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(12) Patent Application Publication (10) Pub. No.: US 2013/0123320 A1 Chervinsky (43) Pub

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(12) Patent Application Publication (10) Pub. No.: US 2013/0123320 A1 Chervinsky (43) Pub US 2013 0123320A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2013/0123320 A1 Chervinsky (43) Pub. Date: May 16, 2013 (54) TOPICAL COMPOSITION FOR PAIN RELIEF Publication Classification (51) Int. Cl. (76) Inventor: Alex Chervinsky, Brooklyn, NY (US) A6IPA613 29/00 L/45 38:8:2006.O1 A6IP 23/02 (2006.01) (52) U.S. Cl. (21) Appl. No.: 13/295,142 USPC .......................................................... 514/.401 (57) ABSTRACT Described is a topically applied composition relief of pain. Also described are methods of preparing the composition and (22) Filed: Nov. 14, 2011 methods of using the composition to relieve pain. US 2013/O123320 A1 May 16, 2013 TOPCAL COMPOSITION FOR PAN RELIEF problems of maintaining the analgesic in Suspension within the solution of the topical pain reliever. Further, topical pain BACKGROUND OF THE INVENTION relievers have been known to have a delayed onset of action 0001 1. Field of the Invention after they have been applied to the integument or skin. Several 0002 The present invention relates to compositions and reasons may cause such a result, for example the topical pain methods for pain relief. reliever may not effectively permeate the skin. 0003 2. Description of the Related Art 0011 Many patients with localized pain due to arthritis, 0004 Pain results from the noxious stimulation of nerve bursitis, sprain or muscle strain, bruises or hematomas cannot endings. Nociceptive pain is caused by stimulation of noci tolerate conventional NSAIDS. In addition, topical adminis ceptors (e.g., a needle Stick or skin pinch), which then trans tration of conventional NSAIDS has been known to be inef mit impulses over neural pathways to the spinal neurons and fective because only a therapeutically ineffective amount of then to the brain. Neuropathic pain is caused by damage to the drug can penetrate the skin. In addition, indications such neural structures, such as peripheral nerve endings or nocice as acne, psoriasis and eczema are typically refractory to topi ptors, which can generate impulses in the absence of Stimu cal or oral administration of NSAIDS. lation (e.g., herpes Zoster pain after the rash has healed). 0012. In addition, joint pain can often indicate the onset of 0005. In contrast to pain treatment with systemic agents, a condition called osteoarthritis. Osteoarthritis is a degenera pain can be treated locally by topically administering a pain tive joint disease affecting articular cartilage developing in relieving agent directly to the painful area to block the noci the fourth and fifth decades of life that was initially believed ceptive mechanistic pathway. Local anesthetics prevent the to be a disease of wear and tear due to mechanical stress on the generation and conduction of nociceptive nerve impulses. joints. It is now known that the pathology of osteoarthritis is Thus, for example, a local anesthetic or analgesic can be not entirely mechanical and involves changes in the joint topically applied at the pain area. Advantages oftopical anes metabolism. Specifically, altered glucosamine metabolism thetic or analgesic administration over systemic administra appears to play a key role in the development of osteoarthritis. tion of pain relievers include decrease or preclusion of certain 0013. An effective treatment of osteoarthritis must address side effects, improved patient compliance, and reversible two types of problems: (i) pain, and joint tenderness, Swelling action (i.e., the action can be reversed by removing the anes and stiffness must be alleviated as an immediate patients thetic from the application site). problem; and (ii) the degenerative process must be stopped 0006 A variety of drug classes have anesthetic or analge preferably at its earlier stages. Treatment with anti-rheumat sic properties and can be administered in topical formula ics and NSAIDs has not proven successful. Anti-rheumatics, tions. Traditional local anesthetics or Sodium-channel block although quickly effective, were recently shown to impair the ers, such as lidocaine prevent the generation and conduction very function that physicians were trying to improve, and of nerve impulses by decreasing or preventing the large tran anti-inflammatory drugs alleviate the pain but do not address sient increase in the permeability of excitable membranes to the underlying degenerative disorder. Na+. Other agents with analgesic properties include the non 0014. Therefore, what is needed is a topical composition steroidal anti-inflammatories (“NSAIDs) and opioids, such that provides effective pain relief, is stable for long periods of as morphine. time and provides a long shelf-life, and avoids the disadvan 0007. It is common practice to provide a topical pain tages associated with other topical analgesics or systemically reliever using the well-known NSAID, salicylic acid (aspi administered drugs. What is further needed is a composition rin). Aspirin has been used effectively for many years in the that is effective in treating a wide variety of inflammatory medical and Scientific community as a pain reliever. Despite conditions by topical application of the composition. its benefits, systemic administration of aspirin has been 0015 These advantageous properties are provided by the shown to cause certain side effects in its users, for example composition set forth in the description that follows. Further stomach irritation and other internal problems associated advantages will be apparent from the description, or may be with ingesting aspirin. realized by the practice of the invention without undue experi 0008. Applying an aspirin solution topically to a user's mentation. skin, thereby avoiding the need for a user to ingest aspirin, has SUMMARY OF THE INVENTION been shown to be an effective manner of gaining the benefits of aspirin without the potential side effects. However, there 0016. The subject invention concerns a composition are difficulties associated with the ability to achieve a safe and which can be topically applied to the skin for the relief of pain stable form of a topical pain reliever containing aspirin that at the site of application. An embodiment of a composition will remain in suspension within the solution of the topical according to the invention comprises an effective amount of pain reliever. at least one anti-spasmodic or GABA-agonist, at least one 0009. In view of these difficulties, other NSAIDs have local anesthetic agent, at least one C2-adrenergic agonist, at been utilized for their anti-inflammatory or analgesic proper least one NMDA-receptor antagonist, at least one Non-Ste ties. It is an important aspect of any NSAID-based topical roidal Anti-inflammatory Drug (NSAID), at least one seroto pain reliever to permeate the necessary layers of the integu nin-norepinephrine reuptake inhibitor (SNRI), together with ment or skin in order to relieve pain without adversely affect a solvent in a cream or ointment base. ing vital internal organs. Accordingly, it is accepted that an 0017. A preferred embodiment for the composition of the effective topical pain reliever should be in the form that dis Subject invention comprises, in a cream or ointment base Solves the analgesic agents and transports it to the area of pain (inactive pharmaceutical compounding base): where it can then permeate the integument or skin to provide 0.018 about 1-20% anti-spasmodic or GABA-agonist effective relief. 0.019 about 1-5% local anesthetic agent 0010 Topical pain relievers have been introduced in the 0020 about 0.1-1.0% C-adrenergic agonist past, but such topical pain relievers have traditionally had 0021 about 1-20% NMDA-receptor antagonist US 2013/O123320 A1 May 16, 2013 0022 about 1-20% Non-Steroidal Anti-inflammatory 0054. It is therefore an object of the present invention to Drug (NSAID) provide a composition and method for the topical or transder 0023 about 1-10% Serotonin-Norepinephrine mal relief of pain to provide immediate, long-lasting and Reuptake Inhibitor (SNRI), and cumulative relief from pain and inflammation of Sore or 0024 about 1-10% solvent. stressed muscles and joints. 0025. The cream or ointment pharmaceutical compound 0055. It is yet another object of the present invention to ing base can comprise about 25% to about 75% (w/w) of the provide a pain relief composition comprising a plurality of composition, and preferably comprises about 50% to about Active Pharmaceutical Ingredients, which is effective and 60% of the composition. comfortable to apply to the skin. 0026. In a more preferred embodiment, the subject com 0056. It is yet another object of the present invention to position comprises, in a cream or ointment base: provide a soothing, anti-inflammatory complex for the joints 0027 gabapentin—1-10% (anti-spasmodic or GABA and muscles, which can be used in combination with other agonist pain relief agents. 0028 baclofen-1-10% (anti-spasmodic or GABA 0057. Other objects and advantages of the present inven agonist) tion will be apparent from a review of the following specifi 0029 lidocaine HC1–1-10% (local anesthetic agent) cation. 0030 clonidine HC1 0.1-1.0% (C2-adrenergic ago nist) DETAILED DESCRIPTION 0031 ketamine HC1–1-20% (NMDA-receptor 0058. The detailed description set forth below is intended antagonist) as a description of exemplary embodiments and is not 0032 ketoprofen-1-20% (NSAID) intended to represent the only forms in which the exemplary 0033 amitriptyline HC1–1-10% (SNRI) embodiments may be constructed and/or utilized. The 0034) DMSO–1-10% (solvent) description sets forth the functions and the sequence of steps 0035. The above ingredients are preferably mixed with or for preparation and/or use of the exemplary embodiments. into a pharmaceutical compounding base, such as PENcream, However, it is to be understood that the same or equivalent which makes up the balance of the composition, and typically functions and sequences which may be accomplished by dif comprises about 50-60% of the composition.
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