<?xml version="1.0" encoding="UTF-8"?>
<!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.3 20210610//EN" "JATS-journalpublishing1-3.dtd">
<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">pharmjournal</journal-id><journal-title-group><journal-title xml:lang="ru">Разработка и регистрация лекарственных средств</journal-title><trans-title-group xml:lang="en"><trans-title>Drug development &amp; registration</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2305-2066</issn><issn pub-type="epub">2658-5049</issn><publisher><publisher-name>LLC «CPHA»</publisher-name></publisher></journal-meta><article-meta><article-id custom-type="elpub" pub-id-type="custom">pharmjournal-544</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ФАРМАЦЕВТИЧЕСКАЯ ТЕХНОЛОГИЯ И НАНОТЕХНОЛОГИИ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>PHARMACEUTICAL TECHNOLOGY AND NANOTECHNOLOGY</subject></subj-group></article-categories><title-group><article-title>ТОКСИКОЛОГИЧЕСКИЕ И ФАРМАКОЛОГИЧЕСКИЕ ХАРАКТЕРИСТИКИ ВСПОМОГАТЕЛЬНЫХ ВЕЩЕСТВ ПРЕПАРАТОВ ТОРАСЕМИДА</article-title><trans-title-group xml:lang="en"><trans-title>TOXICOLOGICAL AND PHARMACOLOGICAL CHARACTERISTICS OF EXCIPIENTS OF DRUG PRODUCTS OF TORASEMIDE</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Ивкин</surname><given-names>Д. Ю.</given-names></name><name name-style="western" xml:lang="en"><surname>Ivkin</surname><given-names>D. Yu.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Теслев</surname><given-names>А. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Teslev</surname><given-names>A. A.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Дзюба</surname><given-names>А. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Dziuba</surname><given-names>A. S.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Ивкина</surname><given-names>А. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Ivkina</surname><given-names>A. S.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>ГБОУ ВО «Санкт-Петербургская государственная химико-фармацевтическая академия» Министерства здравоохранения Российской Федерации</institution></aff><aff xml:lang="en"><institution>St. Petersburg Chemical and Pharmaceutical Academy</institution></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>АО «Фармпроект»</institution></aff><aff xml:lang="en"><institution>JSC «Pharmproject»</institution></aff></aff-alternatives><pub-date pub-type="collection"><year>2018</year></pub-date><pub-date pub-type="epub"><day>09</day><month>01</month><year>2019</year></pub-date><volume>0</volume><issue>1</issue><fpage>46</fpage><lpage>52</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Ивкин Д.Ю., Теслев А.А., Дзюба А.С., Ивкина А.С., 2019</copyright-statement><copyright-year>2019</copyright-year><copyright-holder xml:lang="ru">Ивкин Д.Ю., Теслев А.А., Дзюба А.С., Ивкина А.С.</copyright-holder><copyright-holder xml:lang="en">Ivkin D.Y., Teslev A.A., Dziuba A.S., Ivkina A.S.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.pharmjournal.ru/jour/article/view/544">https://www.pharmjournal.ru/jour/article/view/544</self-uri><abstract><p>В статье представлены сведения о токсикологических и фармакологических характеристиках основных вспомогательных веществ, используемых при разработке препаратов торасемида (натрия кроскармеллозы, микрокристаллической целлюлозы, магния стеарата, крахмала кукурузного прежелатинизированного, кремния диоксида коллоидного, маннитола).</p></abstract><trans-abstract xml:lang="en"><p>Information on the toxicological and pharmacological characteristics of the main excipients used in the formulation of torasemide (sodium croscarmellose, microcrystalline cellulose, magnesium stearate, pregelatinized corn starch, silica, mannitol) is presented in the article.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>торасемид</kwd><kwd>вспомогательное вещество</kwd><kwd>дженерик</kwd><kwd>безопасность</kwd><kwd>токсичность</kwd><kwd>фармацевтическая разработка</kwd></kwd-group><kwd-group xml:lang="en"><kwd>torasemide</kwd><kwd>excipient</kwd><kwd>generic</kwd><kwd>safety</kwd><kwd>toxicity</kwd><kwd>pharmaceutical development</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">А.И. Тенцова, О.И. Терёшкина, И.П. Рудакова. Современные биофармацевтические аспекты вспомогательных веществ // Фармация. 2012. № 7. С. 3-6.</mixed-citation><mixed-citation xml:lang="en">А.И. Тенцова, О.И. Терёшкина, И.П. Рудакова. Современные биофармацевтические аспекты вспомогательных веществ // Фармация. 2012. № 7. С. 3-6.</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">М.М. Миронова, Е.Л. Ковалева. Требования к производству вспомогательных веществ, используемых в составе лекарственных средств (обзор) // Химико-фармацевтический журнал. 2015. Т. 49. № 5. С. 52-56.</mixed-citation><mixed-citation xml:lang="en">М.М. Миронова, Е.Л. Ковалева. Требования к производству вспомогательных веществ, используемых в составе лекарственных средств (обзор) // Химико-фармацевтический журнал. 2015. Т. 49. № 5. С. 52-56.</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">А.П. Мешковский. Обеспечение качества фармацевтических субстанций за рубежом - сегодня и завтра // Фарматека. 2000. № 1. С. 29-34.</mixed-citation><mixed-citation xml:lang="en">А.П. Мешковский. Обеспечение качества фармацевтических субстанций за рубежом - сегодня и завтра // Фарматека. 2000. № 1. С. 29-34.</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">Н.Б. Демина. Биофармация - путь к созданию инновационных лекарственных средств // Разработка и регистрация лекарственных средств. 2013. № 1. С. 8-13.</mixed-citation><mixed-citation xml:lang="en">Н.Б. Демина. Биофармация - путь к созданию инновационных лекарственных средств // Разработка и регистрация лекарственных средств. 2013. № 1. С. 8-13.</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">G. Pifferi, P. Restani. The safety of pharmaceutical excipients // Farmaco. 2003. № 58(8). P. 541-550.</mixed-citation><mixed-citation xml:lang="en">G. Pifferi, P. Restani. The safety of pharmaceutical excipients // Farmaco. 2003. № 58(8). P. 541-550.</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">C. Freeman et al. Subchronic and Developmental Toxicity Studies in Rats with Ac-Di-Sol Croscarmellose Sodium // International Journal of Toxicology. 2003. V. 22. P. 149-157.</mixed-citation><mixed-citation xml:lang="en">C. Freeman et al. Subchronic and Developmental Toxicity Studies in Rats with Ac-Di-Sol Croscarmellose Sodium // International Journal of Toxicology. 2003. V. 22. P. 149-157.</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">M. Weiner, L.A. Kotkoskie, C. Freeman, K.J. Batt, M.J. Fletcher. Acute toxicity evaluation of Ac-Di-Sol and Avicel PH, Avicel RC and CL: pharmaceutical excipients // Toxicol Lett (Suppl). 1992. V. 243.</mixed-citation><mixed-citation xml:lang="en">M. Weiner, L.A. Kotkoskie, C. Freeman, K.J. Batt, M.J. Fletcher. Acute toxicity evaluation of Ac-Di-Sol and Avicel PH, Avicel RC and CL: pharmaceutical excipients // Toxicol Lett (Suppl). 1992. V. 243.</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">U.S. United States Food and Drug Administration (U.S. FDA). Good laboratory practice regulations; ﬁnal rule. 21 CFR Part 58. - Washington, DC: U.S. FDA. 1987.</mixed-citation><mixed-citation xml:lang="en">U.S. United States Food and Drug Administration (U.S. FDA). Good laboratory practice regulations; ﬁnal rule. 21 CFR Part 58. - Washington, DC: U.S. FDA. 1987.</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">E.M. Baker. Microcrystalline cellulose: oral administration. - Rats. Unpublished report from Fitzsimmons General Hospital (Submitted to WHO by FMC Corporation). 1966.</mixed-citation><mixed-citation xml:lang="en">E.M. Baker. Microcrystalline cellulose: oral administration. - Rats. Unpublished report from Fitzsimmons General Hospital (Submitted to WHO by FMC Corporation). 1966.</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">L.A. Kotkoskie, M.T. Butt, E. Selinger, C. Freeman, M.L. Weiner. Qualitative investigation of uptake of fine particle size microcrystalline cellulose following oral administration in rats // J. Anat. 1996. V. 189. P. 531-535.</mixed-citation><mixed-citation xml:lang="en">L.A. Kotkoskie, M.T. Butt, E. Selinger, C. Freeman, M.L. Weiner. Qualitative investigation of uptake of fine particle size microcrystalline cellulose following oral administration in rats // J. Anat. 1996. V. 189. P. 531-535.</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">E.M. Baker. Microcrystalline cellulose: oral administration. - Humans. Unpublished report from Fitzsimmons General Hospital. 1968.</mixed-citation><mixed-citation xml:lang="en">E.M. Baker. Microcrystalline cellulose: oral administration. - Humans. Unpublished report from Fitzsimmons General Hospital. 1968.</mixed-citation></citation-alternatives></ref><ref id="cit12"><label>12</label><citation-alternatives><mixed-citation xml:lang="ru">M.P. Walters, J. Kelleher, J.M. Findlay, S.T. Srinivasan. Preparation and characterisation of a [14C] cellulose suitable for human metabolic studies // Br. J. Nutr. 1989. V. 62. P. 121-129.</mixed-citation><mixed-citation xml:lang="en">M.P. Walters, J. Kelleher, J.M. Findlay, S.T. Srinivasan. Preparation and characterisation of a [14C] cellulose suitable for human metabolic studies // Br. J. Nutr. 1989. V. 62. P. 121-129.</mixed-citation></citation-alternatives></ref><ref id="cit13"><label>13</label><citation-alternatives><mixed-citation xml:lang="ru">T.W. Tusing, O.E. Paynter, O.A. Battista. Birefringence of plant fibrous cellulose and microcrystalline cellulose in human stools freezer-stored immediately after evacuation // Agric. Food Chem. 1964. № 12(3). P. 284-287.</mixed-citation><mixed-citation xml:lang="en">T.W. Tusing, O.E. Paynter, O.A. Battista. Birefringence of plant fibrous cellulose and microcrystalline cellulose in human stools freezer-stored immediately after evacuation // Agric. Food Chem. 1964. № 12(3). P. 284-287.</mixed-citation></citation-alternatives></ref><ref id="cit14"><label>14</label><citation-alternatives><mixed-citation xml:lang="ru">G. Volkheimer, F.H. Schultz, H. Lehmann, I. Aurich, R. Hubner, M. Hubner, A. Hallmayer, H. Munch, H. Opperman, S. Strauch. Primary portal transport of persorbed starch granules from the intestinal wall // Med. Exp. 1968. V. 18. P. 103-108.</mixed-citation><mixed-citation xml:lang="en">G. Volkheimer, F.H. Schultz, H. Lehmann, I. Aurich, R. Hubner, M. Hubner, A. Hallmayer, H. Munch, H. Opperman, S. Strauch. Primary portal transport of persorbed starch granules from the intestinal wall // Med. Exp. 1968. V. 18. P. 103-108.</mixed-citation></citation-alternatives></ref><ref id="cit15"><label>15</label><citation-alternatives><mixed-citation xml:lang="ru">CanTox Inc. Estimated consumption of microcrystalline cellulose and sodium carboxymethylcellulose from current and proposed food use of Avicel cellulose gel. Unpublished report dated December 1993, prepared by CanTox Inc. for FMC Corporation (Submitted to WHO by FMC Europe N.V.). 1993.</mixed-citation><mixed-citation xml:lang="en">CanTox Inc. Estimated consumption of microcrystalline cellulose and sodium carboxymethylcellulose from current and proposed food use of Avicel cellulose gel. Unpublished report dated December 1993, prepared by CanTox Inc. for FMC Corporation (Submitted to WHO by FMC Europe N.V.). 1993.</mixed-citation></citation-alternatives></ref><ref id="cit16"><label>16</label><citation-alternatives><mixed-citation xml:lang="ru">S.K. Egan, J.T. Heimbach, Microcrystalline cellulose, MCC, E460(i). Part four: Exposure data - Estimated intake of MCC in the United Kingdom. Unpublished report dated April 11, 1994, prepared by TAS, Inc., Washington, DC, USA for FMC Corporation (Submitted to WHO by FMC Europe N.V). 1994.</mixed-citation><mixed-citation xml:lang="en">S.K. Egan, J.T. Heimbach, Microcrystalline cellulose, MCC, E460(i). Part four: Exposure data - Estimated intake of MCC in the United Kingdom. Unpublished report dated April 11, 1994, prepared by TAS, Inc., Washington, DC, USA for FMC Corporation (Submitted to WHO by FMC Europe N.V). 1994.</mixed-citation></citation-alternatives></ref><ref id="cit17"><label>17</label><citation-alternatives><mixed-citation xml:lang="ru">G. Pahlke, R. Friedrich. Persorption of microcrystalline cellulose // Naturwissenschaften. 1974. V. 61. P. 35.</mixed-citation><mixed-citation xml:lang="en">G. Pahlke, R. Friedrich. Persorption of microcrystalline cellulose // Naturwissenschaften. 1974. V. 61. P. 35.</mixed-citation></citation-alternatives></ref><ref id="cit18"><label>18</label><citation-alternatives><mixed-citation xml:lang="ru">J.H. Eldridge, R.M. Gilley, J.K. Staas, Z. Moldoveanu, J.A. Meulbroek, T.R. Tice. Biodegradable microspheres: vaccine delivery system for oral immunization // Curr. Top. Microbiol. Imunol. 1989. V. 146. P. 59-66.</mixed-citation><mixed-citation xml:lang="en">J.H. Eldridge, R.M. Gilley, J.K. Staas, Z. Moldoveanu, J.A. Meulbroek, T.R. Tice. Biodegradable microspheres: vaccine delivery system for oral immunization // Curr. Top. Microbiol. Imunol. 1989. V. 146. P. 59-66.</mixed-citation></citation-alternatives></ref><ref id="cit19"><label>19</label><citation-alternatives><mixed-citation xml:lang="ru">A.J. Pallotta. Acute oral administration - Rats; and acute intraperitoneal administration - Rats, of microcrystalline cellulose. Unpublished report from Hazleton Labs, Inc. (Submitted to WHO by FMC Corporation). 1959.</mixed-citation><mixed-citation xml:lang="en">A.J. Pallotta. Acute oral administration - Rats; and acute intraperitoneal administration - Rats, of microcrystalline cellulose. Unpublished report from Hazleton Labs, Inc. (Submitted to WHO by FMC Corporation). 1959.</mixed-citation></citation-alternatives></ref><ref id="cit20"><label>20</label><citation-alternatives><mixed-citation xml:lang="ru">C. Freeman. Avicel RCN-15. Acute oral toxicity study in rats. Unpublished report No. I91-1217 from FMC Corporation Toxicology Laboratory, Princeton, New Jersey, USA (Submitted to WHO by FMC Europe N.V.). 1991a.</mixed-citation><mixed-citation xml:lang="en">C. Freeman. Avicel RCN-15. Acute oral toxicity study in rats. Unpublished report No. I91-1217 from FMC Corporation Toxicology Laboratory, Princeton, New Jersey, USA (Submitted to WHO by FMC Europe N.V.). 1991a.</mixed-citation></citation-alternatives></ref><ref id="cit21"><label>21</label><citation-alternatives><mixed-citation xml:lang="ru">C. Freeman. Avicel AC-815. Acute oral toxicity study in rats Unpublished report No. I95-2040 from FMC Corporation Toxicology Laboratory, Princeton, New Jersey, USA (Submitted to WHO by FMC Europe. 1996d.</mixed-citation><mixed-citation xml:lang="en">C. Freeman. Avicel AC-815. Acute oral toxicity study in rats Unpublished report No. I95-2040 from FMC Corporation Toxicology Laboratory, Princeton, New Jersey, USA (Submitted to WHO by FMC Europe. 1996d.</mixed-citation></citation-alternatives></ref><ref id="cit22"><label>22</label><citation-alternatives><mixed-citation xml:lang="ru">C. Freeman. Avicel AC-815. Acute dermal toxicity study in rats. Unpublished report No. I95-2041 from FMC Corporation Toxicology Laboratory, Princeton, New Jersey, USA (Submitted to WHO by FMC Europe N.V.). 1996e.</mixed-citation><mixed-citation xml:lang="en">C. Freeman. Avicel AC-815. Acute dermal toxicity study in rats. Unpublished report No. I95-2041 from FMC Corporation Toxicology Laboratory, Princeton, New Jersey, USA (Submitted to WHO by FMC Europe N.V.). 1996e.</mixed-citation></citation-alternatives></ref><ref id="cit23"><label>23</label><citation-alternatives><mixed-citation xml:lang="ru">C. Freeman. Avicel RCN-15. Acute dermal toxicity study in rats. Unpublished report No. I91-1219 from FMC Corporation Toxicology Laboratory, Princeton, New Jersey, USA (Submitted to WHO by FMC Europe N.V.). 1991b.</mixed-citation><mixed-citation xml:lang="en">C. Freeman. Avicel RCN-15. Acute dermal toxicity study in rats. Unpublished report No. I91-1219 from FMC Corporation Toxicology Laboratory, Princeton, New Jersey, USA (Submitted to WHO by FMC Europe N.V.). 1991b.</mixed-citation></citation-alternatives></ref><ref id="cit24"><label>24</label><citation-alternatives><mixed-citation xml:lang="ru">J. Signorin. Avicel AC-815. Acute inhalation study in rats. Unpublished report No. I95-2045 by FMC Corporation Toxicology Laboratory, Princeton, New Jersey, USA (Submitted to WHO by FMC Europe N.V.). 1996.</mixed-citation><mixed-citation xml:lang="en">J. Signorin. Avicel AC-815. Acute inhalation study in rats. Unpublished report No. I95-2045 by FMC Corporation Toxicology Laboratory, Princeton, New Jersey, USA (Submitted to WHO by FMC Europe N.V.). 1996.</mixed-citation></citation-alternatives></ref><ref id="cit25"><label>25</label><citation-alternatives><mixed-citation xml:lang="ru">J.W. Frey, E.R. Harding, T.R. Helmbold. Dietetic investigations of edible pure cellulose // Med. J. Rec. 1928. V. 127. P. 585-589.</mixed-citation><mixed-citation xml:lang="en">J.W. Frey, E.R. Harding, T.R. Helmbold. Dietetic investigations of edible pure cellulose // Med. J. Rec. 1928. V. 127. P. 585-589.</mixed-citation></citation-alternatives></ref><ref id="cit26"><label>26</label><citation-alternatives><mixed-citation xml:lang="ru">Asahi Chemical Industry Co. Effect of ingestion of avicel-contained foods on living organisms. Unpublished report from Yoshitoshi Internal Seminar (Submitted to WHO by Asahi Chemical Industry Co., Ltd). 1966.</mixed-citation><mixed-citation xml:lang="en">Asahi Chemical Industry Co. Effect of ingestion of avicel-contained foods on living organisms. Unpublished report from Yoshitoshi Internal Seminar (Submitted to WHO by Asahi Chemical Industry Co., Ltd). 1966.</mixed-citation></citation-alternatives></ref><ref id="cit27"><label>27</label><citation-alternatives><mixed-citation xml:lang="ru">Hazleton Labs. Long-term nutritional balance study - Rats. Unpublished report from Hazleton Labs, Inc. (Submitted to WHO by FMC Corporation). 1963.</mixed-citation><mixed-citation xml:lang="en">Hazleton Labs. Long-term nutritional balance study - Rats. Unpublished report from Hazleton Labs, Inc. (Submitted to WHO by FMC Corporation). 1963.</mixed-citation></citation-alternatives></ref><ref id="cit28"><label>28</label><citation-alternatives><mixed-citation xml:lang="ru">Hazleton Labs Microcrystalline cellulose: reproduction study - Rats. Unpublished report from Hazleton Labs, Inc. (Submitted to WHO by FMC Corporation). 1964.</mixed-citation><mixed-citation xml:lang="en">Hazleton Labs Microcrystalline cellulose: reproduction study - Rats. Unpublished report from Hazleton Labs, Inc. (Submitted to WHO by FMC Corporation). 1964.</mixed-citation></citation-alternatives></ref><ref id="cit29"><label>29</label><citation-alternatives><mixed-citation xml:lang="ru">K.J. Batt. Avicel RCN-15 - Salmonella mammalian microsome plate incorporation assay (Ames test). Unpublished report No. I91-1214 from FMC Corporation Toxicology Laboratory, Princeton, New Jersey, USA. 1992.</mixed-citation><mixed-citation xml:lang="en">K.J. Batt. Avicel RCN-15 - Salmonella mammalian microsome plate incorporation assay (Ames test). Unpublished report No. I91-1214 from FMC Corporation Toxicology Laboratory, Princeton, New Jersey, USA. 1992.</mixed-citation></citation-alternatives></ref><ref id="cit30"><label>30</label><citation-alternatives><mixed-citation xml:lang="ru">M.A. Cifone. Mutagenicity test on Avicel RCN-15 in the L5178Y TK+/- mouse lymphoma forward mutation assay with an independent repeat. Unpublished report by Hazleton Washington Inc., Vienna. Virginia, USA (FMC Study No. 191-1230). 1992.</mixed-citation><mixed-citation xml:lang="en">M.A. Cifone. Mutagenicity test on Avicel RCN-15 in the L5178Y TK+/- mouse lymphoma forward mutation assay with an independent repeat. Unpublished report by Hazleton Washington Inc., Vienna. Virginia, USA (FMC Study No. 191-1230). 1992.</mixed-citation></citation-alternatives></ref><ref id="cit31"><label>31</label><citation-alternatives><mixed-citation xml:lang="ru">M.A. Cifone. Mutagenicity test on Avicel CL-611, E329N in the L5178Y TK+/- mouse lymphoma forward mutation assay with a confirmatory assay. Unpublished report by Hazleton Washington Inc., Vienna,Virginia, USA (FMC Study No. 194-1834). 1994.</mixed-citation><mixed-citation xml:lang="en">M.A. Cifone. Mutagenicity test on Avicel CL-611, E329N in the L5178Y TK+/- mouse lymphoma forward mutation assay with a confirmatory assay. Unpublished report by Hazleton Washington Inc., Vienna,Virginia, USA (FMC Study No. 194-1834). 1994.</mixed-citation></citation-alternatives></ref><ref id="cit32"><label>32</label><citation-alternatives><mixed-citation xml:lang="ru">T.E. Lawlor. Mutagenicity test with Avicel AC-815 in the Salmonella-Escherichia coli/mammalian microsome reverse mutation assay with a confirmatory assay. Unpublished report by Corning Hazleton Inc., Vienna, Virginia, USA (FMC Study No. I95-2047). 1996.</mixed-citation><mixed-citation xml:lang="en">T.E. Lawlor. Mutagenicity test with Avicel AC-815 in the Salmonella-Escherichia coli/mammalian microsome reverse mutation assay with a confirmatory assay. Unpublished report by Corning Hazleton Inc., Vienna, Virginia, USA (FMC Study No. I95-2047). 1996.</mixed-citation></citation-alternatives></ref><ref id="cit33"><label>33</label><citation-alternatives><mixed-citation xml:lang="ru">M.E. McKeon. Genotoxicity test on Avicel RCN-15 in the assay for unscheduled DNA synthesis in rat liver primary cell cultures with a confirmatory assay. Unpublished report by Hazleton Washington Inc., Kensington, Maryland, USA (FMC Study No. I91-1229). 1992.</mixed-citation><mixed-citation xml:lang="en">M.E. McKeon. Genotoxicity test on Avicel RCN-15 in the assay for unscheduled DNA synthesis in rat liver primary cell cultures with a confirmatory assay. Unpublished report by Hazleton Washington Inc., Kensington, Maryland, USA (FMC Study No. I91-1229). 1992.</mixed-citation></citation-alternatives></ref><ref id="cit34"><label>34</label><citation-alternatives><mixed-citation xml:lang="ru">H. Murli. Mutagenicity test on Avicel RCN-15 in vivo micronucleus assay. Unpublished report by Hazleton Washington Inc., Kensington, Maryland, USA ( FMC Study No. I91-1228). 1992.</mixed-citation><mixed-citation xml:lang="en">H. Murli. Mutagenicity test on Avicel RCN-15 in vivo micronucleus assay. Unpublished report by Hazleton Washington Inc., Kensington, Maryland, USA ( FMC Study No. I91-1228). 1992.</mixed-citation></citation-alternatives></ref><ref id="cit35"><label>35</label><citation-alternatives><mixed-citation xml:lang="ru">H. Murli. Mutagenicity test on Avicel pH101 Pharmaceutical in an in vivo mouse micronucleus assay. Unpublished report by Hazleton Washington, Inc., Vienna, Virginia, USA (FMC Study No. I94-1837). 1994a.</mixed-citation><mixed-citation xml:lang="en">H. Murli. Mutagenicity test on Avicel pH101 Pharmaceutical in an in vivo mouse micronucleus assay. Unpublished report by Hazleton Washington, Inc., Vienna, Virginia, USA (FMC Study No. I94-1837). 1994a.</mixed-citation></citation-alternatives></ref><ref id="cit36"><label>36</label><citation-alternatives><mixed-citation xml:lang="ru">H. Murli. Mutagenicity test on Avicel CL-611 in an in vivo mouse micronucleus assay. Unpublished report by Hazleton Washington, Inc., Vienna, Virginia, USA (FMC Study No. I94-1835). 1994b.</mixed-citation><mixed-citation xml:lang="en">H. Murli. Mutagenicity test on Avicel CL-611 in an in vivo mouse micronucleus assay. Unpublished report by Hazleton Washington, Inc., Vienna, Virginia, USA (FMC Study No. I94-1835). 1994b.</mixed-citation></citation-alternatives></ref><ref id="cit37"><label>37</label><citation-alternatives><mixed-citation xml:lang="ru">D. Sondergaard, O. Meyer, G. Würtzen. Magnesium stearate given perorally to rats. A short term study // Toxicology. 1980. № 17(1). P. 51-55.</mixed-citation><mixed-citation xml:lang="en">D. Sondergaard, O. Meyer, G. Würtzen. Magnesium stearate given perorally to rats. A short term study // Toxicology. 1980. № 17(1). P. 51-55.</mixed-citation></citation-alternatives></ref><ref id="cit38"><label>38</label><citation-alternatives><mixed-citation xml:lang="ru">E. Boyland, E.R. Busby, C.E. Dukes, P.L. Grover, D. Manson. Further experiments on implantation of materials into the urinary bladder of mice // Br J Cancer. 1964. V. 13. P. 575-581.</mixed-citation><mixed-citation xml:lang="en">E. Boyland, E.R. Busby, C.E. Dukes, P.L. Grover, D. Manson. Further experiments on implantation of materials into the urinary bladder of mice // Br J Cancer. 1964. V. 13. P. 575-581.</mixed-citation></citation-alternatives></ref><ref id="cit39"><label>39</label><citation-alternatives><mixed-citation xml:lang="ru">Z.T. Chowhan, W.L. Paul, L.T. Grady. Harmonization of Excipient Standards and Test Methods: Challenges and Progress // Pharma Tech. 1994. № 18(6). P. 78-96.</mixed-citation><mixed-citation xml:lang="en">Z.T. Chowhan, W.L. Paul, L.T. Grady. Harmonization of Excipient Standards and Test Methods: Challenges and Progress // Pharma Tech. 1994. № 18(6). P. 78-96.</mixed-citation></citation-alternatives></ref><ref id="cit40"><label>40</label><citation-alternatives><mixed-citation xml:lang="ru">Final Report of the Safety Assessment of Lithium Stearate, Aluminum Distearate, Aluminum Stearate, Aluminum Tristearate, Ammonium Stearate, Calcium Stearate, Magnesium Stearate, Potassium Stearate, Sodium Stearate, and Zinc Stearate/International Journal of Toxicology. Published January 1, 1990.</mixed-citation><mixed-citation xml:lang="en">Final Report of the Safety Assessment of Lithium Stearate, Aluminum Distearate, Aluminum Stearate, Aluminum Tristearate, Ammonium Stearate, Calcium Stearate, Magnesium Stearate, Potassium Stearate, Sodium Stearate, and Zinc Stearate/International Journal of Toxicology. Published January 1, 1990.</mixed-citation></citation-alternatives></ref><ref id="cit41"><label>41</label><citation-alternatives><mixed-citation xml:lang="ru">American Conference of Governmental Industrial Hygienists TLVs and BEIs. Threshold Limit Values for Chemical Substances and Physical Agents and Biological Exposure Indices. Cincinnati, OH, 2008.P. 52.</mixed-citation><mixed-citation xml:lang="en">American Conference of Governmental Industrial Hygienists TLVs and BEIs. Threshold Limit Values for Chemical Substances and Physical Agents and Biological Exposure Indices. Cincinnati, OH, 2008.P. 52.</mixed-citation></citation-alternatives></ref><ref id="cit42"><label>42</label><citation-alternatives><mixed-citation xml:lang="ru">CFR 184.1440; U.S. National Archives and Records Administration’s Electronic Code of Federal Regulations. Available from, as of October 22, 2002. URL: http://www.gpoaccess.gov/ecfr/ (дата обращения 19.08.2011).</mixed-citation><mixed-citation xml:lang="en">CFR 184.1440; U.S. National Archives and Records Administration’s Electronic Code of Federal Regulations. Available from, as of October 22, 2002. URL: http://www.gpoaccess.gov/ecfr/ (дата обращения 19.08.2011).</mixed-citation></citation-alternatives></ref><ref id="cit43"><label>43</label><citation-alternatives><mixed-citation xml:lang="ru">R.H. Dave. Overview of pharmaceutical excipients used in tablets and capsules. Drug Topics (online). Advanstar. 10/24/2008. URL: http://drugtopics.modernmedicine.com/drugtopics/Top+News/Overview-of-pharmaceutical.-excipients-used-in-tabl/ArticleStandard/Article/detail/561047. (дата обращения 19.08.2011).</mixed-citation><mixed-citation xml:lang="en">R.H. Dave. Overview of pharmaceutical excipients used in tablets and capsules. Drug Topics (online). Advanstar. 10/24/2008. URL: http://drugtopics.modernmedicine.com/drugtopics/Top+News/Overview-of-pharmaceutical.-excipients-used-in-tabl/ArticleStandard/Article/detail/561047. (дата обращения 19.08.2011).</mixed-citation></citation-alternatives></ref><ref id="cit44"><label>44</label><citation-alternatives><mixed-citation xml:lang="ru">D.A Bender. Starch, Pregelatinized. A Dictionary of Food and Nutrition. 2005. Retrieved March 19, 2012. URL: http://www.encyclopedia.com/doc/1O39-starchpregelatinized.html (дата обращения 19.08.2011).</mixed-citation><mixed-citation xml:lang="en">D.A Bender. Starch, Pregelatinized. A Dictionary of Food and Nutrition. 2005. Retrieved March 19, 2012. URL: http://www.encyclopedia.com/doc/1O39-starchpregelatinized.html (дата обращения 19.08.2011).</mixed-citation></citation-alternatives></ref><ref id="cit45"><label>45</label><citation-alternatives><mixed-citation xml:lang="ru">FDA’s SCOGS database; Wheat Starch; SCOGS-Report Number: 115; URL: http://www.accessdata.fda.gov/scripts/fcn/fcnDetailNavigation.cfm?rpt=scogsListing&amp;id=365 (дата обращения 19.03.2012).</mixed-citation><mixed-citation xml:lang="en">FDA’s SCOGS database; Wheat Starch; SCOGS-Report Number: 115; URL: http://www.accessdata.fda.gov/scripts/fcn/fcnDetailNavigation.cfm?rpt=scogsListing&amp;id=365 (дата обращения 19.03.2012).</mixed-citation></citation-alternatives></ref><ref id="cit46"><label>46</label><citation-alternatives><mixed-citation xml:lang="ru">D.B. Le Corre, J. Bras, A. Dufresne. Starch Nanoparticles: A Review // Biomacromolecules. 2010. № 11(5). P. 1139-1153.</mixed-citation><mixed-citation xml:lang="en">D.B. Le Corre, J. Bras, A. Dufresne. Starch Nanoparticles: A Review // Biomacromolecules. 2010. № 11(5). P. 1139-1153.</mixed-citation></citation-alternatives></ref><ref id="cit47"><label>47</label><citation-alternatives><mixed-citation xml:lang="ru">М.В. Ходжава, Н.Б. Дёмина, С.А. Скатков, В.А. Кеменова. Влияние скользящих веществ на качество таблетированных лекарственных средств // Фармация. 2011. № 7. С. 31-34.</mixed-citation><mixed-citation xml:lang="en">М.В. Ходжава, Н.Б. Дёмина, С.А. Скатков, В.А. Кеменова. Влияние скользящих веществ на качество таблетированных лекарственных средств // Фармация. 2011. № 7. С. 31-34.</mixed-citation></citation-alternatives></ref><ref id="cit48"><label>48</label><citation-alternatives><mixed-citation xml:lang="ru">Y. Kim et al. Toxicity of colloidal silica nanoparticles administered orally for 90 days in rats // International Journal of Nanomedicine. 2014. № 9 (Suppl 2). P. 67-78.</mixed-citation><mixed-citation xml:lang="en">Y. Kim et al. Toxicity of colloidal silica nanoparticles administered orally for 90 days in rats // International Journal of Nanomedicine. 2014. № 9 (Suppl 2). P. 67-78.</mixed-citation></citation-alternatives></ref><ref id="cit49"><label>49</label><citation-alternatives><mixed-citation xml:lang="ru">C. Fu, T. Liu, L. Li, H. Liu, D. Chen, F. Tang. The absorption, distribution, excretion and toxicity of mesoporous silica nanoparticles in mice following different exposure routes // Biomaterials. 2013. № 34(10). P. 2565-2575.</mixed-citation><mixed-citation xml:lang="en">C. Fu, T. Liu, L. Li, H. Liu, D. Chen, F. Tang. The absorption, distribution, excretion and toxicity of mesoporous silica nanoparticles in mice following different exposure routes // Biomaterials. 2013. № 34(10). P. 2565-2575.</mixed-citation></citation-alternatives></ref><ref id="cit50"><label>50</label><citation-alternatives><mixed-citation xml:lang="ru">C.A. Barnes, A. Elsaesser, J. Arkusz et al. Reproducible comet assay of amorphous silica nanoparticles detects no genotoxicity // Nano Lett. 2008. № 8(9). P. 3069-3074.</mixed-citation><mixed-citation xml:lang="en">C.A. Barnes, A. Elsaesser, J. Arkusz et al. Reproducible comet assay of amorphous silica nanoparticles detects no genotoxicity // Nano Lett. 2008. № 8(9). P. 3069-3074.</mixed-citation></citation-alternatives></ref><ref id="cit51"><label>51</label><citation-alternatives><mixed-citation xml:lang="ru">J.S. Chang, K.L. Chang, D.F. Hwang, Z.L. Kong. In vitro cytotoxicitiy of silica nanoparticles at high concentrations strongly depends on the metabolic activity type of the cell line // Environ Sci Technol. 2007. № 41(6). P. 2064-2068.</mixed-citation><mixed-citation xml:lang="en">J.S. Chang, K.L. Chang, D.F. Hwang, Z.L. Kong. In vitro cytotoxicitiy of silica nanoparticles at high concentrations strongly depends on the metabolic activity type of the cell line // Environ Sci Technol. 2007. № 41(6). P. 2064-2068.</mixed-citation></citation-alternatives></ref><ref id="cit52"><label>52</label><citation-alternatives><mixed-citation xml:lang="ru">M. Guo, X. Xu, X. Yan, S. Wang, S. Gao, S. Zhu. In vivo biodistribution and synergistic toxicity of silica nanoparticles and cadmium chloride in mice // J Hazard Mater. 2013. V. 260. P. 780-788.</mixed-citation><mixed-citation xml:lang="en">M. Guo, X. Xu, X. Yan, S. Wang, S. Gao, S. Zhu. In vivo biodistribution and synergistic toxicity of silica nanoparticles and cadmium chloride in mice // J Hazard Mater. 2013. V. 260. P. 780-788.</mixed-citation></citation-alternatives></ref><ref id="cit53"><label>53</label><citation-alternatives><mixed-citation xml:lang="ru">S. Lee, M.S. Kim, D. Lee et al. The comparative immunotoxicity of mesoporous silica nanoparticles and colloidal silica nanoparticles in mice // Int J Nanomedicine. 2013. V. 8. P. 147-158.</mixed-citation><mixed-citation xml:lang="en">S. Lee, M.S. Kim, D. Lee et al. The comparative immunotoxicity of mesoporous silica nanoparticles and colloidal silica nanoparticles in mice // Int J Nanomedicine. 2013. V. 8. P. 147-158.</mixed-citation></citation-alternatives></ref><ref id="cit54"><label>54</label><citation-alternatives><mixed-citation xml:lang="ru">T. Coccini, E. Roda, S. Barni, C. Signorini, L. Manzo. Long-lasting oxidative pulmonary insult in rat after intratracheal instillation of silica nanoparticles doped with cadmium // Toxicology. 2012. № 302(2-3). P. 203-211.</mixed-citation><mixed-citation xml:lang="en">T. Coccini, E. Roda, S. Barni, C. Signorini, L. Manzo. Long-lasting oxidative pulmonary insult in rat after intratracheal instillation of silica nanoparticles doped with cadmium // Toxicology. 2012. № 302(2-3). P. 203-211.</mixed-citation></citation-alternatives></ref><ref id="cit55"><label>55</label><citation-alternatives><mixed-citation xml:lang="ru">S. Ivanov, S. Zhuravsky, G. Yukina, V. Tomson, D. Korolev, M. Galagudza. In vivo toxicity of intravenously administered silica and silicon nanoparticles // Materials. 2012. № 5(10). P. 1873-1889.</mixed-citation><mixed-citation xml:lang="en">S. Ivanov, S. Zhuravsky, G. Yukina, V. Tomson, D. Korolev, M. Galagudza. In vivo toxicity of intravenously administered silica and silicon nanoparticles // Materials. 2012. № 5(10). P. 1873-1889.</mixed-citation></citation-alternatives></ref><ref id="cit56"><label>56</label><citation-alternatives><mixed-citation xml:lang="ru">Маннитол PEARLITOL® - основа для создания фармацевтических препаратов высокого качества // Фармацевтическая отрасль. 2016. № 1(54). C. 66-70.</mixed-citation><mixed-citation xml:lang="en">Маннитол PEARLITOL® - основа для создания фармацевтических препаратов высокого качества // Фармацевтическая отрасль. 2016. № 1(54). C. 66-70.</mixed-citation></citation-alternatives></ref><ref id="cit57"><label>57</label><citation-alternatives><mixed-citation xml:lang="ru">Государственный реестр лекарственных средств. URL: http://www.grls.rosminzdrav.ru/GRLS.aspx?RegNumber=&amp;MnnR=%D1%82%D0%BE%D1%80%D0%B0%D1%81%D0%B5%D0%BC%D0%B8%D0%B4&amp;lf=&amp;TradeNmR=&amp;OwnerName=&amp;MnfOrg=&amp;MnfOrgCountry=&amp;isfs=0&amp;isND=1&amp;regtype=&amp;pageSize=10&amp;order=RegDate&amp;orderType=desc&amp;pageNum=1 (data obrashcheniya 27.10.2017).</mixed-citation><mixed-citation xml:lang="en">Государственный реестр лекарственных средств. URL: http://www.grls.rosminzdrav.ru/GRLS.aspx?RegNumber=&amp;MnnR=%D1%82%D0%BE%D1%80%D0%B0%D1%81%D0%B5%D0%BC%D0%B8%D0%B4&amp;lf=&amp;TradeNmR=&amp;OwnerName=&amp;MnfOrg=&amp;MnfOrgCountry=&amp;isfs=0&amp;isND=1&amp;regtype=&amp;pageSize=10&amp;order=RegDate&amp;orderType=desc&amp;pageNum=1 (data obrashcheniya 27.10.2017).</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
