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(12) Patent Application Publication (10) Pub. No.: US 2013/0030009 A1 Harish Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2013/0030009 A1 Harish Et Al US 2013 003 OOO9A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2013/0030009 A1 Harish et al. (43) Pub. Date: Jan. 31, 2013 (54) METHOD FOR THE TREATMENT AND/OR C07D 407/12 (2006.01) PREVENTION OF ORAL ALLERGIC A613 L/495 (2006.01) SYMPTIONS OF THE LIPS DUE TO ORAL A613 L/47 (2006.01) CONTACT WITH A FOOD ALLERGEN (52) U.S. Cl. ................... 514/255.04: 514/456; 514/311; 54974O2 (76) Inventors: Ziv Harish, Tenafly, NJ (US); Isaac Rubinstein, Haworth, NJ (US); Russ Weinzimmer, Milford, NH (US); Ehud (57) ABSTRACT Arbit, Englewood, NJ (US) (21) Appl. No.: 13/365,040 A method of applying a topical preparation of at least one of a mast cell stabilizer, an antihistamine, and a leukotriene (22) Filed: Feb. 2, 2012 inhibitor is disclosed for prevention and/or treatment of oral allergy syndrome of the lips, including lip itchiness and/or Related U.S. Application Data Swelling. For example, topical application of Cromolyn (60) Division of application No. 13/026,972, filed on Feb. Sodium to the lips can be used to prevent and/or treat allergic 14, 2011, which is a continuation-in-part of applica- reaction to consumption or other contact with raw fruits and/ tion No. 12/981,726, filed on Dec. 30, 2010, now aban- or raw vegetables. The topical administration can be per doned. formed by using applicator devices that apply at least one of a mast cell stabilizer and an antihistamine in the form of a Publication Classification liquid, or a gel, or a butter, or a wax-like Solid, or a liposome Suspension. Applicator devices can include at least one of a (51) Int. Cl. roller, a brush, a sponge, a Swab, a tube, a lipstick. The taste of A6 IK3I/352 (2006.01) the at least one of a mast cell stabilizer and an antihistamine A6IP37/08 (2006.01) can be masked by flavors. O2 O6 - - - Patent Application Publication Jan. 31, 2013 Sheet 1 of 15 US 2013/0030009 A1 FiO. Patent Application Publication Jan. 31, 2013 Sheet 2 of 15 US 2013/0030009 A1 z FiO. 2 Patent Application Publication Jan. 31, 2013 Sheet 3 of 15 US 2013/0030009 A1 FiO. 3 Patent Application Publication Jan. 31, 2013 Sheet 4 of 15 US 2013/0030009 A1 §§§| | ... 4 Patent Application Publication Jan. 31, 2013 Sheet 5 of 15 US 2013/0030009 A1 Patent Application Publication Jan. 31, 2013 Sheet 6 of 15 US 2013/0030009 A1 Patent Application Publication Jan. 31, 2013 Sheet 7 of 15 US 2013/0030009 A1 ? 704 FiO. 7 Patent Application Publication Jan. 31, 2013 Sheet 8 of 15 US 2013/0030009 A1 FiO. 8 Patent Application Publication Jan. 31, 2013 Sheet 9 of 15 US 2013/0030009 A1 900 908 Patent Application Publication Jan. 31, 2013 Sheet 10 of 15 US 2013/0030009 A1 OOO Patent Application Publication Jan. 31, 2013 Sheet 11 of 15 US 2013/0030009 A1 |! 1108 O4 Patent Application Publication Jan. 31, 2013 Sheet 12 of 15 US 2013/0030009 A1 10 1108 11 O6 104 Fi . 12 Patent Application Publication Jan. 31, 2013 Sheet 13 of 15 US 2013/0030009 A1 1308 1304 Patent Application Publication Jan. 31, 2013 Sheet 14 of 15 US 2013/0030009 A1 Patent Application Publication Jan. 31, 2013 Sheet 15 of 15 US 2013/0030009 A1 US 2013/0030009 A1 Jan. 31, 2013 METHOD FOR THE TREATMENT AND/OR stocks are depleted, this inhaler preparation will no PREVENTION OF ORAL ALLERGIC longer be available to patients. SYMPTIONS OF THE LIPS DUE TO ORAL 0008 Cromolyn Sodium is also available as eye drops CONTACT WITH A FOOD ALLERGEN (OpticromTM and Optrex AllergyTM (UK), CrolomTM) for allergic conjunctivitis; and also in an oral form (Gas CROSS-REFERENCE TO RELATED trocromTM) to treat mastocytosis, dermatographic urti APPLICATIONS caria and ulcerative colitis. Another oral product, Inter 0001. This application is a divisional application of U.S. cronTM (sodium cromoglicate in distilled water, from application Ser. No. 13/026,972, filed Feb. 14, 2011 and Zambon France), is used for systemic treatment of food entitled APPLICATION TO THE LIPS OF PREPARA allergies. However, the physicochemical properties of TIONS FOR TOPICAL PREVENTION AND/OR TREAT cromolyn impede its absorption across epithelial lining MENT OF ALLERGIC SYMPTOMS DUE TO ORAL Such as through the oral mucosa and contribute to its CONTACT WITH FOODS,” which is hereby incorporated poor absorption from the gastrointestinal tract. No more herein by this reference in its entirety; which is a continua than 1% of a dose administered orally is absorbed by tion-in-part (CIP) of U.S. application Ser. No. 12/981,726, humans, the remainder being excreted in the feces. Very filed Dec. 30, 2010 and entitled “PREPARATIONS FOR little absorption of Cromolyn Sodium was seen after TOPICAL PREVENTION AND/OR TREATMENT OF administration of 500 mg by mouth to each of 12 volun ORAL ALLERGIC SYMPTOMS DUE TO ORAL CON teers. From 0.28 to 0.50% of the administered dose was TACT WITH FRUITS AND/OR VEGETABLES, which is recovered in the first 24 hours of urinary excretion in 3 hereby incorporated herein by this reference in its entirety. Subjects. The mean urinary excretion of an orally admin istered dose over 24 hours in the remaining 9 subjects FIELD OF THE INVENTION was 0.45%. 0009. Each 5 mL ampule of GastrocromTM contains 100 0002 This invention relates to prevention and/or treat mg Cromolyn Sodium, USP in purified water. Cromolyn ment of oral allergy symptoms, and particularly to the appli Sodium, USP is a hygroscopic, white powder having little cation of preparations to the lips for topical prevention and/or odor. It may leave a slightly bitter aftertaste. GastrocromTM topical treatment of oral allergy symptoms. Oral Concentrate is clear, colorless, and sterile. It is intended for “oral use, i.e., to be swallowed and reach superficially BACKGROUND OF THE INVENTION situated mast cells along the gastrointestinal tract, or to be 0003 Allergic conditions result from release of mediators, absorbed systemically via the gastrointestinal tract, just as including histamine, from sensitized mast cells upon expo pills, capsules, and tablets are to be swallowed and absorbed Sure to an allergen. systemically. 0004 Individuals with pollen allergy often experience oral 0010. In particular, users of GastrocromTM are instructed itchiness, i.e., irritation of various Surfaces within the mouth to: Squeeze liquid contents of an ampule containing a single and throat, upon ingestion of raw fruits and/or raw vegetables, dose of GastrocromTM into a glass of water. Stir the resulting often resulting in these individuals deciding to avoid eating solution. Drink all of the solution immediately. these foods. The condition of oral itchiness, or other allergic 0011. Also, Cromolyn Sodium is commonly administered symptom, such as irritation and/or Swelling, is the result of via a power-driven nebulizer, under the brand names: IntalTM local activation of mast cells within tissues of the mouth upon and Intal InhalerTM. The nebulizer must have a suitable face exposure to raw fruits and vegetables that cross-react with the mask or mouthpiece. Nebulizers make a liquid into anaerosol pollens to which the individuals are allergic. As defined that one breathes in through one’s mouth, or through one’s herein, "oral itchiness' shall also refer to any allergic symp mouth and nose, into the lungs. However, one is also com tom affecting the throat (pharynx) and/or the voice box (lar monly advised: “Do not take this medicine as a solution by ynx). Such aitchiness, irritation, and/or Swelling thereof. mouth'. One is also advised “If you get a bitter or unpleasant 0005. Currently, no approved medical treatment is avail taste in your mouth, gargle or rinse your mouth after you use able to alleviate this condition. Patients are advised to avoid this medicine.” Patients are also advised: “To relieve dry raw fruits to which they are sensitive, but this deprives the mouth or throat irritation caused by cromolyn inhalation, patient of important nutrients that are found in fruits and rinse your mouth with water, chew gum, or Suck Sugarless Vegetables. Avoidance also causes uncomfortable social hard candy after each treatment.” problems. There are anecdotal reports of relief with allergy 0012 Patients are advised to: "Use cromolyn sodium immunotherapy (allergy shots), and with use of antihista inhalation on a regular basis for best results. It may be several mines. weeks before you see the effects.” Patients are further 0006 Mast cell stabilizers, such as Cromolyn Sodium, are advised: “It is very important that you use your cromolyn commonly used in treatment of multiple allergic conditions, Sodium inhaler properly, so that the medicine gets into your including asthma, rhinoconjunctivitis, eczema, and pruritus. lungs. Your doctor may want you to use a spacer with your 0007 Cromolyn Sodium is a salt of Cromoglicic acid, inhaler.” Cromolyn oral inhalation will no longer be available and is available in multiple forms: as a nasal spray in the U.S. after Dec. 31, 2010. (Rynacrom(UK), Nasalcrom, Prevalin (Netherlands)) to 0013 Stated disadvantages include: “Cromoglicic acid treat allergic rhinitis; in a nebulizer solution for aerosol requires administration four times daily, and does not provide administration to treat asthma, and as an inhaler (Intal) additive benefit in combination with inhaled corticosteroids.” for preventive management of asthma. The maker of 0014. It is commonly accepted that Cromolyn Sodium is IntalTM, King Pharmaceuticals, has discontinued manu poorly absorbed topically through mucosal barriers, and is facturing the inhaled form, cromolyn Sodium inhalation consequently not absorbed well into the oral mucosa. Further, aerosol, due to issues involving CFC-free propellant.
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