View source for Polyhexanide

{{Short description|Pharmaceutical compound}}
{{Use dmy dates|date=May 2024}}
{{cs1 config |name-list-style=vanc |display-authors=6}}
{{Chembox
| Verifiedfields = changed
| verifiedrevid  = 464209914
| ImageFile      = Polyhexanide.svg
| ImageAlt       = 
| IUPACName      = 
| OtherNames     = Polyhexamethylene biguanide; Polyhexamethylene guanide; Poly(iminoimidocarbonyl-iminoimidocarbonyl-iminohexamethylene) Hydrochloride; Poly(hexamethylenebiguanide); Polihexanide; Akantior; Lavasept; Tebasept;  Prontosan
| Section1       = {{Chembox Identifiers
| Abbreviations = PHMB
| CASNo = 28757-47-3
| CASNo_Ref = {{cascite|correct|CAS}}
| CASNo1 = 32289-58-0
| CASNo1_Ref = {{cascite|correct|CAS}}
| CASNo1_Comment = ([[hydrochloride|HCl]])
| PubChem = 
| ChEBI = 149520
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
| ChemSpiderID = none
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = 322U039GMF
| UNII1_Ref = {{fdacite|correct|FDA}}
| UNII1 = 4XI6112496
| UNII1_Comment = ([[hydrochloride|HCl]])
| SMILES = 
}}
| Section2       = {{Chembox Properties
| Formula = (C<sub>8</sub>H<sub>17</sub>N<sub>5</sub>)<sub>n</sub>
| MolarMass = 
| Appearance = 
| Density = 
| MeltingPt = 
| BoilingPt = 
| Solubility = }}
| Section6 = {{Chembox Pharmacology
| Pharmacology_ref = 
| ATCCode_prefix = D08
| ATCCode_suffix = AC05
| ATC_Supplemental= {{ATC|S01|AX24}}
| ATCvet = 
| Licence_EU = 
| INN = 
| INN_EMA = 
| Licence_US = 
| Legal_status = 
| Legal_AU = 
| Legal_AU_comment = 
| Legal_CA = 
| Legal_CA_comment = 
| Legal_NZ = 
| Legal_NZ_comment = 
| Legal_UK = 
| Legal_UK_comment = 
| Legal_US = 
| Legal_US_comment = 
| Legal_EU = Rx-only
| Legal_EU_comment = <ref name="Akantior EPAR" /><ref name="Akantior PI">{{cite web | title=Akantior Product information | website=Union Register of medicinal products | date=23 August 2024 | url=https://ec.europa.eu/health/documents/community-register/html/h1840.htm | access-date=27 August 2024}}</ref>
| Legal_UN = 
| Legal_UN_comment = 
| Pregnancy_category = 
| Pregnancy_AU = 
| Pregnancy_AU_comment = 
| Dependence_liability = 
| AdminRoutes = 
| Bioavail = 
| ProteinBound = 
| Metabolism = 
| Metabolites = 
| OnsetOfAction = 
| HalfLife = 
| DurationOfAction = 
| Excretion = 
  }}
| Section7       = {{Chembox Hazards
| GHSPictograms={{GHS09}} {{GHS08}} {{GHS06}} {{GHS05}} {{GHS exclamation mark}}
| GHSSignalWord=danger
| GHS_ref  = <ref>{{cite web |title=Classification and Labelling of PHMB |url=https://echa.europa.eu/information-on-chemicals/cl-inventory-database/-/discli/details/91740 |publisher=European Chemicals Agency}}</ref>
| HPhrases = {{H-phrases|410|318|351|317|372|330|302}}
| PPhrases =
| MainHazards = 
| FlashPt = 
| AutoignitionPt = 
  }}
}}

'''Polyhexanide''' ('''polyhexamethylene biguanide''', '''PHMB''') is a [[polymer]] used as a [[disinfectant]] and [[antiseptic]]. In [[dermatological]] use,<ref name="pmid12854364">{{cite journal |vauthors=Ansorg R, Rath PM, Fabry W |title=Inhibition of the anti-staphylococcal activity of the antiseptic polihexanide by mucin |journal=Arzneimittel-Forschung |volume=53 |issue=5 |pages=368–71 |year=2003 |pmid=12854364 |doi=10.1055/s-0031-1297121|s2cid=33172373 }}</ref> it is spelled '''polihexanide''' ([[International Nonproprietary Name|INN]]) and sold under various brand names.<ref>{{Drugs.com|international|polihexanide}}: Polihexanide</ref> PHMB has been shown to be effective against ''[[Pseudomonas aeruginosa]]'', ''[[Staphylococcus aureus]]'', ''[[Escherichia coli]]'', ''[[Candida albicans]]'', ''[[Aspergillus brasiliensis]]'', [[enterococci]], and ''[[Klebsiella pneumoniae]]''.<ref>Maribeth Cousin, Kimberly Restivo, Chelsea Rodriguez, and Justin Lien. USP Antimicrobial Effectiveness Test (GLP). Elkhorn, WI: Geneva Laboratories. 2013. {{cite web |url=http://steriwebrx.com/files/STERIWEB-FINAL-JN13J1514.pdf |title=Archived copy |access-date=8 April 2015 |url-status=dead |archive-url=https://web.archive.org/web/20160304060828/http://steriwebrx.com/files/STERIWEB-FINAL-JN13J1514.pdf |archive-date=4 March 2016 }}</ref> Polihexanide, sold under the brand name '''Akantior''' is a [[medication]] used for the treatment of [[Acanthamoeba keratitis|''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, [[Catheter|catheterization]], first aid, surface disinfection, and linen disinfection.<ref>{{Cite web |url=http://www.tulipgroup.com/Bioshields2/html/antiseptics_nusept.htm |title=Nusept |access-date=8 June 2011 |archive-date=25 March 2012 |archive-url=https://web.archive.org/web/20120325041756/http://www.tulipgroup.com/Bioshields2/html/antiseptics_nusept.htm |url-status=dead }}</ref><ref> 
{{cite journal |last1=Rippon |first1=Mark G. |last2=Rogers |first2=Alan A. |last3=Ousey |first3=Karen |title=Polyhexamethylene biguanide and its antimicrobial role in wound healing: a narrative review |journal=J Wound Care |date=2 January 2023 |volume=32 |issue=1 |pages=5–20 |doi=10.12968/jowc.2023.32.1.5 |pmid=36630111 |url=https://pure.hud.ac.uk/en/publications/dff86e10-f01d-4898-be53-cd9eed490bb7 }}</ref> PHMB eye drops have been used as a treatment for eyes affected by [[Acanthamoeba keratitis|''Acanthamoeba'' keratitis]].<ref name="Alkharashi">{{cite journal |vauthors=Alkharashi M, Lindsley K, Law HA, Sikder S |title= Medical interventions for acanthamoeba keratitis |journal=Cochrane Database Syst Rev|volume=2015 |pages= CD0010792 |date=2015 |issue= 2 |pmid= 25710134|doi= 10.1002/14651858.CD010792.pub2 |pmc=4730543}}</ref>

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 ==
Polihexanide is [[indicated]] for the treatment of [[Acanthamoeba keratitis|''Acanthamoeba'' keratitis]] in people aged 12 years of age and older.<ref name="Akantior EPAR" /><ref name="Akantior PI" />

== Society and culture ==
=== 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|''Acanthamoeba'' keratitis]], a severe, progressive and sight threatening corneal infection characterized by intense pain and photophobia.<ref name="Akantior EPAR" /><ref>{{cite press release | title=Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2024 | website=European Medicines Agency | date=31 May 2024 | url=https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-27-30-may-2024 | access-date=13 June 2024}}</ref> ''Acanthamoeba'' keratitis is a rare disease primarily affecting contact lens wearers.<ref name="Akantior EPAR" /> The applicant for this medicinal product is SIFI SPA.<ref name="Akantior EPAR">{{cite web | title=Akantior EPAR | website=[[European Medicines Agency]] | date=30 May 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/akantior | access-date=31 May 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> Polihexanide was approved for medical use in the European Union in August 2024.<ref name="Akantior EPAR" /><ref name="Akantior PI" />

===Safety===
In 2011, polyhexamethylene biguanide was classified as category 2 [[carcinogen]] by the [[European Chemicals Agency|European Chemical Agency]], but it is still allowed in cosmetics in small quantities if exposure by inhalation is impossible.<ref>{{Cite web |title=Polyhexamethylene biguanide Assessment Report |url=https://www.echa.europa.eu/documents/10162/1ab1bdf9-c012-21be-f99f-03d7fad2ab2d |access-date=30 July 2024 |website=europa.eu}}</ref>

===Name controversy===
In some sources, particularly when listed as a cosmetics ingredient ([[International Nomenclature of Cosmetic Ingredients|INCI]]), the polymer is wrongly named as polyaminopropyl biguanide.<ref>{{Cite web |title=Safety Assessment of Polyaminopropyl Biguanide as Used in Cosmetics |last1=Cosmetic Ingredient Review Expert Panel |date=12 May 2014 |url=https://www.cir-safety.org/sites/default/files/polyaminopropyl%20biguanide.pdf |publisher=Cosmetic Ingredient Review (CIR) |access-date=7 May 2024 }}</ref><ref>{{cite journal |last1=Sukakul |first1=Thanisorn |last2=Dahlin |first2=Jakob |last3=Pontén |first3=Ann |last4=Antelmi |first4=Annarita |last5=Bruze |first5=Magnus |last6=Hamnerius |first6=Nils |last7=Hauksson |first7=Inese |last8=Isaksson |first8=Marléne |last9=Lejding |first9=Tina |last10=Svedman |first10=Cecilia |title=Contact allergy to polyhexamethylene biguanide (polyaminopropyl biguanide) |journal=Contact Dermatitis |volume=84 |issue=5 |pages=326–331 |year=2021 |doi=10.1111/cod.13728 |pmid=33098110 |pmc=8048451 |url=https://doi.org/10.1111%2Fcod.13728}}</ref>

==References==
{{reflist}}

{{Antiseptics and disinfectants}}
{{Ophthalmological anti-infectives}}
{{Portal bar | Medicine}}
{{Authority control}}

[[Category:Antiseptics and disinfectants]]
[[Category:Biguanides]]
[[Category:Polymers]]