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Compositions and methods containing high purity fatty alcohol c24 to c36 for cosmetic applications

USPTO Application #: 20070196507
Title: Compositions and methods containing high purity fatty alcohol c24 to c36 for cosmetic applications
Abstract: The present invention discloses the cosmetic applications of alkylalkanols collectively referred to as policosanol, for control of sebum secretion, as anti-acne component and as emollient.
(end of abstract)
Agent: Sabinsa Corporation - Piscataway, NJ, US
Inventors: Muhammed Majeed, Geetha Kanhangad Gangadharan, Subbalakshmi Prakash
USPTO Applicaton #: 20070196507 - Class: 424539000 (USPTO)
Related Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Extract, Body Fluid, Or Cellular Material Of Undetermined Constitution Derived From Animal Is Active Ingredient, Derived From Arthropod (e.g., Insect, Spider, Crustacea, Etc.), Bee
The Patent Description & Claims data below is from USPTO Patent Application 20070196507.
Brief Patent Description - Full Patent Description - Patent Application Claims  monitor keywords

CROSS REFERENCE TO EXISTING APPLICATION

[0001] This application is a divisional application of U.S. patent application Ser. No. 10/604,203 titled "Commercially viable process for high purity of fatty alcohol C24 to C36 and its cosmetic application for skin hair and nails" filed on Jul. 1, 2003.

BACKGROUND OF THE INVENTION

[0002] Policosanol is a natural mixture of higher aliphatic primary alcohols (C24-C36) isolated from sugarcane wax and beeswax. It contains 1-Octacosanol, Triacontanol, Tetracosanol, Hexacosanol, Heptacosanol. These C.sub.24 to C.sub.36 primary alcohols are also found in sugarcane wax, ricebran wax, beeswax and various vegetable wax.

[0003] The structures of these primary alkanols are shown below. TABLE-US-00001 C.sub.24 Tetracosanol CH.sub.3(CH.sub.2).sub.22CH.sub.2OH C.sub.26 Hexacosanol CH.sub.3(CH.sub.2).sub.24CH.sub.2OH C.sub.28 Octacosanol CH.sub.3(CH.sub.2).sub.26CH.sub.2OH C.sub.30 Triacontanol CH.sub.3(CH.sub.2).sub.28CH.sub.2OH C.sub.36 Tetratriacontanol CH.sub.3(CH.sub.2).sub.32CH.sub.2OH C.sub.27 Heptacosanol CH.sub.3(CH.sub.2).sub.25CH.sub.2OH

[0004] C.sub.24 Tetracosanol CH.sub.3 (CH.sub.2).sub.22CH.sub.2OH [0005] C.sub.26 Hexacosanol CH.sub.3 (CH.sub.2).sub.24CH.sub.2OH [0006] C.sub.28 Octacosanol CH.sub.3 (CH.sub.2).sub.26CH.sub.2OH [0007] C.sub.30 Triacontanol CH.sub.3 (CH.sub.2).sub.28CH.sub.2OH [0008] C.sub.36 Tetratriacontanol CH.sub.3 (CH.sub.2).sub.32CH.sub.2OH [0009] C.sub.27 Heptacosanol CH.sub.3 (CH.sub.2).sub.25CH.sub.2OH

[0010] Evaluation of Policosanol on Sebum Levels in Human Volunteers

[0011] Study Methodology and Administration

[0012] Sixteen healthy males of between 18 and 25 years of age were included in the study after they had signed the informed consent form. The main inclusion criterion was those with oily skin (scores >4 on a 0-5 scale). All the subjects were required to abstain from taking drugs, applying cosmetic products to their skin and exposing themselves to sunlight or any other source of ultraviolet radiation throughout the duration of the study.

[0013] 2% or 5% Policosanol colloidal solution in 1,2 hexanediol was applied (0.2 ml) for seven days, twice daily, on the forehead. One side of forehead being treatment and the other side being the control (1,2 hexanediol treatment).

[0014] The efficacy was evaluated based on self-assessment and on the assessment of a panel of five independent cosmetologists, visually, using Sebutape (CuDerm Corp., Dallas, Tex.).

[0015] The sebutape is made of microporous, hydrophobic polymeric film composed of many tiny air cavities. The surface of the film is coated with a lipid porous adhesive layer that enables the tape to adhere to the skin surface. The tape is applied to the skin test site for optimal period of 1 hr. Sebum is absorbed into the tape, displacing the air in the microcavities. As this occurs, the lipid-filled cavities become transparent to light. Through this process, the sebum output from each follicle forms a sharply defined clear spot, its size roughly corresponding to the sebum volume.

[0016] When the sebutape are placed on the black background of the score card, the sebum on the tape becomes clearly visible as black spots. These spots are scored by a panel of cosmetologists on a scale of 0-5. These are pooled and from the mean of the scores, the percentage change is calculated from the control treatment site.

[0017] The safety and adverse events like erythema, burning sensation, itching, urticaria, edema, dermatitis, ochronosis, dryness of skin and any other non specific reactions, if any, were monitored.

[0018] The Policosanol colloidal solution was applied twice a day on one side of the forehead area for seven days. Pre-cleansing with soap/water was done before applications. The following observations were made

[0019] 2% and 5% Policosanol colloidal solution was found to be safe for local application. It did not show any significant side effects and is safe for use on skin

[0020] Topical application of the Policosanol colloidal solution was found to decrease the sebum secretion in a concentration dependent manner. The 2% Policosanol solution reduced the sebum levels by about 11%, while 5% solution reduced sebum secretion by 27%.

[0021] Both the self-assessment and the assessment by the panel of cosmetologist revealed that 100% of the subjects showed marked decrease in sebum release.

[0022] The colloidal solution was found to be effective in people with moderately high oily skin (scores >3.5).

[0023] Additionally, one surprising observation was that Policosanol treatment protected the 1,2 Hexanediol induced dryness of skin and made the skin smooth and soft. TABLE-US-00002 TABLE 1 Effect of Policosanol on the sebum secretion in human volunteers Sebum secretion Percentage (Mean Scores of reduction of sebutape by a five sebum Groups member panel) release Control 4.2 + 0.49 -- 2% 3.71 + 0.41 11.6% Policosanol (n = 8) 5% 3.29 + 0.33 27.66% Policosanol (n = 8)

[0024] Anti-microbial Study against Propionibacterium acnes

[0025] To carry out the antibacterial activity of the products against Pr. acnes, the organism was first cultured in the anaerobic environment for which the anaerobic chamber was used. To standardize the growth of anaerobic culture of Pr. acnes in the anaerobic chamber, different culture media were used.

[0026] The anaerobic chamber [Model 8301-230, 3 ft polymer] used in the study was purchased from COY LABORATORY, USA which is provided with an automatic Air lock purge system.

[0027] The anaerobic condition in the chamber was maintained by initialization with N.sub.2 gas and then the mixture of gases of N.sub.2+H.sub.2+CO.sub.2 in the proportion 80+10+10. Two gas tank arrangement was made wherein only N.sub.2 was connected to the transfer chamber and mixed gas to the main chamber using Gassing Manifold (Hrishi Biotech, Pune, India)

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