Polyhexanide Explained

Polyhexanide (polyhexamethylene biguanide, PHMB) is a polymer used as a disinfectant and antiseptic. In dermatological use,[1] it is spelled polihexanide (INN) and sold under the names Lavasept, Tebasept, Prontosan.[2] PHMB has been shown to be effective against Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, Candida albicans, Aspergillus brasiliensis, enterococci, and Klebsiella pneumoniae.[3]

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.[4] [5] PHMB eye drops have been used as a treatment for eyes affected by Acanthamoeba keratitis.[6]

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.

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, a severe, progressive and sight threatening corneal infection characterized by intense pain and photophobia.[7] Acanthamoeba keratitis is a rare disease primarily affecting contact lens wearers. The applicant for this medicinal product is SIFI SPA.[8]

Safety

In 2011, Polyhexamethylene biguanide is 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.[9]

Name controversy

In some sources, particularly when listed as a cosmetics ingredient (INCI), the polymer is wrongly named as Polyaminopropyl biguanide[10] [11]

Notes and References

  1. Ansorg R, Rath PM, Fabry W . Inhibition of the anti-staphylococcal activity of the antiseptic polihexanide by mucin . Arzneimittel-Forschung . 53 . 5 . 368–71 . 2003 . 12854364 . 10.1055/s-0031-1297121. 33172373 .
  2. Polihexanide

  3. Maribeth Cousin, Kimberly Restivo, Chelsea Rodriguez, and Justin Lien. USP Antimicrobial Effectiveness Test (GLP). Elkhorn, WI: Geneva Laboratories. 2013. Web site: Archived copy . 8 April 2015 . dead . https://web.archive.org/web/20160304060828/http://steriwebrx.com/files/STERIWEB-FINAL-JN13J1514.pdf . 4 March 2016 .
  4. Web site: Nusept . 8 June 2011 . 25 March 2012 . https://web.archive.org/web/20120325041756/http://www.tulipgroup.com/Bioshields2/html/antiseptics_nusept.htm . dead .
  5. Rippon . Mark G. . Rogers . Alan A. . Ousey . Karen . Polyhexamethylene biguanide and its antimicrobial role in wound healing: a narrative review . J Wound Care . 2 January 2023 . 32 . 1 . 5–20 . 10.12968/jowc.2023.32.1.5 . 36630111 .
  6. Alkharashi M, Lindsley K, Law HA, Sikder S . Medical interventions for acanthamoeba keratitis . Cochrane Database Syst Rev. 2015 . CD0010792 . 2015 . 2 . 25710134. 10.1002/14651858.CD010792.pub2 . 4730543.
  7. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2024 . European Medicines Agency . 31 May 2024 . 13 June 2024.
  8. Web site: Akantior EPAR . . 30 May 2024 . 31 May 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  9. Web site: Polyhexamethylene biguanide Assessment Report . 30 July 2024 . europa.eu.
  10. Web site: Safety Assessment of Polyaminopropyl Biguanide as Used in Cosmetics . Cosmetic Ingredient Review Expert Panel . 12 May 2014 . Cosmetic Ingredient Review (CIR) . 7 May 2024 .
  11. Sukakul . Thanisorn . Dahlin . Jakob . Pontén . Ann . Antelmi . Annarita . Bruze . Magnus . Hamnerius . Nils . Hauksson . Inese . Isaksson . Marléne . Lejding . Tina . Svedman . Cecilia . Contact allergy to polyhexamethylene biguanide (polyaminopropyl biguanide) . Contact Dermatitis . 84 . 5 . 326–331 . 2021 . 10.1111/cod.13728 . 33098110 . 8048451 .