potential are evaluated. Pharmacokinetic studies assess absorption and elimination. Each group consists of 6-10 animals with appropriate controls. Data are analyzed using standard statistical methods.
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| ADME/Pharmacokinetics |
Pharmacokinetic properties of Polyoxyl 15 hydroxystearate depend on the route of administration and the formulation. As a nonionic surfactant, it is minimally absorbed following oral administration. When used in parenteral formulations, it is distributed and eliminated through metabolic and excretory pathways. The compound is generally regarded as safe and is not expected to accumulate in tissues. Detailed PK parameters are available from excipient safety studies.
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| Toxicity/Toxicokinetics |
Toxicological data for Polyoxyl 15 hydroxystearate indicate that it is generally regarded as a relatively nontoxic and nonirritant excipient. It is reported not to be mutagenic in bacteria, mammalian cell cultures, and mammals. No significant toxicity has been reported at concentrations used in pharmaceutical formulations. Comprehensive toxicological studies have been conducted as part of its safety evaluation for pharmaceutical use.
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| References | |
| Additional Infomation |
CriticalSorb™ is a novel mucosal drug delivery system whose main component is Solutol® HS15, which has been shown to enhance the bioavailability of certain biologics. This study aims to elucidate the mechanism by which Solutol® HS15 enhances the mucosal absorption of biologics.
Polyoxyl 15 hydroxystearate (Solutol HS 15) is a nonionic surfactant and emulsifier used as a solubilizer for poorly water-soluble compounds in pharmaceutical formulations. It is obtained by reacting 15 moles of ethylene oxide with 1 mole of 12-hydroxystearic acid. It is generally regarded as relatively nontoxic and nonirritant and is used in various pharmaceutical products to improve drug solubility and bioavailability. Not a therapeutic agent; intended as a pharmaceutical excipient. |
| Molecular Formula |
C₁₈H₃₆O₃(C₂H₄O)N
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|---|---|
| Molecular Weight |
963.237860000001
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| CAS # |
70142-34-6
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| Related CAS # |
61909-81-7
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| PubChem CID |
121596032
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| Appearance |
Ointment
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| Density |
1.048 g/cm3 at 20 °C
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| Melting Point |
25-30 °C
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| Flash Point |
272 ℃
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| LogP |
4.134
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| Hydrogen Bond Donor Count |
3
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| Hydrogen Bond Acceptor Count |
19
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| Rotatable Bond Count |
60
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| Heavy Atom Count |
65
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| Complexity |
881
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| Defined Atom Stereocenter Count |
0
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| SMILES |
C(CCCCC(CCCCCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCO)O)CCCCC(=O)O
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| InChi Key |
CYAMZYIUAHNTBO-UHFFFAOYSA-N
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| InChi Code |
1S/C47H94O19/c48-15-17-53-19-21-55-23-25-57-27-29-59-31-33-61-35-37-63-39-41-65-43-45-66-44-42-64-40-38-62-36-34-60-32-30-58-28-26-56-24-22-54-20-18-52-16-11-7-6-9-13-46(49)12-8-4-2-1-3-5-10-14-47(50)51/h46,48-49H,1-45H2,(H,50,51)
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| Chemical Name |
Polyoxyethylated 12-hydroxystearic acid
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| Synonyms |
solutol HS 15; Polyoxyl 15 hydroxystearate ;Polyoxyl 15 hydroxystearate; Polyethylene glycol 12-hydroxystearate; Polyoxyethylated 12-hydroxystearic acid
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| HS Tariff Code |
2934.99.9001
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| Storage |
Powder -20°C 3 years 4°C 2 years In solvent -80°C 6 months -20°C 1 month |
| Shipping Condition |
Room temperature (This product is stable at ambient temperature for a few days during ordinary shipping and time spent in Customs)
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| Solubility (In Vitro) |
May dissolve in DMSO (in most cases), if not, try other solvents such as H2O, Ethanol, or DMF with a minute amount of products to avoid loss of samples
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| Solubility (In Vivo) |
Note: Listed below are some common formulations that may be used to formulate products with low water solubility (e.g. < 1 mg/mL), you may test these formulations using a minute amount of products to avoid loss of samples.
Injection Formulations
Injection Formulation 1: DMSO : Tween 80： Saline = 10 : 5 : 85 (i.e. 100 μL DMSO stock solution → 50 μL Tween 80 → 850 μL Saline)(e.g. IP/IV/IM/SC) *Preparation of saline: Dissolve 0.9 g of sodium chloride in 100 mL ddH ₂ O to obtain a clear solution. Injection Formulation 2: DMSO : PEG300 ：Tween 80 : Saline = 10 : 40 : 5 : 45 (i.e. 100 μL DMSO → 400 μLPEG300 → 50 μL Tween 80 → 450 μL Saline) Injection Formulation 3: DMSO : Corn oil = 10 : 90 (i.e. 100 μL DMSO → 900 μL Corn oil) Example: Take the Injection Formulation 3 (DMSO : Corn oil = 10 : 90) as an example, if 1 mL of 2.5 mg/mL working solution is to be prepared, you can take 100 μL 25 mg/mL DMSO stock solution and add to 900 μL corn oil, mix well to obtain a clear or suspension solution (2.5 mg/mL, ready for use in animals). View More
Injection Formulation 4: DMSO : 20% SBE-β-CD in saline = 10 : 90 [i.e. 100 μL DMSO → 900 μL (20% SBE-β-CD in saline)] Oral Formulations
Oral Formulation 1: Suspend in 0.5% CMC Na (carboxymethylcellulose sodium) Oral Formulation 2: Suspend in 0.5% Carboxymethyl cellulose Example: Take the Oral Formulation 1 (Suspend in 0.5% CMC Na) as an example, if 100 mL of 2.5 mg/mL working solution is to be prepared, you can first prepare 0.5% CMC Na solution by measuring 0.5 g CMC Na and dissolve it in 100 mL ddH2O to obtain a clear solution; then add 250 mg of the product to 100 mL 0.5% CMC Na solution, to make the suspension solution (2.5 mg/mL, ready for use in animals). View More
Oral Formulation 3: Dissolved in PEG400 (Please use freshly prepared in vivo formulations for optimal results.) |
| Preparing Stock Solutions | 1 mg | 5 mg | 10 mg | |
| 1 mM | 1.0382 mL | 5.1908 mL | 10.3816 mL | |
| 5 mM | 0.2076 mL | 1.0382 mL | 2.0763 mL | |
| 10 mM | 0.1038 mL | 0.5191 mL | 1.0382 mL |
*Note: Please select an appropriate solvent for the preparation of stock solution based on your experiment needs. For most products, DMSO can be used for preparing stock solutions (e.g. 5 mM, 10 mM, or 20 mM concentration); some products with high aqueous solubility may be dissolved in water directly. Solubility information is available at the above Solubility Data section. Once the stock solution is prepared, aliquot it to routine usage volumes and store at -20°C or -80°C. Avoid repeated freeze and thaw cycles.
Calculation results
Working concentration： mg/mL；
Method for preparing DMSO stock solution： mg drug pre-dissolved in μL DMSO (stock solution concentration mg/mL). Please contact us first if the concentration exceeds the DMSO solubility of the batch of drug.
Method for preparing in vivo formulation:：Take μL DMSO stock solution, next add μL PEG300, mix and clarify, next addμL Tween 80, mix and clarify, next add μL ddH2O，mix and clarify.
(1) Please be sure that the solution is clear before the addition of next solvent. Dissolution methods like vortex, ultrasound or warming and heat may be used to aid dissolving.
(2) Be sure to add the solvent(s) in order.
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