Formulation Guidelines for Synovea HR

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1 Formulation Guidelines for Synovea HR Synovea $ HR Hexylresorcinol is a well-defined material with a guaranteed purity of 99%. Generally speaking, Synovea $ HR is one of the very few phenolic skin lightening agents, which will be white and remain white in appearance in formulated products. At 45 0 C for two months & > 2 years at RT, lotions containing 1.0% and 0.5% Synovea $ HR showed minimal color shift. We have developed a series of application guideline tips that will assist the formulator to make products that are as aesthetically pleasing and stable as possible. Synovea $ HR is highly soluble in Caprylic/Capric Triglycerides, Isosorbide Dicapylate, Ethyl Linoleate, Ethoxydiglycol, and other high polarity esters, non-ionic solubilizers, glycerol and a wide-range of glycols. Synovea $ HR should be used at a level of % (w/w) of finished formulation. Dissolve 0.5 g of Synovea $ HR in about 2 g of ethoxydiglycol, glycerol, butylene glycol or propylene glycol and add to the formulation after making emulsion, preferably below 50 C. Non-ionic emulsifiers are preferable over anionic types. For preparation of serum or transparent gel, use non-ionic solubilizers having high HLB values like PEG- 40 hydrogenated castor oil, Laureth 23, Polysorbate 20 & Polysorbate 80. Synovea HR is a phenolic compound. Therefore, presence of Iron or Copper ions must be avoided to reduce coloration due to interaction with these metal ions. Addition of a small amount of disodium EDTA (0.1%) or other suitable chelating agents resolves this problem. The finished product must be acidic, preferably having ph below 6.0. A ph below 5.5 is recommended when potassium sorbate or sodium benzoate are used as preservatives. Formulations containing Synovea $ HR may cause drop in viscosity. Anionic (such as, Xanthan gum, Carbomers) or neutral thickeners (such as, Cellulosics) are good for maintaining desired viscosity. The finished product should be protected from prolong exposure to heat and light. Airless/opaque packaging is highly recommended for protecting product integrity and stability over time. July 2013 % & ' ( ) * +, -. / ( + ) 0 ' ). ) 2 / & ', ' ' ) 2. / ( + ) ' & ', ' ( )., ' 5. 4 ' 2 + ) + 6,, ' 4 '., 3 &. ) 2., ' 5 ' 7 ( ' 1 ' 2 / + 5 ' ,. / ' 5 6 / ) ,. ) / ' ' + * / & ' (, ,. 3 8 ( ' 9 % & ( 4 ( ) * +, -. / ( + ) ( 4 ( ) / ' ) 2 ' 2 / + 5 ' & ' 7 : * 6 7 ; 5 6 / ) + <.,,. ) / 8 ( 4 ' = :, ' 4 4 ' 2 +, ( - : 7 ( ' 2. 4 / + / & ', ' /. ( ) ' 2 *, ' + * / & ' * +, / ( + ) ; :, + 3 ' 2 6, ' +, :, / ' 4 / ' 2 & ', ' ( ) 9 > ' (/ & ', ( 4. ) 8 : ', - ( 4 4 ( + ) +,, ' ' ) 2. / ( + ) / + :,. 3 / ( 3 '. ) 8 ( ) 1 ' ) / ( + ) ', ' :. / ' ) / ' (/ & ',! " #

2 Skin Brightening Cream- 0.5% Synovea HR and 2% Synovea EL Formulation RC#01-14 Xanthan Gum Vanzan NF/Vanderbilt 0.15 Acrylates/C10-30 Alkyl Acrylate Copolymer Carbopol Ultrez 21/Lubrizol 0.30 Caprylic/Capric Triglycerides Myritol 318/Cognis 5.00 Tocopheryl Acetate Vitamin E Acetate/DSM 0.20 Glyceryl Stearate, PEG-100 Stearate Arlacel 165/Croda 2.00 Cetearyl Alcohol, Ceteareth 20 Promulgen D/Lubrizol 2.00 Dimethicone DC, 200/100CST/Dow Corning 3.00 Cyclomethicone, Polysilicone-11 Gransil GCM-5/Grant Industries 5.00 Ethyl Linoleate Synovea EL /Sytheon 2.00 Cetyl Esters Crodamol SS/Croda 1.00 Triethanolamine 99% Trolamine 99 (to ph 5.5) 0.25 Polyacrylamide, C13-14 Isoparaffin, Laureth-4 Sepigel 305/Seppic 1.00 Hexylresorcinol Synovea HR/Sytheon 0.50 Procedure: Combine A-1; disperse A2 in A1 while stirring and heat A to 75 0 C. Combine phase B ingredients then heat to 75 0 C. Add phase B to A with good mixing. Homogenize mixture at high speed, while adding phase C & D. Cooling to 40 0 C and slowly add pre-mixed phase E; stir gently until mixture is homogeneous and then add phase F. ph value: 5.5 Viscosity: 50,000-70,000 cps (Brookfield RVT, spindle C, Helipath) at 25 0 C % & ' ( ) * +, -. / ( + ) 0 ' ). ) 2 / & ', ' ' ) 2. / ( + ) ' & ', ' ( )., ' 5. 4 ' 2 + ) + 6,, ' 4 '., 3 &. ) 2., ' 5 ' 7 ( ' 1 ' 2 / + 5 ' ,. / ' 5 6 / ) ,. ) / ' ' + * / & ' (, ,. 3 8 ( ' 9 % & ( 4 ( ) * +, -. / ( + ) ( 4 ( ) / ' ) 2 ' 2 / + 5 ' & ' 7 : * 6 7 ; 5 6 / ) + <.,,. ) / 8 ( 4 ' = :, ' 4 4 ' 2 +, ( - : 7 ( ' 2. 4 / + / & ', ' /. ( ) ' 2 *, ' + * / & ' * +, / ( + ) ; :, + 3 ' 2 6, ' +, :, / ' 4 / ' 2 & ', ' ( ) 9 > ' (/ & ', ( 4. ) 8 : ', - ( 4 4 ( + ) +,, ' ' ) 2. / ( + ) / + :,. 3 / ( 3 '. ) 8 ( ) 1 ' ) / ( + ) ', ' :. / ' ) / ' (/ & ',! "?

3 Dark Spot Corrector - 1% Synovea HR & 2% Niacinamide & 1% Acetyl Glucosamine Formulation RC#01-32 Niacinamide Niacinamide PC/DSM 2.00 Acetyl Glucosamine Acetyl Glucosamine/Universal Presev 1.00 Xanthan Gum Vanzan NF/Vanderbilt 0.10 Acrylates/C10-30 Alkyl Acrylate Copolymer Carbopol Ultrez 21/Lubrizol 0.30 Caprylic/Capric Triglycerides Myritol 318/Cognis 3.00 Jojoba Seed Oil Lipovol J Clear/Lipo 2.00 Tribehenin PEG-20 Esters Emulium 22/Gattefosse 2.50 Butyrospermum Parkii (Shea Butter) Shebu Refined /Rita 2.00 Tocopheryl Acetate Vitamin E Acetate/DSM 0.10 Glyceryl Stearate, PEG-100 Stearate Arlacel 165/Croda 1.00 Cetyl Alcohol Crodacol C-70/Croda 0.70 Dimethicone DC, 200/50CST/Dow Corning 2.00 Isosorbide Dicaprylate Synovea DOI/Sytheon 2.00 Triethanolamine 99% Trolamine 99 (to ph 5.5) 0.20 Polyacrylamide, C13-14 Isoparaffin, Laureth-4 Sepigel 305/Seppic 0.75 Hexylresorcinol Synovea HR/Sytheon 1.00 Phase G Fragrance Frag. #K3258/Carruba 0.20 Procedure: Combine A-1; disperse A2 in A1 while stirring and heat A to 75 0 CCombine phase B ingredients then heat to 75 0 C. Add phase B to A with good mixing. Homogenize mixture at high speed, while adding phase C & D. Cooling to 40 0 C and slowly add pre-mixed phase E. Add phase F; stir gently until mixture is homogeneous and then add phase G. ph value: 5.4; Viscosity: 40,000-60,000 cps (Brookfield RVT, spindle C, Helipath) at 25 0 C!

4 Anti-Melasma Cream with 1% Synovea HR Formulation RC#01-20 Xanthan Gum Vanzan NF/Vanderbilt 0.15 Acrylates/C10-30 Alkyl Acrylate Copolymer Carbopol Ultrez 21/Lubrizol 0.25 Triethanolamine 99% Trolamine 99 (to ph 4.0) 1.00 Caprylic/Capric Triglycerides Myritol 318/Cognis 4.00 Dicaprylyl Ether Cetiol OE/BASF 4.00 Cetyl Alcohol Crodacol C-70/Croda 2.00 Tocopheryl Acetate Vitamin E Acetate/DSM 0.20 Glyceryl Stearate, PEG-100 Stearate Arlacel 165/Croda 3.00 Sorbitan Stearate Arlacel 60/Croda 0.50 Dimethicone DC, 200/100CST/Dow Corning 1.00 Cyclomethicone, Polysilicone-11 Gransil GCM-5/Grant Industries 5.00 Polyacrylamide, C13-14 Isoparaffin, Laureth-4 Sepigel 305/Seppic 1.00 Hexylresorcinol Synovea HR/Sytheon 1.00 Procedure: Combine A-1; disperse A2 in A1 while stirring and heat A to 75. Combine phase B ingredients then heat to 75 0 C. Add phase B to A with good mixing. Homogenize mixture at high speed, while adding phase C & D. Coo batch to 40C; Add phase E and F; stir gently until mixture is homogeneous. ph value: Viscosity: 35,000-50,000 cps (Brookfield RVT, spindle C, Helipath) at 25 C ' = :, ' 4 4 ' 2 +, ( - : 7 (! " A

5 Skin Brightening Lotion with 0.5% Synovea C Formulation # RC INCI name Trade Name/Supplier % w/w Acrylates/C10-30 Alkyl Acrylate Copolymer Carbopol Ultrez 21/Lubrizol 0.20 Caprylic/Capric Triglycerides Myritol 318/BASF 4.00 Cetearyl Isononaoate Cetiol SN/BASF 4.00 Glyceryl Stearate, PEG-100 Stearate Arlacel 165/Croda 2.00 Sorbitan Stearate Arlacel 60/Croda 0.50 Dimethicone DC, 200/100CST 1.00 Cyclomethicone, Polysilicone-11, Petrolatum Gransil GCM /Grant Industries 5.00 Cetyl Esters Crodamol SS/Croda 1.00 Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer/Squalane/Polysorbate 60 Simugel NS/Seppic 1.00 Ethoxydiglycol Transcutol CG/Gattefosse 2.00 Hexylresorcinol Synovea HR/Sytheon 0.50 AMP-95 to ph Phenoxyethanol, Methylparaben, Propylparaben Phenonip XB/Clariant 1.00 Procedure: Disperse phase A-1in A -2 with moderate agitation; mix until a homogeneous clear dispersion is obtained. Combine phase B and heat to 75 C. Add B to A; homogenize for 2-3 min. Add phase C, mix until uniform. At 50 C add phase D, E F in the listed order. Note: ph value- 25 C HR! " B

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