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DESCRIPTION:
Polyhexanide (polyhexamethylene biguanide, PHMB) is a polymer used as a disinfectant and antiseptic.
In dermatological use,[4] Polyhexanide (polyhexamethylene biguanide) is spelled polihexanide (INN) and sold under various brand names.[5]
Polyhexanide (polyhexamethylene biguanide) has been shown to be effective against Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, Candida albicans, Aspergillus brasiliensis, enterococci, and Klebsiella pneumoniae.[6]
Polihexanide, sold under the brand name Akantior is a medication used for the treatment of Acanthamoeba keratitis.
CAS Number
28757-47-3
SYNONYMS:
Polyhexamethylene biguanide; Polyhexamethylene guanide; Poly(iminoimidocarbonyl-iminoimidocarbonyl-iminohexamethylene) Hydrochloride; Poly(hexamethylenebiguanide); Polihexanide; Akantior; Lavasept; Tebasept; Prontosan
Polyhexamethylene biguanidine, also known as PHMB, polyhexanide or polihexanide, is a highly water soluble and hydrolytically stable polymeric material.
The presence of multiple hydrogen bond and chelation sites within PHMB renders it of potential interest in the field of supramolecular chemistry.
PHMB shows activity against both Gram-positive and Gram-negative bacteria and is widely used across several sectors, typically as the hydrochloride salt, in a variety of disinfectant solutions and antiseptics. PHMB is available also as a solid.
Polyhexamethylene biguanidine (also referred to as PHMB, polyhexanide or polihexanide) is a highly water soluble and hydrolytically stable polymeric material.
PHMB shows activity against both Gram-positive and Gram-negative bacteria and is widely used across several sectors, typically as the hydrochloride salt, in a variety of disinfectant solutions and antiseptics.
The presence of multiple hydrogen bond and chelation sites within PHMB renders it of potential interest to those studying supramolecular chemical effects.
PHMB is available also as 20% aqueous solution.
Products containing PHMB are used for inter-operative irrigation, pre- and post-surgery skin and mucous membrane disinfection, post-operative dressings, surgical and non-surgical wound dressings, surgical bath/hydrotherapy, chronic wounds like diabetic foot ulcer and burn wound management, routine antisepsis during minor incisions, catheterization, first aid, surface disinfection, and linen disinfection.
[7] [8] PHMB eye drops have been used as a treatment for eyes affected by Acanthamoeba keratitis.[9]
Polyhexanide (polyhexamethylene biguanide) is sold as a swimming pool and spa disinfectant in place of chlorine or bromine based products under the name Baquacil.
Polyhexanide (polyhexamethylene biguanide) is also used as an ingredient in some contact lens cleaning products, cosmetics, personal deodorants and some veterinary products.
Polyhexanide (polyhexamethylene biguanide) is also used to treat clothing (Purista), purportedly to prevent the development of unpleasant odors.
The PHMB hydrochloride salt (solution) is used in the majority of formulations.
Medical uses:
Polihexanide is indicated for the treatment of Acanthamoeba keratitis in people aged 12 years of age and older.[1][2]
Legal status
In May 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Akantior, intended for the treatment of Acanthamoeba keratitis, a severe, progressive and sight threatening corneal infection characterized by intense pain and photophobia.[1]
[10] Acanthamoeba keratitis is a rare disease primarily affecting contact lens wearers.[1] The applicant for this medicinal product is SIFI SPA.[1]
Polihexanide was approved for medical use in the European Union in August 2024
Poly(hexamethylenebiguanide), or PHMB, may also be called:
polihexanide
polyhexanide
polyaminopropyl biguanide
Polyhexanide (polyhexamethylene biguanide) does not occur naturally in the environment.
It's found in a wide range of products available to consumers.
For example, Polyhexanide (polyhexamethylene biguanide) is used as an antimicrobial agent or preservative in:
fabric softeners
medical devices
cosmetics, such as:
deodorants
moisturizers
bath products
nail care products
hair styling products
shampoos and conditioners
cleansers and make-up removers
contact lens solutions
non-prescription drugs
natural health products
hand washes, sanitizers and rubs
Polyhexanide (polyhexamethylene biguanide) may also be used as an antiseptic, sanitizer or deodorizer in:
textiles
pet litter
wet wipes
air filter treatments
veterinary products
recreational water treatment
preservation of hides and skins
disinfectant solutions and wet wipes
Polyhexanide (polyhexamethylene biguanide) may also be found in food if the food preparation surface has been treated with sanitizers and disinfectants that contain PHMB.
SAFETY INFORMATION ABOUT POLYHEXANIDE (POLYHEXAMETHYLENE BIGUANIDE)
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.
