Polyhexanide
Polyhexanide (polyhexamethylene biguanide, PHMB) is a polymer used as a disinfectant and antiseptic. In dermatological use, it is spelled polihexanide (INN) and sold under various brand names. PHMB has been shown to be effective against Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, Candida albicans, Aspergillus brasiliensis, enterococci, and Klebsiella pneumoniae. Polihexanide, sold under the brand name Akantior is a medication used for the treatment of Acanthamoeba keratitis. 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. PHMB eye drops have been used as a treatment for eyes affected by Acanthamoeba keratitis. It is sold as a swimming pool and spa disinfectant in place of chlorine or bromine based products under the name Baquacil. PHMB is also used as an ingredient in some contact lens cleaning products, cosmetics, personal deodorants and some veterinary products. It 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.
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| Names | |
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| Other names
Polyhexamethylene biguanide; Polyhexamethylene guanide; Poly(iminoimidocarbonyl-iminoimidocarbonyl-iminohexamethylene) Hydrochloride; Poly(hexamethylenebiguanide); Polihexanide; Akantior; Lavasept; Tebasept; Prontosan
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| Identifiers | |
| Abbreviations | PHMB |
| ChEBI | |
| ChemSpider |
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| KEGG | |
| UNII | |
CompTox Dashboard (EPA)
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| Properties | |
| (C8H17N5)n | |
| Pharmacology | |
| D08AC05 (WHO) S01AX24 (WHO) | |
| Legal status | |
| Hazards | |
| GHS labelling:[3] | |
    
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| Danger | |
| H302, H317, H318, H330, H351, H372, H410 | |
Except where otherwise noted, data are given for materials in their standard state (at 25 °C [77 °F], 100 kPa).
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Polyhexanide (polyhexamethylene biguanide, PHMB) is a polymer used as a disinfectant and antiseptic. In dermatological use,[4] it is spelled polihexanide (INN) and sold under various brand names.[5] PHMB 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.
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]
It is sold as a swimming pool and spa disinfectant in place of chlorine or bromine based products under the name Baquacil.
PHMB is also used as an ingredient in some contact lens cleaning products, cosmetics, personal deodorants and some veterinary products. It 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.
Use in Acanthamoeba keratitis treatment
[edit]Polihexanide is indicated for the treatment of Acanthamoeba keratitis in people aged 12 years of age and older.[1][2]
Legal status
[edit]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.[1][2]
Safety
[edit]In 2011, polyhexamethylene biguanide was classified as category 2 carcinogen by the European Chemical Agency, but it is still allowed in cosmetics in small quantities if exposure by inhalation is impossible.[11]
Name controversy
[edit]In some sources, particularly when listed as a cosmetics ingredient (INCI), the polymer is wrongly named as polyaminopropyl biguanide.[12][13]
References
[edit]- ^ a b c d e f "Akantior EPAR". European Medicines Agency. 30 May 2024. Retrieved 31 May 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ a b c "Akantior Product information". Union Register of medicinal products. 23 August 2024. Retrieved 27 August 2024.
- ^ "Classification and Labelling of PHMB". European Chemicals Agency.
- ^ Ansorg R, Rath PM, Fabry W (2003). "Inhibition of the anti-staphylococcal activity of the antiseptic polihexanide by mucin". Arzneimittel-Forschung. 53 (5): 368–71. doi:10.1055/s-0031-1297121. PMID 12854364. S2CID 33172373.
- ^ International Drug Names: Polihexanide
- ^ Maribeth Cousin, Kimberly Restivo, Chelsea Rodriguez, and Justin Lien. USP Antimicrobial Effectiveness Test (GLP). Elkhorn, WI: Geneva Laboratories. 2013. "Archived copy" (PDF). Archived from the original (PDF) on 4 March 2016. Retrieved 8 April 2015.
{{cite web}}: CS1 maint: archived copy as title (link) - ^ "Nusept". Archived from the original on 25 March 2012. Retrieved 8 June 2011.
- ^ Rippon MG, Rogers AA, Ousey K (2 January 2023). "Polyhexamethylene biguanide and its antimicrobial role in wound healing: a narrative review". J Wound Care. 32 (1): 5–20. doi:10.12968/jowc.2023.32.1.5. PMID 36630111.
- ^ Alkharashi M, Lindsley K, Law HA, Sikder S (2015). "Medical interventions for acanthamoeba keratitis". Cochrane Database Syst Rev. 2015 (2): CD0010792. doi:10.1002/14651858.CD010792.pub2. PMC 4730543. PMID 25710134.
- ^ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2024". European Medicines Agency (Press release). 31 May 2024. Retrieved 13 June 2024.
- ^ "Polyhexamethylene biguanide Assessment Report". europa.eu. Retrieved 30 July 2024.
- ^ Cosmetic Ingredient Review Expert Panel (12 May 2014). "Safety Assessment of Polyaminopropyl Biguanide as Used in Cosmetics" (PDF). Cosmetic Ingredient Review (CIR). Retrieved 7 May 2024.
- ^ Sukakul T, Dahlin J, Pontén A, Antelmi A, Bruze M, Hamnerius N, et al. (2021). "Contact allergy to polyhexamethylene biguanide (polyaminopropyl biguanide)". Contact Dermatitis. 84 (5): 326–331. doi:10.1111/cod.13728. PMC 8048451. PMID 33098110.
