Toward the establishment of standardized in vitro tests for lipid-based formulations, part 4: proposing a new lipid formulation performance classification system.
Identifieur interne : 003403 ( Main/Exploration ); précédent : 003402; suivant : 003404Toward the establishment of standardized in vitro tests for lipid-based formulations, part 4: proposing a new lipid formulation performance classification system.
Auteurs : Hywel D. Williams [France] ; Philip Sassene ; Karen Kleberg ; Marilyn Calderone ; Annabel Igonin ; Eduardo Jule ; Jan Vertommen ; Ross Blundell ; Hassan Benameur ; Anette Müllertz ; Christopher J H. Porter ; Colin W. PoutonSource :
- Journal of pharmaceutical sciences [ 1520-6017 ] ; 2014.
Descripteurs français
- KwdFr :
- MESH :
English descriptors
- KwdEn :
- Analgesics (chemistry), Bile Acids and Salts (chemistry), Chemistry, Pharmaceutical (methods), Excipients (chemistry), Fenofibrate (chemistry), Hydrogen-Ion Concentration, Hypolipidemic Agents (chemistry), Lipids (chemistry), Pharmaceutical Preparations (chemistry), Solubility, Surface-Active Agents (chemistry), ortho-Aminobenzoates (chemistry).
- MESH :
- chemical , chemistry : Analgesics, Bile Acids and Salts, Excipients, Fenofibrate, Hypolipidemic Agents, Lipids, Pharmaceutical Preparations, Surface-Active Agents, ortho-Aminobenzoates.
- methods : Chemistry, Pharmaceutical.
- Hydrogen-Ion Concentration, Solubility.
Abstract
The Lipid Formulation Classification System Consortium looks to develop standardized in vitro tests and to generate much-needed performance criteria for lipid-based formulations (LBFs). This article highlights the value of performing a second, more stressful digestion test to identify LBFs near a performance threshold and to facilitate lead formulation selection in instances where several LBF prototypes perform adequately under standard digestion conditions (but where further discrimination is necessary). Stressed digestion tests can be designed based on an understanding of the factors that affect LBF performance, including the degree of supersaturation generated on dispersion/digestion. Stresses evaluated included decreasing LBF concentration (↓LBF), increasing bile salt, and decreasing pH. Their capacity to stress LBFs was dependent on LBF composition and drug type: ↓LBF was a stressor to medium-chain glyceride-rich LBFs, but not more hydrophilic surfactant-rich LBFs, whereas decreasing pH stressed tolfenamic acid LBFs, but not fenofibrate LBFs. Lastly, a new Performance Classification System, that is, LBF composition independent, is proposed to promote standardized LBF comparisons, encourage robust LBF development, and facilitate dialogue with the regulatory authorities. This classification system is based on the concept that performance evaluations across three in vitro tests, designed to subject a LBF to progressively more challenging conditions, will enable effective LBF discrimination and performance grading.
DOI: 10.1002/jps.24067
PubMed: 24985238
Affiliations:
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Williams</name><affiliation wicri:level="3"><nlm:affiliation>Drug Delivery, Disposition and Dynamics, Monash Institute of Pharmaceutical Sciences, Monash University, Parkville, Victoria, 3052, Australia; Capsugel R&D, Strasbourg, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Drug Delivery, Disposition and Dynamics, Monash Institute of Pharmaceutical Sciences, Monash University, Parkville, Victoria, 3052, Australia; Capsugel R&D, Strasbourg</wicri:regionArea><placeName><region type="region">Grand Est</region><region type="old region">Alsace (région administrative)</region><settlement type="city">Strasbourg</settlement></placeName></affiliation></author><author><name sortKey="Sassene, Philip" sort="Sassene, Philip" uniqKey="Sassene P" first="Philip" last="Sassene">Philip Sassene</name></author><author><name sortKey="Kleberg, Karen" sort="Kleberg, Karen" uniqKey="Kleberg K" first="Karen" last="Kleberg">Karen Kleberg</name></author><author><name sortKey="Calderone, Marilyn" sort="Calderone, Marilyn" uniqKey="Calderone M" first="Marilyn" last="Calderone">Marilyn Calderone</name></author><author><name sortKey="Igonin, Annabel" sort="Igonin, Annabel" uniqKey="Igonin A" first="Annabel" last="Igonin">Annabel Igonin</name></author><author><name sortKey="Jule, Eduardo" sort="Jule, Eduardo" uniqKey="Jule E" first="Eduardo" last="Jule">Eduardo Jule</name></author><author><name sortKey="Vertommen, Jan" sort="Vertommen, Jan" uniqKey="Vertommen J" first="Jan" last="Vertommen">Jan Vertommen</name></author><author><name sortKey="Blundell, Ross" sort="Blundell, Ross" uniqKey="Blundell R" first="Ross" last="Blundell">Ross Blundell</name></author><author><name sortKey="Benameur, Hassan" sort="Benameur, Hassan" uniqKey="Benameur H" first="Hassan" last="Benameur">Hassan Benameur</name></author><author><name sortKey="Mullertz, Anette" sort="Mullertz, Anette" uniqKey="Mullertz A" first="Anette" last="Müllertz">Anette Müllertz</name></author><author><name sortKey="Porter, Christopher J H" sort="Porter, Christopher J H" uniqKey="Porter C" first="Christopher J H" last="Porter">Christopher J H. Porter</name></author><author><name sortKey="Pouton, Colin W" sort="Pouton, Colin W" uniqKey="Pouton C" first="Colin W" last="Pouton">Colin W. Pouton</name></author></analytic><series><title level="j">Journal of pharmaceutical sciences</title><idno type="eISSN">1520-6017</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Analgesics (chemistry)</term><term>Bile Acids and Salts (chemistry)</term><term>Chemistry, Pharmaceutical (methods)</term><term>Excipients (chemistry)</term><term>Fenofibrate (chemistry)</term><term>Hydrogen-Ion Concentration</term><term>Hypolipidemic Agents (chemistry)</term><term>Lipids (chemistry)</term><term>Pharmaceutical Preparations (chemistry)</term><term>Solubility</term><term>Surface-Active Agents (chemistry)</term><term>ortho-Aminobenzoates (chemistry)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Acides et sels biliaires ()</term><term>Analgésiques ()</term><term>Chimie pharmaceutique ()</term><term>Concentration en ions d'hydrogène</term><term>Excipients ()</term><term>Fénofibrate ()</term><term>Hypolipémiants ()</term><term>Lipides ()</term><term>Préparations pharmaceutiques ()</term><term>Solubilité</term><term>Tensioactifs ()</term><term>ortho-Aminobenzoates ()</term></keywords><keywords scheme="MESH" type="chemical" qualifier="chemistry" xml:lang="en"><term>Analgesics</term><term>Bile Acids and Salts</term><term>Excipients</term><term>Fenofibrate</term><term>Hypolipidemic Agents</term><term>Lipids</term><term>Pharmaceutical Preparations</term><term>Surface-Active Agents</term><term>ortho-Aminobenzoates</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Chemistry, Pharmaceutical</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Hydrogen-Ion Concentration</term><term>Solubility</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Acides et sels biliaires</term><term>Analgésiques</term><term>Chimie pharmaceutique</term><term>Concentration en ions d'hydrogène</term><term>Excipients</term><term>Fénofibrate</term><term>Hypolipémiants</term><term>Lipides</term><term>Préparations pharmaceutiques</term><term>Solubilité</term><term>Tensioactifs</term><term>ortho-Aminobenzoates</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The Lipid Formulation Classification System Consortium looks to develop standardized in vitro tests and to generate much-needed performance criteria for lipid-based formulations (LBFs). This article highlights the value of performing a second, more stressful digestion test to identify LBFs near a performance threshold and to facilitate lead formulation selection in instances where several LBF prototypes perform adequately under standard digestion conditions (but where further discrimination is necessary). Stressed digestion tests can be designed based on an understanding of the factors that affect LBF performance, including the degree of supersaturation generated on dispersion/digestion. Stresses evaluated included decreasing LBF concentration (↓LBF), increasing bile salt, and decreasing pH. Their capacity to stress LBFs was dependent on LBF composition and drug type: ↓LBF was a stressor to medium-chain glyceride-rich LBFs, but not more hydrophilic surfactant-rich LBFs, whereas decreasing pH stressed tolfenamic acid LBFs, but not fenofibrate LBFs. Lastly, a new Performance Classification System, that is, LBF composition independent, is proposed to promote standardized LBF comparisons, encourage robust LBF development, and facilitate dialogue with the regulatory authorities. This classification system is based on the concept that performance evaluations across three in vitro tests, designed to subject a LBF to progressively more challenging conditions, will enable effective LBF discrimination and performance grading.</div></front></TEI><affiliations><list><country><li>France</li></country><region><li>Alsace (région administrative)</li><li>Grand Est</li></region><settlement><li>Strasbourg</li></settlement></list><tree><noCountry><name sortKey="Benameur, Hassan" sort="Benameur, Hassan" uniqKey="Benameur H" first="Hassan" last="Benameur">Hassan Benameur</name><name sortKey="Blundell, Ross" sort="Blundell, Ross" uniqKey="Blundell R" first="Ross" last="Blundell">Ross Blundell</name><name sortKey="Calderone, Marilyn" sort="Calderone, Marilyn" uniqKey="Calderone M" first="Marilyn" last="Calderone">Marilyn Calderone</name><name sortKey="Igonin, Annabel" sort="Igonin, Annabel" uniqKey="Igonin A" first="Annabel" last="Igonin">Annabel Igonin</name><name sortKey="Jule, Eduardo" sort="Jule, Eduardo" uniqKey="Jule E" first="Eduardo" last="Jule">Eduardo Jule</name><name sortKey="Kleberg, Karen" sort="Kleberg, Karen" uniqKey="Kleberg K" first="Karen" last="Kleberg">Karen Kleberg</name><name sortKey="Mullertz, Anette" sort="Mullertz, Anette" uniqKey="Mullertz A" first="Anette" last="Müllertz">Anette Müllertz</name><name sortKey="Porter, Christopher J H" sort="Porter, Christopher J H" uniqKey="Porter C" first="Christopher J H" last="Porter">Christopher J H. Porter</name><name sortKey="Pouton, Colin W" sort="Pouton, Colin W" uniqKey="Pouton C" first="Colin W" last="Pouton">Colin W. Pouton</name><name sortKey="Sassene, Philip" sort="Sassene, Philip" uniqKey="Sassene P" first="Philip" last="Sassene">Philip Sassene</name><name sortKey="Vertommen, Jan" sort="Vertommen, Jan" uniqKey="Vertommen J" first="Jan" last="Vertommen">Jan Vertommen</name></noCountry><country name="France"><region name="Grand Est"><name sortKey="Williams, Hywel D" sort="Williams, Hywel D" uniqKey="Williams H" first="Hywel D" last="Williams">Hywel D. Williams</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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