Acceleration of in vitro dissolution studies of sustained release dosage form of theophylline and in vitro-in vivo evaluations in terms of correlations

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dc.contributor.authorErtan, Gokhan
dc.contributor.authorKarasulu, Ercument
dc.contributor.authorOzguney, Isik
dc.contributor.authorKarasulu, Yesim
dc.contributor.authorApaydin, Sebnem
dc.contributor.authorKantarci, Gulten
dc.contributor.authorYurdasiper, Aysu
dc.contributor.authorEge, Mehmet Ali
dc.date.accessioned2019-10-27T21:35:03Z
dc.date.available2019-10-27T21:35:03Z
dc.date.issued2011
dc.departmentEge Üniversitesien_US
dc.description.abstractThe aim of the study was to accelerate the dissolution of the sustained release dosage forms using both elevated temperature and high rpm rates. Teokap (R) SR 200 mg pellets were tested by in vitro sustained and accelerated dissolution studies using USP XXIII rotating paddle method. Sustained dissolution studies were carried out for 12 h in phosphate buffer at 37 +/- 0.5 degrees C and 50 rpm. Accelerated dissolution studies were performed for 48 min in distilled water at 90 +/- 1 degrees C and 250 rpm. The results obtained from accelerated and sustained dissolution studies were correlated using both linear and linear kinetic correlation methods by a computer program. While r(2) and maximum error between calculated and observed drug release rates were found to be 0.9129 and 15.9%, respectively, in linear correlation method, these values were observed as 0.9938 and 3.6%, respectively, in linear kinetic correlation method. In vivo plasma concentration data were obtained from six New Zealand rabbits after administration of a single dose of Teokap (R) SR 200 mg pellet. Then, the results of in vivo study were evaluated with in vitro accelerated and sustained dissolution results by applying them to in vitro-in vivo linear correlations. As a result of these correlations, it was shown that the in vitro correlation plots were very similar to the plot which was obtained by the in vivo study (f(2) = 73.81-77.11). This study suggested a way to prevent the loss of time for routine dissolution studies of sustained release preparations for quality control procedures using in vitro accelerated dissolution tests. The storage and quarantine periods of the product in process and process controls in the manufactories could be shortened by this method. Calculation of the in vivo performance of sustained release dosage forms using the results of the accelerated dissolution studies may be counted as another advantage of the method.en_US
dc.identifier.doi10.1007/s13318-011-0049-6en_US
dc.identifier.endpage248en_US
dc.identifier.issn0378-7966
dc.identifier.issue4en_US
dc.identifier.pmid21739190en_US
dc.identifier.scopusqualityN/Aen_US
dc.identifier.startpage243en_US
dc.identifier.urihttps://doi.org/10.1007/s13318-011-0049-6
dc.identifier.urihttps://hdl.handle.net/11454/45765
dc.identifier.volume36en_US
dc.identifier.wosWOS:000300772200008en_US
dc.identifier.wosqualityQ4en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherSpringer Franceen_US
dc.relation.ispartofEuropean Journal of Drug Metabolism and Pharmacokineticsen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.subjectTheophyllineen_US
dc.subjectSustained releaseen_US
dc.subjectAccelerated releaseen_US
dc.subjectCorrelationen_US
dc.subjectSimilarityen_US
dc.titleAcceleration of in vitro dissolution studies of sustained release dosage form of theophylline and in vitro-in vivo evaluations in terms of correlationsen_US
dc.typeArticleen_US

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