Biopharmaceutical classification of poorly soluble drugs with respect to "enabling formulations"
The large number of drug candidates with poor dissolution characteristics seen in the past decade, has fostered interest in so-called "enabling formulations", i.e., formulations which shall make such drugs bio-available. Development of enabling formulations is currently being guided by the...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Buckley, Stephen Timothy [verfasserIn] Frank, Kerstin J. [verfasserIn] Fricker, Gert - 1956- [verfasserIn] Brandl, Martin [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
11 April 2013 |
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| Anmerkung: |
Gesehen am 26.11.2020 |
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| Umfang: |
9 |
| Übergeordnetes Werk: |
Enthalten in: European journal of pharmaceutical sciences - New York, NY [u.a.] : Elsevier, 1993, 50(2013), 1, Seite 8-16 |
|---|---|
| Übergeordnetes Werk: |
volume:50 ; year:2013 ; number:1 ; pages:8-16 ; extent:9 |
| DOI / URN: |
10.1016/j.ejps.2013.04.002 |
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| Katalog-ID: |
1741217202 |
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| 520 | |a The large number of drug candidates with poor dissolution characteristics seen in the past decade, has fostered interest in so-called "enabling formulations", i.e., formulations which shall make such drugs bio-available. Development of enabling formulations is currently being guided by the following (simplified) hypothesis: If a poorly soluble drug (BCS class II drug) can be transferred into a solubilized state, one can achieve an absorption profile close to that of a soluble drug (BCS class I drug). Thus, formulation development typically endeavors to achieve the most robust solubility enhancement. Here we critically review both common in vitro approaches and experimental data available in literature pertaining to the solubility and permeability of poorly soluble drugs from enabling formulations, and discuss their interplay. Recent in vitro data indicate, that commonly employed surfactants as well as endogenous surfactants present in the intestine, although enhancing drug solubility, mostly hamper drug permeation. Mechanistic studies demonstrate a direct correlation between passive transcellular diffusion and the concentration of molecularly dissolved drug. The latter may be reduced due to partitioning into micelles or other solubilizing carriers, but enhanced in supersaturating formulations. We conclude thus that biopharmaceutical assessment approaches that rely on the amount of molecularly dissolved drug should guide us towards successful enabling formulations. | ||
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11 April 2013 |
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2013 |
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10.1016/j.ejps.2013.04.002 doi (DE-627)1741217202 (DE-599)KXP1741217202 (OCoLC)1341382401 DE-627 ger DE-627 rda eng Buckley, Stephen Timothy verfasserin (DE-588)117136833X (DE-627)104051703X (DE-576)51372057X aut Biopharmaceutical classification of poorly soluble drugs with respect to "enabling formulations" Stephen Timothy Buckley, Kerstin Julia Frank, Gert Fricker, Martin Brandl 11 April 2013 9 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Gesehen am 26.11.2020 The large number of drug candidates with poor dissolution characteristics seen in the past decade, has fostered interest in so-called "enabling formulations", i.e., formulations which shall make such drugs bio-available. Development of enabling formulations is currently being guided by the following (simplified) hypothesis: If a poorly soluble drug (BCS class II drug) can be transferred into a solubilized state, one can achieve an absorption profile close to that of a soluble drug (BCS class I drug). Thus, formulation development typically endeavors to achieve the most robust solubility enhancement. Here we critically review both common in vitro approaches and experimental data available in literature pertaining to the solubility and permeability of poorly soluble drugs from enabling formulations, and discuss their interplay. Recent in vitro data indicate, that commonly employed surfactants as well as endogenous surfactants present in the intestine, although enhancing drug solubility, mostly hamper drug permeation. Mechanistic studies demonstrate a direct correlation between passive transcellular diffusion and the concentration of molecularly dissolved drug. The latter may be reduced due to partitioning into micelles or other solubilizing carriers, but enhanced in supersaturating formulations. We conclude thus that biopharmaceutical assessment approaches that rely on the amount of molecularly dissolved drug should guide us towards successful enabling formulations. Absorption active pharmaceutical ingredient amorphous solid dispersion API ASD BCRP BCS Bile Acids and Salts Biological Availability Biopharmaceutical Classification Scheme Biopharmaceutics breast cancer resistant protein Chemistry, Pharmaceutical CMC critical micelle concentration CsA cyclosporin A Excipients FaSSIF fasted state simulated intestinal fluid fed state simulated intestinal fluid FeSSIF Gastrointestinal GI Hank’s buffered salt solution HBSS Micelle MRP multidrug resistance-related protein p-Glycoprotein p-GP Permeability Pharmaceutical Preparations Phospholipids self nanoemulsifying drug delivery system SNEDDS Solubility Solubilization SSDS supersaturating drug delivery systems Surface-Active Agents TEER transepithelial electrical resistance Frank, Kerstin J. verfasserin (DE-588)1042228116 (DE-627)768470552 (DE-576)39378441X aut Fricker, Gert 1956- verfasserin (DE-588)1042227675 (DE-627)768469465 (DE-576)393783464 aut Brandl, Martin verfasserin aut Enthalten in European journal of pharmaceutical sciences New York, NY [u.a.] : Elsevier, 1993 50(2013), 1, Seite 8-16 Online-Ressource (DE-627)300897308 (DE-600)1483522-8 (DE-576)094142033 1879-0720 nnns volume:50 year:2013 number:1 pages:8-16 extent:9 GBV_USEFLAG_U GBV_ILN_2013 ISIL_DE-16-250 SYSFLAG_1 GBV_KXP SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 50 2013 1 8-16 9 2013 01 DE-16-250 3813448010 00 --%%-- --%%-- --%%-- --%%-- l01 26-11-20 2013 01 DE-16-250 00 s hd2013 2013 01 DE-16-250 01 s (DE-627)1410508463 wissenschaftlicher Artikel (Zeitschrift) 2013 01 DE-16-250 02 s per_4 2013 01 DE-16-250 03 s s_9 2013 01 DE-16-250 04 p (DE-627)1727346610 Frank, Kerstin J. 2013 01 DE-16-250 04 k (DE-627)1416822720 Extern 2013 01 DE-16-250 04 s (DE-627)1410501914 Verfasser 2013 01 DE-16-250 04 s pos_2 2013 01 DE-16-250 05 p (DE-627)1463784635 Fricker, Gert 2013 01 DE-16-250 05 k (DE-627)1416535624 Institut für Pharmazie und Molekulare Biotechnologie (IPMB) 2013 01 DE-16-250 05 s (DE-627)1410501914 Verfasser 2013 01 DE-16-250 05 s pos_3 |
| spelling |
10.1016/j.ejps.2013.04.002 doi (DE-627)1741217202 (DE-599)KXP1741217202 (OCoLC)1341382401 DE-627 ger DE-627 rda eng Buckley, Stephen Timothy verfasserin (DE-588)117136833X (DE-627)104051703X (DE-576)51372057X aut Biopharmaceutical classification of poorly soluble drugs with respect to "enabling formulations" Stephen Timothy Buckley, Kerstin Julia Frank, Gert Fricker, Martin Brandl 11 April 2013 9 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Gesehen am 26.11.2020 The large number of drug candidates with poor dissolution characteristics seen in the past decade, has fostered interest in so-called "enabling formulations", i.e., formulations which shall make such drugs bio-available. Development of enabling formulations is currently being guided by the following (simplified) hypothesis: If a poorly soluble drug (BCS class II drug) can be transferred into a solubilized state, one can achieve an absorption profile close to that of a soluble drug (BCS class I drug). Thus, formulation development typically endeavors to achieve the most robust solubility enhancement. Here we critically review both common in vitro approaches and experimental data available in literature pertaining to the solubility and permeability of poorly soluble drugs from enabling formulations, and discuss their interplay. Recent in vitro data indicate, that commonly employed surfactants as well as endogenous surfactants present in the intestine, although enhancing drug solubility, mostly hamper drug permeation. Mechanistic studies demonstrate a direct correlation between passive transcellular diffusion and the concentration of molecularly dissolved drug. The latter may be reduced due to partitioning into micelles or other solubilizing carriers, but enhanced in supersaturating formulations. We conclude thus that biopharmaceutical assessment approaches that rely on the amount of molecularly dissolved drug should guide us towards successful enabling formulations. Absorption active pharmaceutical ingredient amorphous solid dispersion API ASD BCRP BCS Bile Acids and Salts Biological Availability Biopharmaceutical Classification Scheme Biopharmaceutics breast cancer resistant protein Chemistry, Pharmaceutical CMC critical micelle concentration CsA cyclosporin A Excipients FaSSIF fasted state simulated intestinal fluid fed state simulated intestinal fluid FeSSIF Gastrointestinal GI Hank’s buffered salt solution HBSS Micelle MRP multidrug resistance-related protein p-Glycoprotein p-GP Permeability Pharmaceutical Preparations Phospholipids self nanoemulsifying drug delivery system SNEDDS Solubility Solubilization SSDS supersaturating drug delivery systems Surface-Active Agents TEER transepithelial electrical resistance Frank, Kerstin J. verfasserin (DE-588)1042228116 (DE-627)768470552 (DE-576)39378441X aut Fricker, Gert 1956- verfasserin (DE-588)1042227675 (DE-627)768469465 (DE-576)393783464 aut Brandl, Martin verfasserin aut Enthalten in European journal of pharmaceutical sciences New York, NY [u.a.] : Elsevier, 1993 50(2013), 1, Seite 8-16 Online-Ressource (DE-627)300897308 (DE-600)1483522-8 (DE-576)094142033 1879-0720 nnns volume:50 year:2013 number:1 pages:8-16 extent:9 GBV_USEFLAG_U GBV_ILN_2013 ISIL_DE-16-250 SYSFLAG_1 GBV_KXP SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 50 2013 1 8-16 9 2013 01 DE-16-250 3813448010 00 --%%-- --%%-- --%%-- --%%-- l01 26-11-20 2013 01 DE-16-250 00 s hd2013 2013 01 DE-16-250 01 s (DE-627)1410508463 wissenschaftlicher Artikel (Zeitschrift) 2013 01 DE-16-250 02 s per_4 2013 01 DE-16-250 03 s s_9 2013 01 DE-16-250 04 p (DE-627)1727346610 Frank, Kerstin J. 2013 01 DE-16-250 04 k (DE-627)1416822720 Extern 2013 01 DE-16-250 04 s (DE-627)1410501914 Verfasser 2013 01 DE-16-250 04 s pos_2 2013 01 DE-16-250 05 p (DE-627)1463784635 Fricker, Gert 2013 01 DE-16-250 05 k (DE-627)1416535624 Institut für Pharmazie und Molekulare Biotechnologie (IPMB) 2013 01 DE-16-250 05 s (DE-627)1410501914 Verfasser 2013 01 DE-16-250 05 s pos_3 |
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10.1016/j.ejps.2013.04.002 doi (DE-627)1741217202 (DE-599)KXP1741217202 (OCoLC)1341382401 DE-627 ger DE-627 rda eng Buckley, Stephen Timothy verfasserin (DE-588)117136833X (DE-627)104051703X (DE-576)51372057X aut Biopharmaceutical classification of poorly soluble drugs with respect to "enabling formulations" Stephen Timothy Buckley, Kerstin Julia Frank, Gert Fricker, Martin Brandl 11 April 2013 9 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Gesehen am 26.11.2020 The large number of drug candidates with poor dissolution characteristics seen in the past decade, has fostered interest in so-called "enabling formulations", i.e., formulations which shall make such drugs bio-available. Development of enabling formulations is currently being guided by the following (simplified) hypothesis: If a poorly soluble drug (BCS class II drug) can be transferred into a solubilized state, one can achieve an absorption profile close to that of a soluble drug (BCS class I drug). Thus, formulation development typically endeavors to achieve the most robust solubility enhancement. Here we critically review both common in vitro approaches and experimental data available in literature pertaining to the solubility and permeability of poorly soluble drugs from enabling formulations, and discuss their interplay. Recent in vitro data indicate, that commonly employed surfactants as well as endogenous surfactants present in the intestine, although enhancing drug solubility, mostly hamper drug permeation. Mechanistic studies demonstrate a direct correlation between passive transcellular diffusion and the concentration of molecularly dissolved drug. The latter may be reduced due to partitioning into micelles or other solubilizing carriers, but enhanced in supersaturating formulations. We conclude thus that biopharmaceutical assessment approaches that rely on the amount of molecularly dissolved drug should guide us towards successful enabling formulations. Absorption active pharmaceutical ingredient amorphous solid dispersion API ASD BCRP BCS Bile Acids and Salts Biological Availability Biopharmaceutical Classification Scheme Biopharmaceutics breast cancer resistant protein Chemistry, Pharmaceutical CMC critical micelle concentration CsA cyclosporin A Excipients FaSSIF fasted state simulated intestinal fluid fed state simulated intestinal fluid FeSSIF Gastrointestinal GI Hank’s buffered salt solution HBSS Micelle MRP multidrug resistance-related protein p-Glycoprotein p-GP Permeability Pharmaceutical Preparations Phospholipids self nanoemulsifying drug delivery system SNEDDS Solubility Solubilization SSDS supersaturating drug delivery systems Surface-Active Agents TEER transepithelial electrical resistance Frank, Kerstin J. verfasserin (DE-588)1042228116 (DE-627)768470552 (DE-576)39378441X aut Fricker, Gert 1956- verfasserin (DE-588)1042227675 (DE-627)768469465 (DE-576)393783464 aut Brandl, Martin verfasserin aut Enthalten in European journal of pharmaceutical sciences New York, NY [u.a.] : Elsevier, 1993 50(2013), 1, Seite 8-16 Online-Ressource (DE-627)300897308 (DE-600)1483522-8 (DE-576)094142033 1879-0720 nnns volume:50 year:2013 number:1 pages:8-16 extent:9 GBV_USEFLAG_U GBV_ILN_2013 ISIL_DE-16-250 SYSFLAG_1 GBV_KXP SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 50 2013 1 8-16 9 2013 01 DE-16-250 3813448010 00 --%%-- --%%-- --%%-- --%%-- l01 26-11-20 2013 01 DE-16-250 00 s hd2013 2013 01 DE-16-250 01 s (DE-627)1410508463 wissenschaftlicher Artikel (Zeitschrift) 2013 01 DE-16-250 02 s per_4 2013 01 DE-16-250 03 s s_9 2013 01 DE-16-250 04 p (DE-627)1727346610 Frank, Kerstin J. 2013 01 DE-16-250 04 k (DE-627)1416822720 Extern 2013 01 DE-16-250 04 s (DE-627)1410501914 Verfasser 2013 01 DE-16-250 04 s pos_2 2013 01 DE-16-250 05 p (DE-627)1463784635 Fricker, Gert 2013 01 DE-16-250 05 k (DE-627)1416535624 Institut für Pharmazie und Molekulare Biotechnologie (IPMB) 2013 01 DE-16-250 05 s (DE-627)1410501914 Verfasser 2013 01 DE-16-250 05 s pos_3 |
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10.1016/j.ejps.2013.04.002 doi (DE-627)1741217202 (DE-599)KXP1741217202 (OCoLC)1341382401 DE-627 ger DE-627 rda eng Buckley, Stephen Timothy verfasserin (DE-588)117136833X (DE-627)104051703X (DE-576)51372057X aut Biopharmaceutical classification of poorly soluble drugs with respect to "enabling formulations" Stephen Timothy Buckley, Kerstin Julia Frank, Gert Fricker, Martin Brandl 11 April 2013 9 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Gesehen am 26.11.2020 The large number of drug candidates with poor dissolution characteristics seen in the past decade, has fostered interest in so-called "enabling formulations", i.e., formulations which shall make such drugs bio-available. Development of enabling formulations is currently being guided by the following (simplified) hypothesis: If a poorly soluble drug (BCS class II drug) can be transferred into a solubilized state, one can achieve an absorption profile close to that of a soluble drug (BCS class I drug). Thus, formulation development typically endeavors to achieve the most robust solubility enhancement. Here we critically review both common in vitro approaches and experimental data available in literature pertaining to the solubility and permeability of poorly soluble drugs from enabling formulations, and discuss their interplay. Recent in vitro data indicate, that commonly employed surfactants as well as endogenous surfactants present in the intestine, although enhancing drug solubility, mostly hamper drug permeation. Mechanistic studies demonstrate a direct correlation between passive transcellular diffusion and the concentration of molecularly dissolved drug. The latter may be reduced due to partitioning into micelles or other solubilizing carriers, but enhanced in supersaturating formulations. We conclude thus that biopharmaceutical assessment approaches that rely on the amount of molecularly dissolved drug should guide us towards successful enabling formulations. Absorption active pharmaceutical ingredient amorphous solid dispersion API ASD BCRP BCS Bile Acids and Salts Biological Availability Biopharmaceutical Classification Scheme Biopharmaceutics breast cancer resistant protein Chemistry, Pharmaceutical CMC critical micelle concentration CsA cyclosporin A Excipients FaSSIF fasted state simulated intestinal fluid fed state simulated intestinal fluid FeSSIF Gastrointestinal GI Hank’s buffered salt solution HBSS Micelle MRP multidrug resistance-related protein p-Glycoprotein p-GP Permeability Pharmaceutical Preparations Phospholipids self nanoemulsifying drug delivery system SNEDDS Solubility Solubilization SSDS supersaturating drug delivery systems Surface-Active Agents TEER transepithelial electrical resistance Frank, Kerstin J. verfasserin (DE-588)1042228116 (DE-627)768470552 (DE-576)39378441X aut Fricker, Gert 1956- verfasserin (DE-588)1042227675 (DE-627)768469465 (DE-576)393783464 aut Brandl, Martin verfasserin aut Enthalten in European journal of pharmaceutical sciences New York, NY [u.a.] : Elsevier, 1993 50(2013), 1, Seite 8-16 Online-Ressource (DE-627)300897308 (DE-600)1483522-8 (DE-576)094142033 1879-0720 nnns volume:50 year:2013 number:1 pages:8-16 extent:9 GBV_USEFLAG_U GBV_ILN_2013 ISIL_DE-16-250 SYSFLAG_1 GBV_KXP SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 50 2013 1 8-16 9 2013 01 DE-16-250 3813448010 00 --%%-- --%%-- --%%-- --%%-- l01 26-11-20 2013 01 DE-16-250 00 s hd2013 2013 01 DE-16-250 01 s (DE-627)1410508463 wissenschaftlicher Artikel (Zeitschrift) 2013 01 DE-16-250 02 s per_4 2013 01 DE-16-250 03 s s_9 2013 01 DE-16-250 04 p (DE-627)1727346610 Frank, Kerstin J. 2013 01 DE-16-250 04 k (DE-627)1416822720 Extern 2013 01 DE-16-250 04 s (DE-627)1410501914 Verfasser 2013 01 DE-16-250 04 s pos_2 2013 01 DE-16-250 05 p (DE-627)1463784635 Fricker, Gert 2013 01 DE-16-250 05 k (DE-627)1416535624 Institut für Pharmazie und Molekulare Biotechnologie (IPMB) 2013 01 DE-16-250 05 s (DE-627)1410501914 Verfasser 2013 01 DE-16-250 05 s pos_3 |
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10.1016/j.ejps.2013.04.002 doi (DE-627)1741217202 (DE-599)KXP1741217202 (OCoLC)1341382401 DE-627 ger DE-627 rda eng Buckley, Stephen Timothy verfasserin (DE-588)117136833X (DE-627)104051703X (DE-576)51372057X aut Biopharmaceutical classification of poorly soluble drugs with respect to "enabling formulations" Stephen Timothy Buckley, Kerstin Julia Frank, Gert Fricker, Martin Brandl 11 April 2013 9 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Gesehen am 26.11.2020 The large number of drug candidates with poor dissolution characteristics seen in the past decade, has fostered interest in so-called "enabling formulations", i.e., formulations which shall make such drugs bio-available. Development of enabling formulations is currently being guided by the following (simplified) hypothesis: If a poorly soluble drug (BCS class II drug) can be transferred into a solubilized state, one can achieve an absorption profile close to that of a soluble drug (BCS class I drug). Thus, formulation development typically endeavors to achieve the most robust solubility enhancement. Here we critically review both common in vitro approaches and experimental data available in literature pertaining to the solubility and permeability of poorly soluble drugs from enabling formulations, and discuss their interplay. Recent in vitro data indicate, that commonly employed surfactants as well as endogenous surfactants present in the intestine, although enhancing drug solubility, mostly hamper drug permeation. Mechanistic studies demonstrate a direct correlation between passive transcellular diffusion and the concentration of molecularly dissolved drug. The latter may be reduced due to partitioning into micelles or other solubilizing carriers, but enhanced in supersaturating formulations. We conclude thus that biopharmaceutical assessment approaches that rely on the amount of molecularly dissolved drug should guide us towards successful enabling formulations. Absorption active pharmaceutical ingredient amorphous solid dispersion API ASD BCRP BCS Bile Acids and Salts Biological Availability Biopharmaceutical Classification Scheme Biopharmaceutics breast cancer resistant protein Chemistry, Pharmaceutical CMC critical micelle concentration CsA cyclosporin A Excipients FaSSIF fasted state simulated intestinal fluid fed state simulated intestinal fluid FeSSIF Gastrointestinal GI Hank’s buffered salt solution HBSS Micelle MRP multidrug resistance-related protein p-Glycoprotein p-GP Permeability Pharmaceutical Preparations Phospholipids self nanoemulsifying drug delivery system SNEDDS Solubility Solubilization SSDS supersaturating drug delivery systems Surface-Active Agents TEER transepithelial electrical resistance Frank, Kerstin J. verfasserin (DE-588)1042228116 (DE-627)768470552 (DE-576)39378441X aut Fricker, Gert 1956- verfasserin (DE-588)1042227675 (DE-627)768469465 (DE-576)393783464 aut Brandl, Martin verfasserin aut Enthalten in European journal of pharmaceutical sciences New York, NY [u.a.] : Elsevier, 1993 50(2013), 1, Seite 8-16 Online-Ressource (DE-627)300897308 (DE-600)1483522-8 (DE-576)094142033 1879-0720 nnns volume:50 year:2013 number:1 pages:8-16 extent:9 GBV_USEFLAG_U GBV_ILN_2013 ISIL_DE-16-250 SYSFLAG_1 GBV_KXP SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 50 2013 1 8-16 9 2013 01 DE-16-250 3813448010 00 --%%-- --%%-- --%%-- --%%-- l01 26-11-20 2013 01 DE-16-250 00 s hd2013 2013 01 DE-16-250 01 s (DE-627)1410508463 wissenschaftlicher Artikel (Zeitschrift) 2013 01 DE-16-250 02 s per_4 2013 01 DE-16-250 03 s s_9 2013 01 DE-16-250 04 p (DE-627)1727346610 Frank, Kerstin J. 2013 01 DE-16-250 04 k (DE-627)1416822720 Extern 2013 01 DE-16-250 04 s (DE-627)1410501914 Verfasser 2013 01 DE-16-250 04 s pos_2 2013 01 DE-16-250 05 p (DE-627)1463784635 Fricker, Gert 2013 01 DE-16-250 05 k (DE-627)1416535624 Institut für Pharmazie und Molekulare Biotechnologie (IPMB) 2013 01 DE-16-250 05 s (DE-627)1410501914 Verfasser 2013 01 DE-16-250 05 s pos_3 |
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<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a2200265 4500</leader><controlfield tag="001">1741217202</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230428021745.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">201126s2013 xx |||||o 00| ||eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1016/j.ejps.2013.04.002</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)1741217202</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)KXP1741217202</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(OCoLC)1341382401</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rda</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Buckley, Stephen Timothy</subfield><subfield code="e">verfasserin</subfield><subfield code="0">(DE-588)117136833X</subfield><subfield code="0">(DE-627)104051703X</subfield><subfield code="0">(DE-576)51372057X</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Biopharmaceutical classification of poorly soluble drugs with respect to "enabling formulations"</subfield><subfield code="c">Stephen Timothy Buckley, Kerstin Julia Frank, Gert Fricker, Martin Brandl</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">11 April 2013</subfield></datafield><datafield tag="300" ind1=" " ind2=" "><subfield code="a">9</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">Gesehen am 26.11.2020</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">The large number of drug candidates with poor dissolution characteristics seen in the past decade, has fostered interest in so-called "enabling formulations", i.e., formulations which shall make such drugs bio-available. Development of enabling formulations is currently being guided by the following (simplified) hypothesis: If a poorly soluble drug (BCS class II drug) can be transferred into a solubilized state, one can achieve an absorption profile close to that of a soluble drug (BCS class I drug). Thus, formulation development typically endeavors to achieve the most robust solubility enhancement. Here we critically review both common in vitro approaches and experimental data available in literature pertaining to the solubility and permeability of poorly soluble drugs from enabling formulations, and discuss their interplay. Recent in vitro data indicate, that commonly employed surfactants as well as endogenous surfactants present in the intestine, although enhancing drug solubility, mostly hamper drug permeation. Mechanistic studies demonstrate a direct correlation between passive transcellular diffusion and the concentration of molecularly dissolved drug. The latter may be reduced due to partitioning into micelles or other solubilizing carriers, but enhanced in supersaturating formulations. We conclude thus that biopharmaceutical assessment approaches that rely on the amount of molecularly dissolved drug should guide us towards successful enabling formulations.</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Absorption</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">active pharmaceutical ingredient</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">amorphous solid dispersion</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">API</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">ASD</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">BCRP</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">BCS</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Bile Acids and Salts</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield 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The large number of drug candidates with poor dissolution characteristics seen in the past decade, has fostered interest in so-called "enabling formulations", i.e., formulations which shall make such drugs bio-available. Development of enabling formulations is currently being guided by the following (simplified) hypothesis: If a poorly soluble drug (BCS class II drug) can be transferred into a solubilized state, one can achieve an absorption profile close to that of a soluble drug (BCS class I drug). Thus, formulation development typically endeavors to achieve the most robust solubility enhancement. Here we critically review both common in vitro approaches and experimental data available in literature pertaining to the solubility and permeability of poorly soluble drugs from enabling formulations, and discuss their interplay. Recent in vitro data indicate, that commonly employed surfactants as well as endogenous surfactants present in the intestine, although enhancing drug solubility, mostly hamper drug permeation. Mechanistic studies demonstrate a direct correlation between passive transcellular diffusion and the concentration of molecularly dissolved drug. The latter may be reduced due to partitioning into micelles or other solubilizing carriers, but enhanced in supersaturating formulations. We conclude thus that biopharmaceutical assessment approaches that rely on the amount of molecularly dissolved drug should guide us towards successful enabling formulations. Gesehen am 26.11.2020 |
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The large number of drug candidates with poor dissolution characteristics seen in the past decade, has fostered interest in so-called "enabling formulations", i.e., formulations which shall make such drugs bio-available. Development of enabling formulations is currently being guided by the following (simplified) hypothesis: If a poorly soluble drug (BCS class II drug) can be transferred into a solubilized state, one can achieve an absorption profile close to that of a soluble drug (BCS class I drug). Thus, formulation development typically endeavors to achieve the most robust solubility enhancement. Here we critically review both common in vitro approaches and experimental data available in literature pertaining to the solubility and permeability of poorly soluble drugs from enabling formulations, and discuss their interplay. Recent in vitro data indicate, that commonly employed surfactants as well as endogenous surfactants present in the intestine, although enhancing drug solubility, mostly hamper drug permeation. Mechanistic studies demonstrate a direct correlation between passive transcellular diffusion and the concentration of molecularly dissolved drug. The latter may be reduced due to partitioning into micelles or other solubilizing carriers, but enhanced in supersaturating formulations. We conclude thus that biopharmaceutical assessment approaches that rely on the amount of molecularly dissolved drug should guide us towards successful enabling formulations. Gesehen am 26.11.2020 |
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The large number of drug candidates with poor dissolution characteristics seen in the past decade, has fostered interest in so-called "enabling formulations", i.e., formulations which shall make such drugs bio-available. Development of enabling formulations is currently being guided by the following (simplified) hypothesis: If a poorly soluble drug (BCS class II drug) can be transferred into a solubilized state, one can achieve an absorption profile close to that of a soluble drug (BCS class I drug). Thus, formulation development typically endeavors to achieve the most robust solubility enhancement. Here we critically review both common in vitro approaches and experimental data available in literature pertaining to the solubility and permeability of poorly soluble drugs from enabling formulations, and discuss their interplay. Recent in vitro data indicate, that commonly employed surfactants as well as endogenous surfactants present in the intestine, although enhancing drug solubility, mostly hamper drug permeation. Mechanistic studies demonstrate a direct correlation between passive transcellular diffusion and the concentration of molecularly dissolved drug. The latter may be reduced due to partitioning into micelles or other solubilizing carriers, but enhanced in supersaturating formulations. We conclude thus that biopharmaceutical assessment approaches that rely on the amount of molecularly dissolved drug should guide us towards successful enabling formulations. Gesehen am 26.11.2020 |
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