Formulating Hydroalcoholic Gels with Carbopol Technical Data Sheet

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TECHNICAL DATA SHEET
TDS-255
Edition: October 15, 2013
Previous Editions: December, 1999 / March 25, 2004 / May 12, 2008 / September 3, 2009
Original Date: May, 1998
Formulating Hydroalcoholic Gels with
Carbopol® Polymers
Use of Hand Sanitizing Gels to Reduce Germ
Transmission
Hydroalcoholic hand sanitizing gels have found
increasing use by consumers and institutional
facilities. These gels have gained popularity due to
their ability to instantly kill germs and bacteria on the
hands without the use of soap and water. These gels
can be formulated to provide pleasant sensory and
good conditioning on the hands even while providing
effective disinfecting performance.
Carbopol® polymers and other Lubrizol Advanced
Materials’ rheology modifiers are the preferred
polymers to provide cost-effective and aesthetically
pleasing ingredients to thicken and stabilize
hydroalcoholic gels.
Background:
Viruses and bacteria such as Staphylococcus, E.coli,
Salmonella, and influenza can cause illnesses and
are typically transmitted via person-to-person
contact, as well as object to person contact. A
simple handshake, touching of a doorknob, pushing
elevator buttons, answering a telephone and
contacting other common objects in public areas can
all be sources of germs. Whether travelling by
airplane, bus or train, as well as frequenting public
places in general, there is potential exposure to an
array of harmful and potential infectious bacteria and
viruses.
These
environments
represent
an
opportunity for rapid spread of harmful microbes.
The probability of transmission increases when
personal hygiene or hand washing habits are
inadequate.
Washing hands with water and soap is an
effective way to remove visible dirt and reduce
the number of germs on your hands. However, it
is not always feasible or practical to wash your
hands as often as desired. The use of hand
sanitizing gels significantly reduces the potential
for germ transmission as well as the risks of
contamination. These gels can be also used to
supplement disinfection of the hands after normal
washing with soap and water for additional
protection.
Formulating a Hydroalcoholic
Hand Sanitizing Gel
Hydroalcoholic gels basically contain four major
ingredients: alcohol, water, rheology modifier and
neutralizer. The effectiveness of the sanitizer
using alcohol depends on the amount and type of
alcohol. The FDA proposed monograph considers
the effective concentrations as follows:
• Ethanol at 60-95 v/v%
• Isopropanol at 70-91.3 v/v%.
Alcohol can destroy the lipid containing cell
membrane of bacteria and fungus and denatures
proteins and enzymes inside bacteria and fungus.
Alcohol kills bacteria and fungus almost instantly
upon contact.
Lubrizol Advanced Materials, Inc. / 9911 Brecksville Road, Cleveland, Ohio 44141-3247 / TEL: 800.379.5389 or 216.447.5000
The information contained herein is being furnished
for informational purposes only, upon the express condition
that the User makes its own assessment of the appropriate
use of such information. While the information contained
herein is believed to be reliable, no representations,
guarantees or warranties of any kind are made as to its
accuracy, suitability for a particular application or the
results to be obtained herefrom.
Lubrizol Advanced
Materials, Inc. ("Lubrizol") cannot guarantee how any
products associated with this information will perform in
combination with other substances or in the User’s process.
Due to variations in methods, conditions and equipment
used commercially in processing these materials, no
warranties or guarantees are made as to the suitability of
the information or products for the applications
disclosed. Lubrizol shall not be liable and the User
assumes all risk and responsibility for any use or
handling of any material beyond Lubrizol's direct
control. LUBRIZOL MAKES NO WARRANTIES, EXPRESS
OR IMPLIED, INCLUDING, BUT NOT LIMITED TO,
THE IMPLIED WARRANTIES OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE. It is the
User’s sole responsibility to determine if there are any
issues relating to patent infringement of any component or
combination of components relating to the supplied
information. Nothing contained herein is to be
considered as permission, recommendation, nor as
an inducement to practice any patented invention
without permission of the patent owner.
For further information, please visit: www.lubrizol.com/personalcare
Lubrizol Advanced Materials, Inc. is a wholly owned subsidiary of The Lubrizol Corporation
All trademarks owned by The Lubrizol Corporation
© Copyright 2013 / The Lubrizol Corporation
TDS-255
Formulating Hydroalcoholic Gels with Carbopol Polymers
Page 2 of 6
®
Lubrizol Advanced Materials’ rheology modifiers are
efficient
ingredients
to
provide
thickening,
stabilization and suspension of these types of
formulations. Carbopol® polymers are the preferred
polymers to provide cost effective and aesthetically
pleasing hand sanitizing gels. The use of Carbopol
polymers will create thick clear gels that will prevent
dripping and will maximize contact of alcohol on the
skin for optimum performance.
Benefits
•
•
•
•
Quickly kills bacteria when water is not available.
Quickly evaporates on application requiring no
need for rinsing or drying of the hands.
Consumer convenience over ordinary hand
washing with soap and water.
Emollients, botanical extracts, moisturizers and
fragrances can all be incorporated and are
compatible -- thus helping to provide additional
functional benefits such as conditioning.
Polymer Selection
Although all Carbopol polymers can thicken
hydroalcoholic systems, several grades offer
advantages such as higher clarity, better
efficiency, ease of handling and better overall
aesthetics for hand sanitizing gels. All four of our
Carbopol Ultrez polymers are good rheology
modifiers for these gels. A typical hand sanitizing
gel contains less than 40 wt% deionized water.
Due to this constraint, the low dispersion viscosity,
as well as the processing ease, makes the
Carbopol Ultrez polymers well-suited for these
types of formulations as compared to the more
traditional polymer grades. The following table will
assist in polymer selection.
Carbopol® Polymer
Ultrez 10
Ultrez 21
Ultrez 20
Ultrez 30
980
940
HSG Viscosity*, >0.2 wt%












Electrolyte Tolerance






Smoothness after use






Ease of dispersion






Balling or Pilling**






Clarity
 Preferred
 Lower performance
*The HSG Viscosity references the formulation viscosity of the Hand Sanitizing Gel shown in table below
**The more checks the less pilling of system occurs
Screening Formulation for Carbopol® Polymer Comparison
Use Level of Carbopol® Polymer
Deionized Water (wt%)
Ethanol (wt%)
TEA (wt%)
0.1 wt%
0.2 wt%
0.3 wt%
0.4 wt%
0.5 wt%
39.8
60.0
0.1
39.6
60.0
0.2
39.4
60.0
0.3
39.2
60.0
0.4
39.0
60.0
0.5
TDS-255
Formulating Hydroalcoholic Gels with Carbopol Polymers
Page 3 of 6
®
Clarity Results: %Transmittance at 420 nm
Clarity of Hand Sanitizing Gels
120
Clarity, %T
100
Carbopol® Ultrez
20 Polymer
Carbopol® Ultrez
21 Polymer
Carbopol® Ultrez
10 Polymer
Carbopol® 980
Polymer
Carbopol® 940
Polymer
Carbopol® Ultrez
30 Polymer
80
60
40
20
0
0.00
0.10
0.20
0.30
0.40
0.50
Polymer concentration, wt% TS
Viscosity Results: Brookfield RVT, 20 rpm @ 25°C
Viscosity of Hand Sanitizing Gels
Viscosity, m Pa•s
25000
20000
Carbopol® 980
Polymer
Carbopol® Ultrez
21 Polymer
Carbopol® 940
Polymer
Carbopol® Ultrez
10 Polymer
Carbopol® Ultrez
20 Polymer
Carbopol® Ultrez
30 Polymer
15000
10000
5000
0
0.00
0.10
0.20
0.30
0.40
0.50
Polymer concentration, wt% TS
TDS-255
Formulating Hydroalcoholic Gels with Carbopol Polymers
Page 4 of 6
®
Neutralization of Carbopol® Polymers in Hand
Sanitizing Gels
The key to formulating a hydroalcoholic gel with
Carbopol polymers is choosing the correct neutralizing agent. Many neutralizing agents commonly used
to neutralize Carbopol polymers in aqueous systems
do not work in hydroalcoholic systems. There are
amine solubility limitations with high alcohol, low
water containing systems. The solubility of the
Carbopol polymer salt changes as the alcohol level is
increased making the choice of neutralizing agents
important. Different choices are provided as a
guideline for the different alcohol type and level.
Neutralizing Agent versus Alcohol Level
Manufacturer
Maximum
Alcohol
Level
Neutralization Ratio*
Base/ Carbopol® Polymer
Trade Name
INCI Name
NaOH (18%)
Sodium Hydroxide
20%
2.3/1.0
KOH (18%)
Potassium
Hydroxide
30%
2.7/1.0
TEA (99%)
Triethanolamine
60%
1.5/1.0
Tris Amino (40%)**
Tromethamine
Angus / Dow
60%
3.3/1.0
AMP® Ultra PC2000
Aminomethyl
Propanol
Angus / Dow
80%
0.9/1.0
90%
2.3/1.0
90%
1.5/1.0
Neutrol® TE
Tetrahydroxypropyl
Ethylenediamine
BASF
Triisopropanolamine
Triisopropanolamine
Dow
* Ratio values indicated above are for mucilages. For the 60% hydroalcoholic gel, divide the base ratio amount by 1.25
**NOTE: The 40% solution should be made from the Tris Amino crystal provided by the manufacturer. We do not recommend using
the predispersed solution produced by the manufacturer due to its high impurity content
Check your local regulations while selecting the appropriate neutralizing amine since there are often specific
guidelines on the type of amine and impurity level in the amine for these types of formulations.
Modification and Formula Enhancements for Hydroalcoholic Gels
Common Formulation additives for Hand Sanitizing Gels
Emollients
Water soluble emollients
Carbopol® polymers
Rheology modifier
Alcohol
Disinfecting agent
Fragrance
Botanical Actives
Specialty Silicones
TDS-255
Formulating Hydroalcoholic Gels with Carbopol Polymers
Page 5 of 6
®
Formulation and Manufacturing Guidelines
• Typical hand sanitizing gels contain less that 40
wt% water. Due to this formulation constraint, a
common concern is how to effectively incorporate
the Carbopol® polymer. The general methods are
outlined as follows, dependent on your choice of
polymer:
Direct Method: The direct method is the traditional
method for dispersing Carbopol polymers.
Self-Wetting Carbopol Polymers (Carbopol Ultrez
10, 20 and 21 Polymers): This method is made
easy with Carbopol Ultrez polymers since you simply
sprinkle the polymer on the surface of the water.
Allow the polymer to self wet and then begin
agitation. The general procedure is described as
follows:
1. Disperse the polymer into the water. Mix until
smooth to insure a lump free dispersion is
obtained.
2. Slowly add the alcohol with agitation and mix until
homogeneous.
3. Add emollients if desired. Keep in mind that the
order of addition may be critical to maintain
product clarity.
See “Adding Emollients” for
further information.
4. Add the appropriate neutralizing agent with gentle
sweeping agitation and mix until smooth.
NOTE: If production equipment constraints require
the water and alcohol to be combined before the
dispersion of polymer, the self-wetting polymers must
be dispersed like more traditional polymers. The selfwetting polymers will not self wet in a solution of
water and alcohol.
Other Carbopol Polymers (Carbopol Ultrez 30 and
Traditional Grade Polymers): These polymers can
be dispersed in either the water or alcohol/water
mixture. The polymer will swell more slowly when
added to the alcohol/water mixture, so care must be
taken to avoid the clumping and skinning of the
polymer during the dispersion process.
1. Carefully disperse the polymer in the water or
water/alcohol mixture with good agitation. High
mixing speeds are generally preferred as it
prevents agglomeration of the polymer on the
surface of the water. Mix until the polymer is
hydrated and the dispersion is smooth and free of
lumps.
2. Add the alcohol with slow mixing to de-aerate the
formulation if it was not included in Step 1.
3. Add emollients if desired. Keep in mind that the
order of addition may be critical to maintain
product clarity.
See “Adding Emollients” for
further information.
4. Add the appropriate neutralizing agent with gentle
sweeping agitation and mix until smooth.
•
Water Source: Use deionized water. Carbopol
polymers are sensitive to hard water ions,
therefore, the clarity and viscosity may be
negatively affected if regular tap water is used. If
deionized water is unavailable, add a chelating
agent such as tetrasodium EDTA at a level of
about 0.05-0.10% (wt/wt%).
•
Adding Emollients:
Several commercially
available emollients can be added to the hand
sanitizing gel to compensate for removal of oils
on the hands by the alcohol. The following watersoluble emollients can be added directly to the
water and polymer dispersion or just before
neutralization. The use of these emollients from
0.3-0.5 wt% addition will not impact the final
product clarity.
Trade Name
Glucam™ E-20 Humectant
Glucam™ E-10 Humectant
SilSense™ Copolyol-1 Silicone
SilSense™ SW-12 Silicone Ester
Hydramol™ PGPL Emollient
Hydramol™ PGDS Emollient
INCI Name
Methyl Gluceth-20
Methyl Gluceth-10
PEG-33 and PEG-8
Dimethicone and PEG-14
Dimethicone PEG-7 Cocoate
PEG/PPG-8/3 Laurate
PEG-90 Diisostearate
The Hydramol™ emollients can be added at use
levels from 0.5 - 3.0 wt% and will still maintain good
clarity in the system.
The use of other emollients may impact the final
product clarity depending on the solubility profile of
that particular emollient. Other emollients, such as
isopropyl myristate, may need to be added to the
alcohol and the water/polymer dispersion added to
the alcohol/emollient phase to maintain final product
clarity.
TDS-255
Formulating Hydroalcoholic Gels with Carbopol Polymers
Page 6 of 6
®
Clarity (% Transmission @ 420 nm)
Frequently Asked Questions
All polymers suggested for this application have
excellent clarity in hydroalcoholic systems. Clarity
can be affected by many factors including dispersion
techniques, water source, emollient content,
formulation pH, type and level of fragrance and/or
dye addition. Hydroalcoholic gels made with
Carbopol® polymers typically have clarity of 92-98
%T. To obtain optimum clarity we recommend the
following:
• Hand hygiene in healthcare settings.
The US Center for Disease Control (CDC) has
issued guidelines for hand hygiene in healthcare
settings in order to more effectively reduce the
spread of hospital-based infections by healthcare
professionals. The CDC’s guideline, released in
October 2002, strongly recommends alcoholbased hand sanitizers as the primary method of
hand hygiene among healthcare professionals
when hands are not visibly soiled. The World
Health Organization (WHO) issued “Hand Hygiene
in Health Care Guidelines” in May of 2009.
The following is a link to that document: WHO
Guidelines: Hand Hygiene in Health Care
• Safety of direct food contact after using an
alcoholic hand sanitizer?
Using an alcoholic hand sanitizing gel is generally
considered safe. In Canada, workers in the food
industry are allowed to use alcoholic hand
sanitizing gels since they have been approved by
Health Canada. These systems are listed by the
Canadian Food Inspections Agency as acceptable
non-food chemical products. In the food service
industry, an alcohol sanitizer is considered helpful
as an extra hand disinfecting step after washing of
hands with soap and water. The FDA has approved
Carbopol polymers for indirect food contact when
used in hand sanitizers up to 0.5 wt%.
• Protection in Schools.
According to a study issued in October of 2000 in
The American Journal of Infection Control, the use
of hand sanitizing gels was shown to decrease
absenteeism due to illness among elementary
school students by 20%.
• Acceptance of Hand Sanitizing Gels.
According to a study published in the July, 2000
issue of Infection Control and Hospital
Epidemiology, use of a Hand Sanitizing Gel is
accepted by healthcare workers and does not
result in skin irritation and dryness when
compared to frequent soap and water hand
washing.
• Regulations.
Hand Sanitizing Gels may be regulated as drug
products. Review your country’s regulations to
insure compliance.
• Use deionized water.
• Use Direct Method for Polymer Dispersion.
When using self-wetting polymers they should be
dispersed in water, not a water/alcohol mixture.
Reference Lubrizol TDS-103 for details on
dispersing traditional grade Carbopol polymers.
• Choose the correct neutralizing amine. It is
important to insure that the neutralizing amine is
compatible with the alcohol. Reference guidelines
provided.
• For maximum clarity, target appropriate pH.
We recommend the following pH:
 For Carbopol polymers such as Ultrez 10, 30,
940 and 980, the optimum pH is typically
around 7.0.
 For Carbopol Ultrez 21 and Ultrez 20 polymers,
the optimum pH is 5.8-6.3.
 We recommend evaluating various pH levels
and neutralizing amines to determine which
combination provides the best clarity for your
specific formulation.
• Choose a water-soluble emollient. Optimize use
level to provide best balance of clarity and
conditioning aesthetics.
• Use water soluble dyes. Examples of appropriate colors are D&C Red #33, D&C Green #5,
and FD&C Blue #1. Dyes supplied as powders
should be made into dilute (1-3 wt%) solutions and
added at the end of the formulation.
• Addition of oil soluble fragrances.
These
ingredients should be post added at low levels. A
solubilizer such as Polysorbate 20 at about 0.2
wt% may be necessary to insure good clarity.
• Filtration of end product will maximize final
clarity.
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