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DESCRIPTION
Polyhexamethylene Biguanide Hydrochloride (PHMB) 20% is an antimicrobial compound that is commonly used in various medical, cosmetic, and industrial applications.
It's a cationic polymer with a broad-spectrum biocidal activity, meaning it can kill or inhibit the growth of bacteria, fungi, and other microorganisms.
PHMB is particularly effective against gram-positive bacteria and is used in wound care, eye care products, and disinfectants.
Cas Number
27083-27-8
Synonyms
Polyhexanide,Polyhexamethylene biguanide,PHMB, Polyhexamethylene biguanide hydrochloride
Introduction to PHMB (Polyhexamethylene Biguanide Hydrochloride)
Polyhexamethylene Biguanide Hydrochloride, commonly abbreviated as PHMB, is a synthetic, broad-spectrum antimicrobial agent.
First synthesized in the 1970s, PHMB has gained widespread use across a variety of industries, including healthcare, cosmetics, and industrial applications, due to its effectiveness in killing or inhibiting the growth of bacteria, fungi, and viruses.
It is most commonly found in concentrations such as 20%, though lower concentrations are often used in medical and cosmetic products.
PHMB’s primary mode of action is to disrupt the cellular membrane of microorganisms, making it effective as a disinfectant and antiseptic.
Its versatility and low toxicity make it an attractive choice for various applications, especially where long-term use or exposure is required.
Chemical Properties of PHMB
Polyhexamethylene Biguanide Hydrochloride is a water-soluble compound that is a member of the biguanide class of chemicals.
Its chemical structure consists of a polymer backbone with repeating units of hexamethylene and biguanide groups.
The biguanide functional group (–NH–C(=NH)–NH–) is responsible for the antimicrobial activity of PHMB.
Molecular Structure: The polymer is composed of multiple monomeric units of hexamethylene, which provide rigidity to the polymer chain.
The biguanide groups within the structure act as the functional group that interacts with bacterial membranes.
Physical Properties:
Molecular Weight: Typically around 1,000 to 10,000 g/mol, depending on the polymerization degree.
Solubility: PHMB is highly soluble in water, which makes it effective as an aqueous solution.
Stability: PHMB is stable under normal storage conditions, but its stability can be affected by extreme pH or temperature changes.
pH Range: It is stable within a pH range of 4-8.
Synthesis and Manufacturing of PHMB
PHMB is synthesized by the polymerization of hexamethylene diamine with cyanamide or other similar reagents under controlled conditions.
The resulting polymer can have varying molecular weights, which influences its antimicrobial potency and use in different applications.
Synthesis Process: The synthesis involves reacting a biguanide precursor (like hexamethylene diamine) with formaldehyde or related compounds, catalyzed by heat or other chemical agents.
The polymerization forms long chains of repeating hexamethylene-biguinide units.
Industrial Production: In large-scale manufacturing, the process is usually conducted under aqueous conditions, ensuring that the resulting compound is soluble and stable in water.
Due to its use in sensitive applications, high purity standards are maintained.
Challenges: Maintaining consistency in polymer chain length and ensuring uniformity in antimicrobial properties can be challenging during production.
Variations in the synthesis process can lead to variations in the final product's activity.
Mechanism of Action
PHMB’s mechanism of action is primarily based on its ability to disrupt the cell membranes of microorganisms.
It does so by interacting with the phospholipid bilayer of bacterial membranes, altering their integrity.
Membrane Disruption: The biguanide functional groups of PHMB bind to the negatively charged phosphate groups of phospholipids in microbial membranes.
This interaction alters membrane permeability, leading to the leakage of intracellular contents and the eventual death of the microorganism.
Bactericidal vs. Bacteriostatic: PHMB is bactericidal at higher concentrations, killing microorganisms, but at lower concentrations, it can be bacteriostatic, meaning it inhibits the growth of bacteria without necessarily killing them.
Selective Toxicity: PHMB has a selective toxicity, meaning that it preferentially targets microbial cells over human cells.
The difference in membrane composition between human cells and microorganisms helps explain its relative safety in humans.
Comparison to Other Antiseptics: Unlike other antiseptics like alcohols or iodine, PHMB has a broad spectrum of activity and is less toxic to human tissues, making it ideal for long-term or repeated use, especially in wound care.
Applications of PHMB
PHMB has found a variety of uses due to its versatility and effectiveness.
These applications span several industries:
Healthcare:
Wound Care: PHMB is commonly used in wound care products such as dressings, creams, and gels, where it helps reduce the risk of infection by preventing bacterial growth.
Its low toxicity to human tissue makes it ideal for treating chronic wounds.
Contact Lens Solutions: It is used in cleaning solutions to disinfect contact lenses, ensuring they are free of microbial contaminants.
Hospital Disinfection: PHMB is often employed to disinfect medical devices and hospital environments, including surfaces, due to its broad-spectrum antimicrobial activity.
Cosmetics:
Preservative: PHMB is used in cosmetics as a preservative, protecting products from microbial contamination, particularly in water-based formulations like shampoos, lotions, and facial creams.
Antibacterial Agents: Due to its ability to fight bacteria and fungi, PHMB can also be found in some skincare products intended to treat acne or other skin infections.
Industrial Applications:
Water Treatment: PHMB is employed in industrial water systems to control the growth of bacteria and biofilms in pipes and cooling systems.
Agricultural Use: PHMB is used in some agricultural formulations as a pesticide, where it helps control microbial growth on plants or crops.
Regulatory Status
PHMB is regulated by various health and safety organizations across the globe:
FDA (United States): The FDA has approved PHMB for use in certain medical devices, including wound care products and contact lens solutions, with established safety limits for different concentrations.
European Union: PHMB is approved in the EU for use as an active ingredient in medical devices and cosmetics, following rigorous safety assessments by the European Medicines Agency (EMA).
Global Approvals: PHMB is generally recognized as safe in many regions, though its concentration and intended use may be subject to local regulatory frameworks.
For example, it may have different maximum allowable concentrations in consumer products versus medical-grade applications.
Pharmacokinetics and Pharmacodynamics
PHMB’s pharmacokinetic profile is of particular interest due to its use in long-term applications such as wound care.
Absorption and Distribution: PHMB is poorly absorbed through the skin, meaning its effects are largely localized at the site of application.
This makes it ideal for external use in wound care and as a topical disinfectant.
Metabolism and Excretion: Since PHMB is not readily absorbed, its metabolism and excretion pathways are not well studied.
What little enters the bloodstream is likely to be excreted unchanged in the urine.
Resistance Development: One of the notable features of PHMB is its low potential for bacterial resistance. This is attributed to its multiple modes of action, which make it difficult for bacteria to develop resistance mechanisms.
Environmental Impact
The environmental impact of PHMB is an important consideration, particularly due to its use in large quantities in industrial and healthcare settings.
Persistence in the Environment: PHMB is persistent in water and can accumulate in aquatic environments, potentially leading to long-term ecological consequences.
However, its degradation in the environment is relatively slow, and it can persist for months under certain conditions.
Ecotoxicity: PHMB has shown some toxicity to aquatic organisms at high concentrations, raising concerns about its long-term impact on aquatic ecosystems.
Environmental Monitoring: Studies are ongoing to determine the extent of PHMB contamination in water systems and its ecological effects.
Some efforts are being made to develop more environmentally friendly alternatives.
Current Research and Future Trends
Research into PHMB continues, with a focus on expanding its applications and understanding its long-term effects.
Nanotechnology: PHMB is being explored for use in nanotechnology, where its antimicrobial properties may be harnessed in more targeted, precise applications, such as in nanomaterials or advanced wound care devices.
Combination Therapies: There is growing interest in combining PHMB with other antimicrobial agents to enhance its efficacy, particularly in overcoming microbial resistance.
Wound Care Advancements: Research is focused on improving PHMB-based wound care products, including better delivery mechanisms and combination with other therapeutic agents to promote healing.
Conclusion
PHMB is a versatile, effective antimicrobial agent with a broad range of applications across healthcare, cosmetics, and industrial fields.
Its mechanism of action, combined with its low toxicity and broad spectrum, makes it a preferred choice for many products.
While its environmental impact requires attention, ongoing research suggests that PHMB will continue to play an important role in various fields, especially as we move towards more sustainable and effective antimicrobial solutions.
SAFETY INFORMATION ABOUT PHMB - POLYHEXAMETHYLENE BIGUANIDE HYDROCHLORIDE 20%
First aid measures:
Description of first aid measures:
General advice:
Consult a physician.
Show this safety data sheet to the doctor in attendance.
Move out of dangerous area:
If inhaled:
If breathed in, move person into fresh air.
If not breathing, give artificial respiration.
Consult a physician.
In case of skin contact:
Take off contaminated clothing and shoes immediately.
Wash off with soap and plenty of water.
Consult a physician.
In case of eye contact:
Rinse thoroughly with plenty of water for at least 15 minutes and consult a physician.
Continue rinsing eyes during transport to hospital.
If swallowed:
Do NOT induce vomiting.
Never give anything by mouth to an unconscious person.
Rinse mouth with water.
Consult a physician.
Firefighting measures:
Extinguishing media:
Suitable extinguishing media:
Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.
Special hazards arising from the substance or mixture
Carbon oxides, Nitrogen oxides (NOx), Hydrogen chloride gas
Advice for firefighters:
Wear self-contained breathing apparatus for firefighting if necessary.
Accidental release measures:
Personal precautions, protective equipment and emergency procedures
Use personal protective equipment.
Avoid breathing vapours, mist or gas.
Evacuate personnel to safe areas.
Environmental precautions:
Prevent further leakage or spillage if safe to do so.
Do not let product enter drains.
Discharge into the environment must be avoided.
Methods and materials for containment and cleaning up:
Soak up with inert absorbent material and dispose of as hazardous waste.
Keep in suitable, closed containers for disposal.
Handling and storage:
Precautions for safe handling:
Avoid inhalation of vapour or mist.
Conditions for safe storage, including any incompatibilities:
Keep container tightly closed in a dry and well-ventilated place.
Containers which are opened must be carefully resealed and kept upright to prevent leakage.
Storage class (TRGS 510): 8A: Combustible, corrosive hazardous materials
Exposure controls/personal protection:
Control parameters:
Components with workplace control parameters
Contains no substances with occupational exposure limit values.
Exposure controls:
Appropriate engineering controls:
Handle in accordance with good industrial hygiene and safety practice.
Wash hands before breaks and at the end of workday.
Personal protective equipment:
Eye/face protection:
Tightly fitting safety goggles.
Faceshield (8-inch minimum).
Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU).
Skin protection:
Handle with gloves.
Gloves must be inspected prior to use.
Use proper glove
removal technique (without touching glove's outer surface) to avoid skin contact with this product.
Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory practices.
Wash and dry hands.
Full contact:
Material: Nitrile rubber
Minimum layer thickness: 0.11 mm
Break through time: 480 min
Material tested:Dermatril (KCL 740 / Aldrich Z677272, Size M)
Splash contact
Material: Nitrile rubber
Minimum layer thickness: 0.11 mm
Break through time: 480 min
Material tested:Dermatril (KCL 740 / Aldrich Z677272, Size M)
It should not be construed as offering an approval for any specific use scenario.
Body Protection:
Complete suit protecting against chemicals, The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace.
Respiratory protection:
Where risk assessment shows air-purifying respirators are appropriate use a fullface respirator with multi-purpose combination (US) or type ABEK (EN 14387) respirator cartridges as a backup to engineering controls.
If the respirator is the sole means of protection, use a full-face supplied air respirator.
Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU).
Control of environmental exposure
Prevent further leakage or spillage if safe to do so.
Do not let product enter drains.
Discharge into the environment must be avoided.
Stability and reactivity:
Chemical stability:
Stable under recommended storage conditions.
Incompatible materials:
Strong oxidizing agents:
Hazardous decomposition products:
Hazardous decomposition products formed under fire conditions.
Carbon oxides, Nitrogen oxides (NOx), Hydrogen chloride gas.
Disposal considerations:
Waste treatment methods:
Product:
Offer surplus and non-recyclable solutions to a licensed disposal company.
Contact a licensed professional waste disposal service to dispose of this material.
Contaminated packaging:
Dispose of as unused product.
