{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,10,27]],"date-time":"2023-10-27T07:40:24Z","timestamp":1698392424558},"reference-count":8,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2006,1,11]],"date-time":"2006-01-11T00:00:00Z","timestamp":1136937600000},"content-version":"vor","delay-in-days":3847,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Biopharm &amp; Drug Disp"],"published-print":{"date-parts":[[1995,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>A multiple\u2010dose bioequivalence study with six healthy human volunteers was conducted. The bioavailability of an experimental controlled release tablet containg pseudoephedrine was compared with a marketed controlled release pseudoephedrine capsule in a three\u2010way crossover study. Plasma samples, collected serially after oral drug administrtion, were analyzed for pseudoephedrine content using a specific HPLC method with UV detection. The bioavailability parameters, area under the concentration\u2010time curve (AUC), maximum plasma concentraton <jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub>, and time to peak (<jats:italic>T<\/jats:italic><jats:sub>max<\/jats:sub>) were obtained from the plasma concentraton\u2014time data. Additionally, model independent pharmacokinetic parameters were estimated. Analysis of variance of the data revealed no statistically significant differences between the test and the reference formulation. The presence of guaifenesin in the sustained release tablet did not influence pseudoephedrine bioavailability. The relative bioavailability of the tablet dosage form with respect to the capsule was found to be 100.8%. Classical and Westlake 95% confidence limits as well as the two one\u2010sided <jats:italic>t<\/jats:italic> test, proposed by Schuirmann, and the Anderson\u2014Hauck power analysis supported the inference that the two formulations demonstrated comparable bioavailability, even in the presence of guaifenesin.<\/jats:p><jats:p>Using a non\u2010linear regression program, it was found that the parmacokinetics of pseudoephedrine followed a simple one\u2010compartment disposition model with no lag time. Additionally, an <jats:italic>in vitro\u2014in vivo<\/jats:italic> correlation, based on the estimation of cumulative relative fraction absorbed, was developed between the absorption of pseudoephedrine in humans and the <jats:italic>in vitro<\/jats:italic> dissolution time.<\/jats:p>","DOI":"10.1002\/bdd.2510160503","type":"journal-article","created":{"date-parts":[[2006,10,14]],"date-time":"2006-10-14T10:12:04Z","timestamp":1160820724000},"page":"381-391","source":"Crossref","is-referenced-by-count":4,"title":["Bioavailability of pseudoephedrine from controlled release formulations in the presence of guaifenesin in human volunteers"],"prefix":"10.1002","volume":"16","author":[{"given":"Vaishali","family":"Pade","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jagadeesh","family":"Aluri","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Linda","family":"Manning","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Salomon","family":"Stavchansky","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2006,1,11]]},"reference":[{"key":"e_1_2_1_2_2","first-page":"174","volume-title":"The Pharmacologic Basis of Therapeutics","author":"Weiner N.","year":"1985"},{"key":"e_1_2_1_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/0378-5173(90)90157-Y"},{"key":"e_1_2_1_4_2","doi-asserted-by":"publisher","DOI":"10.1080\/00032719308019870"},{"key":"e_1_2_1_5_2","unstructured":"Biopak Statistical Consultants Lexington KY."},{"key":"e_1_2_1_6_2","unstructured":"Pcnonlin Statistical Consultants Lexington KY."},{"key":"e_1_2_1_7_2","unstructured":"Pharmacopoeia of the United States USPXXII United States Pharmacopoeial Convention Rockville MD 1990 pp.1578\u20131579."},{"key":"e_1_2_1_8_2","doi-asserted-by":"publisher","DOI":"10.1002\/jps.2600520629"},{"key":"e_1_2_1_9_2","unstructured":"H.Abdou Bioavailability of controlled release dosage froms. InDissolution Bioavailability and Bioequivalence Mack PA 1989 p.430."}],"container-title":["Biopharmaceutics &amp; Drug Disposition"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fbdd.2510160503","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bdd.2510160503","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,26]],"date-time":"2023-10-26T07:53:07Z","timestamp":1698306787000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/bdd.2510160503"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[1995,7]]},"references-count":8,"journal-issue":{"issue":"5","published-print":{"date-parts":[[1995,7]]}},"alternative-id":["10.1002\/bdd.2510160503"],"URL":"https:\/\/doi.org\/10.1002\/bdd.2510160503","archive":["Portico"],"relation":{},"ISSN":["0142-2782","1099-081X"],"issn-type":[{"value":"0142-2782","type":"print"},{"value":"1099-081X","type":"electronic"}],"subject":[],"published":{"date-parts":[[1995,7]]}}}