Capsule shell material impacts the in vitro disintegration and dissolution behaviour of a green tea extract☆
Identifieur interne : 000331 ( Main/Exploration ); précédent : 000330; suivant : 000332Capsule shell material impacts the in vitro disintegration and dissolution behaviour of a green tea extract☆
Auteurs : Natalie Glube ; Lea Von Moos ; Guus DuchateauSource :
- Results in Pharma Sciences [ 2211-2863 ] ; 2013.
Abstract
A green tea extract was formulated into simple powder-in-capsule formulations of which the capsule shell material was either of gelatin or HPMC origin. The disintegration times were determined together with the dissolution profiles in compendial and biorelevant media.
All formulations disintegrated within 30 min, meeting the USP criteria for botanical formulations. An immediate release dissolution profile was achieved for gelatin capsules in all media but not for the specified HPMC formulations. Dissolution release was especially impaired for HPMCgell at pH 1.2 and for both HPMC formulations in FeSSIF media suggesting the potential for food interactions.
The delayed release from studied HPMC capsule materials is likely attributed to an interaction between the catechins, the major constituents of the green tea extract, and the capsule shell material. An assessment of
Url:
DOI: 10.1016/j.rinphs.2013.08.002
PubMed: 25755998
PubMed Central: 3940125
Affiliations:
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Capsule shell material impacts the <italic>in vitro</italic> disintegration and dissolution behaviour of a green tea extract<sup><xref ref-type="fn" rid="d32e448">☆</xref></sup></title><author><name sortKey="Glube, Natalie" sort="Glube, Natalie" uniqKey="Glube N" first="Natalie" last="Glube">Natalie Glube</name></author><author><name sortKey="Moos, Lea Von" sort="Moos, Lea Von" uniqKey="Moos L" first="Lea Von" last="Moos">Lea Von Moos</name></author><author><name sortKey="Duchateau, Guus" sort="Duchateau, Guus" uniqKey="Duchateau G" first="Guus" last="Duchateau">Guus Duchateau</name></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">25755998</idno><idno type="pmc">3940125</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3940125</idno><idno type="RBID">PMC:3940125</idno><idno type="doi">10.1016/j.rinphs.2013.08.002</idno><date when="2013">2013</date><idno type="wicri:Area/Pmc/Corpus">000427</idno><idno type="wicri:Area/Pmc/Curation">000427</idno><idno type="wicri:Area/Pmc/Checkpoint">000285</idno><idno type="wicri:Area/Ncbi/Merge">000295</idno><idno type="wicri:Area/Ncbi/Curation">000295</idno><idno type="wicri:Area/Ncbi/Checkpoint">000295</idno><idno type="wicri:Area/Main/Merge">000331</idno><idno type="wicri:Area/Main/Curation">000331</idno><idno type="wicri:Area/Main/Exploration">000331</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Capsule shell material impacts the <italic>in vitro</italic> disintegration and dissolution behaviour of a green tea extract<sup><xref ref-type="fn" rid="d32e448">☆</xref></sup></title><author><name sortKey="Glube, Natalie" sort="Glube, Natalie" uniqKey="Glube N" first="Natalie" last="Glube">Natalie Glube</name></author><author><name sortKey="Moos, Lea Von" sort="Moos, Lea Von" uniqKey="Moos L" first="Lea Von" last="Moos">Lea Von Moos</name></author><author><name sortKey="Duchateau, Guus" sort="Duchateau, Guus" uniqKey="Duchateau G" first="Guus" last="Duchateau">Guus Duchateau</name></author></analytic><series><title level="j">Results in Pharma Sciences</title><idno type="eISSN">2211-2863</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Purpose</title><p><italic>In vitro</italic> disintegration and dissolution are routine methods used to assess the performance and quality of oral dosage forms. The purpose of the current work was to determine the potential for interaction between capsule shell material and a green tea extract and the impact it can have on the release.</p></sec><sec><title>Methods</title><p>A green tea extract was formulated into simple powder-in-capsule formulations of which the capsule shell material was either of gelatin or HPMC origin. The disintegration times were determined together with the dissolution profiles in compendial and biorelevant media.</p></sec><sec><title>Results</title><p>All formulations disintegrated within 30 min, meeting the USP criteria for botanical formulations. An immediate release dissolution profile was achieved for gelatin capsules in all media but not for the specified HPMC formulations. Dissolution release was especially impaired for HPMC<sub>gell</sub> at pH 1.2 and for both HPMC formulations in FeSSIF media suggesting the potential for food interactions.</p></sec><sec><title>Conclusions</title><p>The delayed release from studied HPMC capsule materials is likely attributed to an interaction between the catechins, the major constituents of the green tea extract, and the capsule shell material. An assessment of <italic>in vitro</italic> dissolution is recommended prior to the release of a dietary supplement or clinical trial investigational product to ensure efficacy.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Deka, A" uniqKey="Deka A">A Deka</name></author><author><name sortKey="Vita, Ja" uniqKey="Vita J">JA Vita</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Jeukendrup, Ae" uniqKey="Jeukendrup A">AE Jeukendrup</name></author><author><name sortKey="Randell, R" uniqKey="Randell R">R Randell</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Yuan, Jm" uniqKey="Yuan J">JM Yuan</name></author><author><name sortKey="Sun, C" uniqKey="Sun C">C Sun</name></author><author><name sortKey="Butler, Lm" uniqKey="Butler L">LM Butler</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Cabrera, C" uniqKey="Cabrera C">C 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