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An NMR Protocol for In Vitro Paclitaxel Release from an Albumin-Bound Nanoparticle Formulation
The paclitaxel protein-bound particles for injectable suspension (marketed under the brand name Abraxane®) contains nanosized complexes of paclitaxel and albumin. The molecular interaction between paclitaxel and albumin within the higher-order nanostructure is analytically challenging to assess, as...
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Published in: | AAPS PharmSciTech 2020-05, Vol.21 (5), p.136-136, Article 136 |
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description | The paclitaxel protein-bound particles for injectable suspension (marketed under the brand name Abraxane®) contains nanosized complexes of paclitaxel and albumin. The molecular interaction between paclitaxel and albumin within the higher-order nanostructure is analytically challenging to assess, as is any correlation of differences to differences in therapeutic effect. However, because the higher-order nanostructures may affect the paclitaxel release, a suitable
in vitro
assay to detect potential differences in paclitaxel release between comparator lots and products is desirable. Herein, solution NMR spectroscopy with a T
2
-filtering technique was developed to detect paclitaxel signal while suppressing albumin signals to follow the released paclitaxel in the NMR tube upon dilution. The non-invasive nature of NMR allows for precise measurement of a full range of dilution-induced drug release percentage from 14 to 92% without any sample extraction. The critical concentration of the drug product (DP) at 50% of release was 0.63 ± 0.04 mg/mL in PBS buffer. In addition, 2D diffusion ordered NMR spectroscopy (DOSY) results revealed that the released paclitaxel experiencing slightly slowed diffusion rates than free paclitaxel, which was attributed to paclitaxel in equilibrium with albumin-bound states. Collectively, the dilution-based NMR method offered an analytical approach to investigate physicochemical attributes of complex injectable products with minimal needed sample preparation and perturbation to nanoparticle formulation. |
doi_str_mv | 10.1208/s12249-020-01669-1 |
format | article |
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in vitro
assay to detect potential differences in paclitaxel release between comparator lots and products is desirable. Herein, solution NMR spectroscopy with a T
2
-filtering technique was developed to detect paclitaxel signal while suppressing albumin signals to follow the released paclitaxel in the NMR tube upon dilution. The non-invasive nature of NMR allows for precise measurement of a full range of dilution-induced drug release percentage from 14 to 92% without any sample extraction. The critical concentration of the drug product (DP) at 50% of release was 0.63 ± 0.04 mg/mL in PBS buffer. In addition, 2D diffusion ordered NMR spectroscopy (DOSY) results revealed that the released paclitaxel experiencing slightly slowed diffusion rates than free paclitaxel, which was attributed to paclitaxel in equilibrium with albumin-bound states. Collectively, the dilution-based NMR method offered an analytical approach to investigate physicochemical attributes of complex injectable products with minimal needed sample preparation and perturbation to nanoparticle formulation.</description><identifier>ISSN: 1530-9932</identifier><identifier>EISSN: 1530-9932</identifier><identifier>DOI: 10.1208/s12249-020-01669-1</identifier><identifier>PMID: 32419122</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Biochemistry ; Biomedical and Life Sciences ; Biomedicine ; Biotechnology ; Pharmacology/Toxicology ; Pharmacy ; Research Article</subject><ispartof>AAPS PharmSciTech, 2020-05, Vol.21 (5), p.136-136, Article 136</ispartof><rights>American Association of Pharmaceutical Scientists 2020</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c347t-e43950bca439c2aac743814aa6204a169bf8638512a72e9416a6837a3838b9713</citedby><cites>FETCH-LOGICAL-c347t-e43950bca439c2aac743814aa6204a169bf8638512a72e9416a6837a3838b9713</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32419122$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Suh, Min Sung</creatorcontrib><creatorcontrib>Patil, Sharadrao M.</creatorcontrib><creatorcontrib>Kozak, Darby</creatorcontrib><creatorcontrib>Pang, Eric</creatorcontrib><creatorcontrib>Choi, Stephanie</creatorcontrib><creatorcontrib>Jiang, Xiaohui</creatorcontrib><creatorcontrib>Rodriguez, Jason D.</creatorcontrib><creatorcontrib>Keire, David A.</creatorcontrib><creatorcontrib>Chen, Kang</creatorcontrib><title>An NMR Protocol for In Vitro Paclitaxel Release from an Albumin-Bound Nanoparticle Formulation</title><title>AAPS PharmSciTech</title><addtitle>AAPS PharmSciTech</addtitle><addtitle>AAPS PharmSciTech</addtitle><description>The paclitaxel protein-bound particles for injectable suspension (marketed under the brand name Abraxane®) contains nanosized complexes of paclitaxel and albumin. The molecular interaction between paclitaxel and albumin within the higher-order nanostructure is analytically challenging to assess, as is any correlation of differences to differences in therapeutic effect. However, because the higher-order nanostructures may affect the paclitaxel release, a suitable
in vitro
assay to detect potential differences in paclitaxel release between comparator lots and products is desirable. Herein, solution NMR spectroscopy with a T
2
-filtering technique was developed to detect paclitaxel signal while suppressing albumin signals to follow the released paclitaxel in the NMR tube upon dilution. The non-invasive nature of NMR allows for precise measurement of a full range of dilution-induced drug release percentage from 14 to 92% without any sample extraction. The critical concentration of the drug product (DP) at 50% of release was 0.63 ± 0.04 mg/mL in PBS buffer. In addition, 2D diffusion ordered NMR spectroscopy (DOSY) results revealed that the released paclitaxel experiencing slightly slowed diffusion rates than free paclitaxel, which was attributed to paclitaxel in equilibrium with albumin-bound states. Collectively, the dilution-based NMR method offered an analytical approach to investigate physicochemical attributes of complex injectable products with minimal needed sample preparation and perturbation to nanoparticle formulation.</description><subject>Biochemistry</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Biotechnology</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacy</subject><subject>Research Article</subject><issn>1530-9932</issn><issn>1530-9932</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNp9kE1LAzEQhoMotlb_gAfJ0ctqvrq7OdZitVBrKerRMJtmZUs2qcku6L93a6t48jQD87wvzIPQOSVXlJH8OlLGhEwIIwmhaSoTeoD6dMhJIiVnh3_2HjqJcU0I41TyY9TjTFDZpfvodeTw_GGJF8E3XnuLSx_w1OGXqgkeL0DbqoEPY_HSWAPR4DL4GoPDI1u0deWSG9-6FZ6D8xsITaWtwRMf6tZCU3l3io5KsNGc7ecAPU9un8b3yezxbjoezRLNRdYkRnA5JIWGbmoGoDPBcyoAUkYE0FQWZZ7yfEgZZMxIQVNIc54Bz3leyIzyAbrc9W6Cf29NbFRdRW2sBWd8GxUTRPCMi3SLsh2qg48xmFJtQlVD-FSUqK1XtfOqOq_q26vahi72_W1Rm9Vv5EdkB_AdELuTezNBrX0bXPfzf7Vf_uGBew</recordid><startdate>20200517</startdate><enddate>20200517</enddate><creator>Suh, Min Sung</creator><creator>Patil, Sharadrao M.</creator><creator>Kozak, Darby</creator><creator>Pang, Eric</creator><creator>Choi, Stephanie</creator><creator>Jiang, Xiaohui</creator><creator>Rodriguez, Jason D.</creator><creator>Keire, David A.</creator><creator>Chen, Kang</creator><general>Springer International Publishing</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20200517</creationdate><title>An NMR Protocol for In Vitro Paclitaxel Release from an Albumin-Bound Nanoparticle Formulation</title><author>Suh, Min Sung ; Patil, Sharadrao M. ; Kozak, Darby ; Pang, Eric ; Choi, Stephanie ; Jiang, Xiaohui ; Rodriguez, Jason D. ; Keire, David A. ; Chen, Kang</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c347t-e43950bca439c2aac743814aa6204a169bf8638512a72e9416a6837a3838b9713</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Biochemistry</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Biotechnology</topic><topic>Pharmacology/Toxicology</topic><topic>Pharmacy</topic><topic>Research Article</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Suh, Min Sung</creatorcontrib><creatorcontrib>Patil, Sharadrao M.</creatorcontrib><creatorcontrib>Kozak, Darby</creatorcontrib><creatorcontrib>Pang, Eric</creatorcontrib><creatorcontrib>Choi, Stephanie</creatorcontrib><creatorcontrib>Jiang, Xiaohui</creatorcontrib><creatorcontrib>Rodriguez, Jason D.</creatorcontrib><creatorcontrib>Keire, David A.</creatorcontrib><creatorcontrib>Chen, Kang</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>AAPS PharmSciTech</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Suh, Min Sung</au><au>Patil, Sharadrao M.</au><au>Kozak, Darby</au><au>Pang, Eric</au><au>Choi, Stephanie</au><au>Jiang, Xiaohui</au><au>Rodriguez, Jason D.</au><au>Keire, David A.</au><au>Chen, Kang</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>An NMR Protocol for In Vitro Paclitaxel Release from an Albumin-Bound Nanoparticle Formulation</atitle><jtitle>AAPS PharmSciTech</jtitle><stitle>AAPS PharmSciTech</stitle><addtitle>AAPS PharmSciTech</addtitle><date>2020-05-17</date><risdate>2020</risdate><volume>21</volume><issue>5</issue><spage>136</spage><epage>136</epage><pages>136-136</pages><artnum>136</artnum><issn>1530-9932</issn><eissn>1530-9932</eissn><abstract>The paclitaxel protein-bound particles for injectable suspension (marketed under the brand name Abraxane®) contains nanosized complexes of paclitaxel and albumin. The molecular interaction between paclitaxel and albumin within the higher-order nanostructure is analytically challenging to assess, as is any correlation of differences to differences in therapeutic effect. However, because the higher-order nanostructures may affect the paclitaxel release, a suitable
in vitro
assay to detect potential differences in paclitaxel release between comparator lots and products is desirable. Herein, solution NMR spectroscopy with a T
2
-filtering technique was developed to detect paclitaxel signal while suppressing albumin signals to follow the released paclitaxel in the NMR tube upon dilution. The non-invasive nature of NMR allows for precise measurement of a full range of dilution-induced drug release percentage from 14 to 92% without any sample extraction. The critical concentration of the drug product (DP) at 50% of release was 0.63 ± 0.04 mg/mL in PBS buffer. In addition, 2D diffusion ordered NMR spectroscopy (DOSY) results revealed that the released paclitaxel experiencing slightly slowed diffusion rates than free paclitaxel, which was attributed to paclitaxel in equilibrium with albumin-bound states. Collectively, the dilution-based NMR method offered an analytical approach to investigate physicochemical attributes of complex injectable products with minimal needed sample preparation and perturbation to nanoparticle formulation.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>32419122</pmid><doi>10.1208/s12249-020-01669-1</doi><tpages>1</tpages></addata></record> |
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title | An NMR Protocol for In Vitro Paclitaxel Release from an Albumin-Bound Nanoparticle Formulation |
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