<?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-169</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>ЭФФЕКТИВНОСТЬ И БЕЗОПАСНОСТЬ ЛЕКАРСТВЕННЫХ СРЕДСТВ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>DRUG PRODUCTS EFFICACY AND SAFETY</subject></subj-group></article-categories><title-group><article-title>РЕТРОСПЕКТИВА РАЗВИТИЯ НАУКИ О РАСТВОРЕНИИ ТВЁРДЫХ ДОЗИРОВАННЫХ ЛЕКАРСТВЕННЫХ ФОРМ (ОБЗОР)</article-title><trans-title-group xml:lang="en"><trans-title>RETROSPECTIVE OF DISSOLUTION TEST OF SOLID DOSAGE FORMS (REVIEW)</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>Гребёнкин</surname><given-names>Д. Ю.</given-names></name><name name-style="western" xml:lang="en"><surname>Grebenkin</surname><given-names>D. Yu.</given-names></name></name-alternatives><email xlink:type="simple">gredmitrij93@gmail.com</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>Станишевский</surname><given-names>Я. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Stanishevskiy</surname><given-names>Ya. M.</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>Шохин</surname><given-names>И. Е.</given-names></name><name name-style="western" xml:lang="en"><surname>Shohin</surname><given-names>I. E.</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>Малашенко</surname><given-names>Е. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Malashenko</surname><given-names>E. A.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-3"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>ФГАОУ ВО «Российский университет дружбы народов»</institution></aff><aff xml:lang="en"><institution>Peoples' Friendship University of Russia</institution></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>ООО «Центр фармацевтической аналитики»</institution></aff><aff xml:lang="en"><institution>Center of Pharmaceutical Analytics Ltd</institution></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>ФГБОУ ВО Первый МГМУ им. И.М.Сеченова Минздрава России</institution></aff><aff xml:lang="en"><institution>I.M. Sechenov First Moscow State Medical University</institution></aff></aff-alternatives><pub-date pub-type="collection"><year>2016</year></pub-date><pub-date pub-type="epub"><day>09</day><month>01</month><year>2019</year></pub-date><volume>0</volume><issue>4</issue><fpage>158</fpage><lpage>166</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Гребёнкин Д.Ю., Станишевский Я.М., Шохин И.Е., Малашенко Е.А., 2019</copyright-statement><copyright-year>2019</copyright-year><copyright-holder xml:lang="ru">Гребёнкин Д.Ю., Станишевский Я.М., Шохин И.Е., Малашенко Е.А.</copyright-holder><copyright-holder xml:lang="en">Grebenkin D.Y., Stanishevskiy Y.M., Shohin I.E., Malashenko E.A.</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/169">https://www.pharmjournal.ru/jour/article/view/169</self-uri><abstract><p>Работа освещает основные исторические вехи в развитии науки о растворении лекарственных препаратов и сравнительного теста кинетики растворения от первых экспериментальных работ в области растворения твёрдых веществ в начале двадцатого века, осознания тесной взаимосвязи растворения и биодоступности лекарственных препаратов в 1950-х годах, создания первых аппаратов для растворения до введения процедуры «биовейвер», основанной на БКС.</p></abstract><trans-abstract xml:lang="en"><p>The article describes the main historical stages in the development of the science of drug dissolution and the dissolution profile test from the theoretical foundations of dissolution, developed in the first half of the 20th century, and the development of a relationship between dissolution and bioavailability in the 1950s, going to the introduction of biowaiver based on the BCS.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>тест кинетики растворения</kwd><kwd>эквивалентность</kwd><kwd>дженерики</kwd></kwd-group><kwd-group xml:lang="en"><kwd>dissolution profile test</kwd><kwd>equivalence</kwd><kwd>generic drugs</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">A.A. Noyes, W.R. Whitney. The rate of solution of solid substances in their own solutions // Journal of the American Chemical Society. 1897. Т. 19. № 12. С. 930-934.</mixed-citation><mixed-citation xml:lang="en">A.A. Noyes, W.R. Whitney. The rate of solution of solid substances in their own solutions // Journal of the American Chemical Society. 1897. Т. 19. № 12. С. 930-934.</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">А. Dokoumetzidis, P. Macheras. A century of dissolution research: from Noyes and Whitney to the biopharmaceutics classification system // International journal of pharmaceutics. 2006. Т. 321. № 1. С. 1-11.</mixed-citation><mixed-citation xml:lang="en">А. Dokoumetzidis, P. Macheras. A century of dissolution research: from Noyes and Whitney to the biopharmaceutics classification system // International journal of pharmaceutics. 2006. Т. 321. № 1. С. 1-11.</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">L.J. Edwards. The dissolution and diffusion of aspirin in aqueous media // Transactions of the Faraday Society. 1951. Т. 47. С. 1191-1210.</mixed-citation><mixed-citation xml:lang="en">L.J. Edwards. The dissolution and diffusion of aspirin in aqueous media // Transactions of the Faraday Society. 1951. Т. 47. С. 1191-1210.</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">E. Nelson. Solution rate of theophylline salts and effects from oral administration // Journal of the American Pharmaceutical Association. 1957. Т. 46. № 10. С. 607-614.</mixed-citation><mixed-citation xml:lang="en">E. Nelson. Solution rate of theophylline salts and effects from oral administration // Journal of the American Pharmaceutical Association. 1957. Т. 46. № 10. С. 607-614.</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">A.B. Varley. The generic inequivalence of drugs // JAMA. 1968. Т. 206. № 8. С. 1745-1748.</mixed-citation><mixed-citation xml:lang="en">A.B. Varley. The generic inequivalence of drugs // JAMA. 1968. Т. 206. № 8. С. 1745-1748.</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">C.M. Martin et al. Brand, generic drugs differ in man // JAMA. 1968. Т. 205. № 9. С. 23-4.</mixed-citation><mixed-citation xml:lang="en">C.M. Martin et al. Brand, generic drugs differ in man // JAMA. 1968. Т. 205. № 9. С. 23-4.</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">C. MacLeod et al. Comparative bioavailability of three brands of ampicillin // Canadian Medical Association Journal. 1972. Т. 107. № 3. С. 203.</mixed-citation><mixed-citation xml:lang="en">C. MacLeod et al. Comparative bioavailability of three brands of ampicillin // Canadian Medical Association Journal. 1972. Т. 107. № 3. С. 203.</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">J.H. Tyrer et al. Outbreak of anticonvulsant intoxication in an Australian city // Br Med J. 1970. Т. 4. № 5730. С. 271-273.</mixed-citation><mixed-citation xml:lang="en">J.H. Tyrer et al. Outbreak of anticonvulsant intoxication in an Australian city // Br Med J. 1970. Т. 4. № 5730. С. 271-273.</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">J.C. Cloyd, R.J. Gumnit, T.S. Lesar. Reduced seizure control due to spoiled phenytoin capsules // Annals of neurology. 1980. Т. 7. № 2. С. 191-193.</mixed-citation><mixed-citation xml:lang="en">J.C. Cloyd, R.J. Gumnit, T.S. Lesar. Reduced seizure control due to spoiled phenytoin capsules // Annals of neurology. 1980. Т. 7. № 2. С. 191-193.</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">J. Lindenbaum et al. Variation in biologic availability of digoxin from four preparations // New England Journal of Medicine. 1971. Т. 285. № 24. С. 1344-1347.</mixed-citation><mixed-citation xml:lang="en">J. Lindenbaum et al. Variation in biologic availability of digoxin from four preparations // New England Journal of Medicine. 1971. Т. 285. № 24. С. 1344-1347.</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">E.J. Fraser, R.H. Leach, J.W. Poston. Bioavailability of digoxin // The Lancet. 1972. Т. 300. № 7776. С. 541.</mixed-citation><mixed-citation xml:lang="en">E.J. Fraser, R.H. Leach, J.W. Poston. Bioavailability of digoxin // The Lancet. 1972. Т. 300. № 7776. С. 541.</mixed-citation></citation-alternatives></ref><ref id="cit12"><label>12</label><citation-alternatives><mixed-citation xml:lang="ru">L.T. Grady. Perspective on the History of Dissolution Testing. URL: http://www.layloff.net/articles/Gradys Corner/A Perspective on the History of Dissolution Testing.pdf (дата обращения: 24.03.2016).</mixed-citation><mixed-citation xml:lang="en">L.T. Grady. Perspective on the History of Dissolution Testing. URL: http://www.layloff.net/articles/Gradys Corner/A Perspective on the History of Dissolution Testing.pdf (дата обращения: 24.03.2016).</mixed-citation></citation-alternatives></ref><ref id="cit13"><label>13</label><citation-alternatives><mixed-citation xml:lang="ru">L.T. Grady. An early look at dissolution testing, including equipment, calibration, and acceptance criteria // Dissolution Technologies. 2014. Т. 21. № 3. С. 20-23.</mixed-citation><mixed-citation xml:lang="en">L.T. Grady. An early look at dissolution testing, including equipment, calibration, and acceptance criteria // Dissolution Technologies. 2014. Т. 21. № 3. С. 20-23.</mixed-citation></citation-alternatives></ref><ref id="cit14"><label>14</label><citation-alternatives><mixed-citation xml:lang="ru">P.J. Marroum. History and evolution of the dissolution test // Dissolution Technol. 2014. Т. 21. № 3. С. 11-16.</mixed-citation><mixed-citation xml:lang="en">P.J. Marroum. History and evolution of the dissolution test // Dissolution Technol. 2014. Т. 21. № 3. С. 11-16.</mixed-citation></citation-alternatives></ref><ref id="cit15"><label>15</label><citation-alternatives><mixed-citation xml:lang="ru">D.E. Wurster, P.W. Taylor. Dissolution kinetics of certain crystalline forms of prednisolone // Journal of pharmaceutical sciences. 1965. Т. 54. № 5. С. 670-676.</mixed-citation><mixed-citation xml:lang="en">D.E. Wurster, P.W. Taylor. Dissolution kinetics of certain crystalline forms of prednisolone // Journal of pharmaceutical sciences. 1965. Т. 54. № 5. С. 670-676.</mixed-citation></citation-alternatives></ref><ref id="cit16"><label>16</label><citation-alternatives><mixed-citation xml:lang="ru">T.R. Bates, M. Gibaldi, J.L. Kanig. Rate of dissolution of griseofulvin and hexoestrol in bile salt solutions // Nature. 1966. № 5043. С. 1331-1333.</mixed-citation><mixed-citation xml:lang="en">T.R. Bates, M. Gibaldi, J.L. Kanig. Rate of dissolution of griseofulvin and hexoestrol in bile salt solutions // Nature. 1966. № 5043. С. 1331-1333.</mixed-citation></citation-alternatives></ref><ref id="cit17"><label>17</label><citation-alternatives><mixed-citation xml:lang="ru">J.C. Tao, E.L. Cussler, D.F. Evans. Accelerating gallstone dissolution // Proceedings of the National Academy of Sciences. 1974. Т. 71. № 10. С. 3917-3921.</mixed-citation><mixed-citation xml:lang="en">J.C. Tao, E.L. Cussler, D.F. Evans. Accelerating gallstone dissolution // Proceedings of the National Academy of Sciences. 1974. Т. 71. № 10. С. 3917-3921.</mixed-citation></citation-alternatives></ref><ref id="cit18"><label>18</label><citation-alternatives><mixed-citation xml:lang="ru">P.H. Elworthy, A.T. Florence, C.B. Macfarlane. Solubilization by surface-active agents and its applications in chemistry and the biological sciences. - London: Chapman &amp; Hall, 1968.</mixed-citation><mixed-citation xml:lang="en">P.H. Elworthy, A.T. Florence, C.B. Macfarlane. Solubilization by surface-active agents and its applications in chemistry and the biological sciences. - London: Chapman &amp; Hall, 1968.</mixed-citation></citation-alternatives></ref><ref id="cit19"><label>19</label><citation-alternatives><mixed-citation xml:lang="ru">W.L. Chiou. Mechanism of increased rates of dissolution and oral absorption of chloramphenicol from chloramphenicol-urea solid dispersion system // Journal of pharmaceutical sciences. 1971. Т. 60. № 9. С. 1406-1408.</mixed-citation><mixed-citation xml:lang="en">W.L. Chiou. Mechanism of increased rates of dissolution and oral absorption of chloramphenicol from chloramphenicol-urea solid dispersion system // Journal of pharmaceutical sciences. 1971. Т. 60. № 9. С. 1406-1408.</mixed-citation></citation-alternatives></ref><ref id="cit20"><label>20</label><citation-alternatives><mixed-citation xml:lang="ru">A.J. Jounela, P.J. Pentikäinen, A. Sothmann. Effect of particle size on the bioavailability of digoxin // European journal of clinical pharmacology. 1975. Т. 8. № 5. С. 365-370.</mixed-citation><mixed-citation xml:lang="en">A.J. Jounela, P.J. Pentikäinen, A. Sothmann. Effect of particle size on the bioavailability of digoxin // European journal of clinical pharmacology. 1975. Т. 8. № 5. С. 365-370.</mixed-citation></citation-alternatives></ref><ref id="cit21"><label>21</label><citation-alternatives><mixed-citation xml:lang="ru">T. Higuchi. Rate of release of medicaments from ointment bases containing drugs in suspension // Journal of pharmaceutical sciences. 1961. Т. 50. № 10. С. 874-875.</mixed-citation><mixed-citation xml:lang="en">T. Higuchi. Rate of release of medicaments from ointment bases containing drugs in suspension // Journal of pharmaceutical sciences. 1961. Т. 50. № 10. С. 874-875.</mixed-citation></citation-alternatives></ref><ref id="cit22"><label>22</label><citation-alternatives><mixed-citation xml:lang="ru">T.T. Wang, T.K. Kwei, H.L. Frisch. Diffusion in glassy polymers. III // Journal of Polymer Science. Part A-2: Polymer Physics. 1969. Т. 7. № 12. С. 2019-2028.</mixed-citation><mixed-citation xml:lang="en">T.T. Wang, T.K. Kwei, H.L. Frisch. Diffusion in glassy polymers. III // Journal of Polymer Science. Part A-2: Polymer Physics. 1969. Т. 7. № 12. С. 2019-2028.</mixed-citation></citation-alternatives></ref><ref id="cit23"><label>23</label><citation-alternatives><mixed-citation xml:lang="ru">B. Cabana, R. O’Neil. FDA Report on Drug Dissolution // Pharmacopeial Forum. 1980. № 6. С. 71-75.</mixed-citation><mixed-citation xml:lang="en">B. Cabana, R. O’Neil. FDA Report on Drug Dissolution // Pharmacopeial Forum. 1980. № 6. С. 71-75.</mixed-citation></citation-alternatives></ref><ref id="cit24"><label>24</label><citation-alternatives><mixed-citation xml:lang="ru">Dissolution Testing of Immediate Release Solid Oral Dosage Forms; Guidance for Industry; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), U.S. Government Printing Office: Washington, DC, 1997.</mixed-citation><mixed-citation xml:lang="en">Dissolution Testing of Immediate Release Solid Oral Dosage Forms; Guidance for Industry; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), U.S. Government Printing Office: Washington, DC, 1997.</mixed-citation></citation-alternatives></ref><ref id="cit25"><label>25</label><citation-alternatives><mixed-citation xml:lang="ru">Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations; Guidance for Industry; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), U.S. Government Printing Office: Washington, DC, 1997.</mixed-citation><mixed-citation xml:lang="en">Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations; Guidance for Industry; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), U.S. Government Printing Office: Washington, DC, 1997.</mixed-citation></citation-alternatives></ref><ref id="cit26"><label>26</label><citation-alternatives><mixed-citation xml:lang="ru">G.L. Amidon et al. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability // Pharmaceutical research. 1995. Т. 12. № 3. С. 413-420.</mixed-citation><mixed-citation xml:lang="en">G.L. Amidon et al. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability // Pharmaceutical research. 1995. Т. 12. № 3. С. 413-420.</mixed-citation></citation-alternatives></ref><ref id="cit27"><label>27</label><citation-alternatives><mixed-citation xml:lang="ru">J.B. Dressman, G.L. Amidon, D. Fleisher. Absorption potential: estimating the fraction absorbed for orally administered compounds // Journal of pharmaceutical sciences. 1985. Т. 74. № 5. С. 588-589.</mixed-citation><mixed-citation xml:lang="en">J.B. Dressman, G.L. Amidon, D. Fleisher. Absorption potential: estimating the fraction absorbed for orally administered compounds // Journal of pharmaceutical sciences. 1985. Т. 74. № 5. С. 588-589.</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>
