DOCSLIB.ORG

(12) Patent Application Publication (43) Pub

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
(12) Patent Application Publication (43) Pub US 2016037.4914A2 (19) United States (10) Pub. No.: US 2016/037.4914 A2 (12) Patent Application Publication (43) Pub. Date: Dec. 29, 2016 SHARMA et al. REPUBLICATION (54) ANT-DANDRUFF COMPOSITIONS AND Publication Classification HAR CARE FORMULATIONS CONTAINING (51) Int. Cl. ZINC PYRITHIONE AND QUATERNARY A6IR 8/58 (2006.01) AMMONUMI SALT A6IR 8/4I (2006.01) A6IR 8/49 (2006.01) Applicant: JUBILANT LIFE SCIENCES A61O 5/00 (2006.01) (71) (52) U.S. Cl. LIMITED, NOIDA, UTTAR CPC ................. A61K 8/58 (2013.01); A61O 5/006 PRADESH (IN) (2013.01); A61K 8/416 (2013.01); A61K 8/41 (2013.01); A61K 8/4926 (2013.01); A61 K (72) Inventors: VINEET SHARMA, NOIDA, UTTAR 2800/262 (2013.01); A6 IK 2800/524 PRADESH (IN); ASHUTOSH (2013.01); A6 IK 2800/591 (2013.01) AGARWAL, NOIDA, UTTAR (57) ABSTRACT PRADESH (IN) The present invention discloses a stable biocidal composi tion with enhanced anti-fungal activity at low concentration (21) Appl. No.: 14/916,267 of active(s) and a process for preparing the same. The composition comprises: Zinc pyrithione, C8-C18 quaternary (22) PCT Fed: Sep. 2, 2014 ammonium salt (preferably cetylpyridinium chloride), water miscible glycol/polyol/glycol ether/lactam, organic amine (86) PCT No.: PCT/N2014/000570 and/or alkanol amine The composition can be formulated S 371 (c)(1), into: hair care formulations, antidandruff hair care formula tions, water based paints, coatings, adhesives, hard Surface (2) Date: Mar. 3, 2016 cleaners, fabric care compositions, wood products, plastic Prior Publication Data products and medical products. The biocidal compositions and the resulting formulations are transparent or opaque and (65) US 2016/0220468 A1 Aug. 4, 2016 are stable at varying pH and humidity conditions. US 2016/037.4914 A2 Dec. 29, 2016 ANTI-DANDRUFF COMPOSITIONS AND water system using polyethylenimine has pH of about 9.0 or HAR CARE FORMULATIONS CONTAINING above and reducing pH less than 8.0 leads to precipitation of ZINC PYRITHIONE AND QUATERNARY ZPTO in the system. AMMONUMI SALT 0008 U.S. Pat. No. 4,835,149 discloses the use of alkanol and/or alkyl amines in the Solublizing a metal pyrithione salt CROSS REFERENCE TO RELATED in the preparation of a shampoo effective for the treatment APPLICATIONS of seborrhea and dandruff. The amines include etha nolamine, diethanolamine, monoisopropylamine and others 0001. This application is a National Stage of International together with a cosmetically effective amount of an amin Application No. PCT/IN2014/000570, filed on Sep. 2, 2014, opolycarboxylic acid to regulate the pH of the system which claims priority to Indian patent application no. 2640/ between 6.5-7.5. DEL/2013, filed on Sep. 6, 2013, the disclosures of which 0009 U.S. Pat. No. 6,908,912 discloses a stable, soluble, are incorporated by reference in their entirety. antimicrobial composition where insoluble metal salts of pyrithione in combination with a Zinc source (Zinc salts, FIELD OF INVENTION -Oxides, -hydroxides, -borates, -sulfates, -chlorides etc.) were solubilised in an organic amine (1.2-alkanolamines and 0002 The present invention relates to a stable, transpar 1,3-alkanolamines) alone or in combination with a second ent or opaque biocidal compositions comprising Zinc pyri organic amine (monomeric and polymeric forms of 1.2- thione alone or in combination with a C-C quaternary alkyldiamines and 1,3-alkyldiamines). These compositions ammonium salt, preferably cetylpyridinium chloride. The deliver higher concentration of pyrithione and Zinc ions to compositions possess higher bio-availability and enhanced an application (in-can preservatives and metalworking flu antifungal activity and are capable for being formulated into ids) and thus provide enhanced biocidal efficacy against various personal care and industrial formulations. microorganisms and bio-films. 0010. It is known that below pH 4.5 zinc complex dis BACKGROUND OF THE INVENTION sociates into free pyrithione and above pH 9.5., Zinc complex 0003) Zinc pyrithione (ZPTO), also known as Zinc pyri hydrolyzes to yield ionized pyrithione and Zincate species. dine-2-thiol-N-oxide or bis-(1-hydroxy-2(H) pyridinethion Both free and ionized pyrithione are biologically active but ato-zinc is a broad spectrum antimicrobial agent and has being much more water Soluble than the Zinc complex they been used as fungicide and bactericide in various personal are most susceptible to degradation from exposure to light or care and pharmaceutical products, particularly in anti-dan oxygen. In the patent applications cited above, where dif druff shampoos. ZPTO is also used as a biologically active ferent types of amines have been used to solubilize ZPTO, agent for cutting oils and coolant systems, as an agent for either require pH adjustment, pre-formulation of the actives protecting cellulosic fibres from loss of tensile strength due or give precipitate on pH adjustment. Also these prior arts do to action of fungi and as a preservative for water based not disclose any improved or enhanced antifungal or anti paints, coatings, adhesives, wet-state preservatives, hard microbial activity particularly the anti-dandruff efficacy for Surface cleaners, fabric care compositions, wood products, the resulting solubilized ZPTO as compared to ZPTO sus plastic products, medical products, fibres or any other appli pensions. Further, it is extremely difficult to simultaneously cation where microorganism growth must be stopped or attain Superior hair sensory attributes along with higher slowed. anti-dandruff efficacy from ZPTO containing compositions 0004. The antifungal and antimicrobial activity of ZPTO (US 2006/0182696). depends on the bio-availability of ZPTO molecule on scalp. (0011 WO 20010095717 discloses that cationic polymers Because of poor solubility in water (6-12 ppm), the concen can increase the efficacy of Zinc pyrithione in an anti tration of ZPTO molecules in aqueous media and thereafter dandruff shampoos by enhancing the deposition and reten on hair and scalp also remains low, leading to poor bio tion of the water insoluble ZPTO particles on scalp. Simi availability. Also, when used in personal care formulations, larly polyethylenimine or the reaction product of it produces white Suspension that precipitate in the packag polyethylenimine and ethylene oxide or propylene oxide ing bottle. Therefore, to overcome these disadvantages of (U.S. Pat. No. 3,489,686); water-soluble cationic nitrogen low water solubility, precipitations and poor bio-availability, containing polymers or nitrogen-substituted cellulose ether derivatives (U.S. Pat. No. 3,580,853) and piperidinum chlo ZPTO is generally used in excess (1-2% w/w) but higher ride (U.S. Pat. No. 3,761,417) have also been disclosed to concentration of ZPTO lacks ready consumer acceptability increase the efficacy of ZPTO. However, the effect on due to harshness. adsorption of a metal pyrithione salt such as Zinc pyrithione 0005. There had been many approaches to increase the was not found Sufficient for required or enhanced anti solubilisation and antimicrobial efficacy of zinc pyrithione. dandruff efficacy. 0006 U.S. Pat. No. 3,636,213 discloses solubilisation of (0012 U.S. Pat. No. 4,557,928 describes the use of acry heavy metal pyrithione salts in common organic solvents lamide copolymer quaternium 41 and Methocel to create and/or water by combination with primary alkyl and aryl more efficacious Zinc pyrithione anti-dandruff shampoo but monoamines or polyalkyleneimines, preferably dodecyl these shampoos were found unstable over a long period of amine and diglycol amine for use in hair dressings. The time. compositions have pH's from about 8.5-9.0. 0013 Cationic surfactants such as amino or quaternary 0007 U.S. Pat. No. 3,785,985 and U.S. Pat. No. 3,940, ammonium hydrophilic moieties has been used as cationic 482 describe the solubilization of heavy metal pyrithione Surfactant or emulsifying agent in hair conditioners, sham salts in water and detergent containing compositions with poos, anti-static formulations, fabric softeners and other aliphatic polyamine. However, ZPTO solubilized in alcohol/ cosmetics and toiletries preparations (EP 0034385, EP US 2016/037.4914 A2 Dec. 29, 2016 0941061, US 2008/0057015, U.S. Pat. No. 8,506,942, US DETAILED DESCRIPTION OF THE 2012/0064136, U.S. Pat. No. 8,206,694 and US 2012/ INVENTION 01.00092). Some of them like cetyl pyridinium chloride, is 0022. The present invention provides a stable biocidal also commonly used as antiseptic and/or antimicrobial com composition with enhanced antifungal activity and efficacy. ponent at low concentrations (0.025-0.1%) in many OTC The present invention also provides a biocidal composition health care products (creams, dentifrices, deodorizing and having one or more Cs-Cs quaternary ammonium salt in antiperspirant preparations mouth washes, toothpastes, loz addition to Zinc pyrithione. The biocidal compositions of the enges, throat sprays, cough syrups, nasal sprays and pre present invention possess high bio-availability of Zinc pyri moistened wipes) deodorant. thione. The compositions of the present invention is opaque 0014 US 2007/0020221 describes the use of cetylpyri or transparent. dinium chloride (CPC) as a skin lightening or pigmentation 0023 The inventors of the present invention have sur reducing cosmetic agent in cosmetic compositions to regu prisingly found that quaternary ammonium salt, in particular late the condition of mammalian keratinous tissue particu Cs-Cs quaternary ammonium salt such as cetylpyridinium larly for preventing, retarding, and/or treating uneven skin chloride (CPC) possess significant anti-malassezia or anti tOne. dandruff activity alone and shows enhanced anti-dandruff 0015 US 2006/0241190 describes the specific utility of activity in combination with lower concentrations of ZPTO. cetylpyridinium chloride in cosmetic compositions as a The compositions and formulations of the present invention keratolytic active with SLES for the treatment of psoriasis, possess Superior anti-dandruff efficacy at lower concentra eczema and like skin disorders. tions of active (S), ZPTO and Cs-Cs quaternary ammonium 0016.
Load more

Recommended publications
  • Toxicological Evaluation Purifog.Pdf
    Università degli Studi di Torino Prof Valter Maurino Dipartimento di Chimica phone: +39 0116705218 fax: +39 0116707615 Via P. Giuria, 7 10125 Torino Italy e-mail: [email protected] Toxicological evaluation of “PURIFOG” Page 2/24 Short term/single exposure .................................................................................................................................... 17 Inhalation ............................................................................................................................................................... 17 Oral administration LD50 ..................................................................................................................................... 17 Dermal application LD50 ...................................................................................................................................... 18 Skin irritation ........................................................................................................................................................ 18 Sensitisation .......................................................................................................................................................... 18 Mucous membranes and eye ................................................................................................................................ 18 LD and LC50 reported values for Benzyldimethyldecylammonium chloride ................................................... 19 LD and LC50 reported values for Dimethyldioctadecylammonium
    [Show full text]
  • Wo 2010/127231 A2
    (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 4 November 2010 (04.11.2010) WO 2010/127231 A2 (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every AOlN 33/12 (2006.01) A61K 31/14 (2006.01) kind of national protection available): AE, AG, AL, AM, AOlN 25/04 (2006.01) CIlD 3/26 (2006.01) AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, AOlP 1/00 (2006.01) CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (21) International Application Number: HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, PCT/US2010/033 148 KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, (22) International Filing Date: ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, 30 April 2010 (30.04.2010) NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, (25) Filing Language: English TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (26) Publication Language: English (84) Designated States (unless otherwise indicated, for every (30) Priority Data: kind of regional protection available): ARIPO (BW, GH, 61/174,724 1 May 2009 (01 .05.2009) US GM, KE, LR, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, (71) Applicant (for all designated States except US): SIG¬ TM), European (AT, BE, BG, CH, CY, CZ, DE, DK, EE, NAL INVESTMENT AND MANAGEMENT CO.
    [Show full text]
  • Toxicological Evaluation and Limit Values for 2-Ethylhexyl Acryate, Propylene Carbonate, Quaternary Ammonium Compounds, Triglyci
    Environmental Project No. 555 2000 Miljøprojekt Toxicological Evaluation and Limit Values for 2-Ethylhexyl acryate, Propylene carbonate, Quaternary ammonium compounds, triglycidyl isocyanurate and tripropyleneglycol diacrylate Pia Berthelsen, Vibe Beltoft, Inger Thorup, Inge Søborg and Elsa Nielsen The Institute of Food Safety and Toxicology Danish Veterinary and Food Administration The Danish Environmental Protection Agency will, when opportunity offers, publish reports and contributions relating to environmental research and development projects financed via the Danish EPA. Please note that publication does not signify that the contents of the reports necessarily reflect the views of the Danish EPA. The reports are, however, published because the Danish EPA finds that the studies represent a valuable contribution to the debate on environmental policy in Denmark. Contents Preface 5 Principles for setting of limit values for chemical substances 7 2-Ethylhexyl acrylate 11 Propylene carbonate 35 Quaternary ammonium compounds 51 Triglycidyl isocyanurate 81 Tripropyleneglycol diacrylate 111 3 4 Preface This series of reports constitutes a part of the work related to the setting of health based limit values for chemical substances in air, soil and drinking water. In this report, the toxicological documentation for the setting of limit values for 2-ethylhexyl acrylate, propylene carbonate, quaternary ammo- nium compounds, triglycidyl isocyanurate, and tripropyleneglycol diac- rylate are presented. For every substance, the following items are
    [Show full text]
  • Toxicological Evaluation of “PURIFOG Hypo” Page 1/30 Spett.Le FONDERIA MESTIERI Via Almese, 72 - 10093 Collegno (TO) - IT Tel
    Università degli Studi di Torino Prof Valter Maurino Dipartimento di Chimica phone: +39 0116705218 fax: +39 0116707615 Via P. Giuria, 7 10125 Torino Italy e-mail: [email protected] Toxicological evaluation of “PURIFOG Hypo” Page 1/30 Spett.le FONDERIA MESTIERI via Almese, 72 - 10093 Collegno (TO) - IT Tel. +393355977772 / +393494388929 [email protected] Toxicological evaluation of “PURIFOG Hypo” INDEX EXECUTIVE SUMMARY ....................................................................................................................................... 3 PRODUCT TO BE EVALUATED ........................................................................................................................ 3 TOXICOLOGICAL EVALUATION OF “PURIFOG HYPO” ......................................................................... 3 DIPROPYLENE GLYCOL (CAS# 25265-71-8) ........................................................................................................ 4 2, TOXICITY SUMMARY .......................................................................................................................................... 4 3 SKIN IRRITATING AND SENSITIZING EFFECTS ....................................................................................................... 5 3 REPRODUCTIVE AND DEVELOPMENTAL TOXICOLOGY ......................................................................................... 5 3 SKIN, EYE, AND RESPIRATORY IRRITATIONS .......................................................................................................
    [Show full text]
  • Pharmacy Data Management Drug Exception List
    Pharmacy Data Management Drug Exception List Patch PSS*1*127 updated the following drugs with the listed NCPDP Multiplier and NCPDP Dispense Unit. These two fields were added as part of this patch to the DRUG file (#50). Please refer to the Release notes for ePharmacy/ECME Enhancements for Pharmacy Release Notes (BPS_1_5_EPHARMACY_RN_0907.PDF) on the VistA Documentation Library (VDL). The IEN column reflects the IEN for the VA PRODUCT file (#50.68). The ePharmacy Change Control Board provided the following list of drugs with the specified NCPDP Multiplier and NCPDP Dispense Unit values. This listing was used to update the DRUG file (#50) with a post install routine in the PSS*1*127 patch. NCPDP File 50.68 NCPDP Dispense IEN Product Name Multiplier Unit 2 ATROPINE SO4 0.4MG/ML INJ 1.00 ML 3 ATROPINE SO4 1% OINT,OPH 3.50 GM 6 ATROPINE SO4 1% SOLN,OPH 1.00 ML 7 ATROPINE SO4 0.5% OINT,OPH 3.50 GM 8 ATROPINE SO4 0.5% SOLN,OPH 1.00 ML 9 ATROPINE SO4 3% SOLN,OPH 1.00 ML 10 ATROPINE SO4 2% SOLN,OPH 1.00 ML 11 ATROPINE SO4 0.1MG/ML INJ 1.00 ML 12 ATROPINE SO4 0.05MG/ML INJ 1.00 ML 13 ATROPINE SO4 0.4MG/0.5ML INJ 1.00 ML 14 ATROPINE SO4 0.5MG/ML INJ 1.00 ML 15 ATROPINE SO4 1MG/ML INJ 1.00 ML 16 ATROPINE SO4 2MG/ML INJ 1.00 ML 18 ATROPINE SO4 2MG/0.7ML INJ 0.70 ML 21 ATROPINE SO4 0.3MG/ML INJ 1.00 ML 22 ATROPINE SO4 0.8MG/ML INJ 1.00 ML 23 ATROPINE SO4 0.1MG/ML INJ,SYRINGE,5ML 5.00 ML 24 ATROPINE SO4 0.1MG/ML INJ,SYRINGE,10ML 10.00 ML 25 ATROPINE SO4 1MG/ML INJ,AMP,1ML 1.00 ML 26 ATROPINE SO4 0.2MG/0.5ML INJ,AMP,0.5ML 0.50 ML 30 CODEINE PO4 30MG/ML
    [Show full text]
  • Safety Data Sheet
    SAFETY DATA SHEET SECTION 1: CHEMICAL PRODUCT and COMPANY IDENTIFICATION Product Name: Cetyldimethylbenzylammonium chloride hydrate 97% Product Code: C07180 Supplier: Pfaltz & Bauer, Inc. 172 E. Aurora Street Waterbury, CT 06708 USA Phone: 203-574-0075 FAX: 203-574-3181 Emergency Phone: INFOTRAC, US: 1-800-535-5053 INFOTRAC, INTERNATIONAL: +1-352-323-3500 SECTION 2: HAZARDS IDENTIFICATION Statement of Hazard: Corrosive, Environmentally hazardous, Irritant, Respiratory irritant Acute Health Hazard: Irritant to eyes, skin, mucous membranes and respiratory system. May be harmful by ingestion, skin absorption and inhalation. Chronic Health Hazard: Not Available HMIS Rating: H: 3 F: 0 P: 0 NFPA Rating: H: 3 F: 0 R: 0 To the best of our knowledge, the toxicological properties of this chemical have not been thoroughly investigated. Use appropriate procedures and precautions to prevent or minimize exposure. GHS Classification in accordance with 29 CFR 1910 (OSHA HCS): Acute toxicity, dermal (Category 4), H312 Acute toxicity, inhalation (Category 4), H332 Acute toxicity, oral (Category 4), H302 Hazardous to the aquatic environment, chronic toxicity (Category 1), H410 Serious eye damage/eye irritation (Category 1), H318 Skin corrosion/irritation (Category 1A), H314 Specific target organ toxicity, single exposure; Respiratory tract irritation (Category 3), H335 Page 1 of 7 Pictogram: Signal Word: Danger Hazard Statement(s): H302 Harmful if swallowed. H312 Harmful in contact with skin. H314 Causes severe skin burns and eye damage. H318 Causes serious eye damage. H332 Harmful if inhaled. H335 May cause respiratory irritation. H410 Very toxic to aquatic life with long-lasting effects. Precautionary Statement(s): P261 Avoid breathing dust/fume/gas/mist/vapors/spray.
    [Show full text]
  • | Oli Ka Atau Tutului Ma Da Matawi
    |OLI KA ATAU TUTULUIUS009968537B2 MA DA MATAWI (12 ) United States Patent ( 10 ) Patent No. : US 9 ,968 , 537 B2 Sharma et al. ( 45 ) Date of Patent : May 15 , 2018 ( 54 ) ANTI- DANDRUFF COMPOSITIONS AND (56 ) References Cited HAIR CARE FORMULATIONS CONTAINING ZINC PYRITHIONE AND QUATERNARY U . S . PATENT DOCUMENTS AMMONIUM SALT 3 ,489 , 686 A 1 /1970 Parran , Jr. 3 ,580 ,853 A 5 / 1971 Parran , Jr. ( 71 ) Applicant : JUBILANT LIFE SCIENCES 3 ,636 ,213 A 1 / 1972 Gerstein et al. LIMITED , Noida , Uttar Pradesh ( IN ) 3 ,761 , 417 A 9 / 1973 Parran , Jr . 3 , 785 , 985 A 1 / 1974 Grand 3 , 940 , 482 A 2 / 1976 Grand (72 ) Inventors : Vineet Sharma, Uttar Pradesh ( IN ) ; 4 , 396 ,766 A * 8 / 1983 Farmer , Jr . .. .. .. CO7D 213 /89 Ashutosh Agarwal, Uttar Pradesh ( IN ) 546 / 290 4 , 557 , 928 A 12 / 1985 Glover ( * ) Notice : Subject to any disclaimer , the term of this 4 , 835 , 129 A * 5 / 1989 Travers B01J 29 /90 patent is extended or adjusted under 35 502 /37 U . S . C . 154 (b ) by 0 days . days . 4 , 835 , 149 A 5 / 1989 Burke et al . 6 ,908 , 912 B2 6 / 2005 Rioux et al. 8 ,206 ,694 B2 6 / 2012 Chang et al . (21 ) Appl . No. : 14 /916 , 267 8 , 506 ,942 B2 8 / 2013 Burry et al . 2002 /0168327 A1 * 11/ 2002 Bailey . .. .. .. .. A61K 8 / 365 (22 ) PCT Filed : Sep . 2 , 2014 424 / 70 . 1 2003 /0228272 Al 12 /2003 Amjad et al . (86 ) PCT No .: PCT / IN2014 /000570 2004 / 0058855 A1 3 / 2004 Schwartz et al. 2005 /0158263 A1 7 / 2005 Rioux et al .
    [Show full text]
  • Benzalkonium Chloride and Pyrene
    Microencapsulation of cationic antimicrobial surfactants in core-shell particles Master’s thesis in Materials Chemistry EMIL LUKASIEWICZ Department of Chemistry and Chemical Engineering CHALMERS UNIVERSITY OF TECHNOLOGY Gothenburg, Sweden 2019 ii Master’s Thesis 2019 Microencapsulation of cationic antimicrobial surfactants in core-shell particles EMIL LUKASIEWICZ Department of Chemistry and Chemical Engineering Division of Applied Chemistry Chalmers University of Technology Gothenburg, Sweden 2019 Microencapsulation of cationic antimicrobial surfactants in core-shell particles EMIL LUKASIEWICZ © EMIL LUKASIEWICZ, 2019. Supervisor: Lars Nordstierna, Department of Chemistry and Chemical Engineering Supervisor: Markus Andersson Trojer, RISE IVF Examiner: Lars Nordstierna, Department of Chemistry and Chemical Engineering Master’s Thesis 2019 Department of Chemistry and Chemical Engineering Division of Applied Chemistry Chalmers University of Technology SE-412 96 Gothenburg Cover: Picture taken with fluorescene microscope (100x magnification) visualizing core-shell particles of PLGA consisting of ethyl linoleate, benzalkonium chloride and pyrene. Gothenburg, Sweden 2019 v Microencapsulation of cationic antimicrobial surfactants in core-shell particles EMIL LUKASIEWICZ Department of Chemistry and Chemical Engineering Chalmers University of Technology Abstract Within the health care industry, there has been an increasing frequency of non- healing chronic wounds. This development is associated with an increasing portion of the population being older. Momentarily, the issue is addressed with various antiseptics that are impregnated in wound care dressings. The concentration of an- tiseptics is a vital design parameter. If the antibacterial substance is impregnated in the wound care dressing material, an excess of antibacterial substance is needed to retain a concentration above the minimum inhibitory concentration and mul- tiresistant development will become a significant risk.
    [Show full text]
  • 21 CFR Ch. I (4–1–19 Edition) § 310.545
    § 310.545 21 CFR Ch. I (4–1–19 Edition) for marketing. In the absence of an ap- Chloroxylenol proved new drug application or abbre- Cloxyquin viated new drug application, such prod- Coal tar uct is also misbranded under section Dibenzothiophene Estrone 502 of the act. Magnesium aluminum silicate (c) Clinical investigations designed Magnesium sulfate to obtain evidence that any drug prod- Phenol uct labeled, represented, or promoted Phenolate sodium for OTC use as a smoking deterrent is Phenyl salicylate safe and effective for the purpose in- Povidone-iodine tended must comply with the require- Pyrilamine maleate ments and procedures governing the Resorcinol (as single ingredient) use of investigational new drugs set Resorcinol monoacetate (as single ingre- dient) forth in part 312 of this chapter. Salicylic acid (over 2 up to 5 percent) (d) After May 7, 1991, any such OTC Sodium borate drug product containing cloves, cori- Sodium thiosulfate ander, eucalyptus oil, ginger (Ja- Tetracaine hydrochloride maica), lemon oil (terpeneless), licorice Thymol root extract, menthol, methyl salicy- Vitamin E late, quinine ascorbate, silver nitrate, Zinc oxide and/or thymol initially introduced or Zinc stearate initially delivered for introduction into Zinc sulfide interstate commerce that is not in (2) Anticaries drug products—(i) Ap- compliance with this section is subject proved as of May 7, 1991. to regulatory action. After December 1, 1993, any such OTC drug product con- Hydrogen fluoride Sodium carbonate taining lobeline (in the form of lobeline Sodium monofluorophosphate (6 percent sulfate or natural lobelia alkaloids or rinse) Lobelia inflata herb), povidone-silver ni- Sodium phosphate trate, silver acetate, or any other in- gredients initially introduced or ini- (ii) Approved as of October 7, 1996.
    [Show full text]
  • Benzyldimethylhexadecylammon
    Benzyldimethylhexadecylammonium chloride sc-239325 Material Safety Data Sheet Hazard Alert Code Key: EXTREME HIGH MODERATE LOW Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION PRODUCT NAME Benzyldimethylhexadecylammonium chloride STATEMENT OF HAZARDOUS NATURE CONSIDERED A HAZARDOUS SUBSTANCE ACCORDING TO OSHA 29 CFR 1910.1200. NFPA FLAMMABILITY1 HEALTH3 HAZARD INSTABILITY1 SUPPLIER Santa Cruz Biotechnology, Inc. 2145 Delaware Avenue Santa Cruz, California 95060 800.457.3801 or 831.457.3800 EMERGENCY ChemWatch Within the US & Canada: 877-715-9305 Outside the US & Canada: +800 2436 2255 (1-800-CHEMCALL) or call +613 9573 3112 SYNONYMS C25-H46-N-Cl, C6H5CH2N(CH3)2(C16H33)Cl, "benzenemethanaminium , N-hexadecyl-N, N-dimethyl-, chloride", "benzyldimethylcetylammonium chloride", "benzyldimethylhexadecylammonium chloride", "benzylhexadecyl-dimethylammonium chloride", "benzyl(hexadecyl)dimethylammonium chloride", "cetyldimethyl-benzylammonium chloride", "ammonium, benzyldimethylhexadecyl-, chloride", "ammonium benzylhexadecyldimethyl-, chloride", Acinol, "Ammonyx G, T", Baktonium, Banicol, Benzaletas, Bicetonium, Bonjela, Cdbac, Cetol, Cetylon, "Cetyl Zephiran", CKC, "Dehyquart CBB, CDB", Dmcbac, "Pharycidin concentrate", Rodalon, Splian, Tetraseptan, WIN-357, "Winzer Solution", "Zettyn chloride", USAN, "quaternary ammonium germicide", "benzalkonium chloride family" Section 2 - HAZARDS IDENTIFICATION CHEMWATCH HAZARD RATINGS Min Max Flammability: 1 Toxicity: 2 Body Contact: 3 Min/Nil=0 Low=1 Reactivity: 1 Moderate=2 High=3 Chronic: 2 Extreme=4 CANADIAN WHMIS SYMBOLS 1 of 9 EMERGENCY OVERVIEW RISK Causes burns. Risk of serious damage to eyes. Harmful in contact with skin and if swallowed. Very toxic to aquatic organisms. POTENTIAL HEALTH EFFECTS ACUTE HEALTH EFFECTS SWALLOWED ! Accidental ingestion of the material may be harmful; animal experiments indicate that ingestion of less than 150 gram may be fatal or may produce serious damage to the health of the individual.
    [Show full text]
  • 21 CFR Ch. I (4–1–20 Edition) § 310.545
    SUBCHAPTER D—DRUGS FOR HUMAN USE PART 300—GENERAL presented for it, then formulation, la- beling, or dosage changes may be pro- Subpart A [Reserved] posed and any resulting formulation may meet the appropriate criteria list- Subpart B—Combination Drugs ed in paragraph (a) of this section. (c) A fixed-combination prescription Sec. 300.50 Fixed-combination prescription drugs drug for humans that has been deter- for humans. mined to be effective for labeled indica- tions by the Food and Drug Adminis- Subpart C—Substances Generally tration, based on evaluation of the Prohibited From Drugs NAS-NRC report on the combination, is considered to be in compliance with 300.100 Chlorofluorocarbon propellants. the requirements of this section. AUTHORITY: 21 U.S.C. 331, 351, 352, 355, 360b, 361, 371. [40 FR 13496, Mar. 27, 1975, as amended at 64 FR 401, Jan. 5, 1999] Subpart A [Reserved] Subpart C—Substances Generally Subpart B—Combination Drugs Prohibited From Drugs § 300.50 Fixed-combination prescrip- § 300.100 Chlorofluorocarbon propel- tion drugs for humans. lants. The Food and Drug Administration’s The use of chlorofluorocarbons in policy in administering the new-drug, human drugs as propellants in self- antibiotic, and other regulatory provi- pressurized containers is generally pro- sions of the Federal Food, Drug, and hibited except as provided by § 2.125 of Cosmetic Act regarding fixed combina- this chapter. tion dosage form prescription drugs for [43 FR 11317, Mar. 17, 1978] humans is as follows: (a) Two or more drugs may be com- bined in a single dosage form when PART 310—NEW DRUGS each component makes a contribution to the claimed effects and the dosage of Subpart A—General Provisions each component (amount, frequency, Sec.
    [Show full text]
  • Wo 2007/044693 A2
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date PCT (10) International Publication Number 19 April 2007 (19.04.2007) WO 2007/044693 A2 (51) International Patent Classification: Tuscaloosa, AL 35401 (US). SWATLOSKI, Richard, P. A61K 31/555 (2006.01) A61K 31/28 (2006.01) [US/US]; 1801 Waterford Lane, Tuscaloosa, AL 35405 (21) International Application Number: (US). HOUGH, Whitney, L. [US/US]; 226 Wolf Creek PCT/US2006/039454 Drive, Albertville, AL 35951 (US). DAVIS, James, Hillard [US/US]; 324 Vanderbilt Drive, Mobile, AL (22) 10 October 2006 (10.10.2006) International Filing Date: 36608 (US). SMIGLAK, Marcin [PL/US]; 3302 Sixth (25) Filing Language: English Avenue East, Apt. C, Tuscaloosa, AL 35405 (US). PER- (26) Publication Language: English NAK, Juliusz [PL/PL]; UL. Nalkowskiej, 8A, PL-60-573 Poznan (PL). SPEAR, Scott, K. [US/US]; 302 County (30) Priority Data: Road 49, Bankston, AL 35542 (US). 60/724,604 7 October 2005 (07.10.2005) US 60/724,605 7 October 2005 (07.10.2005) US (74) Agents: KATZ, Mitchell, A. et al.; Needle & Rosenberg, 60/764,850 2 February 2006 (02.02.2006) US PC, Suite 1000, 999 Peachtree Street, Atlanta, GA 30309- (71) Applicant (for all designated States except US): THE 3915 (US). UNIVERSITY OF ALABAMA [US/US]; 222 Rose (81) Designated States (unless otherwise indicated, for every Administration Building, Post Office Box 870106, kind of national protection available): AE, AG, AL, AM, Tuscaloosa, AL 35487-0106 (US). AT,AU, AZ, BA, BB, BG, BR, BW, BY, BZ, CA, CH, CN, (72) Inventors; and CO, CR, CU, CZ, DE, DK, DM, DZ, EC, EE, EG, ES, FI, (75) Inventors/Applicants (for US only): ROGERS, Robin, GB, GD, GE, GH, GM, HN, HR, HU, ID, IL, IN, IS, JP, D.
    [Show full text]