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GLOBAL REGULATIONS The second most popular form of hand


sanitisers on the market is the gel. Most gels are formulations containing an alcohol level between 60-80%. Many gels are thickened with Carbomer or an acrylate variant such as Acrylates/C10-30 Alkyl Acrylate Crosspolymer. Due to the high level of alcohol in these formulations, the use of sodium hydroxide to neutralise Carbomer is generally not suggested. Typically, it is recommended to neutralise acrylates polymers with organic amines. Formulators have used triethanolamine, aminomethyl propanol, and tris amino. The use of acrylates in making the gels provides a good cost advantage and helps create crystal clear gels. The formulations typically crumble during rub out due to the inability of acrylates to handle residual salt in hands. Due to recent attacks on acrylates from various organisations and their potential labelling as micro-plastics, many formulators switched to cellulosics as rheology modifiers. Cellulosics are naturally-derived and can thicken alcohol-based formulations as well. The most commonly used thickener is hydroxypropylcellulose followed by hydroxyethylcellulose. Cellulosics will yield transparent gels and will impart a slip to the formulation. Cellulosic gels do not need to be neutralised and do not crumble in hands upon rubbing. Alcohol-free hand sanitisers typically capture


a small slice of the market by targeting some customers that prefer not to use alcohol. These products are based on Benzalkonium Chloride and come in various forms like emulsions, gel- creams, and gels as well. Due to the absence of alcohol these products could be considered Halal if they meet the rest of the criteria necessary for certification. A myriad of ingredients can be typically


added to hand sanitiser gels. Glycerin is very popular as it helps moisturise the skin and changes the feel and application of the gel as well. Aloe is another ingredient commonly added to the formulation due to its well-known healing and soothing properties. Several alcohol-soluble esters have been used as well. Esters of alpha-hydroxy acids are popular due to their high polarity and ease of incorporation into such formulations. Such esters are lauryl lactate, myristyl lactate, and C12-15 alkyl lactate. Other alcohol-compatible esters with high polarity include diisopropyl adipate, and isodecyl neopentanoate. One important key ingredient present in


most gels is the fragrance. Selecting a fragrance for a hand sanitiser is not quite simple. One must make sure that the fragrance is stable at such high level of alcohol for the duration of the accelerated stability (typically, 3 months at 45°C). In addition, the fragrance must cover the alcohol odour without being overwhelming since many professionals apply the product more than 10 times a day.


When checking the stability of such


formulations, one should not forget to store them in explosion-proof ovens. These formulations are quite flammable, and if stored in a regular laboratory oven can cause a fire hazard. The compatibility of these formulations with the final packaging should also be tested as the high level of alcohol could deform many types of plastics.


www.personalcaremagazine.com July 2021 PERSONAL CARE BiTop Junior 1CvAd 21.qxp_Layout 1 02/06/2021 11:24 Page 1


Conclusion I hope this quick review of hand sanitiser formulations is quite helpful for formulators and would give them a head-start when formulating such products. Now it is up to the individual formulator to be creative and add his/her personal touch to make such formulations unique in this crowded undifferentiated market.


References 1 Federal register/Vol 81, No. 126/Thursday June 30, 2016 – 21 CFR Part 310


2 Federal register/Vol 82, No. 243/ Wednesday December 20, 2017 – 21 CFR Part 310


3 Federal register/Vol 84, No. 71/Friday April 12, 2019 – 21 CFR Part 310


4 Temporary Policy for Certain Alcohol-based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry. March 2020, Updated Feb 10, 2021


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