Polyhexanide
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| Names | |
|---|---|
| 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 |
|
| UNII | |
CompTox Dashboard(EPA)
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|
| Properties | |
| (C8H17N5)n | |
| Pharmacology | |
| D08AC05(WHO)S01AX24(WHO) | |
| Legal status | |
| Hazards | |
| GHSlabelling:[3] | |
    
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| Danger | |
| H302,H317,H318,H330,H351,H372,H410 | |
Except where otherwise noted, data are given for materials in theirstandard state(at 25 °C [77 °F], 100 kPa).
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Polyhexanide(polyhexamethylene biguanide,PHMB) is apolymerused as adisinfectantandantiseptic.Indermatologicaluse,[4]it is spelledpolihexanide(INN) and sold under various brand names.[5]PHMB has been shown to be effective againstPseudomonas aeruginosa,Staphylococcus aureus,Escherichia coli,Candida albicans,Aspergillus brasiliensis,enterococci,andKlebsiella pneumoniae.[6]Polihexanide, sold under the brand nameAkantioris amedicationused for the treatment ofAcanthamoebakeratitis.
Products containing PHMB are used for inter-operative irrigation, pre- and post-surgery skin andmucous membranedisinfection, post-operative dressings, surgical and non-surgical wound dressings, surgical bath/hydrotherapy,chronic wounds like diabetic footulcerand 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 byAcanthamoebakeratitis.[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.
Medical uses
[edit]Polihexanide isindicatedfor the treatment ofAcanthamoebakeratitisin people aged 12 years of age and older.[1][2]
Society and culture
[edit]Legal status
[edit]In May 2024, theCommittee for Medicinal Products for Human Useof theEuropean Medicines Agencyadopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Akantior, intended for the treatment ofAcanthamoebakeratitis,a severe, progressive and sight threatening corneal infection characterized by intense pain and photophobia.[1][10]Acanthamoebakeratitis 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 2carcinogenby theEuropean 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]- ^abcdef"Akantior EPAR".European Medicines Agency.30 May 2024.Retrieved31 May2024.Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^abc"Akantior Product information".Union Register of medicinal products.23 August 2024.Retrieved27 August2024.
- ^"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.PMID12854364.S2CID33172373.
- ^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 fromthe original(PDF)on 4 March 2016.Retrieved8 April2015.
{{cite web}}:CS1 maint: archived copy as title (link) - ^"Nusept".Archived fromthe originalon 25 March 2012.Retrieved8 June2011.
- ^ 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.PMID36630111.
- ^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.PMC4730543.PMID25710134.
- ^"Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2024".European Medicines Agency(Press release). 31 May 2024.Retrieved13 June2024.
- ^"Polyhexamethylene biguanide Assessment Report".europa.eu.Retrieved30 July2024.
- ^Cosmetic Ingredient Review Expert Panel (12 May 2014)."Safety Assessment of Polyaminopropyl Biguanide as Used in Cosmetics"(PDF).Cosmetic Ingredient Review (CIR).Retrieved7 May2024.
- ^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.PMC8048451.PMID33098110.
