HyaCare ® Filler CL The topical wrinkle smoother April 2010.

HyaCare® Filler CL The topical wrinkle smoother

April 2010

Consumer Specialties | 18/04/23 Page | 2

Properties & Features

HyaCare® Filler CL is

• based on a unique, cross-linked polysaccharide

• made from very pure, fermentation-derivedhyaluronic acid

• a W/O emulsion containing super-absorbingspherical particles

• preservative free

• INCI (proposed): Aqua, Ethylhexyl Stearate, Sodium Hyaluronate Crosspolymer, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Sodium Isostearate, Alcohol


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


Cross-linking in emulsion

O

OH

HO

COOH

OO

NH

OHO

O

OH

Emulsion Droplets

Spherical CL-HA Particles

Cross-linking

The average particle size distribution of HyaCare® Filler CL is approx. 700 nm

Particle size distribution


Water uptake test

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

HyaCare® Filler CL particles • have super-absorbing properties• show superior water binding

t = 0 min

t = 30 min

____20 µm___


In vitro enzymatic degradation - Test design & result

HyaCare® Filler CL• is stable against enzymatic degradation• supports longer lasting moisturization

Method:• Measurement of enzymatic cleavage by hyaluronidase

• Photometrically quantification by determination of released reducing sugars


In vitro MTT-assay –Test design & result

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

40,0

50,0

60,0

70,0

80,0

90,0

100,0

110,0

+ cover - cover - cover

vehicle RT vehicle RT HyaCare Filler CL

viab

ilit

y [%

]

***

++

*** p<0.001 vs. vehicle (+ cover), ++ p<0.01 vs. vehicle (- cover)

Method:

• Cell viability during drying of skin models (SkinEthic) under laminar flow (rel. to vehicle formulation cultivated at RT with plate cover)

MTT-assay


In vitro MTT-assay test –Histology image result

HyaCare® Filler CL leads to a better structured epidermis


Ex vivo wrinkle filling testDesign & result

HyaCare® Filler CL particles fill fine lines & wrinkles

Fluorescently labelled HyaCare® Filler CL was applied on pig skin


In vivo evaluation – Test design

Test formulation #24

Number of volunteers: 16

Application: O/W vehicle with 0.1 % HyaCare®

O/W vehicle with 2.5 % HyaCare® Filler CLOn inner forearm

Selected time points: After 2 h

Analysis: CorneometerVisioscan VC 98

Observed activity: Skin moisturizationSkin surface


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


In vivo evaluation of wrinkles – Test design

Application: O/W cream with 5% HyaCare® Filler CLOn face

Selected time points: After 15 min & 1h

Analysis: Photo


Before application 15 min after application

HyaCare® Filler CL instantly fills fine lines & wrinkles

In vivo evaluation of wrinkles – Test result


In vivo evaluation of wrinkles – Test result

Before application 1h after application

HyaCare® Filler CL smoothes skin surface


HyaCare® Filler CLFormulation 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.


HyaCare® Filler CL -Guideline formulation

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.

Dermal Filler Cream(MAC 672/3/1)

A 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 %

B Glycerin 3.0 %

Water 68.0 %

C TEGO® Carbomer 134(Carbomer)

0.2 %


0.8 %

D Sodium Hydroxide (10 % in water) q.s.

Z Preservative, parfum q.s.


HyaCare® Filler CL -Guideline formulation

Eye Cream(MAC 672/1/1)

A TEGO® Care 450(Polyglyceryl-3 Methylglucose Distearate)

3.0 %


2.0 %


2.0 %


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 %

B Glycerin 3.0 %

Water 67.5 %

C Lactic Acid (10 % in water) q.s.

Z Preservative, parfum q.s.

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.


• 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

HyaCare® Filler CL -Your benefits at a glance



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.


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)-2,5-diphenyltetrazolium bromide, a tetrazole) is reduced to purple formazan in living cells.


Particle Size Distribution

• Method:Detection by SPOS (single particle optical sensing; lower and upper limits of measurement are 0,5 and 400 µm, respectively)

• Microsope image of dispersion:

0

2

4

6

8

10

12

14

16

0,6

0,7

0,8

1,0

1,2

1,4

1,6

1,9

2,2

2,6

3,1

3,6

4,2

5,0

d / µm

% (

num

ber

wei

ghte

d)

Back #4


In vitro test design

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)

drying of skin models under laminar flow without plate-cover

topical application of testsubstances and incubation in

CO2-incubator for 1h

4 h 8 h6 h

a. analysis of viability (MTT);b. histology of skin models

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

Back #7


In vivo evaluation – Test formulation

MM151/2 MM151/6

A TEGO® Care 450(Polyglyceryl-3 Methylglucose Distearate)

3.0 % 3.0 %


2.0 % 2.0 %


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 74.1 % 71.7 %

Back #10

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HyaCare ® Filler CL The topical wrinkle smoother April 2010.

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