Bioanalytical HPLC method with fluorescence detector for determination of Entresto™ when co-administered with ibuprofen and fexofenadine: a pharmacokinetic study
Entresto™ (LCZ696) has been approved globally for heart failure management. However, its lifelong use alongside over-the-counter (OTC) drugs like ibuprofen (IBU) and fexofenadine (FEX) necessitates an in-depth investigation of potential pharmacokinetic interactions, as they share the same metabolic...
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| Veröffentlicht in: | RSC advances 2024-06, Vol.14 (27), p.19197-1925 |
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| creator | Ahmed, Aya R Galal, Shereen M Korany, Mohamed A Elsheikh, Manal A Bedair, Asser F Ragab, Marwa A. A |
| description | Entresto™ (LCZ696) has been approved globally for heart failure management. However, its lifelong use alongside over-the-counter (OTC) drugs like ibuprofen (IBU) and fexofenadine (FEX) necessitates an in-depth investigation of potential pharmacokinetic interactions, as they share the same metabolic and elimination pathways. This study aimed to develop a bioanalytical HPLC method with a fluorescence detector (FLD) to quantify LCZ696 analytes (valsartan, VAL; sacubitril, SAC; and sacubitril active metabolite, LBQ657) in rat plasma. Additionally, an
in vivo
study was performed to investigate the pharmacokinetic interactions of LCZ696 with IBU and FEX. Utilizing HPLC with a gradient-mode mobile phase of acetonitrile and 0.025 M phosphate buffer (pH 3), the study demonstrated a significant increase in the bioavailability of LCZ696 analytes (VAL and LBQ657) when co-administered with IBU (
C
max
0.23 ± 0.07 and 0.53 ± 0.21 μg mL
−1
, respectively) compared to the control (0.17 ± 0.03 and 0.33 ± 0.14 μg mL
−1
). A more significant increase in
C
max
was noticed with FEX (0.38 ± 0.01 and 0.77 ± 0.18 μg mL
−1
, respectively). Moreover, a decrease in the clearance (Cl/
F
) of VAL and LBQ657 was observed (18.05 ± 1.94 and 12.42 ± 2.97 L h
−1
kg, respectively) with a more pronounced effect in the case of FEX (30.87 ± 4.29 and 33.14 ± 9.57 L h
−1
kg, respectively) compared to the control (49.99 ± 7.31 and 51.19 ± 9.12 L h
−1
kg, respectively). In conclusion, our study underscores the importance of cautious administration and appropriate dose spacing of IBU and FEX in patients treated with LCZ696 to prevent elevated serum concentrations and potential toxicity. The novelty of this work lies in its dual contribution: developing a highly sensitive HPLC-FLD method and comprehensively elucidating significant pharmacokinetic interactions between LCZ696 and common OTC drugs.
In vivo
pharmacokinetic interaction of Entresto™ (LCZ696) with ibuprofen and fexofenadine. |
| doi_str_mv | 10.1039/d4ra02163k |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_3069174253</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3069174253</sourcerecordid><originalsourceid>FETCH-LOGICAL-c318t-b3cd0f9b152beeb898592aa7662f2788f478dad9cc94b2b538a9d845f7eb9b9a3</originalsourceid><addsrcrecordid>eNpdkk1v1DAQhiMEolXphTvIEheEtBB_JLG5oLItFLESCME5Gn8Rt4m9OA7t3vkl8M_4JTjsshQsWZ7RPHo1M6-L4j4un-KSimeaRSgJrunlreKQlKxekLIWt2_EB8XxOF6U-dQVJjW-WxxQzjlhjTgsfrx0ATz0m-QU9Oj8_WqJBpO6oNGVSx2y_RSiGZXxyiBtklEpRGTznZM4OA_JBY-CRWc-ZTKFn9--o6vOeKTCAnQm3JhJsxN0clrHYHMZvEbWXM8xaOfNcwRo3UEcQIXLnOeO0JgmvblX3LHQj-Z49x4Vn16dfVyeL1bvXr9ZnqwWimKeFpIqXVohcUWkMZILXgkC0NQ1saTh3LKGa9BCKcEkkRXlIDRnlW2MFFIAPSpebHXXkxyMzjOnCH27jm6AuGkDuPbfindd-zl8bTHGTdMwnhUe7xRi-DLlZbSDy7vre_AmTGNLsx24YaSiGX30H3oRppidmKkGcyEwm6knW0rFMI7R2H03uGxn_9tT9uHkt_9vM_zwZv979I_bGXiwBeKo9tW_H4j-AneOus4</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3071899143</pqid></control><display><type>article</type><title>Bioanalytical HPLC method with fluorescence detector for determination of Entresto™ when co-administered with ibuprofen and fexofenadine: a pharmacokinetic study</title><source>DOAJ Directory of Open Access Journals</source><source>EZB-FREE-00999 freely available EZB journals</source><source>PubMed Central</source><source>PubMed Central Open Access</source><creator>Ahmed, Aya R ; Galal, Shereen M ; Korany, Mohamed A ; Elsheikh, Manal A ; Bedair, Asser F ; Ragab, Marwa A. A</creator><creatorcontrib>Ahmed, Aya R ; Galal, Shereen M ; Korany, Mohamed A ; Elsheikh, Manal A ; Bedair, Asser F ; Ragab, Marwa A. A</creatorcontrib><description>Entresto™ (LCZ696) has been approved globally for heart failure management. However, its lifelong use alongside over-the-counter (OTC) drugs like ibuprofen (IBU) and fexofenadine (FEX) necessitates an in-depth investigation of potential pharmacokinetic interactions, as they share the same metabolic and elimination pathways. This study aimed to develop a bioanalytical HPLC method with a fluorescence detector (FLD) to quantify LCZ696 analytes (valsartan, VAL; sacubitril, SAC; and sacubitril active metabolite, LBQ657) in rat plasma. Additionally, an
in vivo
study was performed to investigate the pharmacokinetic interactions of LCZ696 with IBU and FEX. Utilizing HPLC with a gradient-mode mobile phase of acetonitrile and 0.025 M phosphate buffer (pH 3), the study demonstrated a significant increase in the bioavailability of LCZ696 analytes (VAL and LBQ657) when co-administered with IBU (
C
max
0.23 ± 0.07 and 0.53 ± 0.21 μg mL
−1
, respectively) compared to the control (0.17 ± 0.03 and 0.33 ± 0.14 μg mL
−1
). A more significant increase in
C
max
was noticed with FEX (0.38 ± 0.01 and 0.77 ± 0.18 μg mL
−1
, respectively). Moreover, a decrease in the clearance (Cl/
F
) of VAL and LBQ657 was observed (18.05 ± 1.94 and 12.42 ± 2.97 L h
−1
kg, respectively) with a more pronounced effect in the case of FEX (30.87 ± 4.29 and 33.14 ± 9.57 L h
−1
kg, respectively) compared to the control (49.99 ± 7.31 and 51.19 ± 9.12 L h
−1
kg, respectively). In conclusion, our study underscores the importance of cautious administration and appropriate dose spacing of IBU and FEX in patients treated with LCZ696 to prevent elevated serum concentrations and potential toxicity. The novelty of this work lies in its dual contribution: developing a highly sensitive HPLC-FLD method and comprehensively elucidating significant pharmacokinetic interactions between LCZ696 and common OTC drugs.
In vivo
pharmacokinetic interaction of Entresto™ (LCZ696) with ibuprofen and fexofenadine.</description><identifier>ISSN: 2046-2069</identifier><identifier>EISSN: 2046-2069</identifier><identifier>DOI: 10.1039/d4ra02163k</identifier><identifier>PMID: 38882479</identifier><language>eng</language><publisher>England: Royal Society of Chemistry</publisher><subject>Acetonitrile ; Bioavailability ; Biocompatibility ; Chemistry ; Drugs ; Fluorescence ; Ibuprofen ; In vivo methods and tests ; Metabolites ; Nonsteroidal anti-inflammatory drugs ; Pharmacokinetics</subject><ispartof>RSC advances, 2024-06, Vol.14 (27), p.19197-1925</ispartof><rights>This journal is © The Royal Society of Chemistry.</rights><rights>Copyright Royal Society of Chemistry 2024</rights><rights>This journal is © The Royal Society of Chemistry 2024 The Royal Society of Chemistry</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c318t-b3cd0f9b152beeb898592aa7662f2788f478dad9cc94b2b538a9d845f7eb9b9a3</cites><orcidid>0000-0001-6340-3745 ; 0000-0001-8536-1507</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC11177748/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC11177748/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27903,27904,53769,53771</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38882479$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ahmed, Aya R</creatorcontrib><creatorcontrib>Galal, Shereen M</creatorcontrib><creatorcontrib>Korany, Mohamed A</creatorcontrib><creatorcontrib>Elsheikh, Manal A</creatorcontrib><creatorcontrib>Bedair, Asser F</creatorcontrib><creatorcontrib>Ragab, Marwa A. A</creatorcontrib><title>Bioanalytical HPLC method with fluorescence detector for determination of Entresto™ when co-administered with ibuprofen and fexofenadine: a pharmacokinetic study</title><title>RSC advances</title><addtitle>RSC Adv</addtitle><description>Entresto™ (LCZ696) has been approved globally for heart failure management. However, its lifelong use alongside over-the-counter (OTC) drugs like ibuprofen (IBU) and fexofenadine (FEX) necessitates an in-depth investigation of potential pharmacokinetic interactions, as they share the same metabolic and elimination pathways. This study aimed to develop a bioanalytical HPLC method with a fluorescence detector (FLD) to quantify LCZ696 analytes (valsartan, VAL; sacubitril, SAC; and sacubitril active metabolite, LBQ657) in rat plasma. Additionally, an
in vivo
study was performed to investigate the pharmacokinetic interactions of LCZ696 with IBU and FEX. Utilizing HPLC with a gradient-mode mobile phase of acetonitrile and 0.025 M phosphate buffer (pH 3), the study demonstrated a significant increase in the bioavailability of LCZ696 analytes (VAL and LBQ657) when co-administered with IBU (
C
max
0.23 ± 0.07 and 0.53 ± 0.21 μg mL
−1
, respectively) compared to the control (0.17 ± 0.03 and 0.33 ± 0.14 μg mL
−1
). A more significant increase in
C
max
was noticed with FEX (0.38 ± 0.01 and 0.77 ± 0.18 μg mL
−1
, respectively). Moreover, a decrease in the clearance (Cl/
F
) of VAL and LBQ657 was observed (18.05 ± 1.94 and 12.42 ± 2.97 L h
−1
kg, respectively) with a more pronounced effect in the case of FEX (30.87 ± 4.29 and 33.14 ± 9.57 L h
−1
kg, respectively) compared to the control (49.99 ± 7.31 and 51.19 ± 9.12 L h
−1
kg, respectively). In conclusion, our study underscores the importance of cautious administration and appropriate dose spacing of IBU and FEX in patients treated with LCZ696 to prevent elevated serum concentrations and potential toxicity. The novelty of this work lies in its dual contribution: developing a highly sensitive HPLC-FLD method and comprehensively elucidating significant pharmacokinetic interactions between LCZ696 and common OTC drugs.
In vivo
pharmacokinetic interaction of Entresto™ (LCZ696) with ibuprofen and fexofenadine.</description><subject>Acetonitrile</subject><subject>Bioavailability</subject><subject>Biocompatibility</subject><subject>Chemistry</subject><subject>Drugs</subject><subject>Fluorescence</subject><subject>Ibuprofen</subject><subject>In vivo methods and tests</subject><subject>Metabolites</subject><subject>Nonsteroidal anti-inflammatory drugs</subject><subject>Pharmacokinetics</subject><issn>2046-2069</issn><issn>2046-2069</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNpdkk1v1DAQhiMEolXphTvIEheEtBB_JLG5oLItFLESCME5Gn8Rt4m9OA7t3vkl8M_4JTjsshQsWZ7RPHo1M6-L4j4un-KSimeaRSgJrunlreKQlKxekLIWt2_EB8XxOF6U-dQVJjW-WxxQzjlhjTgsfrx0ATz0m-QU9Oj8_WqJBpO6oNGVSx2y_RSiGZXxyiBtklEpRGTznZM4OA_JBY-CRWc-ZTKFn9--o6vOeKTCAnQm3JhJsxN0clrHYHMZvEbWXM8xaOfNcwRo3UEcQIXLnOeO0JgmvblX3LHQj-Z49x4Vn16dfVyeL1bvXr9ZnqwWimKeFpIqXVohcUWkMZILXgkC0NQ1saTh3LKGa9BCKcEkkRXlIDRnlW2MFFIAPSpebHXXkxyMzjOnCH27jm6AuGkDuPbfindd-zl8bTHGTdMwnhUe7xRi-DLlZbSDy7vre_AmTGNLsx24YaSiGX30H3oRppidmKkGcyEwm6knW0rFMI7R2H03uGxn_9tT9uHkt_9vM_zwZv979I_bGXiwBeKo9tW_H4j-AneOus4</recordid><startdate>20240612</startdate><enddate>20240612</enddate><creator>Ahmed, Aya R</creator><creator>Galal, Shereen M</creator><creator>Korany, Mohamed A</creator><creator>Elsheikh, Manal A</creator><creator>Bedair, Asser F</creator><creator>Ragab, Marwa A. A</creator><general>Royal Society of Chemistry</general><general>The Royal Society of Chemistry</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7SR</scope><scope>8BQ</scope><scope>8FD</scope><scope>JG9</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-6340-3745</orcidid><orcidid>https://orcid.org/0000-0001-8536-1507</orcidid></search><sort><creationdate>20240612</creationdate><title>Bioanalytical HPLC method with fluorescence detector for determination of Entresto™ when co-administered with ibuprofen and fexofenadine: a pharmacokinetic study</title><author>Ahmed, Aya R ; Galal, Shereen M ; Korany, Mohamed A ; Elsheikh, Manal A ; Bedair, Asser F ; Ragab, Marwa A. A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c318t-b3cd0f9b152beeb898592aa7662f2788f478dad9cc94b2b538a9d845f7eb9b9a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Acetonitrile</topic><topic>Bioavailability</topic><topic>Biocompatibility</topic><topic>Chemistry</topic><topic>Drugs</topic><topic>Fluorescence</topic><topic>Ibuprofen</topic><topic>In vivo methods and tests</topic><topic>Metabolites</topic><topic>Nonsteroidal anti-inflammatory drugs</topic><topic>Pharmacokinetics</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ahmed, Aya R</creatorcontrib><creatorcontrib>Galal, Shereen M</creatorcontrib><creatorcontrib>Korany, Mohamed A</creatorcontrib><creatorcontrib>Elsheikh, Manal A</creatorcontrib><creatorcontrib>Bedair, Asser F</creatorcontrib><creatorcontrib>Ragab, Marwa A. A</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Engineered Materials Abstracts</collection><collection>METADEX</collection><collection>Technology Research Database</collection><collection>Materials Research Database</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>RSC advances</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ahmed, Aya R</au><au>Galal, Shereen M</au><au>Korany, Mohamed A</au><au>Elsheikh, Manal A</au><au>Bedair, Asser F</au><au>Ragab, Marwa A. A</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Bioanalytical HPLC method with fluorescence detector for determination of Entresto™ when co-administered with ibuprofen and fexofenadine: a pharmacokinetic study</atitle><jtitle>RSC advances</jtitle><addtitle>RSC Adv</addtitle><date>2024-06-12</date><risdate>2024</risdate><volume>14</volume><issue>27</issue><spage>19197</spage><epage>1925</epage><pages>19197-1925</pages><issn>2046-2069</issn><eissn>2046-2069</eissn><abstract>Entresto™ (LCZ696) has been approved globally for heart failure management. However, its lifelong use alongside over-the-counter (OTC) drugs like ibuprofen (IBU) and fexofenadine (FEX) necessitates an in-depth investigation of potential pharmacokinetic interactions, as they share the same metabolic and elimination pathways. This study aimed to develop a bioanalytical HPLC method with a fluorescence detector (FLD) to quantify LCZ696 analytes (valsartan, VAL; sacubitril, SAC; and sacubitril active metabolite, LBQ657) in rat plasma. Additionally, an
in vivo
study was performed to investigate the pharmacokinetic interactions of LCZ696 with IBU and FEX. Utilizing HPLC with a gradient-mode mobile phase of acetonitrile and 0.025 M phosphate buffer (pH 3), the study demonstrated a significant increase in the bioavailability of LCZ696 analytes (VAL and LBQ657) when co-administered with IBU (
C
max
0.23 ± 0.07 and 0.53 ± 0.21 μg mL
−1
, respectively) compared to the control (0.17 ± 0.03 and 0.33 ± 0.14 μg mL
−1
). A more significant increase in
C
max
was noticed with FEX (0.38 ± 0.01 and 0.77 ± 0.18 μg mL
−1
, respectively). Moreover, a decrease in the clearance (Cl/
F
) of VAL and LBQ657 was observed (18.05 ± 1.94 and 12.42 ± 2.97 L h
−1
kg, respectively) with a more pronounced effect in the case of FEX (30.87 ± 4.29 and 33.14 ± 9.57 L h
−1
kg, respectively) compared to the control (49.99 ± 7.31 and 51.19 ± 9.12 L h
−1
kg, respectively). In conclusion, our study underscores the importance of cautious administration and appropriate dose spacing of IBU and FEX in patients treated with LCZ696 to prevent elevated serum concentrations and potential toxicity. The novelty of this work lies in its dual contribution: developing a highly sensitive HPLC-FLD method and comprehensively elucidating significant pharmacokinetic interactions between LCZ696 and common OTC drugs.
In vivo
pharmacokinetic interaction of Entresto™ (LCZ696) with ibuprofen and fexofenadine.</abstract><cop>England</cop><pub>Royal Society of Chemistry</pub><pmid>38882479</pmid><doi>10.1039/d4ra02163k</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0001-6340-3745</orcidid><orcidid>https://orcid.org/0000-0001-8536-1507</orcidid><oa>free_for_read</oa></addata></record> |
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| source | DOAJ Directory of Open Access Journals; EZB-FREE-00999 freely available EZB journals; PubMed Central; PubMed Central Open Access |
| subjects | Acetonitrile Bioavailability Biocompatibility Chemistry Drugs Fluorescence Ibuprofen In vivo methods and tests Metabolites Nonsteroidal anti-inflammatory drugs Pharmacokinetics |
| title | Bioanalytical HPLC method with fluorescence detector for determination of Entresto™ when co-administered with ibuprofen and fexofenadine: a pharmacokinetic study |
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