UNIBIOVIT B-33 UNIBIOVIT B-332 WSL

Transcription

1 UNIBIOVIT B-33 UNIBIOVIT B-332 WSL BIOACTIVE INGREDIENT COMPLEX WITH SKIN MOISTURIZING AND WRINKLE SOOTHING PROPERTIES FOR COSMETIC SKIN CARE PRODUCTS FM-097B TDS Unibiovit en(04).doc Version: 04 / /13

2 Contents 1. Introduction Concept of the Unibiovit active ingredient complex Mode of action Significance for cosmetic applications Efficacy tests Moisture in the skin Roughness of the skin (profilometry with quantitative image analysis) Further Tests Transepidermal water loss (TEWL) Evaluation of cutaneous sebum formation Summary Characteristics of Unibiovit B-33 (oil soluble) Characteristics of Unibiovit B-332 wsl (water soluble) References FM-097B TDS Unibiovit en(04).doc Version: 04 / /13

3 1. Introduction A prerequisite for healthy skin with a fresh, youthful appearance is the maintenance of the equilibrium of the skin's metabolism. Cosmetological experience has shown that certain bioactive ingredients can make a very substantial contribution towards sustaining this equilibrium. It is the task of modern scientific treatment cosmetics to make such active ingredients accessible to the skin and thereby to delay changes caused by ageing, the environment, material displacements; and to replenish or compensate for missing substances and actively protect the healthy condition of the skin. 2. Concept of the Unibiovit active ingredient complex It has only recently become possible, by virtue of new scientific knowledge, to gain a more thorough understanding of the well-known fact that the properties of essential fatty acids and isoprenoid lipid precursors are bioactive and exceptionally beneficial to the skin. Essential fatty acids are polyunsaturated carboxylic acids and are also known as Vitamin F. This group of substances is regarded very particularly as a skin vitamin. In the strictly scientific sense, Vitamin F has long been considered not to belong to the true vitamins. The exceptional properties of the essential fatty acids, however, suggest that the term Vitamin F is becoming increasingly justified. Isoprenoids play an extremely important part in the life of the cells. As biochemical precursors they participate in the endogenous synthesis of the steroids which make an essential contribution towards maintaining the biological equilibrium in the skin. Furthermore, all fat-soluble vitamins are synthesized from isoprenoid units. Combining the active principles of essential fatty acids on the one hand, and isoprenoid lipid precursors on the other, results in an outstanding concept for an exceptional active ingredient complex with excellent properties of caring for the skin in terms of sustaining its regeneration. FM-097B TDS Unibiovit en(04).doc Version: 04 / /13

4 3. Mode of action Essential fatty acids cannot be synthesized by the human body and their absence causes deficiency syndromes [1,2]. They are essential for the synthesis of the cell membranes, where they are usually incorporated in the form of phospholipids. They also have a functional role in lipoprotein metabolism [1,3]. Essential fatty acids are important constituents of the ceramides, which play a decisive part in the integrity of the skin s barrier function. A deficiency of essential fatty acids results, inter alia, in a loss of the skin's barrier function with changes in the intraepidermal fluid equilibrium and transepidermal water loss [4], as well as in disorganization of the keratinization process with hyperkeratosis [3]. Essential fatty acids are precursors for the biological synthesis of prostaglandins [5]. Prostaglandins have important functions in the cell balance and play an important part in immunological phenomena [6]. In the skin, they regulate homeostasis of the epidermis and keratinization [3]. Essential fatty acids remedy dry, flaccid and livid skin conditions and reduce the incidence of eczema and acne. Moreover, the function of the sebaceous glands is normalized, the subcutaneous cell tissue is strengthened and the skin's resistance is increased [7]. Because of these properties, which are extremely important dermatologically and cosmetologically, the essential fatty acids - the most important representative of which is 9,12-cis, cis-linoleic acid - are predestined for use in cosmetic treatment preparations which prevent premature ageing of the skin [8]. Farnesol and farnesol derivatives occupy a prime position among the isoprenoids as biological precursors for numerous biosyntheses of vital importance. These are natural substances of high biological potency, which also occur in this form as bioactivators in the human skin [9]. Farnesol and farnesol derivatives are widely distributed in the plant and animal kingdoms as well. It has been possible to detect them in countless blossom oils and other ethereal oils [10], for example in lime blossom oil, acacia blossom oil, rose oil and the blossom oils of lily of the valley, lilac, orange etc., in musk, sandalwood oil and so on. It has also been possible to detect such substances in champagne [11], the farnesol content being regarded as a significant quality factor in its bouquet. Farnesol and farnesol derivatives are compounds and intermediates in the biosynthesis of sterols and steroids which takes place in the skin [9, 12]. Also, all oil soluble vitamins are isoprene derivatives in whose biosynthetic pathway farnesol derivatives represent an important intermediate. Both, ß-carotene and Vitamins A, E and K are formed in nature by this synthetic pathway. Farnesol is at the centre of this biological synthetic process, one branch of the biogenesis leading to the steroid hormones and the other branch producing the oil soluble vitamins mentioned above [13]. The Unibiovit active ingredient complex is an optimum combination of the essential active principles of unsaturated fatty acids with isoprenoid precursors. FM-097B TDS Unibiovit en(04).doc Version: 04 / /13

5 In order to be suitable for the diverse applications of finished cosmetic products, Unibiovit is obtainable in both oil soluble and water soluble forms. In both variants, the essential fatty acids are present as ethyl 9,12-cis, cis-linoleate, the molecular structure of which is such that it is particularly readily absorbed by the skin. Furthermore, the ethyl ester can be saponified considerably more rapidly than the glyceryl ester and at the same time is markedly less sensitive to oxidation, even compared with the free fatty acid [14]. A combination consisting of farnesol and farnesyl acetate is used as the isoprenoid component. In the case of the oil soluble variant, the active ingredient combination is dissolved as a concentrate in decyl oleate; in the case of the water soluble variant, the same active ingredients are present in the same concentration in a complex of highly effective, nonionic solubilizers. 4. Significance for cosmetic applications In general, the following possible modes of action can be found in the specialized literature: promotes regeneration of the epidermis through increased cell division stimulates growth of elastic fibers stimulates growth and strengthening of collagen fibers stimulates formation of mucopolysaccharides increases tissue elasticity and tissue tonicity smoothes wrinkles counteracts flabbiness of cutaneous connective tissue delays premature ageing of the skin normalizes the skin's moisture retaining capacity normalizes the skin's fat balance strengthens subcutaneous cell tissue improves dandruff and eczema conditions regulates keratinization improves the skin's immune mechanisms soothes the cutaneous tissue FM-097B TDS Unibiovit en(04).doc Version: 04 / /13

6 5. Efficacy tests For quantifying the efficacy of cosmetic products, the methods of determining the moisture in the skin (capacitance measurement with stray field capacitor) and the roughness of the skin (profilometry with quantitative image analysis) have become established as meaningful and highly reliable assessment criteria [15]. The Unibiovit active ingredient complex - incorporated at 5% in a neutral test cream - was therefore subjected to such measurements. 5.1 Moisture in the skin The tests on moisture in the skin were carried out with a corneometer. This is an instrument which measures the dielectric constant of the skin by means of a stray field capacitor as the measuring probe; the dielectric constant being a direct measure of the skin's moisture content [16].The measurements were made on the inside forearms of 20 test subjects. The period of application was 14 days with two applications per day. The measurements of the product value and the control patch (untreated) were made before the start of the treatment and on day 15. The last application of the test preparation was made approx. 12 hours prior to measurement. Result: In consideration of the measured values of the control patch, the test product effects a significant increase of the skin's moisture of more than 17% [%] Moisture content Control field Cream with 5% UNIBIOVIT B-33 Figure 1: Moisture content FM-097B TDS Unibiovit en(04).doc Version: 04 / /13

7 5.2 Roughness of the skin (profilometry with quantitative image analysis) For the profilometric examination of the efficacy of our test cream, silicone impressions of one control patch and one test patch were taken on the subjects' upper arms under precisely defined climatic conditions, before and after the treatment. These impressions were evaluated with an image analysis system (IBAS from Zeiss/Kontron). A microscope image magnified 20 times was fed into a computer via a TV camera and displayed on the screen. Using complex evaluation programs, the depth of the profile lines was determined and the results from at least 10 subjects were secured statistically [17].Our measurements were made on 20 test subjects. The period of application was 14 days with two applications per day. The measurements of the product value and the control patch were made before the start of the treatment and on day 15. The last application of the test preparation was made approx 12 hours before the silicone impression was taken. Result: In consideration of the measured values of the control patch, the test product effects a significant smoothing of the wrinkles of more than 10%. [%] Reduction of skin roughness Control field Cream with 5% UNIBIOVIT B-33 Figure 2: Reduction of skin roughness FM-097B TDS Unibiovit en(04).doc Version: 04 / /13

8 5.3 Further Tests The efficacy studies described below were conducted in the USA by Consumer Product Testing in 4 volunteers in each case, using proven test methods and the latest equipment for measurement and evaluation Transepidermal water loss (TEWL) For 7 days prior to the test phase, in preparation for the measurement of transepidermal water loss, volunteers were instructed not to use any cosmetics apart from soap. Four areas on the inner surface of the forearm of volunteers were marked for measurements. A neutral test cream containing 5% Unibiovit B-33 was applied to one area, a placebo preparation with no active ingredient to another, petrolatum as standard to another and a control area was left untreated. These areas were allowed to dry for one hour under precisely defined climatic conditions. After one, two and four hours, transepidermal water loss was measured with an evaporimeter. The results of this study may be summarized as follows: The placebo preparation was found to have a slight effect, reducing transepidermal water loss by 29%. The preparation containing 5% Unibiovit B-33 showed a pronounced effect, reducing water loss by 52%. Pure petrolatum is known to have a strongly occlusive effect and in the test methods selected was used as a standard, achieving a reduction in transepidermal water loss of 66%. The test preparation containing 5% Unibiovit B-33 therefore achieves a reduction in transepidermal water loss of around 80% of the effect of pure petrolatum Evaluation of cutaneous sebum formation For the investigations to assess the effect of the Unibiovit B-33 active substance complex on sebum formation, only volunteers with greasy skin were selected. For seven days prior to the test phase they were instructed not to use any cosmetics except for soap At the beginning of the 28-day test phase sebum levels were measured on the foreheads of the volunteers using the proven sebumeter method with sebutapes. The volunteers were then instructed to apply the test cream containing 5% Unibiovit B-33 twice daily to one side of the forehead and a placebo preparation containing no active substance to the other side, keeping a precise record of these applications. At the end of the 28-day test phase both halves of the forehead were tested with sebutape. FM-097B TDS Unibiovit en(04).doc Version: 04 / /13

9 All sebutape impressions were evaluated by computer assisted quantitative image analysis. The results may be summarized as follows: Number of active sebaceous glands: test cream: 14% reduction placebo cream: 10% reduction Average size of sebaceous glands: test cream: 23% reduction placebo cream: 6% increase The following graph illustrates these results: 10 5 Placebo Testcream Change in % Number of sebaceous glands Size of sebaceous glands Figure 3: Talgdrüsen FM-097B TDS Unibiovit en(04).doc Version: 04 / /13

10 The photographs below show the digitalized image analysis of sebutape impressions before and after the 28-day treatment with test cream containing 5% Unibiovit B-33, taken from the original report: Three dimensional representation of digitalized image with a two dimensional projection: Figure 4: Before Figure 5: After Two dimensional representation of digitalized image: Figure 6: Before Figure 7: After Summary The test results shown here confirm the outstanding characteristics of the Unibiovit active substance complex in relation to transepidermal water loss (TEWL) and to sebum reduction. Together with its previously known efficacy with regard to moisture retention and the smoothing of wrinkles, they demonstrate the success of this complex, based on biological precursors in skin care cosmetics. FM-097B TDS Unibiovit en(04).doc Version: 04 / /13

11 6. Characteristics of Unibiovit B-33 (oil soluble) Description Slightly viscous liquid. Analytical data See specifications. Solubility Readily soluble in isopropyl myristate, polyethylene glycol, Cetiol V, Miglyol 812 and vegetable oils. Insoluble in water. Storage 5 C - 25 C (see safety data sheet) Shelf life 2 years (see specification) Processing By virtue of special stabilization against atmospheric oxidation, both Unibiovit B-33 and Unibiovit B-332 wsl are relatively stable and can be processed under the conditions conventionally used for the preparation of cosmetic products. Contact with the air should be minimized as far as possible, however, and temperatures above 70 C should be avoided. Skin tolerance Unibiovit B-33 and Unibiovit B-332 wsl have been thoroughly examined by means of extensive patch tests involving subjects with different degrees of skin sensitivity. Neither primary irritation nor intolerance is evident. Both products show very good skin tolerance. Application Unibiovit is a high quality active ingredient complex for cosmetics. By virtue of being soluble in oil, Unibiovit B-33 can be used in formulations such as emulsions (O/W and W/O), lotions, oils or sticks. Because of its solubility properties, Unibiovit B-332 wsl is predestined for use in aqueous and aqueous-alcoholic treatment products for the skin and hair, such as hair lotions, hair tinctures, shampoos, shaving lotions etc. Dosage On the basis of experience and the test results described in section 5, a use concentration of about 5% in finished products is recommended for both Unibiovit B-33 and Unibiovit B-332 wsl. Identification INCI name Chinese name CAS No. Decyl Oleate 油酸癸酯 Farnesol 金合欢醇 Ethyl Linoleate 亚油酸乙酯 Farnesyl Acetate 金合欢醇乙酸酯 FM-097B TDS Unibiovit en(04).doc Version: 04 / /13

12 7. Characteristics of Unibiovit B-332 wsl (water soluble) Description Analytical data Solubility Storage Shelf life Processing Skin tolerance Application Dosage Slightly viscous liquid. See specifications. Soluble in water, aqueous and pure ethanol and glycerol. 15 C - 25 C (see safety data sheet) 2 years (see specification) By virtue of special stabilization against atmospheric oxidation, both Unibiovit B-33 and Unibiovit B-332 wsl are relatively stable and can be processed under the conditions conventionally used for the preparation of cosmetic products. Contact with the air should be minimized as far as possible, however, and temperatures above 70 C should be avoided. Unibiovit B-33 and Unibiovit B-332 wsl have been thoroughly examined by means of extensive patch tests involving subjects with different degrees of skin sensitivity. Neither primary irritation nor intolerance is evident. Both products show very good skin tolerance. Unibiovit is a high quality active ingredient complex for cosmetics. By virtue of being soluble in oil, Unibiovit B-33 can be used in formulations such as emulsions (O/W and W/O), lotions, oils or sticks. Because of its solubility properties, Unibiovit B-332 wsl is predestined for use in aqueous and aqueous-alcoholic treatment products for the skin and hair, such as hair lotions, hair tinctures, shampoos, shaving lotions etc. On the basis of experience and the test results described in section 5, a use concentration of about 5% in finished products is recommended for both Unibiovit B-33 and Unibiovit B-332 wsl. Identification INCI name Chinese name CAS No. PEG-12 Glyceryl Laurate PEG-12 甘油月桂酸酯 PEG-36 Castor Oil PEG-36 蓖麻油 Farnesol 金合欢醇 Ethyl Linoleate 亚油酸乙酯 Farnesyl Acetate 金合欢醇乙酸酯 FM-097B TDS Unibiovit en(04).doc Version: 04 / /13

13 8. References ** 1. Friedmann, Z. Am. J. Dis. Child 134, (1980). 2. Riella, M.C. et al. Ann. Intern. Med. 83, (1975). 3. Truchtet, E. et al. Z. Hautkr. 63 (4), (1988). 4. Friberg, S.E. et al. Cosmet. and Toil. 102 (4), (1987). 5. Brooks, G. Cosmet. and Toil. 99 (5), (1984). 6. Mertin, J. et al. Int. Archs. Allergy appl. Immun. 77, (1985). 7. Tur, W. Fette, Seifen, Anstrichm. 75, (1973). 8. Morganti, P. et al. J. Appl. Cosmetol. 3, (1985). 9. Cottron, H.A. Dermatologie und Venerologie, pp Georg Thieme Verlag, Stuttgart (1962). 10. Karrer, W. Konstitution und Vorkommen der organischen Pflanzenstoffe, pp. 57. Birkhäuser Verlag, Basel (1958). 11. Rodopulo, A.K. et al. Lozar. Vinar. 24 (7), (1975). 12. Karlson, P. Kurzes Lehrbuch der Biochemie, pp Georg Thieme Verlag, Stuttgart (1970). 13. Schrader, K. et al. Parf. und Kosm. 70 (2), (1989.) 14. Winkler, A. et al. Arch. Derm. Res. 254, (1975). 15. Corcuff, P. et al. Int. J. Cosm. Sci. 6, (1984). 16. Isler, O. et al. Vitamine I, pp Georg Thieme Verlag, Stuttgart (1982). 17. Yanishlieva, N. et al. SÖFW 97 (20), (1971). Our indications and recommendations have been worked out to the best of our knowledge and conscience, but without any obligation from our part. In particular, we do not take any responsibility concerning protection rights of a third party. FM-097B TDS Unibiovit en(04).doc Version: 04 / /13