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(12) Patent Application Publication (10) Pub. No.: US 2012/0208890 A1 Gousse Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2012/0208890 A1 Gousse Et Al US 20120208890A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2012/0208890 A1 Gousse et al. (43) Pub. Date: Aug. 16, 2012 (54) STABLE HYDROGEL COMPOSITIONS of application No. 127956,542, filed on Nov.30, 2010, INCLUDING ADDITIVES which is a continuation-in-part of application No. 12/714,377, filed on Feb.26, 2010, which is a continu (75) Inventors: Cecile Gousse, Dingy Saint Clair ation-in-part of application No. 12/687,048, filed on (FR); Pierre F. Lebreton, Annecy Jan. 13, 2010. (FR); Nicolas Prost, Mornant (FR): Sumit Paliwal, Goleta, CA (US); Publication Classification Dennis Van Epps, Goleta, CA (US) (51) Int. C. (73) Assignee: ALLERGAN, INC. Irvine, CA A6IR 8/4I (2006.01) (US) A61O 19/08 (2006.01) A6IR 8/42 (2006.01) (21) Appl. No.: 13/350,518 (52) U.S. Cl. ......................................... 514/626; 514/653 (22) Filed: Jan. 13, 2012 (57) ABSTRACT Related U.S. Application Data The present specification generally relates to hydrogel com (63) Continuation-in-part of application No. 13/005,860, positions and methods of treating a soft tissue condition using filed on Jan. 13, 2011, which is a continuation-in-part Such hydrogel compositions. Patent Application Publication Aug. 16, 2012 Sheet 1 of 7 US 2012/0208890 A1 lication Publication ug. 16, 2012 Sheet 2 of 7 co & S. N SESo 9 CD s Y NI C O O CN ve ve D an an 5 S. 5 3. 9. S. Patent Application Publication Aug. 16, 2012 Sheet 3 of 7 US 2012/0208890 A1 00Z?000).00800900700Z0 O.GZ?eSÅep~ Patent Application Publication Aug. 16, 2012 Sheet 4 of 7 Patent Application Publication Aug. 16, 2012 Sheet 5 of 7 US 2012/0208890 A1 Z°0 00Z),000),00800900700Z0 Patent Application Publication Aug. 16, 2012 Sheet 6 of 7 US 2012/0208890 A1 077 OZ7 007 089 099 079 009 Patent Application Publication Aug. 16, 2012 Sheet 7 of 7 US 2012/0208890 A1 ?Z-VVpueeu?eoop??Me?Inuuep?Anp: au?eoop??Me?InuJep9anp• 0007009€.000€009Z000Z S 009 US 2012/0208890 A1 Aug. 16, 2012 STABLE HYDROGEL COMPOSITIONS a dermal filler. Tezel and Fredrickson, The Science of Hvalu INCLUDINGADDITIVES ronic Acid Dermal Fillers, J. Cosmet. Laser Ther. 10(1): 35-42 (2008); Kablik, et al., Comparative Physical Proper CROSS REFERENCE ties of Hyaluronic Acid Dermal Fillers, Dermatol. Surg. 35 Suppl 1: 302-312 (2009); Beasley, et al., Hyaluronic Acid 0001. This patent application is a continuation-in-part of Fillers: A Comprehensive Review, Facial Plast. Surg. 25(2): U.S. patent application Ser. No. 13/005,860, filed Jan. 13, 86-94 (2009); each of which is hereby incorporated by refer 2011, which is a continuation-in-part of U.S. patent applica ence in its entirety. One primary reason is that because this tion Ser. No. 127956,542, filed on Nov.30, 2010, which is a polymer is uncrosslinked, it is highly soluble and, as Such, is continuation-in-part of U.S. patent application Ser. No. cleared rapidly when administered into a skin region. Tezel, 12/714,377, filed on Feb. 26, 2010, which is a continuation supra, 2008; Kablik, supra, 2009; Beasley, supra, 2009. This in-part of U.S. patent application Ser. No. 12/687,048, filed in vivo clearance is primarily achieved by rapid degradation Jan. 13, 2010, the disclosure of each of these three applica of the polymers, principally enzymatic degradation via hyalu tions incorporated in its entirety by this reference. ronidase and chemical degradation via free-radicals. Thus, while still in commercial use, compositions comprising BACKGROUND uncrosslinked hyaluronan polymers tend to degrade within a 0002 Skin aging is a progressive phenomenon, occurs few days after administration and thus require fairly frequent over time and can be affected by lifestyle factors, such as reinjection to maintain their skin improving effect. alcohol consumption, tobacco and Sun exposure. Aging of the 0006 To minimize the effect of these in vivo degradation facial skin can be characterized by atrophy, slackening, and pathways, matrix polymers are crosslinked to one another to fattening. Atrophy corresponds to a massive reduction of the form a stabilized hydrogel. Because hydrogels comprising thickness of skin tissue. Slackening of the Subcutaneous tis crosslinked matrix polymers are a more solid Substance, der Sues leads to an excess of skin and ptosis and leads to the mal fillers comprising Such hydrogels remain in place at the appearance of drooping cheeks and eyelids. Fattening refers implant site longer. Tezel, supra, 2008; Kablik, supra, 2009: to an increase in excess weight by Swelling of the bottom of Beasley, supra, 2009. In addition, these hydrogels are more the face and neck. These changes are typically associated suitable as a dermal filler because it's more solid nature with dryness, loss of elasticity, and rough texture. improves the mechanical properties of the filler, allowing the 0003 Hyaluronan, also known as hyaluronic acid (HA) is filler to better lift and fill a skin region. Tezel, supra, 2008: a non-sulfated glycosaminoglycan that is distributed widely Kablik, supra, 2009; Beasley, supra, 2009. Hyaluronan poly throughout the human body in connective, epithelial, and mers are typically crosslinked with a crosslinking agent to neural tissues. Hyaluronan is abundant in the different layers form covalent bonds between hyaluronan polymers. Such of the skin, where it has multiple functions such as, e.g., to crosslinked polymers form a less water Soluble hydrogel net ensure good hydration, to assist in the organization of the work that is more resistant to degradation, and thus requires extracellular matrix, to act as a filler material; and to partici less frequent reinjection, than the non-crosslinked hyaluro pate in tissue repair mechanisms. However, with age, the nan compositions. quantity of hyaluronan, collagen, elastin, and other matrix 0007 Current dermal fillers can be associated with a vari polymers present in the skin decreases. For example, repeated ety of side effects. For example, administration of a dermal exposed to ultra violet light, e.g., from the Sun, causes dermal filler to an individual is typically performed using a syringe or cells to both decrease their production of hyaluronan as well needle. Such administration could result in one or more as increase the rate of its degradation. This hyaluronan loss unwanted side-effects, such as, e.g., pain and discomfort to results in various skin conditions such as, e.g., imperfects, the individual, bleeding in and under the site of administra defects, diseases and/or disorders, and the like. For instance, tion, and itching, inflammation and irritation in the vicinity of there is a strong correlation between the water content in the the administration site during and after the administration of skin and levels of hyaluronan in the dermal tissue. As skin the dermal filler. The dermal fillers disclosed in the present ages, the amount and quality of hyaluronan in the skin is specification address these and other unwanted side-effects reduced. These changes lead to drying and wrinkling of the by providing hydrogel compositions comprising agents that skin. reduce, step, or prevent one or more of these side-effects. 0004 Dermal fillers are useful in treating soft tissue con 0008. Additionally, a dermal filler formulation must be dition and in other skin therapies because the fillers can capable of withstanding sterilization which is a strict require replace lost endogenous matrix polymers, or enhance/facili ment before the product can be sold (the product must be tate the function of existing matrix polymers, in order to treat sterile). Sterilization can be carried out by steamsterilization, these skin conditions. In the past, such compositions have filtration, microfiltration, gamma radiation, ETO light or by a been used in cosmetic applications to fill wrinkles, lines, combination of these methods. It is known that a dermal filler folds, Scars, and to enhance dermal tissue, such as, e.g., to can be steam sterilized (autoclaved) without Substantial deg plump thin lips, or fill-in Sunken eyes or shallow cheeks. One radation of physical properties, but when a dermal filler for common matrix polymer used in dermal filler compositions is mulation contains an additional labile ingredient (Such as an hyaluronan. Because hyaluronan is natural to the human antioxidant, anti-itch agent, an anti-cellulite agent, an anti body, it is a generally well tolerated and a fairly low risk scarring agent, an anti-inflammatory agent, an anesthetic treatment for a wide variety of skin conditions. agent, an anti-irritant agent, a vasoconstrictor, a vasodilator, 0005 Originally, compositions comprising hyaluronan an anti-hemorrhagic agent like a hemostatic agent or anti where made from naturally-occurring polymers, which exist fibrinolytic agent, a descquamating agent, a tensioning agent, in an uncrosslinked State. Although exhibiting excellent bio an anti-acne agent, a pigmentation agent, an anti-pigmenta compatibility and affinity for water molecules, naturally-oc tion agent, or a moisturizing agent) the entire dermal filler curring hyaluronan exhibits poor biomechanical properties as formulation or at least the additional (heat labile) agent is US 2012/0208890 A1 Aug. 16, 2012 traditionally sterilized by a non-heat treatment Such as by a hemorrhagic agent like a hemostatic agent oranti-fibrinolytic filtration sterilization method. Thus, a known dermal filler agent, a descquamating agent, a tensioning agent, an anti-acne product (REVITACARER Bio-Revitalisation, REVITAC agent, a pigmentation agent, an anti-pigmentation agent, or a ARER Laboratory, Saint-Ouen-l'Aumone, France) is sold in moisturizing agent. Glycosaminoglycan polymers useful to two separate vials or containers, one vial containing the HA make such compositions include, without limitation, chon (which is autoclave sterilized)) and the second vial containing droitin Sulfate polymers, dermatan Sulfate polymers, keratan any additional ingredients (the second vial contents are ster Sulfate polymers, and hyaluronan polymers.
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