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WO 2016/044374 Al 24 March 2016 (24.03.2016) P O PCT

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WO 2016/044374 Al 24 March 2016 (24.03.2016) P O PCT (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2016/044374 Al 24 March 2016 (24.03.2016) P O PCT (51) International Patent Classification: AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, A61K 31/74 (2006.01) BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (21) International Application Number: HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, PCT/US2015/050350 KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, (22) International Filing Date: MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, 16 September 2015 (16.09.201 5) PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, (25) Filing Language: English TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (26) Publication Language: English (84) Designated States (unless otherwise indicated, for every (30) Priority Data: kind of regional protection available): ARIPO (BW, GH, 62/05 1,988 18 September 2014 (18.09.2014) US GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, 62/057,760 30 September 2014 (30.09.2014) US TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, 62/166,906 27 May 2015 (27.05.2015) us TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, (71) Applicant: GLAXOSMITHKLINE CONSUMER LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, HEALTHCARE HOLDINGS (US) LLC [US/US]; 271 1 SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, Centerville Road, Suite 400, Wilmington, DE 19808 (US). GW, KM, ML, MR, NE, SN, TD, TG). (72) Inventors: MAHALINGAM, Harish; 1500 Littleton Declarations under Rule 4.17 : Road, Parsippany, NJ 07054 (US). LIN, Connie, — as to applicant's entitlement to apply for and be granted a Baozhen; 25 12 S. TriCenter Boulevard, Research Triangle patent (Rule 4.1 7(H)) Park, NC 27709 (US). MODI, Swati; 25 12 S. TriCenter Boulevard, Research Triangle Park, NC 27709 (US). EL¬ — as to the applicant's entitlement to claim the priority of the LIOTT, Russell, Phillip; 42 Waterloo Court, Belmont, earlier application (Rule 4.1 7(in)) CA 94002 (US). — of inventorship (Rule 4.17(iv)) (74) Agents: DINNER, Dara, L. et al; GlaxoSmithKline, Published: Global Patents, UW2220, 709 Swedeland Road, P.O. Box 1539, King of Prussia, PA 19406-0939 (US). — with international search report (Art. 21(3)) (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, o (54) Title: NOVEL FORMULATIONS (57) Abstract: The invention provides for a topical o/w emulsion having moisturizing, and protecting, repairing or restoring the skin lipid barrier of the lips of a mammal, and is a topical oil-in- water emulsion composition comprising: (a) a discontinuous oil phase; (b) a continuous aqueous phase comprising water and glycerin, wherein glycerin is present in an amount greater than about 12% w/w; (c) a thickening agent; and (d) at least one lamellar membrane structure; and wherein the composition is a lip protectant com- position. NOVEL FORMULATIONS FIELD OF THE INVENTION The present invention relates to a novel moisturizing and barrier repair and/or restoration lip protectant composition comprising high levels of glycerin. BACKGROUND OF THE INVENTION Unprotected skin is susceptible to dehydration and becoming irritated from exposure to the elements. This is especially true for the lips, which have been found to be even more vulnerable to water loss than typical skin. In this regard, the lips have a thinner stratum corneum and also contain lesser amounts of lipids than skin on other parts of the body. When the lipid barrier is depleted or is inadequate, the lips dry out becoming irritated and prone to cracking. Lips also contain less melanin than other areas of skin, and thus are at risk of sunburn and UV damage. Accordingly, effective lip protectant compositions are highly desirable. Many products have been introduced into the market to keep the lips in a moisturized and smooth condition, and protect them from damage. These products typically contain waxes and/or oils that mitigate the amount of moisture that is lost, known as trans-epidermal water loss. Some products may additionally contain emollients, humectants and healing agents. A conventional lipstick includes five basic components: waxes, emollients, functional ingredients, stabilizers and colorants. Waxes and emollients tend to make up the base to which the other non-aqueous ingredients are added. A lipstick base, as such, tends to be anhydrous and simply minimizes the amount of trans-epidermal water loss, rather than replace any lost moisture. Moisturizing compositions are typically oil-in-water emulsions and usually contain thickeners and/or conventional emulsifiers to stabilize the emulsion. Such compositions have a relatively high water content and so are able to replace moisture lost from the stratum corneum. They also typically contain one or more humectants to help retain moisture. However, while moisturizing compositions temporarily decrease visible scaling and roughness of the skin, they may offer little improvement to the integrity of the stratum corneum barrier. In fact, common moisturizing compositions which contain conventional emulsifiers can actually cause disruptions to the barrier function of the skin. Thus, a composition with high water content may suggest that the product provides good moisturization, but it will not necessarily maintain, protect or restore the barrier function of the skin. Accordingly, an effective topical composition that will maintain, protect and restore good barrier function to the lips is needed. U.S. Patent No. 5,643,899, Elias et al., discloses compositions directed specifically to treatment of epidermal barrier disorders such as hyperproliferative cutaneous diseases, papulosquamous diseases, and eczematous diseases. The disclosed compositions contain various combinations of essential lipids that include cholesterol and a ceramide, particularly acylceramide. The compositions, while described for repair of the epidermal barrier function, do not discuss application to the lips. U.S. Patent No. 5,508,034, Bernstein et al., discloses compositions containing various lipids naturally found in the stratum corneum as essential components for the treatment of dry skin disorders. These compositions must contain a fatty acid, cholesterol, and a phospholipid or a glycolipid. The compositions, while described for repair of the epidermal barrier function, do not discuss application to the lips. US Patent No. 6,663,853, Singh, discloses compositions as lip care moisturizing products which comprise fatty acid esters, a wax, an emulsifier and 1.0% unilamellar liposomes in a water-in-oil emulsion. The liposomes contain a mixture of water and glycerin. The emulsions are stated to preferably contain squalane and panthenol. Accordingly, an object of the present invention is to provide a topical composition that is effective in moisturizing the lips an optimally minimizing transepidermal water loss, while also protecting and repairing barrier function. A further object of the present invention is to provide a topical composition which is convenient, easily applied to the lips and cosmetically elegant. SUMMARY OF THE INVENTION One embodiment of the disclosure is a topical oil-in-water emulsion composition comprising: (a) a discontinuous oil phase; (b) a continuous aqueous phase comprising water and glycerin, wherein the glycerin is present in an amount greater than about 12% by weight, based on the total weight of the composition; (c) a thickening agent; and (d) at least one lamellar membrane structure; and wherein the composition is a lip protectant composition. In one embodiment, the glycerin in the aqueous phase is present in an amount from about 12% to about 40% by weight, based on the total weight of the composition. In another embodiment, the glycerin in the aqueous phase is present in an amount from about 20% to about 30% by weight, based on the total weight of the composition. In yet another embodiment, the glycerin in the aqueous phase is present in an amount from about 20% to about 25% by weight, based on the total weight of the composition. Another embodiment of the disclosure is a method for moisturizing, and protecting, repairing, or restoring the skin lipid barrier of the lips of a mammal, the method comprising applying to the lips of the mammal in need thereof an effective amount of a topical oil-in- water emulsion composition comprising: (a) a discontinuous oil phase; (b) a continuous aqueous phase comprising water and glycerin, wherein the glycerin is present in an amount greater than about 12% by weight, based on the total weight of the composition; (c) a thickening agent; and (d) at least one lamellar membrane structure; and wherein the composition is a lip protectant composition. In one embodiment, the glycerin in the aqueous phase is present in an amount from about 12% to about 40% by weight, based on the total weight of the composition. In another embodiment, the glycerin in the aqueous phase is present in an amount from about 20% to about 30% by weight, based on the total weight of the composition. In yet another embodiment, the glycerin in the aqueous phase is present in an amount from about 20% to about 25% by weight, based on the total weight of the composition. Another embodiment of the disclosure
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