HyaCare ® Filler CL

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HyaCare® Filler CL
The topical wrinkle smoother
April 2010
Properties & Features
HyaCare® Filler CL is
• based on a unique, cross-linked polysaccharide
• made from very pure, fermentation-derived
hyaluronic acid
• a W/O emulsion containing super-absorbing
spherical particles
• preservative free
• INCI (proposed): Aqua, Ethylhexyl Stearate, Sodium
Hyaluronate Crosspolymer, Polyglyceryl-4
Diisostearate/Polyhydroxystearate/Sebacate, Sodium
Isostearate, Alcohol
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Benefits & Claims
HyaCare® Filler CL
• Instantly fills fine lines & wrinkles
• Topical alternative to injectables
• Thoroughly hydrates the skin
• Increases skin elasticity
• Smoothes skin surface
Start
Before application
15 min after application
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Cross-linking in emulsion
HO
OH
COOH
O HO
O
OH
O
O
NH
O
Emulsion Droplets
Cross-linking
Spherical CL-HA Particles
The average particle size distribution of HyaCare® Filler CL is approx. 700 nm
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Particle size distribution
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Water uptake test
t = 0 min
t = 30 min
Addition of water to the
CL-HA W/O emulsion leads
to water uptake
Water is not taken up by
a hyaluronic acid W/O emulsion
____20 µm___
HyaCare® Filler CL particles
• have super-absorbing properties
• show superior water binding
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In vitro enzymatic degradation Test design & result
Method:
• Measurement of enzymatic
cleavage by hyaluronidase
• Photometrically quantification
by determination of released
reducing sugars
HyaCare® Filler CL
• is stable against enzymatic degradation
• supports longer lasting moisturization
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In vitro MTT-assay –
Test design & result
110,0
++
Method:
100,0
• Cell viability during drying of skin
models (SkinEthic) under laminar flow
(rel. to vehicle formulation cultivated
at RT with plate cover)
viability [%]
90,0
80,0
***
70,0
60,0
50,0
40,0
+ cover
- cover
- cover
vehicle RT
vehicle RT
HyaCare Filler CL
*** p<0.001 vs. vehicle (+ cover), ++ p<0.01 vs. vehicle (- cover)
HyaCare® Filler CL protects the skin models from drying out
HyaCare® Filler CL even shows a superior long term effect compared to the vehicle
formulation
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MTT-assay
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In vitro MTT-assay test –
Histology image result
HyaCare® Filler CL leads to a better structured epidermis
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Ex vivo wrinkle filling test
Design & result
Fluorescently labelled HyaCare® Filler CL was applied on pig skin
HyaCare® Filler CL particles fill fine lines & wrinkles
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In vivo evaluation –
Test design
Number of volunteers:
16
Application:
O/W vehicle with 0.1 % HyaCare®
O/W vehicle with 2.5 % HyaCare® Filler CL
On inner forearm
Selected time points:
After 2 h
Analysis:
Corneometer
Visioscan VC 98
Observed activity:
Skin moisturization
Skin surface
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Test formulation #24
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In vivo evaluation –
Test results
Skin moisturization
Skin surface
HyaCare® Filler CL
• thoroughly hydrates the skin
• smoothes skin surface by reducing number & depth of wrinkles
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In vivo evaluation of wrinkles –
Test design
Application:
O/W cream with 5% HyaCare® Filler CL
On face
Selected time points:
After 15 min & 1h
Analysis:
Photo
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In vivo evaluation of wrinkles –
Test result
Before application
15 min after application
HyaCare® Filler CL instantly fills fine lines & wrinkles
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In vivo evaluation of wrinkles –
Test result
Before application
1h after application
HyaCare® Filler CL smoothes skin surface
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HyaCare® Filler CL
Formulation Hints
Recommended usage concentration: 0.5 – 5 %
Preparation of an O/W-Emulsion (Cream or Lotion):
Normally, HyaCare® Filler CL should be added to the oil phase of the emulsion.
Then the emulsion is prepared as usual.
In some cases HyaCare® Filler CL might disturb the build up of the liquid
crystalline structure of the O/W-emulsion. In these cases, it is recommended to
add it during the cooling process at temperatures below 40°C.
If high concentrations of HyaCare® Filler CL are used (4 - 5%), it increases the
viscosity of the O/W emulsion. In this case, the viscosity can be adjusted by
decreasing the concentration of consistency enhancers like fatty alcohols (TEGO®
Alkanol 16, 1618 or 18) and glyceryl stearate (TEGIN® M Pellets).
Preparation of a W/O-Emulsion (Cream or Lotion):
The W/O emulsion is prepared as usual. At the end of the production HyaCare®
Filler CL is added.
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HyaCare® Filler CL Guideline formulation
Dermal Filler Cream
(MAC 672/3/1)
A
B
Axol®
C 62 Pellets
(Glyceryl Stearate Citrate)
1.5 %
TEGIN® M Pellets
(Glyceryl Stearate)
3.0 %
TEGO® Alkanol 18
(Stearyl Alcohol)
2.0 %
Stearic Acid
1.0 %
TEGOSOFT® CT
(Caprylic/Capric Triglyceride)
8.5 %
TEGOSOFT® M
(Isopropyl Myristate)
7.0 %
TEGOSOFT® CR
(Cetyl Ricinoleate)
2.0 %
HyaCare® Filler CL
(Aqua; Ethylhexyl Stearate; Sodium Hyaluronate Crosspolymer;
Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate; Sodium
Isostearate; Alcohol (proposed))
3.0 %
Glycerin
3.0 %
Water
C
68.0 %
TEGO® Carbomer 134
(Carbomer)
0.2 %
TEGOSOFT® CT
(Caprylic/Capric Triglyceride)
0.8 %
D
Sodium Hydroxide (10 % in water)
q.s.
Z
Preservative, parfum
q.s.
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Preparation:
1. Heat phase A and B to approx. 80°C.
2. Add phase A to B while stirring.
3. Homogenize.
4. Cool down to 60°C and add phase C.
5. Homogenize again for a short time.
6. Cool down to 30°C. Add phase D and
Z below 40°C.
Important: If phase A has to be charged
into the vessel first, add phase B without
stirring.
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HyaCare® Filler CL Guideline formulation
Eye Cream
(MAC 672/1/1)
A
B
TEGO® Care 450
(Polyglyceryl-3 Methylglucose Distearate)
3.0 %
TEGIN® M Pellets
(Glyceryl Stearate)
2.0 %
TEGO® Alkanol 18
(Stearyl Alcohol)
2.0 %
TEGOSOFT® CT
(Caprylic/Capric Triglyceride)
7.5 %
TEGOSOFT® DC
(Decyl Cocoate)
9.5 %
Avocade (Persea Gratissima) Oil
2.0 %
Tocopheryl Acetate
0.5 %
HyaCare® Filler CL
(Aqua; Ethylhexyl Stearate; Sodium Hyaluronate Crosspolymer;
Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate;
Sodium Isostearate; Alcohol (propsosed))
3.0 %
Glycerin
3.0 %
Water
67.5 %
C
Lactic Acid (10 % in water)
q.s.
Z
Preservative, parfum
q.s.
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Preparation:
1. Heat phase A and B to approx. 80°C.
2. Add phase A to B while stirring.
3. Homogenize.
4. Cool down to 30°C. Add phase C and
Z below 40°C.
Important: If phase A has to be charged
into the vessel first, add phase B without
stirring.
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HyaCare® Filler CL Your benefits at a glance
• Instantly fills fine lines & wrinkles
• Topical alternative to injectables
• Thoroughly hydrates the skin
• Increases skin elasticity
• Smoothes skin surface
Possible applications:
• Anti-wrinkle eye care products
• Anti-aging facial serum
• Special care for expression lines
• Skin plumping face care
• Facial sun care
• Intense moisturizing skin care
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Especially concerning Active Ingredients
This product information is not intended to provide legal or regulatory advice
about product uses or claims in any jurisdiction and should not be relied
upon for such guidance (especially in the United States, Canada, and
Mexico). Since global regulatory requirements differ, parties accessing this
information are solely responsible for determining whether the products
and/or claims comply with applicable local laws and regulations, including
but not limited to import and export regulations. Please contact your local
Evonik representative for more product information. Evonik assumes no
liability for any use of our products that is not in compliance with the
requirements of the country of the user.
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Glossary
CL-HA: cross-linked hyaluronic acid
MTT-assay: Is a cell culture test & standard colometric assay for measuring cell viability
based on mitochondrial activity. Yellow MTT (3-(4,5-Dimethylthiazol-2-yl)-2,5diphenyltetrazolium bromide, a tetrazole) is reduced to purple formazan in living cells.
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Particle Size Distribution
• Method:
Detection by SPOS (single particle
optical sensing; lower and upper
limits of measurement are 0,5 and
400 µm, respectively)
14
12
% (n u m b e r w e ig h te d )
• Microsope image of dispersion:
16
10
8
6
4
2
6
7
8
0
2
4
6
9
2
6
1
6
2
0
0,
0,
0,
1,
1,
1,
1,
1,
2,
2,
3,
3,
4,
5,
0
d / µm
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In vitro test design
Purpose of the study:
Exploration of the physical effect (water-binding capacity)
of cross-linked Hyaluronic Acid on dried epidermal skin models.
Model:
SkinEthic reconstructed human epidermis
topical application of testsubstances
and incubation in CO2-incubator for 1h
1) vehicle formulation 1
“normal” cultivation at room temperature with
plate-cover under laminar flow
2) vehicle formulation 2
cultivation at room temperature without plate-cover
under laminar flow (drying of the skin models)
3) formulation + HyaCare® Filler CL
cultivation at room temperature without plate-cover
under laminar flow (drying of the skin models)
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drying of skin models under laminar
flow without plate-cover
4h
6h
8h
a. analysis of viability (MTT);
b. histology of skin models
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In vivo evaluation –
Test formulation
MM151/2
A
MM151/6
TEGO® Care 450
(Polyglyceryl-3 Methylglucose Distearate)
3.0 %
3.0 %
TEGIN® M Pellets
(Glyceryl Stearate)
2.0 %
2.0 %
TEGO® Alkanol 18
(Stearyl Alcohol)
1.0 %
1.0 %
TEGOSOFT® OS
(Ethylhexyl Stearate)
9.5 %
9.5 %
TEGOSOFT® CT
(Caprylic/Capric Triglyceride)
9.5 %
9.5 %
Methylisothiazolinone, Methyl and Ethyl Parabens
(Microcare MEM)
0.8 %
0.8 %
HyaCare®
0.1 %
HyaCare® Filler CL
2.5 %
Water
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74.1 %
Back #10
71.7 %
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