Hibiscus sabdariffa increases hydroxocobalamin oral bioavailability and clinical efficacy in vitamin B 12 deficiency with neurological symptoms
The aim of the study was to evaluate the bioavailability and clinical benefits of oral new formulation (HB ) of hydroxocobalamin (Hdrx) with Hibiscus sabdariffa (HS). First, in an observational study, a cohort of 30 vitamin B -deficient patients (vit B < 200 pg/mL) with neurological symptoms rece...
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| Veröffentlicht in: | Fundamental & clinical pharmacology 2016-12, Vol.30 (6), p.568-576 |
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| creator | Souirti, Zouhayr Loukili, Mouna Soudy, Imar D Rtibi, Kaies Özel, Aslihan Limas-Nzouzi, Nicolas El Ouezzani, Seloua Eto, Bruno |
| description | The aim of the study was to evaluate the bioavailability and clinical benefits of oral new formulation (HB
) of hydroxocobalamin (Hdrx) with Hibiscus sabdariffa (HS). First, in an observational study, a cohort of 30 vitamin B
-deficient patients (vit B
< 200 pg/mL) with neurological symptoms received oral fixed dose of Hdrx containing 15 mg Hdrx daily for 10 days followed by 15 mg monthly. Clinical benefits were evaluated on haematological and biochemical parameters, and neurological improvement at days 10 and 90 compared to day 0. To understand the mechanism, intestinal mucosa from mice were mounted in vitro in Ussing chambers to measure Hdrx Fluxes. In the clinical study, serum vitamin B
level increased from 55.1 ± 36.9 to 1330 ± 335.5 pg/mL at day 10 and 431.0 ± 24.27 pg/mL at day 90, without overt adverse effects. In mice ileum, (i) intestinal bioavailability of Hdrx increased in dose-dependent manner with HB
. The apparent permeability of Hdrx was P
= 34.9 ± 4.6 × 10
cm/s in the presence of 3 mg/mL (HB
B) compared to the control P
= 6.2 ± 0.7 × 10
cm/s. (ii) Total transepithelial electrical conductance (G
) increased in dose-dependent manner with HB
, G
= 161.5 ± 10.8 mS/cm² with HB
B (Hdrx 1 mg + HS 3 mg) compared to the control Hdrx, G
= 28.7 ± 4.0 mS/cm². In conclusion, the clinical study suggests that injections are not required when Hdrx is given orally. Intestinal bioavailability of Hdrx increased in vitro when it was used concomitantly with HS. |
| doi_str_mv | 10.1111/fcp.12220 |
| format | Article |
| fullrecord | <record><control><sourceid>pubmed_cross</sourceid><recordid>TN_cdi_crossref_primary_10_1111_fcp_12220</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>27416488</sourcerecordid><originalsourceid>FETCH-LOGICAL-c182t-757faecfd5490182ac16605fb84cfa384358a9c40196ea9a9d8a0e0d3784c8af3</originalsourceid><addsrcrecordid>eNo9kMtOwzAURC0EoqWw4AeQtyxSbOdhZwkVUKRKbGAd3fhBjZI4spNCvoJfxrTA3Yx058wsBqFLSpY03o2R_ZIyxsgRmtOMs0QwUhyjOeEFT9JS0Bk6C-GdEMoJLU7RjPGMFpkQc_S1trUNcgw4QK3AW2MA2056DUEHvJ2Ud59OuhoaaG2HnYcG19bBDmwDtW3sMGHoFJaN7ayMpjYmqpxiC97ZYZ-6w5RhpaNhdRetDztscadH7xr3tk-Fqe0H14ZzdGKgCfriVxfo9eH-ZbVONs-PT6vbTSKpYEPCc25AS6PyrCTxA5IWBclNLTJpIBVZmgsoZUZoWWgooVQCiCYq5REQYNIFuj70Su9C8NpUvbct-KmipPoZtYqjVvtRI3t1YPuxbrX6J_9WTL8B9-92Kw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Hibiscus sabdariffa increases hydroxocobalamin oral bioavailability and clinical efficacy in vitamin B 12 deficiency with neurological symptoms</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><creator>Souirti, Zouhayr ; Loukili, Mouna ; Soudy, Imar D ; Rtibi, Kaies ; Özel, Aslihan ; Limas-Nzouzi, Nicolas ; El Ouezzani, Seloua ; Eto, Bruno</creator><creatorcontrib>Souirti, Zouhayr ; Loukili, Mouna ; Soudy, Imar D ; Rtibi, Kaies ; Özel, Aslihan ; Limas-Nzouzi, Nicolas ; El Ouezzani, Seloua ; Eto, Bruno</creatorcontrib><description>The aim of the study was to evaluate the bioavailability and clinical benefits of oral new formulation (HB
) of hydroxocobalamin (Hdrx) with Hibiscus sabdariffa (HS). First, in an observational study, a cohort of 30 vitamin B
-deficient patients (vit B
< 200 pg/mL) with neurological symptoms received oral fixed dose of Hdrx containing 15 mg Hdrx daily for 10 days followed by 15 mg monthly. Clinical benefits were evaluated on haematological and biochemical parameters, and neurological improvement at days 10 and 90 compared to day 0. To understand the mechanism, intestinal mucosa from mice were mounted in vitro in Ussing chambers to measure Hdrx Fluxes. In the clinical study, serum vitamin B
level increased from 55.1 ± 36.9 to 1330 ± 335.5 pg/mL at day 10 and 431.0 ± 24.27 pg/mL at day 90, without overt adverse effects. In mice ileum, (i) intestinal bioavailability of Hdrx increased in dose-dependent manner with HB
. The apparent permeability of Hdrx was P
= 34.9 ± 4.6 × 10
cm/s in the presence of 3 mg/mL (HB
B) compared to the control P
= 6.2 ± 0.7 × 10
cm/s. (ii) Total transepithelial electrical conductance (G
) increased in dose-dependent manner with HB
, G
= 161.5 ± 10.8 mS/cm² with HB
B (Hdrx 1 mg + HS 3 mg) compared to the control Hdrx, G
= 28.7 ± 4.0 mS/cm². In conclusion, the clinical study suggests that injections are not required when Hdrx is given orally. Intestinal bioavailability of Hdrx increased in vitro when it was used concomitantly with HS.</description><identifier>ISSN: 0767-3981</identifier><identifier>EISSN: 1472-8206</identifier><identifier>DOI: 10.1111/fcp.12220</identifier><identifier>PMID: 27416488</identifier><language>eng</language><publisher>England</publisher><subject>Administration, Oral ; Animals ; Biological Availability ; Chemistry, Pharmaceutical - methods ; Cohort Studies ; Dose-Response Relationship, Drug ; Female ; Herb-Drug Interactions ; Hibiscus - chemistry ; Humans ; Hydroxocobalamin - pharmacokinetics ; Hydroxocobalamin - therapeutic use ; Intestines - metabolism ; Male ; Mice ; Mice, Inbred C57BL ; Middle Aged ; Nervous System Diseases - drug therapy ; Nervous System Diseases - metabolism ; Teas, Herbal ; Vitamin B 12 Deficiency - drug therapy ; Vitamin B 12 Deficiency - metabolism ; Vitamin B Complex - pharmacokinetics ; Vitamin B Complex - therapeutic use</subject><ispartof>Fundamental & clinical pharmacology, 2016-12, Vol.30 (6), p.568-576</ispartof><rights>2016 Société Française de Pharmacologie et de Thérapeutique.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c182t-757faecfd5490182ac16605fb84cfa384358a9c40196ea9a9d8a0e0d3784c8af3</citedby><cites>FETCH-LOGICAL-c182t-757faecfd5490182ac16605fb84cfa384358a9c40196ea9a9d8a0e0d3784c8af3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,777,781,27905,27906</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27416488$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Souirti, Zouhayr</creatorcontrib><creatorcontrib>Loukili, Mouna</creatorcontrib><creatorcontrib>Soudy, Imar D</creatorcontrib><creatorcontrib>Rtibi, Kaies</creatorcontrib><creatorcontrib>Özel, Aslihan</creatorcontrib><creatorcontrib>Limas-Nzouzi, Nicolas</creatorcontrib><creatorcontrib>El Ouezzani, Seloua</creatorcontrib><creatorcontrib>Eto, Bruno</creatorcontrib><title>Hibiscus sabdariffa increases hydroxocobalamin oral bioavailability and clinical efficacy in vitamin B 12 deficiency with neurological symptoms</title><title>Fundamental & clinical pharmacology</title><addtitle>Fundam Clin Pharmacol</addtitle><description>The aim of the study was to evaluate the bioavailability and clinical benefits of oral new formulation (HB
) of hydroxocobalamin (Hdrx) with Hibiscus sabdariffa (HS). First, in an observational study, a cohort of 30 vitamin B
-deficient patients (vit B
< 200 pg/mL) with neurological symptoms received oral fixed dose of Hdrx containing 15 mg Hdrx daily for 10 days followed by 15 mg monthly. Clinical benefits were evaluated on haematological and biochemical parameters, and neurological improvement at days 10 and 90 compared to day 0. To understand the mechanism, intestinal mucosa from mice were mounted in vitro in Ussing chambers to measure Hdrx Fluxes. In the clinical study, serum vitamin B
level increased from 55.1 ± 36.9 to 1330 ± 335.5 pg/mL at day 10 and 431.0 ± 24.27 pg/mL at day 90, without overt adverse effects. In mice ileum, (i) intestinal bioavailability of Hdrx increased in dose-dependent manner with HB
. The apparent permeability of Hdrx was P
= 34.9 ± 4.6 × 10
cm/s in the presence of 3 mg/mL (HB
B) compared to the control P
= 6.2 ± 0.7 × 10
cm/s. (ii) Total transepithelial electrical conductance (G
) increased in dose-dependent manner with HB
, G
= 161.5 ± 10.8 mS/cm² with HB
B (Hdrx 1 mg + HS 3 mg) compared to the control Hdrx, G
= 28.7 ± 4.0 mS/cm². In conclusion, the clinical study suggests that injections are not required when Hdrx is given orally. Intestinal bioavailability of Hdrx increased in vitro when it was used concomitantly with HS.</description><subject>Administration, Oral</subject><subject>Animals</subject><subject>Biological Availability</subject><subject>Chemistry, Pharmaceutical - methods</subject><subject>Cohort Studies</subject><subject>Dose-Response Relationship, Drug</subject><subject>Female</subject><subject>Herb-Drug Interactions</subject><subject>Hibiscus - chemistry</subject><subject>Humans</subject><subject>Hydroxocobalamin - pharmacokinetics</subject><subject>Hydroxocobalamin - therapeutic use</subject><subject>Intestines - metabolism</subject><subject>Male</subject><subject>Mice</subject><subject>Mice, Inbred C57BL</subject><subject>Middle Aged</subject><subject>Nervous System Diseases - drug therapy</subject><subject>Nervous System Diseases - metabolism</subject><subject>Teas, Herbal</subject><subject>Vitamin B 12 Deficiency - drug therapy</subject><subject>Vitamin B 12 Deficiency - metabolism</subject><subject>Vitamin B Complex - pharmacokinetics</subject><subject>Vitamin B Complex - therapeutic use</subject><issn>0767-3981</issn><issn>1472-8206</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo9kMtOwzAURC0EoqWw4AeQtyxSbOdhZwkVUKRKbGAd3fhBjZI4spNCvoJfxrTA3Yx058wsBqFLSpY03o2R_ZIyxsgRmtOMs0QwUhyjOeEFT9JS0Bk6C-GdEMoJLU7RjPGMFpkQc_S1trUNcgw4QK3AW2MA2056DUEHvJ2Ud59OuhoaaG2HnYcG19bBDmwDtW3sMGHoFJaN7ayMpjYmqpxiC97ZYZ-6w5RhpaNhdRetDztscadH7xr3tk-Fqe0H14ZzdGKgCfriVxfo9eH-ZbVONs-PT6vbTSKpYEPCc25AS6PyrCTxA5IWBclNLTJpIBVZmgsoZUZoWWgooVQCiCYq5REQYNIFuj70Su9C8NpUvbct-KmipPoZtYqjVvtRI3t1YPuxbrX6J_9WTL8B9-92Kw</recordid><startdate>201612</startdate><enddate>201612</enddate><creator>Souirti, Zouhayr</creator><creator>Loukili, Mouna</creator><creator>Soudy, Imar D</creator><creator>Rtibi, Kaies</creator><creator>Özel, Aslihan</creator><creator>Limas-Nzouzi, Nicolas</creator><creator>El Ouezzani, Seloua</creator><creator>Eto, Bruno</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>201612</creationdate><title>Hibiscus sabdariffa increases hydroxocobalamin oral bioavailability and clinical efficacy in vitamin B 12 deficiency with neurological symptoms</title><author>Souirti, Zouhayr ; Loukili, Mouna ; Soudy, Imar D ; Rtibi, Kaies ; Özel, Aslihan ; Limas-Nzouzi, Nicolas ; El Ouezzani, Seloua ; Eto, Bruno</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c182t-757faecfd5490182ac16605fb84cfa384358a9c40196ea9a9d8a0e0d3784c8af3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Administration, Oral</topic><topic>Animals</topic><topic>Biological Availability</topic><topic>Chemistry, Pharmaceutical - methods</topic><topic>Cohort Studies</topic><topic>Dose-Response Relationship, Drug</topic><topic>Female</topic><topic>Herb-Drug Interactions</topic><topic>Hibiscus - chemistry</topic><topic>Humans</topic><topic>Hydroxocobalamin - pharmacokinetics</topic><topic>Hydroxocobalamin - therapeutic use</topic><topic>Intestines - metabolism</topic><topic>Male</topic><topic>Mice</topic><topic>Mice, Inbred C57BL</topic><topic>Middle Aged</topic><topic>Nervous System Diseases - drug therapy</topic><topic>Nervous System Diseases - metabolism</topic><topic>Teas, Herbal</topic><topic>Vitamin B 12 Deficiency - drug therapy</topic><topic>Vitamin B 12 Deficiency - metabolism</topic><topic>Vitamin B Complex - pharmacokinetics</topic><topic>Vitamin B Complex - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Souirti, Zouhayr</creatorcontrib><creatorcontrib>Loukili, Mouna</creatorcontrib><creatorcontrib>Soudy, Imar D</creatorcontrib><creatorcontrib>Rtibi, Kaies</creatorcontrib><creatorcontrib>Özel, Aslihan</creatorcontrib><creatorcontrib>Limas-Nzouzi, Nicolas</creatorcontrib><creatorcontrib>El Ouezzani, Seloua</creatorcontrib><creatorcontrib>Eto, Bruno</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Fundamental & clinical pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Souirti, Zouhayr</au><au>Loukili, Mouna</au><au>Soudy, Imar D</au><au>Rtibi, Kaies</au><au>Özel, Aslihan</au><au>Limas-Nzouzi, Nicolas</au><au>El Ouezzani, Seloua</au><au>Eto, Bruno</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Hibiscus sabdariffa increases hydroxocobalamin oral bioavailability and clinical efficacy in vitamin B 12 deficiency with neurological symptoms</atitle><jtitle>Fundamental & clinical pharmacology</jtitle><addtitle>Fundam Clin Pharmacol</addtitle><date>2016-12</date><risdate>2016</risdate><volume>30</volume><issue>6</issue><spage>568</spage><epage>576</epage><pages>568-576</pages><issn>0767-3981</issn><eissn>1472-8206</eissn><abstract>The aim of the study was to evaluate the bioavailability and clinical benefits of oral new formulation (HB
) of hydroxocobalamin (Hdrx) with Hibiscus sabdariffa (HS). First, in an observational study, a cohort of 30 vitamin B
-deficient patients (vit B
< 200 pg/mL) with neurological symptoms received oral fixed dose of Hdrx containing 15 mg Hdrx daily for 10 days followed by 15 mg monthly. Clinical benefits were evaluated on haematological and biochemical parameters, and neurological improvement at days 10 and 90 compared to day 0. To understand the mechanism, intestinal mucosa from mice were mounted in vitro in Ussing chambers to measure Hdrx Fluxes. In the clinical study, serum vitamin B
level increased from 55.1 ± 36.9 to 1330 ± 335.5 pg/mL at day 10 and 431.0 ± 24.27 pg/mL at day 90, without overt adverse effects. In mice ileum, (i) intestinal bioavailability of Hdrx increased in dose-dependent manner with HB
. The apparent permeability of Hdrx was P
= 34.9 ± 4.6 × 10
cm/s in the presence of 3 mg/mL (HB
B) compared to the control P
= 6.2 ± 0.7 × 10
cm/s. (ii) Total transepithelial electrical conductance (G
) increased in dose-dependent manner with HB
, G
= 161.5 ± 10.8 mS/cm² with HB
B (Hdrx 1 mg + HS 3 mg) compared to the control Hdrx, G
= 28.7 ± 4.0 mS/cm². In conclusion, the clinical study suggests that injections are not required when Hdrx is given orally. Intestinal bioavailability of Hdrx increased in vitro when it was used concomitantly with HS.</abstract><cop>England</cop><pmid>27416488</pmid><doi>10.1111/fcp.12220</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0767-3981 |
| ispartof | Fundamental & clinical pharmacology, 2016-12, Vol.30 (6), p.568-576 |
| issn | 0767-3981 1472-8206 |
| language | eng |
| recordid | cdi_crossref_primary_10_1111_fcp_12220 |
| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Administration, Oral Animals Biological Availability Chemistry, Pharmaceutical - methods Cohort Studies Dose-Response Relationship, Drug Female Herb-Drug Interactions Hibiscus - chemistry Humans Hydroxocobalamin - pharmacokinetics Hydroxocobalamin - therapeutic use Intestines - metabolism Male Mice Mice, Inbred C57BL Middle Aged Nervous System Diseases - drug therapy Nervous System Diseases - metabolism Teas, Herbal Vitamin B 12 Deficiency - drug therapy Vitamin B 12 Deficiency - metabolism Vitamin B Complex - pharmacokinetics Vitamin B Complex - therapeutic use |
| title | Hibiscus sabdariffa increases hydroxocobalamin oral bioavailability and clinical efficacy in vitamin B 12 deficiency with neurological symptoms |
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