DOCSLIB.ORG

Safety Assessment of Polysorbates As Used in Cosmetics

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Safety Assessment of Polysorbates As Used in Cosmetics Safety Assessment of Polysorbates as Used in Cosmetics Status: Draft Final Amended Report for Panel Review Release Date: May 22, 2015 Panel Meeting Date: June 15-16, 2015 The 2015 Cosmetic Ingredient Review Expert Panel members are: Chair, Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V. Belsito, M.D.; Ronald A. Hill, Ph.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; James G. Marks, Jr., M.D.; Ronald C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. The CIR Director is Lillian J. Gill, D.P.A. This report was prepared by Lillian C. Becker, Scientific Analyst/Writer. © Cosmetic Ingredient Review 1620 L Street, NW, Suite 1200 Washington, DC 20036-4702 ph 202.331.0651 fax 202.331.0088 [email protected] Commitment & Credibility since 1976 MEMORANDUM To: CIR Expert Panel and Liaisons From: Lillian C. Becker, M.S. Scientific Analyst and Writer Date: May 22, 2015 Subject: Draft Final Amended Report of Polysorbates as Used in Cosmetics Attached is the draft final amended report of Polysorbates as used in cosmetics. [PSorba_062015_Rep] In March, 2015, the Panel issued a tentative amended report with a conclusion of safe as used when formulated to be nonirritating. This safety assessment combined 3 previous reports and added new polysorbate ingredients. There were three polysorbate ingredients reported in the VCRP but were not listed in the Dictionary (PEG-20 sorbitan laurate, PEG-20 sorbitan stearate, and PEG-30 sorbitan beeswax). The Council has asserted that PEG-20 sorbitan laurate is another term for polysorbate 20 and PEG-20 sorbitan stearate is another term for polysorbate 60. Therefore, these two ingredients do not add to the ingredient count of this report. On the other hand, there is no reason to not add PEG-30 sorbitan beeswax to the report. The report now has a total of 80 ingredients. Industry comments have been addressed. [PSorba_062015_Council] The Council would like the Panel to consider whether or not the cyto/genotoxicity study of polysorbate 20 (reference 44) should remain in the genotoxicity section or be moved to a cytotoxicity section. In this study, the authors considered the results of multiple assays (MTT, DAPI, DNA fragmentation, DNA fragmentation, alkaline comet, and annexin V apoptosis assays) to come to a conclusion on genotoxcity. While these individual assays should stay together for continuity and understanding of the paper, should they be moved to a different section in the report? No new data have been submitted. The Council is conducting a concentration of use survey on PEG- 40 sorbitan laurate. The Panel is to examine the Abstract, Discussion, and Conclusion to ensure that they reflect the Panel’s thinking. The Panel is to issue a final amended report. __________________________________________________________________________________________ 1620 L Street, NW Suite 1200, Washington, DC 20036 (Main) 202-331-0651 (Fax) 202-331-0088 (Email) [email protected] (Website) www.cir-safety.org Distributed for comment only -- do not cite or quote Public Comment CIR Expert Panel Re-Review Rpt Status 15 years New Data; or announce OR request since last Re-review to 60 day public comment period Panel PRIORITY LIST Mar 2015 Are new data cause to reopen? The original polysorbates report was published in 1984. It was proposed that the RR also include the ingredients in the PEG Polysorbates (2000) and Sorbeth Beeswax (2001) reports . YES NO Previously unreviewed ingredients were also added. DRAFT AMENDED DAR REPORT* Are new ingredients appropriate for inclusion/re-open? Table Table IDA TAR Yes No IDA Notice IDA RE-REVIEW SUMMARY DRAFT TENTATIVE Draft TAR AMENDED REPORT 60 day public comment period Table Table Tentative Amended Report Mar 2015 Issue TAR Draft FAR DRAFT FINAL 60 day Public comment period AMENDED REPORT June 2015 Table Table Different Conclusion Final Amended Issue PUBLISH Report FAR *If Draft Amended Report (DAR) is available, the Panel may choose to review (and issue a TAR: if not, CIR staff prepares DAR for Panel Review. Distributed for comment only -- do not cite or quote History – Polysorbates 1984 – Report on polysorbates 20, 21, 40, 60, 61, 65, 80, 81, and 85 published with a safe as used conclusion. 2000 – A safety assessment was published of a re-review if the above polysorbates as well as additional polysorbates with a safe as used conclusion. 2001 – A safety assessment was published of Sorbeth-6 beeswax, Sorbeth-8 beeswax, and Sorbeth-20 beeswax with a safe as used conclusion. March, 2015 – The Panel reviewed the re-review document. The safety assessment was reopened to combine three reports on various polysorbates, add new ingredients, and to remove the caveat concerning the use of PEGs on damaged skin from the sorbeth beeswaxes. A safe as used conclusion was issued. June, 2015 – The Panel is to review the Abstract, Discussion and Conclusion and issue a final amended report. Distributed for comment only -- do not cite or quote Polysorbate Data Profile for June, 2015. Writer - Lillian Becker Repeated dose Sensitizatio ADME Acute toxicity Irritation toxicity n Use Oral Dermal Inhale Oral Dermal Ocular Animal Dermal Irr. Human Dermal Irr Animal Sensitization Human Sensitization toxicity Repro/Devel Genotoxicity Carcinogenicity Phototoxicity Penetration Dermal Log K Inhale Irritation ow Polysorbate 21 ON O O O O O Sorbeth-6 laurate PEG-10 sorbitan ON laurate PEG-40 sorbitan N laurate Polysorbate 20 ON ON O ON ON O O O O O ON O O PEG-44 sorbitan ON laurate PEG-75 sorbitan N laurate PEG-80 sorbitan ON laurate Polysorbate 40 ON O O O O O O O O O PEG-80 sorbitan O O palmitate Sorbeth-3 isostearate PEG-2 sorbitan isostearate PEG-5 sorbitan isostearate PEG-20 sorbitan ON isostearate PEG-3 sorbitan N stearate PEG-4 sorbitan O O O stearate Polysorbate 61 ON O O O PEG-6 sorbitan stearate Polysorbate 60 ON O O O O ON ON O O ON O O O Polysorbate 65 ON O O O O O PEG-40 Sorbitan ON Stearate PEG-60 sorbitan N stearate PEG-3 sorbitan ON oleate Polysorbate 81 ON ON O O O N N O PEG-6 sorbitan N oleate PEG-20 sorbitan O O O O O O O O oleate Polysorbate 80 O ON ON ON O O O O O O O ON ON O O PEG-40 sorbitan oleate PEG-20 sorbitan N cocoate Sorbeth-2 cocoate PEG-40 sorbitan O O O O lanolate PEG-75 sorbitan lanolate Sorbeth-2 beeswax Sorbeth-6 N O O O O beeswax Sorbeth-8 beeswax Sorbeth-20 ON O O O O O beeswax PEG-40 sorbitan N diisostearate Distributed for comment only -- do not cite or quote Polysorbate Data Profile for June, 2015. Writer - Lillian Becker Repeated dose Sensitizatio ADME Acute toxicity Irritation toxicity n Use Oral Dermal Inhale Oral Dermal Ocular Animal Dermal Irr. Human Dermal Irr Animal Sensitization Human Sensitization toxicity Repro/Devel Genotoxicity Carcinogenicity Phototoxicity Penetration Dermal Log K Inhale Irritation ow PEG-4 sorbitan triisostearate PEG-20 sorbitan triisostearate PEG-160 sorbitan triisostearate PEG-3 sorbitan tristearate Sorbeth-3 tristearate Sorbeth-160 tristearate Sorbeth-450 tristearate PEG-2 sorbitan trioleate PEG-18 sorbitan trioleate Polysorbate 85 ON O O O O O O Sorbeth-20 tetraisostearate Sorbeth-30 N tetraisostearate Sorbeth-40 tetraisostearate Sorbeth-50 tetraisostearate PEG-60 sorbitan N tetrastearate Sorbeth-60 tetrastearate (PEG-60 sorbitol tetrastearate) Sorbeth-4 N tetraoleate Sorbeth-6 N tetraoleate PEG-20 Sorbitan Tetraoleate PEG-30 sorbitan N tetraoleate Sorbeth-30 N tetraoleate PEG-40 sorbitan ON tetraoleate Sorbeth-40 N tetraoleate PEG-60 sorbitan tetraoleate Sorbeth-60 N tetraoleate Sorbeth-20 pentaisostearate Sorbeth-30 pentaisostearate Sorbeth-40 pentaisostearate Sorbeth-50 pentaisostearate Sorbeth-40 pentaoleate Sorbeth-30 O O O tetraoleate laurate (PEG-30 sorbitol tetraoleate Distributed for comment only -- do not cite or quote Polysorbate Data Profile for June, 2015. Writer - Lillian Becker Repeated dose Sensitizatio ADME Acute toxicity Irritation toxicity n Use Oral Dermal Inhale Oral Dermal Ocular Animal Dermal Irr. Human Dermal Irr Animal Sensitization Human Sensitization toxicity Repro/Devel Genotoxicity Carcinogenicity Phototoxicity Penetration Dermal Log K Inhale Irritation ow laurate) Sorbeth-2 hexalaurate Sorbeth-2 hexaisostearate PEG-40 sorbitan perisostearate Sorbeth-6 hexastearate Sorbeth-150 hexastearate Sorbeth-2 hexaoleate Sorbeth-40 hexaoleate (PEG- 40 sorbitol hexaoleate) Sorbeth-50 O O O hexaoleate (PEG- 50 sorbitol hexaoleate) PEG-40 sorbitan ON O O O peroleate Sorbeth-2 hexacaprylate/ca prate Sorbeth-12 hexacocoate Sorbeth- 2/oleate/dimer dilinoleate crosspolymer Sorbitan N monooleate, ethoxylated Sorbitan N N N N monolaurate, ethoxylated Sorbitan N N N N monstearate, ethoxylated Sorbitan esters O O O O O O O O O O N – New data O – Data from previous reports Distributed for comment only -- do not cite or quote Search Strategy - Polysorbates SciFinder Search Terms: Polysorbate 20, 9005-64-5, Polysorbate 21, Polysorbate 40, 9005-66-7, Polysorbate 60, 9005-67-8, Polysorbate 61, Polysorbate 65, 9005-71-4, Polysorbate 80, 9005-65-6, Polysorbate 81, Polysorbate 85, 9005-70-3 HITS: 9005-64-5 – 664; Remove patents – 120; refine by index terms (toxicity, etc.) – 120. 4 selected. - 9005-66-7 - 981; remove patents – 365; refine by index terms (toxicity, etc.) – 365. - 4482: remove patents – 1245; refine by index terms (toxicity, etc.) – 1245; English – 922; Toxicity – 66 - 2592; Remove patents – 994; 9005-66-7, 9005-70-3 – 1044; remove patents 404; English 315; toxicity 17 hits, none useful. 9005-71-4 – 689; remove patents 136; English 98; 4 selected 9005-67-8 – 7818; 4779; remove patents 1428; English 1001; toxicity 70 hits; 4 selected 9005-65-6 – 33,579; 24,295; remove patents 9947; English 7337; “toxicity” 576; 1990 – 486; Index term “toxicity” – 64; 4 selected Search Terms: PEG-2 Sorbitan lsostearate, PEG-5 Sorbitan lsostearate, PEG-20 Sorbitan Isostearate, PEG-40 Sorbitan Lanolate, PEG-75 Sorbitan Lanolate, PEG-10 Sorbitan Laurate, PEG- 40 Sorbitan Laurate, PEG-44 Sorbitan Laurate, PEG-75 Sorbitan Laurate, PEG-80 Sorbitan Laurate HITS: -Substance Identifier "PEG-20 Sorbitan Cocoate; PEG-4..
Load more

Recommended publications
  • Safety Assessment of Sorbitan Esters As Used in Cosmetics
    Safety Assessment of Sorbitan Esters as Used in Cosmetics Status: Re-Review for Panel Review Release Date: August 18, 2014 Panel Meeting Date: September 8-9, 2014 The 2014 Cosmetic Ingredient Review Expert Panel members are: Chairman, Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V. Belsito, M.D.; Ronald A. Hill, Ph.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; James G. Marks, Jr., M.D., Ronald C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. The CIR Director is Lillian J. Gill, D.P.A. This safety assessment was prepared by Monice M. Fiume, Assistant Director/Senior Scientific Analyst and Bart Heldreth, Ph.D., Chemist. © Cosmetic Ingredient Review 1620 L Street, NW, Suite 1200 ♢ Washington, DC 20036-4702 ♢ ph 202.331.0651 ♢ fax 202.331.0088 ♢ [email protected] Commitment & Credibility since 1976 Memorandum To: CIR Expert Panel Members and Liaisons From: Monice M. Fiume MMF Assistant Director/Senior Scientific Analyst Date: August 18, 2014 Subject: Safety Assessment of Sorbitan Esters as Used in Cosmetics Enclosed is the Re-Review of the Safety Assessment on Sorbitan Esters as Used in Cosmetics. (It is identified as sorbes092014rep_final for posting in the pdf document.) In 1985, the Panel determined that a group of seven sorbitan esters were safe as used in cosmetic ingredients. In 2002, the Panel reviewed the safety of an additional 10 sorbitan ester, and issued an addendum to that report, concluding that the sorbitan fatty acid esters were safe as used in cosmet- ic ingredients.
    [Show full text]
  • Docetaxel Formulation in Polysorbate 80
    American Journal of Pharmacology & Therapeutics Research Article Docetaxel Formulation in Polysorbate 80: A Complex and Sensitive System - Jean-René Authelin1*, Doris Andert2, Lucile Boilait3, Jean-Jacques Nguyen-Huu1, Yan-Yan Zhang4 and Ping Ni1 1Sanofi R&D, 94400 Vitry sur Seine, France 2Sanofi Industrial Affairs, 65926 Frankfurt am Main, Germany 3Sanofi R&D, 34000 Montpellier, France 4Sanofi R&D, 200040 Shanghai, China *Address for Correspondence: Jean-René Authelin, Sanofi R&D, 94400 Vitry sur Seine, France, E-mail: Submitted: 21 September 2020; Approved: 25 September 2020; Published: 30 September 2020 Cite this article: Authelin JR, Andert D, Boilait L, Nguyen-Huu JJ, Zhang YY, Ni P. Docetaxel Formulation in Polysorbate 80: A Complex and Sensitive System. Am J Pharmacol Ther. 2020 Sep 30;4(1): 001-006. doi: 10.37871/ajpt.id19 Copyright: © 2020 Authelin JR, et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. American Journal of Pharmacology & Therapeutics ABSTRACT Background: Innovator docetaxel (in Taxotere reference product), a poorly water-soluble agent with a narrow therapeutic index, is developed as a solution in Polysorbate 80 and ethanol. Such formulations form metastable micelles and are considered complex parenterals. Formulation process control impacts quality attributes effi cacy and safety. Characterization of micellar systems in infusion bags is required to ensure good biopharmaceutical performance and equivalence of docetaxel generic formulation. Methods: HPLC, GC, water content (Karl Fischer) and pH were used to characterize chemical properties and oxygen content in the vial headspace.
    [Show full text]
  • Effects of Selected Polysorbate and Sucrose Ester Emulsifiers on the Physicochemical Properties of Astaxanthin Nanodispersions
    Molecules 2013, 18, 768-777; doi:10.3390/molecules18010768 OPEN ACCESS molecules ISSN 1420-3049 www.mdpi.com/journal/molecules Article Effects of Selected Polysorbate and Sucrose Ester Emulsifiers on the Physicochemical Properties of Astaxanthin Nanodispersions Navideh Anarjan 1,2 and Chin Ping Tan 1,* 1 Department of Food Technology, Faculty of Food Science and Technology, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia; E-Mail: [email protected] 2 Young Researchers and Elites Club, East Azarbaijan Science and Research Branch, Islamic Azad University, 15655/461, Tabriz, Iran * Author to whom correspondence should be addressed; E-Mail: [email protected]; Tel.: +603-8946-8418; Fax: +603-8942-3552. Received: 7 December 2012; in revised form: 28 December2012 / Accepted: 31 December 2012 / Published: 9 January 2013 Abstract: The effects of selected nonionic emulsifiers on the physicochemical characteristics of astaxanthin nanodispersions produced by an emulsification/evaporation technique were studied. The emulsifiers used were polysorbates (Polysorbate 20, Polysorbate 40, Polysorbate 60 and Polysorbate 80) and sucrose esters of fatty acids (sucrose laurate, palmitate, stearate and oleate). The mean particle diameters of the nanodispersions ranged from 70 nm to 150 nm, depending on the emulsifier used. In the prepared nanodispersions, the astaxanthin particle diameter decreased with increasing emulsifier hydrophilicity and decreasing carbon number of the fatty acid in the emulsifier structure. Astaxanthin nanodispersions with the smallest particle diameters were produced with Polysorbate 20 and sucrose laurate among the polysorbates and the sucrose esters, respectively. We also found that the Polysorbate 80- and sucrose oleate-stabilized nanodispersions had the highest astaxanthin losses (i.e., the lowest astaxanthin contents in the final products) among the nanodispersions.
    [Show full text]
  • Polysorbate 80
    Pharmacopeial Forum Vol. 35(4) [July±Aug. 2009] STAGE 6 HARMONIZATION 1019 BRIEFING ASSAY • COMPOSITION OF FATTY ACIDS Diluent: 20 g/L sodium hydroxide in methanol Polysorbate 80. The European Pharmacopoeia is the coordi- Saturated sodium chloride solution: Sodium chloride and nating pharmacopeia for the international harmonization of the water (1:2). Before use, decant the solution from any undis- compendial standards for the Polysorbate 80 monograph, as solved substance and filter, if necessary. part of the process of international harmonization of Reference solution A: Prepare 0.50 g of the mixture of cali- monographs and general analytical methods of the European, brating substances with the composition described in Table 1. Japanese, and United States pharmacopeias. The following mon- Dissolve in heptane, and dilute with heptane to 50.0 mL. Reference solution B: Reference solution A in heptane (1 in ograph, which represents the ADOPTION STAGE 6 document, Stage 6 Harmonization is based on the corresponding monograph for Polysorbate 80 10) that was prepared by the European Pharmacopoeia and pub- Reference solution C: Prepare 0.50 g of a mixture of fatty lished in PF 33(5) [Sept.±Oct. 2007]. The European Pharmaco- acid methyl esters, which corresponds to the composition of poeia draft was based in part on comments from the Japanese the substance to be examined. Dissolve in heptane, and dilute Pharmacopoeia and the United States Pharmacopeia in response with heptane to 50.0 mL. [NOTEÐCommercially available mix- to the Provisional Harmonized Text Stage 5A and 5B drafts pre- tures of fatty acid methyl esters may also be used.] pared by the European Pharmacopoeia.
    [Show full text]
  • Immediate Hypersensitivity Reactions Caused by Drug Excipients: a Literature Review Caballero ML, Quirce S
    REVIEWS Immediate Hypersensitivity Reactions Caused by Drug Excipients: A Literature Review Caballero ML, Quirce S Department of Allergy, La Paz University Hospital, IdiPAZ, Madrid, Spain J Investig Allergol Clin Immunol 2020; Vol. 30(2): 86-100 doi: 10.18176/jiaci.0476 Abstract The European Medicines Agency defines excipients as the constituents of a pharmaceutical form apart from the active substance. Immediate hypersensitivity reactions (IHRs) caused by excipients contained in the formulation of medications have been described. However, there are no data on the prevalence of IHRs due to drug excipients. Clinical manifestations of allergy to excipients can range from skin disorders to life-threatening systemic reactions. The aim of this study was to review the literature on allergy to pharmaceutical excipients and to record the IHRs described with various types of medications, specifically reactions due to the excipients contained in their formulations. The cases reported were sorted alphabetically by type of medication and excipient in order to obtain a list of the excipients most frequently involved for each type of medication. Key words: Allergy. Drug immediate hypersensitivity reaction. Excipient. Pharmaceutical excipients. Resumen La Agencia Europea de Medicamentos define los excipientes como los componentes de una forma farmacéutica diferenciados del principio activo. Se han descrito reacciones de hipersensibilidad inmediata causadas por los excipientes contenidos en la formulación de medicamentos. Sin embargo, no hay datos sobre la prevalencia de dichas reacciones. Las manifestaciones clínicas de la alergia a los excipientes pueden ir desde trastornos de la piel hasta reacciones sistémicas que ponen en peligro la vida. El objetivo de este estudio fue realizar una revisión de la literatura sobre la alergia a los excipientes farmacéuticos y recopilar las reacciones inmediatas descritas con diferentes tipos de medicamento, debido solo a excipientes contenidos en sus formulaciones.
    [Show full text]
  • Synthèse Et Évaluation Pharmacologique D'analogues Préactivés De L'ifosfamide
    Synthèse et évaluation pharmacologique d’analogues préactivés de l’ifosfamide : prodrogues et nanoparticules à visée antitumorale Charles Skarbek To cite this version: Charles Skarbek. Synthèse et évaluation pharmacologique d’analogues préactivés de l’ifosfamide : prodrogues et nanoparticules à visée antitumorale. Pharmacie galénique. Université Paris Saclay (COmUE), 2017. Français. NNT : 2017SACLS247. tel-01618196 HAL Id: tel-01618196 https://tel.archives-ouvertes.fr/tel-01618196 Submitted on 17 Oct 2017 HAL is a multi-disciplinary open access L’archive ouverte pluridisciplinaire HAL, est archive for the deposit and dissemination of sci- destinée au dépôt et à la diffusion de documents entific research documents, whether they are pub- scientifiques de niveau recherche, publiés ou non, lished or not. The documents may come from émanant des établissements d’enseignement et de teaching and research institutions in France or recherche français ou étrangers, des laboratoires abroad, or from public or private research centers. publics ou privés. 1 2 REMERCIEMENTS Je voudrais exprimer mes remerciements aux membres du jury, aux rapporteurs : les Maitres de Conférences Joseph Ciccolini et Sylvie Bégu, ainsi qu’aux examinateurs : les professeurs Elias Fattal, Thierry Martens et Nathalie Chaput ainsi que les docteurs Alain Herrera et Emilie Roger, d’avoir accepté de juger mon travail de thèse. Je souhaite remercier le Dr Lluis Mir, directeur de l’unité UMR CNRS 8203 pour m’avoir accueilli dans son laboratoire « vectorologie et thérapeutiques anticancéreuses » et de m’avoir permis de réaliser mes travaux de thèse après mon stage de Master 2, au cours desquels j’ai pu développer la formulation des dérivés préactivés de l’ifosfamide et réaliser leur évaluation pharmacologique.
    [Show full text]
  • United States Patent (19) 11 Patent Number: 5,858,330 Boltri Et Al
    USOO585833OA United States Patent (19) 11 Patent Number: 5,858,330 Boltri et al. (45) Date of Patent: *Jan. 12, 1999 54). PHARMACEUTICAL FORMULATIONS IN 52 U.S. Cl. ............................ 424/45; 424/450; 424/484; FORM OF THIXOTROPIC GEL 424/401; 514/772 58 Field of Search ............................. 424/45, 450, 484; 75 Inventors: Luigi Boltri, Antonietta Coppola; 514/772 Marco Gentile; Gaetano Clavenna, all of Milan, Italy 56) References Cited 73) ASSignee: Dompe' S.p.A., L'Aquila, Italy U.S. PATENT DOCUMENTS * Notice: This patent issued on a continued pros- 4,992.256 2/1991 Skaggs ...................................... 424/45 ecution application filed under 37 CFR 4,996,240 2/1991 Osipow et al.. 1.53(d), and is subject to the twenty year patent term provisions of 35 U.S.C. Primary Examiner Rebecca Cook 154(a)(2). Attorney, Agent, or Firm-Griffin, Butler, Whisenhunt & Szipl, LLP 22 Filed: Mar 18, 1996 The present invention relates to a topical formulation of 30 Foreign Application Priority Data gel-like consistency, but nebulizable by a mechanical pump, containing colloidal Silices as gelifying agent. Mar. 22, 1995 IT Italy ................................. MI95AO568 (51) Int. Cl. .................................................. A61L 9/04 9 Claims, No Drawings 5,858,330 1 2 PHARMACEUTICAL FORMULATIONS IN Surface area from 50 to 400 m/g FORM OF THXOTROPIC GEL Average diameter from 7 to 40 nm. All of these materials give Similar gelification phenomena The present invention relates to a topical formulation of but, Since gelification occurs through adsorption, the Surface gel-like consistency, but nebulizable by mechanical pump, area characteristics become paramount for the choice of the containing colloidal Silices as gelifying agent.
    [Show full text]
  • The Effects of Polysorbate 80 on the Fat Emulsion in Ice Cream Mix: Evidence from Transmission Electron Microscopy Studies
    Food Structure Volume 6 Number 2 Article 11 1987 The Effects of Polysorbate 80 on the Fat Emulsion in Ice Cream Mix: Evidence from Transmission Electron Microscopy Studies H. D. Goff M. Liboff W. K. Jordan J. E. Kinsella Follow this and additional works at: https://digitalcommons.usu.edu/foodmicrostructure Part of the Food Science Commons Recommended Citation Goff, H. D.; Liboff, M.; Jordan, W. K.; and Kinsella, J. E. (1987) "The Effects of Polysorbate 80 on the Fat Emulsion in Ice Cream Mix: Evidence from Transmission Electron Microscopy Studies," Food Structure: Vol. 6 : No. 2 , Article 11. Available at: https://digitalcommons.usu.edu/foodmicrostructure/vol6/iss2/11 This Article is brought to you for free and open access by the Western Dairy Center at DigitalCommons@USU. It has been accepted for inclusion in Food Structure by an authorized administrator of DigitalCommons@USU. For more information, please contact [email protected]. FOOD MICROSTRUCTURE, VoL 6 (1987), pp. 193- 198 0730-54 19/87$3 . 00+- . 00 Scanning Microscopy International , Chicago (AMF O'Hare). IL 60666 USA THE EFFECTS OF POLYSORBATE 80 ON THE FAT EMULSION IN ICE CREAM MIX EVIDENCE FROM TRANSMISSION ELECTRON MICROSCOPY STUDIES H. D. Goff", M. Uboff, W. K. Jordan, and J. E. Kinsella Institute of Food Science, Stocking Hall Cornell University, Ithaca, New York 14853 Introduction Emulsifiers are used in ice cream to produce a dry, smooth Emulsifiers, such as mono- and di -glycerides or textured product with desirable melting properties. They function polyoxyethylene sorbitan esters, are used in ice cream to improve by promoting a partial destabilization of the fat emulsion.
    [Show full text]
  • An Efficient UV-Based Method for the Assessment of Oleic Acid Content in Biotherapeutic Drug Products Containing Polysorbate-80 Robert E
    [ APPLICATION NOTE ] An Efficient UV-Based Method for the Assessment of Oleic Acid Content in Biotherapeutic Drug Products Containing Polysorbate-80 Robert E. Birdsall and Ying Qing Yu Waters Corporation, Milford, MA, USA APPLICATION BENEFITS INTRODUCTION ■■ A robust and sensitive method in the Surfactants such as polyoxyethylene sorbitan monooleate (PS-80) are analysis of PS-80 degradants commonly used in formulated biopharmaceuticals to reduce protein denaturing, aggregation, and surface adsorption to vials and syringes.1 ■■ UV-based workflow that enables rapid deployment in regulated environments While PS-80 plays a critical role in stabilizing drug products, degradation of surfactants in formulated drugs can decrease overall product efficacy ■■ Minimal sample preparation with ability and safety. To this end, characterization, identification, and quantitation to perform high throughput analysis of excipients such as PS-80 must be performed to demonstrate the drug product is safe and efficacious in its formulated state. Due to its non-volatile and UV-inactive nature, direct analysis of PS-80 has resulted in methods that incorporate alternative detection techniques such as evaporative light scattering detection (ELSD).2 Yet, given the ubiquitous nature of UV-based instruments in pharmaceutical labs, methods that can utilize existing equipment would be beneficial. Conveniently, the degradation of PS-80 through radical autoxidation or enzymatic processes results in the cleavage of the hydrophobic ester tail (Figure 1) to produce the UV-active fatty acid, oleic acid.1,3,4 Various extraction techniques of fatty acids from biological matrices have resulted in assays that range in degree of sample preparation required, sensitivity, and reproducibility.3-5 UV-based methods that are robust, sensitive, and can be readily deployed in regulated environments are highly valuable in ensuring product quality and safety.
    [Show full text]
  • Gad Compounds Assessed
    Name CAS # ((5-Amino-2-carboxyphenyl)thio)gold sodium salt 17010-23-0 (2-Hydroxypropyl)-γ-cyclodextrin 128446-34-4 (4-hydroxy-4-isobutylpiperidin-1-yl)(1H-imidazol-1-yl)methanone (5aR, 9aR)-octahydrobenzo[e][1,3,2]dioxathiepine 3,3- (LMPC) 1-myristoyl-2-hydroxy-sn-glycero-3-phosphocholine 20559-16-4 (Trimethylsilyl)acetic acid 2345-38-2 (Z) 7-Hexadecenal 56797-40-1 (Z)-2-chloro-4-(diethylamino)but-2-en-1-yl 2-cyclohexyl-2-hydroxy-2-phenylacetate (Z)-3-chloro-4-(diethylamino)but-2-en-1-yl 2-cyclohexyl-2-hydroxy-2-phenylacetate (Z,Z,Z) 8,11,14-Eicosatrienoic acid 1783-84-2 1-(2-butoxyethoxy)-ethanol 5446-78-5 1,1,1,3,5,5,7,7,7-Nonamethyl-3-(trimethylsiloxy) tetrasiloxane 38146-99-5 1,10-decanedithiol 1191-67-9 1,1'-bicyclohexyl-4,4'-diol 20601-38-1 1,1-bis(p-ethoxyphenyl)-2,2-dimethylpropane 27955-87-9 1,1-carbonyldiimidazole (CDI) 530-62-1 1,1-cyclohexanedithiol 3855-24-1 1,2,3,4-Tetrahydronaphthalene 119-6-2 1,2,3-trichloro-2-methylpropane 1871-58-5 1,2,3-triethylbenzene 42205-08-3 1,2,4-benzenetriol 533-73-3 1,2,4-triethylbenzene 877-44-1 1,2-cyclohexanediamine 694-83-7 1,2-cyclohexanedicarboxylic acid 1687-30-5 1,2-cyclohexanediol 931-17-9 1,2-dichlorobenzene 95-50-1 1,2-Ethanediamine 107-15-3 1,2-ethanedithiol 540-63-6 1,2-propanediol, monobutyl ether 29387-86-8 1,3,5-Tributyl-2,4,6-trioxo-hexahydro-striazine 846-74-2 1,3,5-triethylbenzene 102-25-0 1,3,5-Trioxane 110-88-3 1,3:2,4-Bis(3,4-dimethylbenzylidene)sorbitol 135861-56-2 1,3-Bis(diallylamino)-2-propanol 4831-46-3 1,3-butanediol 107-88-0 1,3-cycloheptadiene 4054-38-0 1,3-cyclohexanedicarboxylic
    [Show full text]
  • Journal of Chromatography A, 1599 (2019) 136–143
    Journal of Chromatography A, 1599 (2019) 136–143 Contents lists available at ScienceDirect Journal of Chromatography A jo urnal homepage: www.elsevier.com/locate/chroma Development of a design of experiments optimized method for quantification of polysorbate 80 based on oleic acid using UHPLC-MS a,b,c,∗ b,c a,d Julia Puschmann , Dirk-H. Evers , Christel C. Müller-Goymann , b,c Michael E. Herbig a Institut für Pharmazeutische Technologie, TU Braunschweig, Braunschweig, Germany b Almirall Hermal GmbH, Reinbek, Germany c RaDes GmbH, Hamburg, Germany d Center of Pharmaceutical Engineering (PVZ), TU Braunschweig, Braunschweig, Germany a r a t i c l e i n f o b s t r a c t Article history: The aim was to develop a straightforward UHPLC-MS quantification method for polysorbate 80 using Received 24 December 2018 oleic acid as surrogate marker, which was the commonest substance within the emulsifier. However, Received in revised form 2 April 2019 hydrolysis of polysorbate 80 and subsequent analysis of fatty acids revealed a co-elution of oleic acid Accepted 7 April 2019 and an isomer while all the other fatty acids were successfully separated by varying retention times Available online 8 April 2019 and mass-to-charge ratios. For identification and separation of the isomer a derivatization method was evaluated. Oxidation to the corresponding dihydroxystearic acids with potassium permanganate resulted Keywords: in peak separation of cis/trans and structural isomers of the 18:1 fatty acids. Hydrolyzed and derivatized Polysorbate 80 2 polysorbate 80 was quantified indirectly in the range of 0.046–5.83 ␮g/mL (R > 0.997) with a limit of Design of experiments Quantification detection of 11.4 ng/mL.
    [Show full text]
  • Polysorbates 20, 60, 65 and 80)
    Original: Japanese Provisional translation Evaluation Report of Food Additives Polysorbates (Polysorbates 20, 60, 65 and 80) June 2007 Food Safety Commission Contents History of deliberation.......................................................................................................1 Members of the Food Safety Commission.........................................................................1 Expert members of the Expert Committee on Food Additives, Food Safety Commission.…………1 Evaluation results on the Health Risk Assessment of Polysorbate 20, Polysorbate 60, Polysorbate 65 and Polysorbate 80 as food additives...................................................................................................2 Summary.............................................................................................................................................. 2 1. Introduction...................................................................................................................................... 3 2. Background...................................................................................................................................... 3 3. Outline of the designation of food additives.................................................................................... 3 4. Name, etc. ........................................................................................................................................ 3 (1) Polysorbate 20 ......................................................................................................................
    [Show full text]