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WO 2016/204959 Al 22 December 2016 (22.12.2016) P O P C T

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WO 2016/204959 Al 22 December 2016 (22.12.2016) P O P C T (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 2016/204959 Al 22 December 2016 (22.12.2016) P O P C T (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 47/06 (2006.01) A61K 31/14 (2006.01) kind of national protection available): AE, AG, AL, AM, A61K 47/44 (2006.01) A61K 31/155 (2006.01) AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, A61K 9/00 (2006.01) A01P 1/00 (2006.01) BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, A0 33/12 (2006.01) DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, (21) International Application Number: KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, PCT/US20 16/034747 MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, (22) International Filing Date: PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, 27 May 2016 (27.05.2016) SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (25) Filing Language: English (84) Designated States (unless otherwise indicated, for every (26) Publication Language: English kind of regional protection available): ARIPO (BW, GH, (30) Priority Data: GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, 62/182,034 19 June 2015 (19.06.2015) US TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, 62/3 19,449 7 April 2016 (07.04.2016) US TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, 62/326,150 22 April 2016 (22.04.2016) US DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, 62/338,995 19 May 2016 (19.05.2016) US LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, (71) Applicant: GLOBAL HEALTH SOLUTIONS, INC. GW, KM, ML, MR, NE, SN, TD, TG). [US/US]; 1360 Redmond Circle, Rome, Georgia 30165 (US). Published: — with international search report (Art. 21(3)) (72) Inventor: BURNAM, Bradley; 1360 Redmond Circle, Rome, Georgia 30165 (US). (74) Agent: BARRON, Briana; Polsinelli PC, 900 W. 48th Place, Suite 900, Kansas City, Missouri 641 12 (US). o v o (54) Title: PETROLATUM-BASED DELIVERY SYSTEMS AND FOR ACTIVE INGREDIENTS o (57) Abstract: The present disclosure is broadly concerned with petrolatum-based compositions as a suspension matrix for the act ive ingredients. The disclosure is also concerned with processes for forming stable emulsions of active ingredients in petrolatum. PETROLATUM-BASED DELIVERY SYSTEMS AND FOR ACTIVE INGREDIENTS CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to U.S. Provisional Application No. 62/182,034 filed June 19, 2015, U.S. Provisional Application No. 62/319,449 filed April 7, 2016, U.S. Provisional Application No. 62/326,150 filed April 22, 2016, and U.S. Provisional Application No. 62/338,995 filed May 19, 2016, each of which are incorporated herein by reference in their entirety. FIELD [0002] The present disclosure is broadly concerned with petrolatum-based compositions as a suspension matrix for active ingredients. The disclosure is also concerned with processes for forming stable emulsions of active ingredients in petrolatum. BACKGROUND [0003] Petrolatum is a semi-solid mixture of long chain (greater than C=20) hydrocarbons. Petrolatum is a known skin protectant and has been widely used in cosmetic and dermatological applications. Although petrolatum is known to have advantageous protective properties when applied to the skin, its hydrophobic nature had previously made it a poor candidate for formulating active ingredients. It was previously thought that an emulsifier would be necessary to disperse active ingredients throughout petrolatum. It was also thought that the petrolatum was incapable of delivering active ingredients because the active ingredients would be trapped within the petrolatum and therefore would be unable to reach the desired delivery site. [0004] The Applicant has discovered that active ingredients can be formulated in petrolatum. The petrolatum-based compositions described herein contain nanodroplets of active ingredients dispersed in petrolatum. The nanodroplets release the active ingredients to the application site continuously. Additionally, the petrolatum-based compositions described herein are gentle. They do not irritate the skin and are not cytotoxic to mammalian cells. The Applicant has further discovered processes leading to a stable delivery system for a variety of ingredients. BRIEF DESCRIPTION OF THE FIGURES [0005] The application file contains at least one photograph executed in color. Copies of this patent application publication with color photographs will be provided by the Office upon request and payment of the necessary fee. [0006] FIG. 1 depicts an image of the formulation structure when using the mixing methodology disclosed herein for permanently encapsulating active ingredients as nanodroplets into petrolatum. [0007] FIG. 2 depicts a schematic of the arrangement of test and control sites in the rabbit skin irritation study. [0008] FIG. 3 depicts a graph showing the reduction of MRSA in the presence of Formulation 1 in the suspension time-kill procedure. [0009] FIG. 4 depicts a graph showing the reduction of T. rubrum in the presence of Formulation 1 in the suspension time-kill procedure. DETAILED DESCRIPTION [0010] The disclosure provides for petrolatum-based compositions of active ingredients, processes for making petrolatum-based compositions of active ingredients, and applications and uses of petrolatum-based compositions described herein. The active ingredients of the present disclosure are dispersed throughout the petrolatum as nanodroplets with the petrolatum. The petrolatum serves as a suspension matrix for the active ingredients. Importantly, petrolatum-based compositions of the present disclosure do not contain an emulsifier. As it was discovered by the inventors, generally emulsifiers were not necessary for dispersing the active ingredient nanodroplets in the petrolatum. Surprisingly, compositions in accordance with the present disclosure are shelf stable for extended periods of time even under non-ideal conditions. In addition, the compositions exhibit exceptional chemical stability of the active ingredients, and are capable of delivering an active ingredient over extended periods of time to the desired site. I. COMPOSITIONS [0011] The disclosure provides for compositions that are petrolatum-based. A petrolatum-based composition is made up primarily of petrolatum. The characteristics of a petrolatum-based composition differ from a composition containing only a small amount of petrolatum. In some embodiments, the petrolatum-based composition is greater than about 80% petrolatum. In other embodiments, the petrolatum-based composition is greater than about 81% petrolatum, greater than about 82% petrolatum, greater than about 83% petrolatum, greater than about 84% petrolatum, greater than about 85% petrolatum, greater than about 86% petrolatum, greater than about 87% petrolatum, greater than about 88% petrolatum, greater than about 89% petrolatum, greater than about 90% petrolatum, greater than about 91% petrolatum, greater than about 92% petrolatum, greater than about 93% petrolatum, greater than about 94% petrolatum, greater than about 95% petrolatum, greater than about 96% petrolatum, greater than about 97% petrolatum, greater than about 98% petrolatum, or greater than about 99% petrolatum. The petrolatum is preferably medical grade petrolatum. [0012] The composition also contains one or more active ingredients dispersed throughout the petrolatum. The total amount of active ingredient in the composition generally constitutes less than about 1% by weight of the total composition. In preferred embodiments, the active ingredient constitutes from about 0.1% to about 0.5% by weight, or more preferably, from about 0.1% to about 0.3% by weight to the total composition. [0013] The remaining weight of the composition, typically from about 0.1% to about 6% by weight of the petrolatum-based composition, is water or another solvent. In a preferred embodiment, the composition contains about 5% water. [0014] Importantly, the active ingredients do not react with the petrolatum. Instead, the active ingredient is dispersed in the petrolatum as nanodroplets, and the petrolatum serves as a suspension matrix for the active ingredients. "Nanodroplet," as used herein, is an aggregation of molecules of active ingredient in the petrolatum base. The nanodroplets typically contain a small amount of solvent in addition to the active ingredient. Nanodroplets in accordance with the invention are shown in FIG. 1. The nanodroplets may vary in size but generally the longest dimension of the nanodroplets measures from about 10 nm to about 10,000 nm. In various embodiments, the nanodroplets range from about 10 nm to about 100 nm, from about 100 nm to about 1000 nm, from about 1000 nm to about 2000 nm, from about 2000 nm to about 3000 nm, from about 3000 nm to about 4000 nm, from about 4000 nm to about 5000 nm, from about 5000 nm to about 6000 nm, from about 6000 nm to about 7000 nm, from about 7000 nm to about 8000 nm, from about 8000 nm to about 9000 nm, from about 9000 nm to about 10,000 nm. The nanodroplets are dispersed through the petrolatum homogeneously. [0015] In one embodiment, the compositions do not contain an emulsifier. An emulsifier, as used herein, is an added formulation ingredient used to reduce the tension between hydrophilic and hydrophobic surface ingredients, thereby facilitating the mixture hydrophilic and hydrophobic ingredients. In embodiments with an emulsifier, the HLB of the emulsifier is generally around 10. [0016] The compositions described herein are stable. In one aspect, stability refers to the integrity of the composition as a whole, and in particular, the stability of the nanodroplets in the petrolatum.
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