Trolamine

(pINN)
Trolamine Chemical formula
Synonyms: Trietanoloamina; Triethanolamine; Trolamiini; Trolamin; Trolamina; Trolaminas; Trolaminum.
Cyrillic synonym: Троламин.

💊 Chemical information

CAS — 102-71-6.

Description.

Trolamine is a variable mixture of bases containing mainly 2,2′,2′′-nitrilotriethanol (trolamine (CH 2 OH.CH 2 ) 3 N), together with 2,2′-iminobisethanol (diolamine) and smaller amounts of 2-aminoethanol (monoethanolamine).

Pharmacopoeias.

In Eur.. Also in USNF.

Ph. Eur. 6.2

(Trolamine; Triethanolamine BP 2008). A clear, viscous, colourless or slightly yellow, very hygroscopic liquid. Miscible with water and with alcohol; soluble in dichloromethane. Store in airtight containers. Protect from light.

USNF 26

(Trolamine). A mixture of alkanolamines consisting largely of trolamine containing some diolamine and monoethanolamine. A colourless to pale yellow, viscous, hygroscopic liquid having a slight ammoniacal odour. Miscible with water and with alcohol; soluble in chloroform. Store in airtight containers. Protect from light.

💊 Adverse Effects

Trolamine salts may be irritating to the skin and mucous membranes. Contact dermatitis has been reported after the use of ear drops containing trolamine polypeptide oleate-condensate.

Carcinogenicity.

Because of concern about the possible production of carcinogenic nitrosamines in the stomach, the Swiss authorities restricted the use of trolamine to preparations for external use.1
1. Anonymous. Trolamine: concerns regarding potential carcinogenicity. WHO Drug Inf 1991; 5: 9.

💊 Uses and Administration

Trolamine is used with fatty acids such as stearic and oleic acids as an emulsifier and as an alkalinising agent. It has also been used to reduce dithranol-induced staining of the skin. Ear drops containing trolamine polypeptide oleate-condensate 10% are used for the removal of impacted ear wax. Trolamine salicylate has also been used.

Radiotherapy.

An emulsion of trolamine has been widely used in the treatment and prevention of radiation-induced dermatitis in patients undergoing radiotherapy. However, several studies have suggested that it is of little or no benefit.1-3
1. Fisher J, et al. Randomized phase III study comparing best supportive care to Biafine as a prophylactic agent for radiation-induced skin toxicity for women undergoing breast irradiation: Radiation Therapy Oncology Group (RTOG) 97-13. Int J Radiat Oncol Biol Phys 2000; 48: 1307–10
2. Szumacher E, et al. Phase II study assessing the effectiveness of Biafine cream as a prophylactic agent for radiation-induced acute skin toxicity to the breast in women undergoing radiotherapy with concomitant CMF chemotherapy. Int J Radiat Oncol Biol Phys 2001; 51: 81–6
3. Elliott EA, et al. Phase III trial of an emulsion containing trolamine for the prevention of radiation dermatitis in patients with advanced squamous cell carcinoma of the head and neck: results of Radiation Therapy Oncology Group Trial 99-13. J Clin Oncol 2006; 24: 2092–7.

💊 Preparations

Proprietary Preparations

Arg.: Biafine; Orla-Wax†; Solucer; Austral.: Neutrogena; Belg.: Xerumenex; Canad.: Cerumenex; Chile: Biafine; Fr.: Biafine; Lamiderm; Ger.: Cerumenex N; Hong Kong: Biafine; Israel: Biafine; Malaysia: Biafine†; Mex.: Orlawax; S.Afr.: Cerumenex†; Singapore: Biafine†; Switz.: Biafine; Cerumenex; USA: Biafine; Cerumenex†; Venez.: Biafine. Multi-ingredient: Arg.: Eucos-L†; Onixol†; Tereonsit†; Braz.: Cerumin; Paraqueimol; Canad.: Soropon; Ital.: Dopo Pik; USA: Maxilube.
Published May 08, 2019.