An in vitro-in vivo correlation study for nifedipine immediate release capsules administered with water, alcoholic and non-alcoholic beverages: Impact of in vitro dissolution media and hydrodynamics.
Identifieur interne : 000340 ( Main/Exploration ); précédent : 000339; suivant : 000341An in vitro-in vivo correlation study for nifedipine immediate release capsules administered with water, alcoholic and non-alcoholic beverages: Impact of in vitro dissolution media and hydrodynamics.
Auteurs : A. Mercuri [Autriche] ; R. Fares [Royaume-Uni] ; M. Bresciani [Autriche] ; N. Fotaki [Royaume-Uni]Source :
- International journal of pharmaceutics [ 1873-3476 ] ; 2016.
English descriptors
- KwdEn :
- Administration, Oral, Alcoholic Beverages, Calcium Channel Blockers (administration & dosage), Calcium Channel Blockers (chemistry), Capsules, Citrus sinensis, Drug Liberation, Food-Drug Interactions, Fruit and Vegetable Juices, Gastric Juice (metabolism), Hydrodynamics, Hydrogen-Ion Concentration, Nifedipine (administration & dosage), Nifedipine (chemistry), Solubility, Water (administration & dosage).
- MESH :
- chemical , administration & dosage : Calcium Channel Blockers, Nifedipine, Water.
- chemical , chemistry : Calcium Channel Blockers, Nifedipine.
- metabolism : Gastric Juice.
- Administration, Oral, Alcoholic Beverages, Capsules, Citrus sinensis, Drug Liberation, Food-Drug Interactions, Fruit and Vegetable Juices, Hydrodynamics, Hydrogen-Ion Concentration, Solubility.
Abstract
The impact of hydrodynamics and media composition on nifedipine dissolution profile from IR (immediate release) soft capsules was investigated using dissolution apparatus USP1, USP2, USP3 and USP4 (United State Pharmacopoeia). Media composition was varied in terms of pH and content, to mimic the dosage form intake with water or non-alcoholic beverages (orange juice) and alcoholic beverages (orange juice/ethanol mixture (47% v/v)). Through construction of in vitro-in vivo correlations (IVIVC) with corresponding in vivo data from the literature, it was possible to evaluate the in vitro conditions that are likely to simulate the in vivo formulation behaviour. Both linear and nonlinear correlations were obtained depending on experimental set-ups. Testing of 20mg nifedipine capsules in FaSSGFst (Fasted State Simulated Gastric Fluid pH 1.6; water administration) produced IVIVC with the USP3 (after time scaling) and USP4 apparatus. IVIVC were obtained for USP2, USP3 and USP4 in FaSSGFoj (Fasted State Simulated Gastric Fluid pH 3.4; orange juice administration). Linear and nonlinear correlations were obtained with the USP1, USP2 and USP3 apparatus when testing the capsules in FaSSGFoj/EtOH (orange juice/ethanol administration). This study highlighted that selection of physiologically relevant dissolution set-ups is critical for predicting the in vivo impact of formulations co-administration with water, non-alcoholic and alcoholic beverages.
DOI: 10.1016/j.ijpharm.2015.12.047
PubMed: 26721731
Affiliations:
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Fares</name><affiliation wicri:level="1"><nlm:affiliation>Research Center Pharmaceutical Engineering GmbH, Graz, Austria; Department of Pharmacy and Pharmacology, University of Bath, Bath, United Kingdom.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Research Center Pharmaceutical Engineering GmbH, Graz, Austria; Department of Pharmacy and Pharmacology, University of Bath, Bath</wicri:regionArea><wicri:noRegion>Bath</wicri:noRegion></affiliation></author><author><name sortKey="Bresciani, M" sort="Bresciani, M" uniqKey="Bresciani M" first="M" last="Bresciani">M. 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Fares</name><affiliation wicri:level="1"><nlm:affiliation>Research Center Pharmaceutical Engineering GmbH, Graz, Austria; Department of Pharmacy and Pharmacology, University of Bath, Bath, United Kingdom.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Research Center Pharmaceutical Engineering GmbH, Graz, Austria; Department of Pharmacy and Pharmacology, University of Bath, Bath</wicri:regionArea><wicri:noRegion>Bath</wicri:noRegion></affiliation></author><author><name sortKey="Bresciani, M" sort="Bresciani, M" uniqKey="Bresciani M" first="M" last="Bresciani">M. Bresciani</name><affiliation wicri:level="1"><nlm:affiliation>Research Center Pharmaceutical Engineering GmbH, Graz, Austria.</nlm:affiliation><country xml:lang="fr">Autriche</country><wicri:regionArea>Research Center Pharmaceutical Engineering GmbH, Graz</wicri:regionArea><wicri:noRegion>Graz</wicri:noRegion></affiliation></author><author><name sortKey="Fotaki, N" sort="Fotaki, N" uniqKey="Fotaki N" first="N" last="Fotaki">N. Fotaki</name><affiliation wicri:level="1"><nlm:affiliation>Department of Pharmacy and Pharmacology, University of Bath, Bath, United Kingdom. Electronic address: n.fotaki@bath.ac.uk.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Pharmacy and Pharmacology, University of Bath, Bath</wicri:regionArea><wicri:noRegion>Bath</wicri:noRegion></affiliation></author></analytic><series><title level="j">International journal of pharmaceutics</title><idno type="eISSN">1873-3476</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Administration, Oral</term><term>Alcoholic Beverages</term><term>Calcium Channel Blockers (administration & dosage)</term><term>Calcium Channel Blockers (chemistry)</term><term>Capsules</term><term>Citrus sinensis</term><term>Drug Liberation</term><term>Food-Drug Interactions</term><term>Fruit and Vegetable Juices</term><term>Gastric Juice (metabolism)</term><term>Hydrodynamics</term><term>Hydrogen-Ion Concentration</term><term>Nifedipine (administration & dosage)</term><term>Nifedipine (chemistry)</term><term>Solubility</term><term>Water (administration & dosage)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Calcium Channel Blockers</term><term>Nifedipine</term><term>Water</term></keywords><keywords scheme="MESH" type="chemical" qualifier="chemistry" xml:lang="en"><term>Calcium Channel Blockers</term><term>Nifedipine</term></keywords><keywords scheme="MESH" qualifier="metabolism" xml:lang="en"><term>Gastric Juice</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Administration, Oral</term><term>Alcoholic Beverages</term><term>Capsules</term><term>Citrus sinensis</term><term>Drug Liberation</term><term>Food-Drug Interactions</term><term>Fruit and Vegetable Juices</term><term>Hydrodynamics</term><term>Hydrogen-Ion Concentration</term><term>Solubility</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The impact of hydrodynamics and media composition on nifedipine dissolution profile from IR (immediate release) soft capsules was investigated using dissolution apparatus USP1, USP2, USP3 and USP4 (United State Pharmacopoeia). Media composition was varied in terms of pH and content, to mimic the dosage form intake with water or non-alcoholic beverages (orange juice) and alcoholic beverages (orange juice/ethanol mixture (47% v/v)). Through construction of in vitro-in vivo correlations (IVIVC) with corresponding in vivo data from the literature, it was possible to evaluate the in vitro conditions that are likely to simulate the in vivo formulation behaviour. Both linear and nonlinear correlations were obtained depending on experimental set-ups. Testing of 20mg nifedipine capsules in FaSSGFst (Fasted State Simulated Gastric Fluid pH 1.6; water administration) produced IVIVC with the USP3 (after time scaling) and USP4 apparatus. IVIVC were obtained for USP2, USP3 and USP4 in FaSSGFoj (Fasted State Simulated Gastric Fluid pH 3.4; orange juice administration). Linear and nonlinear correlations were obtained with the USP1, USP2 and USP3 apparatus when testing the capsules in FaSSGFoj/EtOH (orange juice/ethanol administration). This study highlighted that selection of physiologically relevant dissolution set-ups is critical for predicting the in vivo impact of formulations co-administration with water, non-alcoholic and alcoholic beverages.</div></front></TEI><affiliations><list><country><li>Autriche</li><li>Royaume-Uni</li></country></list><tree><country name="Autriche"><noRegion><name sortKey="Mercuri, A" sort="Mercuri, A" uniqKey="Mercuri A" first="A" last="Mercuri">A. Mercuri</name></noRegion><name sortKey="Bresciani, M" sort="Bresciani, M" uniqKey="Bresciani M" first="M" last="Bresciani">M. Bresciani</name></country><country name="Royaume-Uni"><noRegion><name sortKey="Fares, R" sort="Fares, R" uniqKey="Fares R" first="R" last="Fares">R. 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