Physical and Biological Effects of Modified Polysorbate 20 Kevin Penfield Croda Inc
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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. -
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. -
A New Look at Old Stuff. Molecular Heterogeneity of Polysorbates And
Slide 1 A New Look at Old Stuff. Molecular Heterogeneity of Polysorbates and Its Implications Studied with LC-MS. Oleg Borisov 9th Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry 09/14/12 Properties of Polysorbates Slide 2 • Non-Ionic Amphiphilic Surfactants (HLB > 10, O/W) hydrophilic head hydrophobic tail • Trade names: Tween, Crillet, Sorlate, Monitan, Olothorb… • General: Emulsifiers and stabilizers in foods, cosmetics, drugs, textiles, plastics, agricultural chemicals, • Biothech: Minimize protein adsorption to surfaces and to reduce the air-liquid and solid-liquid interfacial surface tension (aggregation). Stabilizing agent. What Is Polysorbate? Slide 3 For example, PS20 is described as: “Mixture of partial esters of fatty acids, mainly lauric acid, with sorbitol and its anhydrides ethoxylated with approximately 20 moles of ethhylene oxide for each mole of sorbitol and sorbitol anhydrides.” (USP-NF and EU Pharmacopoeia) O(CH2CH2O)xH Hw(OCH2CH2)O O(CH2CH2O)yH O O(CH2CH2O)x R x + y + z + w = 20 O Heterogeneity with Regard to FAs Slide 4 Fatty Acid Content, % Fatty Acid Structure MW, Da Polysorbate 20 Polysorbate 80 Caproic (C6) CH3(CH2)4COOH 116.08 < 1% --- Caprylic (C8) CH3(CH2)6COOH 144.12 < 10% --- Capric (C10) CH3(CH2)8COOH 172.15 < 10% --- Lauric (C12) CH3(CH2)10COOH 200.18 40 – 60% --- Myristic (C14) CH3(CH2)12COOH 228.21 14 – 25% < 5% Palmitic (C16) CH3(CH2)14COOH 256.24 7 – 15% < 16% Palmitoleic (C16:1) CH3(CH2)5CH=CH(CH2)7COOH 254.22 --- < 8% Stearic (C18) CH3(CH2)16COOH 284.27 < 7% > 6% Oleic (C18:1) CH3(CH2)7CH=CH(CH2)7COOH 282.26 < 11% > 58% Linoleic (C18:2) CH3(CH2)4CH=CHCH2CH=CH(CH2)7COOH 280.24 < 3% < 18% Linolenic (C18:3) CH3CH2CH=CHCH2CH=CHCH2CH=CH(CH2)7COOH 278.22 --- < 4% According to European Pharmacopoeia 6.3 Molecular Complexity of Polysorbates. -
Sorbitan Monooleate
Accessed from 128.83.63.20 by nEwp0rt1 on Wed Nov 30 03:54:17 EST 2011 NF 30 Official Monographs / Sorbitan 1963 . IdentificationÐ Sorbic Acid A: The residue of lauric acid obtained in the Assay for fatty acids has an acid value (see Fats 〈401〉) between 260 and 280, about 1 g of the residue, accurately weighed, being used, and an iodine value (see Fats and Fixed Oils 〈401〉) of not more than 5. B: It responds to Identification test B under Sorbitan C6H8O2 112.13 Monooleate. 2,4-Hexadienoic acid, (E,E)-; 2,4-Hexadienoic acid; Acid value 〈401〉: not more than 8. (E,E)-Sorbic acid; Sorbic acid [110-44-1]. Hydroxyl value 〈401〉: between 330 and 358. DEFINITION Saponification value 〈401〉: between 158 and 170. Sorbic Acid contains NLT 99.0% and NMT 101.0% of C6H8O2, Water, Method I 〈921〉: not more than 1.5%. calculated on the anhydrous basis. Residue on ignition 〈281〉: not more than 0.5%. IDENTIFICATION Heavy metals, Method II 〈231〉: not more than 0.001%. • A. INFRARED ABSORPTION 〈197K〉 Assay for fatty acidsÐTransfer about 10 g of Sorbitan Mono- • B. A 1-in-400,000 solution in isopropyl alcohol exhibits an laurate, accurately weighed, to a 500-mL conical flask, cau- absorbance maximum at 254 ± 2 nm. tiously add 100 mL of alcohol and 3.0 g of potassium hydrox- ide, and mix. Proceed as directed in the Assay for fatty acids ASSAY under Sorbitan Monooleate, beginning with ªConnect a suitable • PROCEDURE condenser.º Sample solution: Dissolve 250 mg of Sorbic Acid in a mix- Assay for polyolsÐProceed with Sorbitan Monolaurate as di- ture of 50 mL of methanol and 25 mL of water that previ- rected for Assay for polyols under Sorbitan Monooleate. -
Sorbitan Monolaurate
SORBITAN MONOLAURATE Prepared at the 55th JECFA (2000) and published in FNP 52 Add 8 (2000), superseding specifications prepared at the 44th JECFA (1995) and published in FNP 52 Add 3 (1995). A group ADI of 0-25 mg/kg bw for sorbitan esters of lauric, oleic, palmitic, and stearic acid was established at the 26th JECFA (1982). SYNONYMS Sorbitan laurate; INS No. 493 DEFINITION A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible lauric acid C.A.S. number 1338-39-2 Structural formula Contains lauric acid esterified with polyols derived from sorbitol including the following types: Assay Saponification of 100 g of the sample yields not less than 36 g and not more than 49 g of polyols, and not less than 56 g and not more than 68 g of fatty acids. The polyol content shall be not less than 95% of a mixture of sorbitol, 1,4-sorbitan and isosorbide. DESCRIPTION Amber-coloured oily viscous liquid, light cream to tan beads or flakes or a hard, waxy solid with a slight odour FUNCTIONAL USES Emulsifier, stabilizer CHARACTERISTICS IDENTIFICATION Solubility (Vol. 4) Dispersible in hot and cold water PURITY Water (Vol. 4) Not more than 2% (Karl Fischer Method) Sulfated ash (Vol. 4) Not more than 0.5% Acid value (Vol. 4) Not more than 7 Saponification value Not less than 155 and not more than 170 (Vol. 4) Hydroxyl value (Vol. 4) Not less than 330 and not more than 358 Lead (Vol. 4) Not more than 2 mg/kg Determine using an atomic absorption technique appropriate to the specified level. -
United States Patent Office Patented Nov
2,913,359 United States Patent Office Patented Nov. 17, 1959 2 effective with raw starch, lightly treated oxidized starch, 2,913,359 heavily treated oxidized starch and thin boiling starches of all types. FILTERATION PROCESS FOR STARCH Furthermore, the Baumé of the starch slurry does not Glenn E. Pollock, Jr., Affton, and Harold A. Jett, St. seem to have any effect on the efficiency of the moisture Louis, Mo., Thomas Gerwitz, Jackson Heights, N.Y., removal from the filter cake, and although best results and Barrett L. Scalet, Clayton, Mo., assignors to An were obtained with certain of the surfactants when the heuser-Busch, incorporated, St. Louis, Mo., a corpora pH of the slurry was about 4, good results were also ob tion of Missouri tained at ranges of pH of about 3 to about 10. No Drawing. Application September 19, 1957 0. The surfactants which we have found to be satisfactory Seria No. 684,862 can be most conveniently grouped under 12 main head lingS. 12 Claims. (C. 127-71) The approximate amount of surfactant required to provide the maximum dewatering effect is in the neigh The present invention relates generally to the treat 15 borhood of 0.1%, based on the dry weight of starch being ment of starch, and more particularly to a novel method treated, but it has been determined that smaller amounts for increasing the amount of water which is removed of these materials have a partial effect. from a starch slurry during the filtration thereof, and to The surfactants include: the surfactants which are used in the treatment. -
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 ...................................................................................................................... -
Polysorbate 20 Polysorbate 65 Polysorbate 21 Polysorbate 80 Polysorbate 40 Polysorbate 81 Polysorbate 60 Polysorbate 85 Polysorbate 61
Safety Assessment of Polysorbates as Used in Cosmetics Status: Tentative Amended Report for Public Comment Release Date: March 31, 2015 Panel Meeting Date: June 15-16, 2015 All interested persons are provided 60 days from the above date to comment on this safety assessment and to identify additional published data that should be included or provide unpublished data which can be made public and included. Information may be submitted without identifying the source or the trade name of the cosmetic product containing the ingredient. All unpublished data submitted to CIR will be discussed in open meetings, will be available at the CIR office for review by any interested party and may be cited in a peer-reviewed scientific journal. Please submit data, comments, or requests to the CIR Director, Dr. Lillian J. Gill. 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] ABSTRACT This is a safety assessment of polysorbates as used in cosmetics. These ingredients mostly function as surfactants in cosmetics. -
Material Safety Data Sheet
341 Christian Street, Oxford, CT 06478 USA Tel: (203) 267-6061 Fax: (203) 267-6065 www.naturalsourcing.com [email protected] MATERIAL SAFETY DATA SHEET POLYSORBATE 20 MSDS 1. PRODUCT NAME AND COMPANY IDENTIFICATION Product Name: POLYSORBATE 20 Product Use: Personal Care Formulations – Non-Ionic Surfactant Company Name: Natural Sourcing Company Address: 341 Christian Street, Oxford, CT 06478, USA Date Issued: 7/24/2008 Emergency Telephone Number: Chemtrec Tel: (800) 262-8200 2. COMPOSITION/INGREDIENT INFORMATION Chemical Identity: Polysorbate 20, Poe (20) Sorbitan monolaurate Formula: Ethoxylation of reaction between sorbitol and lauric acid Components: CAS No % (w/w) OSHA PEL ACGIH TLV Polyoxyethylene (20) Sorbitan monolaurate 9005-64-5 97-100 Not established Not established Ingredients not precisely identified are proprietary or nonhazardous. Values are not product specifications. Exposure Limits: N/A CAS #: 9005-64-5 3. HAZARDS IDENTIFICATION HMIS Rating: Health: 0 Flammability: 1 Reactivity: 0 NO HAZARDS ARE KNOWN TO BE ASSOCIATED WITH EXPOSURES TO THIS PRODUCT. Limited toxicity data are available on this specific product; this hazard assessment is based on the results of screening tests. Routes of Entry: • Eyes • Skin • Ingestion • Inhalation Eye Contact: No irritation is likely to develop following contact with eyes. Skin Contact: No irritation is likely to develop following contact with skin. This product will probably not be absorbed through human skin. Ingestion: Low oral toxicity, but ingestion may cause irritation of the gastrointestinal tract. No toxic effects are expected following ingestion of this product. Inhalation: No irritation is expected to be associated with inhalation of this material. No toxic effects are known to be associated with inhalation of vapors from this material. -
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. -
Supporting Document 1 – Safety Assessment (Pdf 1461
26 June 2018 [51-18] Supporting document 1 Risk and technical assessment report – Application A1137 Polysorbate 20 as a Food Additive Executive summary The purpose of the application is to seek approval for the use of polyoxyethylene (20) sorbitan monolaurate, more commonly known as polysorbate 20, as a food additive. Polysorbate 20 is intended to be used as an emulsifier at levels of less than 0.05% (500 mg/kg(L)) in the final food product. An assessment of the stated purpose of using polysorbate 20 as an emulsifier to surface treat meat and fish products indicates it is able to perform this role in the amounts and form proposed to be used. Its use is therefore technologically justified for its proposed stated purpose and it has proven advantages over currently permitted emulsifiers. There are internationally accepted specifications for polysorbate 20. The submitted data, and information from other sources, are considered adequate to define the hazard of polysorbate 20. The available evidence shows that polysorbate 20 is not genotoxic. At the very high dose of 25% w/w in the diet, polysorbate 20 causes diarrhoea and associated weight loss and ill-health in laboratory rodents. However, these adverse effects would not be observed in humans since these levels are extremely high and not relevant to human consumption levels. There is no evidence that the polysorbates are reproductive or developmental toxicants. Although clinical data on human tolerance are limited, polysorbates are widely used as emulsifiers in foods and pharmaceuticals internationally, and have not been associated with adverse effects in consumers. Polysorbates 60, 65 and 80 are already permitted in the Australia New Zealand Food Standards Code (the Code) at levels consistent with Good Manufacturing Practice (GMP). -
Inert Reassessment - Members of the Sorbitan Fatty Acid Esters and The
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASIiINGTON, D.C. 20460 DATE: May 20,2005 ACTION MEMORANDUM SUBJECT: Inert Reassessment - Members of the Sorbitan Fatty Acid Esters and the FROM: sponse Branch TO: Lois A. Rossi, Director Registration Division I. FQPA REASSESSMENT ACTION Action: Reassessment of six inert ingredient exemptions from the requirement of a tolerance. The six tolerance exemptions are to be maintained. Chemicals: CFR Reference Number 40 CFR Tolerance Exemption Expression Limits Uses exemptions ** 1 180.920 Poly(oxyethylene)(5) sorbitan monooleate (none) Surfactants, related adjuvants of surfactants 1 180.910 Polyoxyethylene (20) sorbitan (none) Surfactants, related adjuvants monostearate of surfactants 1 180.920 Polysorbate 60, conformng to 21 CFR (none) Surfactant 172.836 1 180.910 Polysorbate 65, conforming to 21 CFR (none) Emulsifier 172.838, CFR Reference Number 40 CFR Tolerance Exemption Expression Limits Uses exemptions ** Sorbitan fatty acid esters (fatty acids (none) Surfactants, related adjuvants limited to C12, C14, C16, and C18 of surfactants containing minor amounts of associated fatty acids) and their derivatives; the poly(oxyethy1ene) content averages 5-20 moles. 180.930 Sorbitan fatty acid esters (fatty acids (none) Buffering agent, corrosion limited to C12, C14, C16, and C18 inhibition 1 containing minor amounts of associated fatty acids) and their poly(oxyethy1ene) derivatives of sorbitan fatty acid esters; the poly(oxyethy1ene) content averages 16-20 moles. **Residues listed in 40 CFR 180.910 (formerly 180.1001(c)) are exempt from the requirement of a tolerance when used in accordance with good agricultural practice as inert (or occasionally active) ingredients in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest.