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USOO8647671B2 (12) United States Patent (10) Patent No.: US 8,647,671 B2 Pearlman (45) Date of Patent: *Feb. 11, 2014 (54) COMPOSITIONS AND METHODS FOR THE 4,246.261 A 1/1981 Van Scott et al. TREATMENT OF SKN DISEASES 4.954,487 A 9/1990 Cooper et al. 5,486,537 A 1/1996 Farinas 5,629,006 A 5/1997 Hoang et al. (71) Applicant: Dale L. Pearlman, Menlo Park, CA 2003.0118511 A1 6/2003 Jones et al. (US) 2008. O131385 A1 6/2008 ROSo et al. 2011, 0070183 A1 3/2011 Neumann et al. (72) Inventor: Dale L. Pearlman, Menlo Park, CA (US) OTHER PUBLICATIONS (*) Notice: Subject to any disclaimer, the term of this "Guideline for Hand Hygiene in Healthcare Settings”. Centers for patent is extended or adjusted under 35 Disease Control, online Oct. 25, 2002, http://www.cdc.gov/mmwr/ U.S.C. 154(b) by 0 days. previewimmwrhtml/rrS116al.htm, retrieved Aug. 22, 2012). This patent is Subject to a terminal dis Acne Vulgaris, Medscape Reference Drugs, Diseases & Procedures, claimer. online Jun. 28, 2012, retrieved Aug. 23, 2012 Retrieved from http://emedicine.medscape.com/article/1069804-overview. (21) Appl. No.: 13/787,680 Boguniewicz, M., et al. "Atopic dermatitis: a disease of altered skin barrier and immune dysregulation.” Immunolog Rev. 2011; 24; 233 (22) Filed: Mar. 6, 2013 46. Buhse L., et al. “Topical drug classification.” International Journal of (65) Prior Publication Data Pharmaceutics 295 (2005) 101-112. US 2013/0243825A1 Sep. 19, 2013 (Continued) Related U.S. Application Data Primary Examiner — Benjamin Packard (63) Continuation-in-part of application No. 13/633,832, (74) Attorney, Agent, or Firm — Wilson, Sonsini, Goodrich filed on Oct. 2, 2012, which is a continuation-in-part of & Rosati application No. 13/466,860, filed on May 8, 2012. (60) Provisional application No. 61/612.203, filed on Mar. 16, 2012. (57) ABSTRACT Int. C. Provided herein are chemical matrices, compositions, and (51) methods for the treatment of skin diseases and disorders in an A6 IK9/32 (2006.01) individual. Said chemical matrices and compositions com (52) U.S. C. prise an alcohol selected from ethanol, isopropanol or n-pro USPC .......................................................... 424/484 panol, at least one excipient, and, a corticosteroid, wherein (58) Field of Classification Search the alcohol is distributed within the chemical matrix as a USPC .......................................................... 424/484 microbubble and the corticosteroid is present in less than the See application file for complete search history. standardized topical corticosteroid concentration. Addition ally, methods are described for the use of said chemical matri (56) References Cited ces and compositions for the treatment of skin diseases and U.S. PATENT DOCUMENTS disorders. 4,147,770 A 4, 1979 Sichak 4,185,100 A 1, 1980 ROvee et al. 31 Claims, 1 Drawing Sheet Final % of Single or multi use standard corticosteroid standard | #patients |# patients success medication Corticosteroid corticosteroid in formulation amount treated successful rate Single Use (2.5:2.5:1) Desonide Ung 0.05% 0.02.1% 42% 4. 4. 100% Single Use (2.5.2.5:1) Mometasone Ung O.1% 0.042% 42% 3. 3 100% Single Use (2.5.2.5.1) TAC Ung O.1% 0.042% 42% 1 1 100% Single Use (2.5:2.5:1) TAC Cr O.1% 0.042 42% 1 1 100% Single Use (102.5.2.5) Mometasome Ung 0.1% 0.017% 17% 1 1 100% Multi Use (2.5:2.5:1 Ziplock) Desonide Ung 0.05% 0.02.1% 42% 1 1 100% Multi Use (10:2.5:2.5 Ziplock) Desonide Ung 0.05% 0.0085% 17% 2 2 100% Multi Use (10:2.5:2.5 Ziplock) Mometasone Ung O.1% 0.017% 17% 7 7 100% US 8,647,671 B2 Page 2 (56) References Cited Pagnoni A. etal. “Lack ofburning and stinging from a novel first-aid formulation applied to experimental wounds.” J. Cosmet. Sci. Mar.- OTHER PUBLICATIONS Apr. 2004: 55(2): 157-62. PCT/US2012/36966 International Search Report dated Jul 30, 2012. Psoriasis, Medscape Reference Drugs, Diseases & Procedures, Bunikowski R. etal. “Prevalence and role of serum IgE antibodies to online Aug. 6, 2012, retrieved Aug. 23, 2012 Retrieved from the Staphylococcus aureus-derived superantigens SEA and SEB in http://emedicine.medscape.com/article/1943419-overviewiao 156. children with atopic dermatitis.J. Allergy Clin. Immunol. 1999; Rafanelli A. et al. “Mometasone furoate in the treatment of atopic 103:119-24. dermatitis in children.” J. Eur: Acad. Dermatol. Venereol. 1993; 2(3): 225-230. Cho S-H... etal “Fibronectin and fibrinogen contribute to the Reginald K., et. al. “Staphylococcus aureus fibronectin-binding pro enhanced binding of Staphylococcus aureus to atopic skin' J. Allergy tein specifically binds IgE from patients with atopic dermatitis and Clin. Immunol. 2001; 108:269-74. requires antigen presentation for cellular immune responses.” J. Department of Health and Human Services, Food and Drug Admin Allergy Clin. Immunol. 2011; 128:82-91. istration “Topical Antimicrobial Drug Products for Over-the-Counter Rosacea incidence on Rise, National Rosacea Society, online Apr. Human Use; Tentative Final Monograph for Healthcare Antiseptic 1, 2010, retrieved Aug. 23, 2012 Retrieved from http://www. Drug Products”. Federal Register, vol. 59, No. 116, online Jun. 17. rosacea.org/weblog/2010/04/01/rosacea incidence on rise?in 1994 retrieved Aug. 23, 2012 Retrieved from http://www.fda.gov/ dex.php. downloads/Drugs/Development ApprovalProcess/ Trookman N.S., et al. "Randomized Controlled Trial of Desonide DevelopmentResources/Over-the-counterOTCDrugs/ Hydrogel 0.05% versus Desonide Ointment 0.05% in the treatment of StatusofCTCRulemakings/UCM1 10451.pdf. Mild-to-Moderate Atopic Dermatitis.” J. Clin Aesthet Dermatol. Hebert A.A., et al. “Safety and Efficacy of Desonide Hydrogel 0.05% Nov. 2011; 4(11): 34-38. in Pediatric Subjects with Atopic Dermatitis.” J Drugs Dermatol. Trookman N.S., et al. "Irritation and allergy patch test analysis of Feb. 2007; 6(2): 175-81. topical treatments commonly used in wound care: Evaluation on Huang J.T., et al. “Treatment of Staphylococcus aureus Colonization normal and compromised skin.”.J. Amer: Acad Dermatol. Mar. 2011; in Atopic Dermatitis Decreases Disease Severity.” Pediatrics May 64(3), Suppl 1:S16-22. 2009; 123(5): 808–814. U.S. Appl. No. 13/633,832 Office Action dated Dec. 17, 2012. Kampf, et al. “Epidemiologic Background of Hand Hygiene and US Food and Drug Administration, Drug Nomenclature Monograph, Evaluation of the Most Important Agents for Scrubs and Rubs' No. C-DRG-00201 online Jan. 30, 2009, retrieved online Aug. 22. Microbiol. Rev. (2004), 17(4), 863-93. 2012 Retrieved from http://www.fda.gov/Drugs/Development Ap Leung D.Y.M., et al. “Presence of IgE Antibodies to Staphylococcal provalProcess/FormsSubmissionRequirements/ElectronicSubmis Exotoxins on the Skin of Patients with Atopic Dermatitis' J. Clin. sions/DataStandardsManualmonographs/ucm071666.htm. Invest. 1993; 92: 1374-80. Vernon H.J., et al. "Comparison of mometasone furoate 0.1% cream Miajlovic H. et al. “Effect of filaggrin breakdown products on and hydrocortisone 1.0% cream in the treatment of childhood atopic growth of and protein expression by Staphylococcus aureus." J. dermatitis.” J. Am. Acad. Dermatol Apr. 1991; 24:603-7. Allergy Clin. Immunol. 2010; 126:1184-1190. Zollner TM et al. “Colonization with Superantigen-producing Ong P.Y., et al. “Immune Dysregulation in Atopic Dermatitis' Curr Staphylococcus aureus is associated with increased severity of atopic Allergy Asthma Rep. Sep. 2006; 6(5):384-9. dermatitis.” Clin. Exp. Allergy 2000; 30: 994-1000. U.S. Patent Feb. 11, 2014 US 8,647,671 B2 JO% US 8,647,671 B2 1. 2 COMPOSITIONS AND METHODS FOR THE topical corticosteroid concentration is 0.05%. Another TREATMENT OF SKN DISEASES embodiment provides the chemical matrix wherein the des onide is present in an amount of about 0.0005%, about CROSS REFERENCE 0.0025%, about 0.005%, about 0.009%, about 0.02%, or about 0.045%. Another embodiment provides the chemical This application claims the benefit of U.S. Provisional matrix wherein the desonide is present in an amount of about Application No. 61/612.203, filed Mar. 16, 2012, U.S. appli 0.0025%, about 0.005%, about 0.01%, about 0.02%, about cation Ser. No. 13/466,860, filed May 8, 2012, and U.S. 0.03%, or about 0.04%. Another embodiment provides the application Ser. No. 13/633,832, filed Oct. 2, 2012, the con chemical matrix wherein the desonide is present in an amount tents of which are hereby incorporated by reference in their 10 of about 0.005%, about 0.01%, about 0.015%, or about entireties. O.O2%. Another embodiment provides the chemical matrix BACKGROUND OF THE INVENTION wherein the corticosteroid is mometasone and the standard ized topical corticosteroid concentration is 0.1%. Another High ethanol content Sanitizer gel is known to be a very 15 embodiment provides the chemical matrix wherein the effective topical antimicrobial agent for preventing infec mometasone is present in an amount of about 0.001%, about tions. Direct application to bacterial, fungal, and viral organ 0.005%, about 0.01%, about 0.02%, about 0.04%, or about isms in the laboratory setting results in 99.99% killing within 0.09%. Another embodiment provides the chemical matrix 15 seconds of contact. This efficacy is due to its concentration wherein the mometaSone is present in an amount of about of ethyl alcohol greater than, or equal to, 60% (Federal Reg 0.005%, about 0.01%, about 0.02%, about 0.03%, about ister, Vol. 59, No. 116, Jun. 17, 1994). Similar antiseptic 0.04%, or about 0.05%. Another embodiment provides the activity has been observed for isopropanol (Federal Register, chemical matrix wherein the mometasone is present in an Vol.
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    DOXEPIN CREAM 5% (Prudoxin, Zonalon) Pre - PA Allowance Age 18 years of age or older Quantity 60 grams every 90 days _______________________________________________________________ Prior-Approval Requirements Age 18 years of age or older Diagnosis Patient must have the following: Moderate pruritus, due to atopic dermatitis (eczema) or lichen simplex chronicus AND the following: 1. Inadequate response, intolerance or contraindication to ONE medication in EACH of the following categories: a. Topical antihistamine (see Appendix I) b. High potency topical corticosteroid (see Appendix II) 2. Physician agrees to taper patient’s dose to the FDA recommended dose, and after tapered will only use for short-term pruritus relief (up to 8 days) a. Patients using over 60 grams of topical doxepin in 90 days be required to taper to 60 grams topical doxepin within 90 days Prior - Approval Limits Quantity 180 grams for 90 days Duration 3 months ___________________________________________________________________ Prior – Approval Renewal Requirements None (see appendix below) Doxepin 5% cream FEP Clinical Rationale DOXEPIN CREAM 5% (Prudoxin, Zonalon) APPENDIX I Drug Dosage Form Diphenhydramine Cream Phenyltoloxamine Lotion/ Cream Tripelennamine Cream Phendiamine Cream APPENDIX II Relative Potency of Selected Topical Corticosteroid Drug ProductsDosage Form Strength I. Very high potency Augmented betamethasone Ointment, Gel 0.05% dipropionate Clobetasol propionate Cream, Ointment 0.05% Diflorasone diacetate Ointment 0.05% Halobetasol propionate Cream, Ointment 0.05% II. High potency Amcinonide Cream, Lotion, 0.1% Augmented betamethasone Cream,Ointment Lotion 0.05% dipropionate Betamethasone Cream, Ointment 0.05% Betamethasonedipropionate valerate Ointment 0.1% Desoximetasone Cream, Ointment 0.25% Gel 0.05% Diflorasone diacetate Cream, Ointment 0.05% (emollient base) Fluocinonide Cream, Ointment, Gel 0.05% Halcinonide Cream, Ointment 0.1% Triamcinolone acetonide Cream, Ointment 0.5% III.
  • Pharmaceutical Appendix to the Tariff Schedule 2

    Pharmaceutical Appendix to the Tariff Schedule 2

    Harmonized Tariff Schedule of the United States (2007) (Rev. 2) Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE Harmonized Tariff Schedule of the United States (2007) (Rev. 2) Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 2 Table 1. This table enumerates products described by International Non-proprietary Names (INN) which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. ABACAVIR 136470-78-5 ACIDUM LIDADRONICUM 63132-38-7 ABAFUNGIN 129639-79-8 ACIDUM SALCAPROZICUM 183990-46-7 ABAMECTIN 65195-55-3 ACIDUM SALCLOBUZICUM 387825-03-8 ABANOQUIL 90402-40-7 ACIFRAN 72420-38-3 ABAPERIDONUM 183849-43-6 ACIPIMOX 51037-30-0 ABARELIX 183552-38-7 ACITAZANOLAST 114607-46-4 ABATACEPTUM 332348-12-6 ACITEMATE 101197-99-3 ABCIXIMAB 143653-53-6 ACITRETIN 55079-83-9 ABECARNIL 111841-85-1 ACIVICIN 42228-92-2 ABETIMUSUM 167362-48-3 ACLANTATE 39633-62-0 ABIRATERONE 154229-19-3 ACLARUBICIN 57576-44-0 ABITESARTAN 137882-98-5 ACLATONIUM NAPADISILATE 55077-30-0 ABLUKAST 96566-25-5 ACODAZOLE 79152-85-5 ABRINEURINUM 178535-93-8 ACOLBIFENUM 182167-02-8 ABUNIDAZOLE 91017-58-2 ACONIAZIDE 13410-86-1 ACADESINE 2627-69-2 ACOTIAMIDUM 185106-16-5 ACAMPROSATE 77337-76-9
  • Cloderm® Cream (Clocortolone Pivalate 0.1%): a Moisturizing, Hydrating Formulation Enhances Epidermal Barrier Function

    Cloderm® Cream (Clocortolone Pivalate 0.1%): a Moisturizing, Hydrating Formulation Enhances Epidermal Barrier Function

    CLINICAL INSIGHTS SUPPORTED BY PROMIUS PHARMA 2013, No. 2 Cloderm® Cream (clocortolone pivalate 0.1%): A Moisturizing, Hydrating Formulation Enhances Epidermal Barrier Function Leon Kircik, MD, FAAD It has been shown that application of some topical corti- DermResearch, PLLC, costeroids can increase TEWL and potentially contribute to Physicians Skin Care, PLLC, epidermal barrier dysfunction.6,7 In mice, application of topical Indiana University Medical Center, Indianapolis, IN, corticosteroids induced progressive increases in TEWL and a Mount Sinai Medical Center, New York, NY reduction in intercellular lipids in the SC.7 It is now well known The stratum corneum (SC) is a dynamic structure marked that even short-term use of topical corticosteroids can com- by multiple complex interactions and feedback loops.1-4 Self- promise epidermal barrier function and SC integrity by inhibit- repair of the permeability barrier has been documented; i.e., the ing epidermal lipid synthesis.8 However, certain formulations of SC can quickly adapt and initiate natural physiologic recovery. topical corticosteroids have been shown to improve skin hydra- Dysfunction of the SC is associated with specific disease states, tion and reduce TEWL.9,10 Perhaps the beneficial or detrimental perhaps most notably atopic dermatitis (AD), but also rosacea, effects of a given topical corticosteroid on TEWL have less to do psoriasis, and other inflammatory cutaneous disorders. More with the corticosteroid itself than with the vehicle in which it precisely, researchers and clinicians believe that AD may be is delivered.11 Thus, treatment becomes an act of balancing the driven in part by poor epidermal barrier function, perhaps as negative effects of the corticosteroid molecule itself on epider- a result of impairments in the permeability, immune response, mal barrier versus the positive impact of the vehicle that deliv- and antimicrobial barriers.