Evaluation of “External” Predictability of an In Vitro–In Vivo Correlation for an Extended‐Release Formulation Containing Metoprolol Tartrate
The purpose of this study was to examine the external predictability of an in vitro–in vivo correlation (IVIVC) for a metoprolol hydrophilic matrix extended‐release formulation, with an acceptable internal predictability, in the presence of a range of formulation/manufacturing changes. In addition,...
Saved in:
| Published in | Journal of pharmaceutical sciences Vol. 89; no. 10; pp. 1354 - 1361 |
|---|---|
| Main Authors | , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
New York
Elsevier Inc
01.10.2000
John Wiley & Sons, Inc Wiley American Pharmaceutical Association |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0022-3549 1520-6017 |
| DOI | 10.1002/1520-6017(200010)89:10<1354::AID-JPS13>3.0.CO;2-P |
Cover
| Abstract | The purpose of this study was to examine the external predictability of an in vitro–in vivo correlation (IVIVC) for a metoprolol hydrophilic matrix extended‐release formulation, with an acceptable internal predictability, in the presence of a range of formulation/manufacturing changes. In addition, this report evaluated the predictability of the IVIVC for another formulation of metoprolol tartrate differing in its release mechanism. Study 1 examined the scale up of a matrix extended‐release tablet from a 3‐kg small batch (I) to a 50‐kg large batch (II). The second study examined the influence of scale and processing changes [3‐kg small batch with fluid bed granulation and drying (III); 80‐kg large batch with high shear granulation and microwave drying (IV), and a formulation with an alternate release mechanism formulated as a multiparticulate capsule (V)]. In vitro dissolution of all formulations (I–V) was conducted with a USP apparatus I at pH 6.8 and 150 rpm. Subjects received the metoprolol formulations, and serial blood samples were collected over 48 h and analyzed by a validated HPLC assay using fluorescence detection. A previously developed IVIVC was used to predict plasma profiles. Prediction errors (PE) were <10% for Cmax and area under the curve (AUC) of concentration versus time for I, II, and IV. The Cmax for III was slightly underestimated (11.7%); however, the PE of the AUC was <10%. Formulation V displayed a PE for Cmax > 20% and an AUC within 5% of observed values. The low PEs for Cmax and AUC observed for I–IV strongly suggest that the metoprolol IVIVC is externally valid, predictive of alternate processing methods (IV), scale‐up (II, III), and allows the in vitro dissolution data to be used as a surrogate for validation studies. However, the lack of predictability for V supports the contention that IVIVCs are formulation specific. © 2000 Wiley‐Liss, Inc. and the American Pharmaceutical Association J Pharm Sci 89: 1354–1361, 2000 |
|---|---|
| AbstractList | The purpose of this study was to examine the external predictability of an in vitro-in vivo correlation (IVIVC) for a metoprolol hydrophilic matrix extended-release formulation, with an acceptable internal predictability, in the presence of a range of formulation/manufacturing changes. In addition, this report evaluated the predictability of the IVIVC for another formulation of metoprolol tartrate differing in its release mechanism. Study 1 examined the scale up of a matrix extended-release tablet from a 3-kg small batch (I) to a 50-kg large batch (II). The second study examined the influence of scale and processing changes [3-kg small batch with fluid bed granulation and drying (III); 80-kg large batch with high shear granulation and microwave drying (IV), and a formulation with an alternate release mechanism formulated as a multiparticulate capsule (V)]. In vitro dissolution of all formulations (I-V) was conducted with a USP apparatus I at pH 6.8 and 150 rpm. Subjects received the metoprolol formulations, and serial blood samples were collected over 48 h and analyzed by a validated HPLC assay using fluorescence detection. A previously developed IVIVC was used to predict plasma profiles. Prediction errors (PE) were <10% for C(max) and area under the curve (AUC) of concentration versus time for I, II, and IV. The C(max) for III was slightly underestimated (11.7%); however, the PE of the AUC was <10%. Formulation V displayed a PE for C(max) > 20% and an AUC within 5% of observed values. The low PEs for C(max) and AUC observed for I-IV strongly suggest that the metoprolol IVIVC is externally valid, predictive of alternate processing methods (IV), scale-up (II, III), and allows the in vitro dissolution data to be used as a surrogate for validation studies. However, the lack of predictability for V supports the contention that IVIVCs are formulation specific.The purpose of this study was to examine the external predictability of an in vitro-in vivo correlation (IVIVC) for a metoprolol hydrophilic matrix extended-release formulation, with an acceptable internal predictability, in the presence of a range of formulation/manufacturing changes. In addition, this report evaluated the predictability of the IVIVC for another formulation of metoprolol tartrate differing in its release mechanism. Study 1 examined the scale up of a matrix extended-release tablet from a 3-kg small batch (I) to a 50-kg large batch (II). The second study examined the influence of scale and processing changes [3-kg small batch with fluid bed granulation and drying (III); 80-kg large batch with high shear granulation and microwave drying (IV), and a formulation with an alternate release mechanism formulated as a multiparticulate capsule (V)]. In vitro dissolution of all formulations (I-V) was conducted with a USP apparatus I at pH 6.8 and 150 rpm. Subjects received the metoprolol formulations, and serial blood samples were collected over 48 h and analyzed by a validated HPLC assay using fluorescence detection. A previously developed IVIVC was used to predict plasma profiles. Prediction errors (PE) were <10% for C(max) and area under the curve (AUC) of concentration versus time for I, II, and IV. The C(max) for III was slightly underestimated (11.7%); however, the PE of the AUC was <10%. Formulation V displayed a PE for C(max) > 20% and an AUC within 5% of observed values. The low PEs for C(max) and AUC observed for I-IV strongly suggest that the metoprolol IVIVC is externally valid, predictive of alternate processing methods (IV), scale-up (II, III), and allows the in vitro dissolution data to be used as a surrogate for validation studies. However, the lack of predictability for V supports the contention that IVIVCs are formulation specific. The purpose of this study was to examine the external predictability of an in vitro–in vivo correlation (IVIVC) for a metoprolol hydrophilic matrix extended‐release formulation, with an acceptable internal predictability, in the presence of a range of formulation/manufacturing changes. In addition, this report evaluated the predictability of the IVIVC for another formulation of metoprolol tartrate differing in its release mechanism. Study 1 examined the scale up of a matrix extended‐release tablet from a 3‐kg small batch (I) to a 50‐kg large batch (II). The second study examined the influence of scale and processing changes [3‐kg small batch with fluid bed granulation and drying (III); 80‐kg large batch with high shear granulation and microwave drying (IV), and a formulation with an alternate release mechanism formulated as a multiparticulate capsule (V)]. In vitro dissolution of all formulations (I–V) was conducted with a USP apparatus I at pH 6.8 and 150 rpm. Subjects received the metoprolol formulations, and serial blood samples were collected over 48 h and analyzed by a validated HPLC assay using fluorescence detection. A previously developed IVIVC was used to predict plasma profiles. Prediction errors (PE) were <10% for Cmax and area under the curve (AUC) of concentration versus time for I, II, and IV. The Cmax for III was slightly underestimated (11.7%); however, the PE of the AUC was <10%. Formulation V displayed a PE for Cmax > 20% and an AUC within 5% of observed values. The low PEs for Cmax and AUC observed for I–IV strongly suggest that the metoprolol IVIVC is externally valid, predictive of alternate processing methods (IV), scale‐up (II, III), and allows the in vitro dissolution data to be used as a surrogate for validation studies. However, the lack of predictability for V supports the contention that IVIVCs are formulation specific. © 2000 Wiley‐Liss, Inc. and the American Pharmaceutical Association J Pharm Sci 89: 1354–1361, 2000 The purpose of this study was to examine the external predictability of an in vitro-in vivo correlation (IVIVC) for a metoprolol hydrophilic matrix extended-release formulation, with an acceptable internal predictability, in the presence of a range of formulation/manufacturing changes. In addition, this report evaluated the predictability of the IVIVC for another formulation of metoprolol tartrate differing in its release mechanism. Study 1 examined the scale up of a matrix extended-release tablet from a 3-kg small batch (I) to a 50-kg large batch (II). The second study examined the influence of scale and processing changes [3-kg small batch with fluid bed granulation and drying (III); 80-kg large batch with high shear granulation and microwave drying (IV), and a formulation with an alternate release mechanism formulated as a multiparticulate capsule (V)]. In vitro dissolution of all formulations (I-V) was conducted with a USP apparatus I at pH 6.8 and 150 rpm. Subjects received the metoprolol formulations, and serial blood samples were collected over 48 h and analyzed by a validated HPLC assay using fluorescence detection. A previously developed IVIVC was used to predict plasma profiles. Prediction errors (PE) were <10% for C(max) and area under the curve (AUC) of concentration versus time for I, II, and IV. The C(max) for III was slightly underestimated (11.7%); however, the PE of the AUC was <10%. Formulation V displayed a PE for C(max) > 20% and an AUC within 5% of observed values. The low PEs for C(max) and AUC observed for I-IV strongly suggest that the metoprolol IVIVC is externally valid, predictive of alternate processing methods (IV), scale-up (II, III), and allows the in vitro dissolution data to be used as a surrogate for validation studies. However, the lack of predictability for V supports the contention that IVIVCs are formulation specific. |
| Author | Rekhi, G. S. Eddington, N. D. Uppoor, R. S. Hussain, A. S. Marroum, P. Mahayni, H. Augsburger, L. L. |
| Author_xml | – sequence: 1 givenname: H. surname: Mahayni fullname: Mahayni, H. organization: Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, Maryland 20857 – sequence: 2 givenname: G.S. surname: Rekhi fullname: Rekhi, G.S. organization: Elan Pharma, Inc., 1300 Gould Drive, Gainesville, Georgia 30504 – sequence: 3 givenname: R.S. surname: Uppoor fullname: Uppoor, R.S. organization: Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, Maryland 20857 – sequence: 4 givenname: P. surname: Marroum fullname: Marroum, P. organization: Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, Maryland 20857 – sequence: 5 givenname: A.S. surname: Hussain fullname: Hussain, A.S. organization: Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, Maryland 20857 – sequence: 6 givenname: L.L. surname: Augsburger fullname: Augsburger, L.L. organization: Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, 100 Penn Street, AHB, Baltimore, Maryland 21201‐6808 – sequence: 7 givenname: N.D. surname: Eddington fullname: Eddington, N.D. email: eddingto@pharmacy.ab.umd.edu organization: Pharmacokinetics Biopharmaceutics Laboratory, School of Pharmacy, University of Maryland, Baltimore, 100 Penn Street, AHB, Baltimore, Maryland 21201‐6808 |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=836718$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/10980510$$D View this record in MEDLINE/PubMed |
| BookMark | eNqdksFu0zAYgC00xLrCK6BISAgOKXacxElBSCO0a9GghQ0m7WK5iTMZXHvYbllvfQQkxA1erk-C05SKAxc42Yq_fIn-z0fgQGnFAcgR7CEIoycoiWCYQkQeRRBCBB9neR_BZwgncb9_PH4ZvpqeIfwc92CvmDyNwukt0Nm_cwA63hGFHs4PwZG1H70jhUlyBxwimGcwQbADvg-WTC6YE1oFug426x-DG8eNYnKz_hlMDa9E6dhMSOFWDcBUMFbBB-GM3qy_bbdLHRTaGC5bS61NQzUaVfFqs_76jkvOLA-G2swXO6rQyjGhhLoKXnOnr42WWgbnzDjDHL8LbtdMWn5vt3bB--HgvBiFp5OTcXF8GpYJiXDICIa4jqssRnGaRaSqCEMElQhnOapyyGoC07qsZqRMogrVOMZkFvEUsTqLeQZxFzxsvf77nxfcOjoXtuRSMsX1wlISRUmapcSD93fgYjbnFb02Ys7Miv4epAce7ABmSyZrw1Qp7J7LcEpQ5qm3LVUaba3h9R8i2iSnTT7a5KNtcprl2zNfkVKfnG6TU0whLSY0olPvPGudX4Tkq38S_s3XPvDWsLUK6_jN3srMJ-rHQRJ68eaEvhglo-HF5dDbuuCy5bnPtRTcUFsKrkp_fwwvHa20-O9fwr8AnIfq8A |
| CODEN | JPMSAE |
| Cites_doi | 10.3109/10837459709022605 10.1007/BF00558166 10.1016/S0731-7085(97)00115-5 10.1111/j.2042-7158.1988.tb05220.x 10.1016/0378-5173(89)90234-2 10.1023/A:1011988601696 10.1023/A:1015849700421 10.1016/S0168-3659(97)00141-7 |
| ContentType | Journal Article |
| Copyright | 2000 Wiley‐Liss, Inc. and the American Pharmaceutical Association Copyright © 2000 Wiley‐Liss, Inc. and the American Pharmaceutical Association 2001 INIST-CNRS Copyright 2000 Wiley-Liss, Inc. and the American Pharmaceutical Association J Pharm Sci 89: 1354-1361, 2000 |
| Copyright_xml | – notice: 2000 Wiley‐Liss, Inc. and the American Pharmaceutical Association – notice: Copyright © 2000 Wiley‐Liss, Inc. and the American Pharmaceutical Association – notice: 2001 INIST-CNRS – notice: Copyright 2000 Wiley-Liss, Inc. and the American Pharmaceutical Association J Pharm Sci 89: 1354-1361, 2000 |
| DBID | BSCLL AAYXX CITATION IQODW CGR CUY CVF ECM EIF NPM 7X8 |
| DOI | 10.1002/1520-6017(200010)89:10<1354::AID-JPS13>3.0.CO;2-P |
| DatabaseName | Istex CrossRef Pascal-Francis Medline MEDLINE MEDLINE (Ovid) MEDLINE MEDLINE PubMed MEDLINE - Academic |
| DatabaseTitle | CrossRef MEDLINE Medline Complete MEDLINE with Full Text PubMed MEDLINE (Ovid) MEDLINE - Academic |
| DatabaseTitleList | MEDLINE - Academic MEDLINE |
| Database_xml | – sequence: 1 dbid: NPM name: PubMed url: https://proxy.k.utb.cz/login?url=http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed sourceTypes: Index Database – sequence: 2 dbid: EIF name: MEDLINE url: https://proxy.k.utb.cz/login?url=https://www.webofscience.com/wos/medline/basic-search sourceTypes: Index Database |
| DeliveryMethod | fulltext_linktorsrc |
| Discipline | Pharmacy, Therapeutics, & Pharmacology |
| EISSN | 1520-6017 |
| EndPage | 1361 |
| ExternalDocumentID | 10980510 836718 10_1002_1520_6017_200010_89_10_1354__AID_JPS13_3_0_CO_2_P JPS13 ark_67375_WNG_BH5HFWZF_1 S0022354916306670 |
| Genre | article Clinical Trial Randomized Controlled Trial Journal Article |
| GroupedDBID | --- -~X .3N .GA .GJ .Y3 05W 0R~ 10A 1CY 1L6 1OC 1ZS 31~ 33P 36B 3O- 3WU 4.4 457 4ZD 50Y 50Z 51W 51X 52M 52N 52O 52P 52S 52T 52W 52X 53G 5GY 5RE 5VS 66C 702 7PT 8-0 8-1 8-3 8-4 8-5 8UM 930 A03 A8Z AAEVG AAHHS AAIAV AAKUH AALRI AAOIN AAONW AAXUO AAYOK AAZKR ABCQN ABEML ABFRF ABIJN ABJNI ABMAC ABOCM ABPVW ABWRO ACBWZ ACCFJ ACGFO ACGFS ACIWK ACPRK ACSCC ACXME ACXQS ADBBV ADIZJ AEEZP AEFWE AEIMD AENEX AEQDE AEUQT AFBPY AFFNX AFRAH AFTJW AFZJQ AGHFR AI. AITUG AIWBW AJAOE AJBDE ALAGY ALMA_UNASSIGNED_HOLDINGS AMBMR AMRAJ ATUGU AZBYB BAFTC BDRZF BFHJK BNHUX BROTX BRXPI BY8 CS3 D-E D-F DCZOG DPXWK DR2 DU5 E3Z EBD EBS EJD EMB EMOBN ESTFP F00 F01 F04 F5P FDB FEDTE G-S G.N GNP GODZA H.T H.X HBH HF~ HHY HHZ HOLLA HVGLF HX~ HZ~ IX1 J0M JPC KQQ L7B LAW LC2 LC3 LH4 LP6 LP7 LSO LW6 M41 M6Q MK0 MK4 N04 N05 N9A NF~ NNB O66 O9- P2P P2X P4D Q.N Q11 QB0 QRW R.K RNS ROL RWI RX1 RYL SSZ SUPJJ SV3 UB1 UKR UNMZH V2E V8K VH1 W8V W99 WBFHL WH7 WIB WJL WQJ WRC WUP WWP WYUIH XG1 XPP XV2 Y6R YCJ ZE2 ZGI ZXP ~IA ~WT ADVLN AFJKZ AKRWK BSCLL OIG AAMMB AANHP AAYWO ACRPL ACVFH ACYXJ ADCNI ADNMO AEFGJ AEUPX AFPUW AGCQF AGQPQ AGXDD AIDQK AIDYY AIGII AKBMS AKYEP APXCP EFKBS AAYXX CITATION IQODW CGR CUY CVF ECM EIF NPM VXZ Z5M 7X8 |
| ID | FETCH-LOGICAL-c5723-a7303f4d84146827dd7a171c13891d90af706fcdb7c52d1f3437b2e61af84e803 |
| IEDL.DBID | DR2 |
| ISSN | 0022-3549 |
| IngestDate | Thu Sep 04 21:59:28 EDT 2025 Wed Feb 19 02:35:06 EST 2025 Mon Jul 21 09:16:08 EDT 2025 Tue Jul 01 00:45:48 EDT 2025 Wed Aug 20 07:25:33 EDT 2025 Wed Oct 30 09:52:32 EDT 2024 Fri Feb 23 02:28:09 EST 2024 |
| IsPeerReviewed | true |
| IsScholarly | true |
| Issue | 10 |
| Keywords | correlation metoprolol extended‐release in vitro in vivo drug release mechanism Human Correlation Metoprolol Pharmaceutical technology Prediction Oral administration Antiarrhythmic agent Normal Dissolution In vitro Blood plasma In vivo Dosage form Antihypertensive agent Active ingredient Tablet Pharmacokinetics Release Beta blocking agent |
| Language | English |
| License | https://www.elsevier.com/tdm/userlicense/1.0 CC BY 4.0 Copyright 2000 Wiley-Liss, Inc. and the American Pharmaceutical Association J Pharm Sci 89: 1354-1361, 2000 |
| LinkModel | DirectLink |
| MergedId | FETCHMERGED-LOGICAL-c5723-a7303f4d84146827dd7a171c13891d90af706fcdb7c52d1f3437b2e61af84e803 |
| Notes | istex:A8A769F28F0F3439D24DF7393B2FCB7DFAC69AF8 ark:/67375/WNG-BH5HFWZF-1 ArticleID:JPS13 ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23 ObjectType-Undefined-3 |
| PMID | 10980510 |
| PQID | 72256867 |
| PQPubID | 23479 |
| PageCount | 8 |
| ParticipantIDs | proquest_miscellaneous_72256867 pubmed_primary_10980510 pascalfrancis_primary_836718 crossref_primary_10_1002_1520_6017_200010_89_10_1354__AID_JPS13_3_0_CO_2_P wiley_primary_10_1002_1520_6017_200010_89_10_1354_AID_JPS13_3_0_CO_2_P_JPS13 istex_primary_ark_67375_WNG_BH5HFWZF_1 elsevier_sciencedirect_doi_10_1002_1520_6017_200010_89_10_1354_AID_JPS13_3_0_CO_2_P |
| ProviderPackageCode | CITATION AAYXX |
| PublicationCentury | 2000 |
| PublicationDate | October 2000 |
| PublicationDateYYYYMMDD | 2000-10-01 |
| PublicationDate_xml | – month: 10 year: 2000 text: October 2000 |
| PublicationDecade | 2000 |
| PublicationPlace | New York |
| PublicationPlace_xml | – name: New York – name: Washington, DC – name: Hoboken, NJ – name: United States |
| PublicationTitle | Journal of pharmaceutical sciences |
| PublicationTitleAlternate | J. Pharm. Sci |
| PublicationYear | 2000 |
| Publisher | Elsevier Inc John Wiley & Sons, Inc Wiley American Pharmaceutical Association |
| Publisher_xml | – name: Elsevier Inc – name: John Wiley & Sons, Inc – name: American Pharmaceutical Association – name: Wiley |
| References | Nellore, Rekhi, Hussain, Tillman, Augsburger (bb0030) 1998; 50 Hildebrand, Seifert, Reichenberger (bb0040) 1989; 19 Moore, Flanner (bb0050) 1996; 6 Guidance for the industry: Extended‐release solid oral dosage forms: Development, evaluation and application of in vitro/in vivo correlations. U.S. Department of Health, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), September, 1997. Mistry, Leslie, Eddington (bb0045) 1998; 16 Khosla, Feely, Davis (bb0065) 1989; 53 Mahayni (bb0035) 1997 Rekhi, Eddington, Fossler, Schwartz, Lesko, Augsburger (bb0025) 1997; 29 Coupe, Davis, Wilding (bb0055) 1991; 8 Eddington, Marroum, Uppoor, Hussain, Augsburger (bb0020) 1998; 15 Davis SS, Christensen FN, Khosla R, Feely LC. 19898. Gastric emptying of large single-unit dosage forms. J Pharm Pharmacol 40:205–207. Modified release solid oral dosage form guidance: Scale‐up and postapproval changes: Chemistry, manufacturing and controls, in vitro dissolution testing and in vivo bioequivalence documentation. U.S. Department of Health, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), September, 1997. Moore JW, Flanner HH. 1996. Mathematical comparison of curves with an emphasis on dissolution profiles. Pharm Technol 6:64-74. Coupe AJ, Davis SS, Wilding IR. 1991. Variation in gastrointestinal transit of pharmaceutical dosage forms in healthy subjects. Pharm Res 8:360-364. Mistry B, Leslie J, Eddington ND. 1998. A sensitive assay of metoprolol and its metabolite, α-hydroxy metoprolol in human plasma and determination of dextromethorphan and its metabolite dextrophan in human urine using high-performance liquid chromatographic methods. J Pharmaceut Biomed Anal 16:1041-1049. Nellore RV, Rekhi GS, Hussain AS, Tillman LG, Augsburger LL. 1998. Development of metoprolol tartrate extended-release matrix tablet formulations for regulatory considerations. J Controlled Rel 50:247-256. Khosla R, Feely LC, Davis SS. 1989. Gastrointestinal transit of non-disintegrating tablets in fed subjects. Int J Pharm 53:107-117. Eddington ND, Marroum P, Uppoor R, Hussain A, Augsburger LL. 1998. Development and internal validation of an in vitro in vivo correlation for a hydrophilic metoprolol tartrate extended-release tablet formulation. Pharm Res 15:464-471. Davis SS, Christensen FN, Khosla R, Feely LC. 19898. Gastric emptying of large single-unit dosage forms. J Pharm Pharmacol 40:205-207. Hildebrand M, Seifert W, Reichenberger A. 1989. Determination of dextromethorphan metabolizer phenotype in healthy volunteers. Eur J Clin Pharmacol 19:315-318. Rekhi GS, Eddington ND, Fossler MJ, Schwartz P, Lesko LJ, Augsburger LL. 1997. Evaluation of in vitro release rate and in vivo absorption characteristics of four metoprolol tartrate immediate release tablet formulations. Pharm Dev Technol 29:11-24. 1998; 16 1997 1998; 15 1997; 29 1998; 50 1989; 53 1989; 19 1991; 8 19898; 40 1996; 6 Rekhi (10.1002/1520-6017(200010)89:10<1354::AID-JPS13>3.0.CO;2-P_bb0025) 1997; 29 Moore (10.1002/1520-6017(200010)89:10<1354::AID-JPS13>3.0.CO;2-P_bb0050) 1996; 6 10.1002/1520-6017(200010)89:10<1354::AID-JPS13>3.0.CO;2-P_bb0010 Khosla (10.1002/1520-6017(200010)89:10<1354::AID-JPS13>3.0.CO;2-P_bb0065) 1989; 53 Eddington (10.1002/1520-6017(200010)89:10<1354::AID-JPS13>3.0.CO;2-P_bb0020) 1998; 15 Hildebrand (10.1002/1520-6017(200010)89:10<1354::AID-JPS13>3.0.CO;2-P_bb0040) 1989; 19 Mistry (10.1002/1520-6017(200010)89:10<1354::AID-JPS13>3.0.CO;2-P_bb0045) 1998; 16 10.1002/1520-6017(200010)89:10<1354::AID-JPS13>3.0.CO;2-P_bb0015 Nellore (10.1002/1520-6017(200010)89:10<1354::AID-JPS13>3.0.CO;2-P_bb0030) 1998; 50 Coupe (10.1002/1520-6017(200010)89:10<1354::AID-JPS13>3.0.CO;2-P_bb0055) 1991; 8 Mahayni (10.1002/1520-6017(200010)89:10<1354::AID-JPS13>3.0.CO;2-P_bb0035) 1997 10.1002/1520-6017(200010)89:10<1354::AID-JPS13>3.0.CO;2-P_bb0060 |
| References_xml | – reference: Modified release solid oral dosage form guidance: Scale‐up and postapproval changes: Chemistry, manufacturing and controls, in vitro dissolution testing and in vivo bioequivalence documentation. U.S. Department of Health, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), September, 1997. – volume: 53 start-page: 107 year: 1989 end-page: 117 ident: bb0065 article-title: Gastrointestinal transit of non‐disintegrating tablets in fed subjects publication-title: Int J Pharm – volume: 8 start-page: 360 year: 1991 end-page: 364 ident: bb0055 article-title: Variation in gastrointestinal transit of pharmaceutical dosage forms in healthy subjects publication-title: Pharm Res – volume: 15 start-page: 464 year: 1998 end-page: 471 ident: bb0020 article-title: Development and internal validation of an publication-title: Pharm Res – volume: 29 start-page: 11 year: 1997 end-page: 24 ident: bb0025 article-title: Evaluation of publication-title: Pharm Dev Technol – volume: 50 start-page: 247 year: 1998 end-page: 256 ident: bb0030 article-title: Development of metoprolol tartrate extended‐release matrix tablet formulations for regulatory considerations publication-title: J Controlled Rel – year: 1997 ident: bb0035 publication-title: The development of metoprolol tartrate extended‐release dosage form, its – reference: Guidance for the industry: Extended‐release solid oral dosage forms: Development, evaluation and application of in vitro/in vivo correlations. U.S. Department of Health, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), September, 1997. – volume: 16 start-page: 1041 year: 1998 end-page: 1049 ident: bb0045 article-title: A sensitive assay of metoprolol and its metabolite, α‐hydroxy metoprolol in human plasma and determination of dextromethorphan and its metabolite dextrophan in human urine using high‐performance liquid chromatographic methods publication-title: J Pharmaceut Biomed Anal – volume: 19 start-page: 315 year: 1989 end-page: 318 ident: bb0040 article-title: Determination of dextromethorphan metabolizer phenotype in healthy volunteers publication-title: Eur J Clin Pharmacol – reference: Davis SS, Christensen FN, Khosla R, Feely LC. 19898. Gastric emptying of large single-unit dosage forms. J Pharm Pharmacol 40:205–207. – volume: 6 start-page: 64 year: 1996 end-page: 74 ident: bb0050 article-title: Mathematical comparison of curves with an emphasis on dissolution profiles publication-title: Pharm Technol – reference: Moore JW, Flanner HH. 1996. Mathematical comparison of curves with an emphasis on dissolution profiles. Pharm Technol 6:64-74. – reference: Eddington ND, Marroum P, Uppoor R, Hussain A, Augsburger LL. 1998. Development and internal validation of an in vitro in vivo correlation for a hydrophilic metoprolol tartrate extended-release tablet formulation. Pharm Res 15:464-471. – reference: Mistry B, Leslie J, Eddington ND. 1998. A sensitive assay of metoprolol and its metabolite, α-hydroxy metoprolol in human plasma and determination of dextromethorphan and its metabolite dextrophan in human urine using high-performance liquid chromatographic methods. J Pharmaceut Biomed Anal 16:1041-1049. – reference: Nellore RV, Rekhi GS, Hussain AS, Tillman LG, Augsburger LL. 1998. Development of metoprolol tartrate extended-release matrix tablet formulations for regulatory considerations. J Controlled Rel 50:247-256. – reference: Rekhi GS, Eddington ND, Fossler MJ, Schwartz P, Lesko LJ, Augsburger LL. 1997. Evaluation of in vitro release rate and in vivo absorption characteristics of four metoprolol tartrate immediate release tablet formulations. Pharm Dev Technol 29:11-24. – reference: Davis SS, Christensen FN, Khosla R, Feely LC. 19898. Gastric emptying of large single-unit dosage forms. J Pharm Pharmacol 40:205-207. – reference: Coupe AJ, Davis SS, Wilding IR. 1991. Variation in gastrointestinal transit of pharmaceutical dosage forms in healthy subjects. Pharm Res 8:360-364. – reference: Hildebrand M, Seifert W, Reichenberger A. 1989. Determination of dextromethorphan metabolizer phenotype in healthy volunteers. Eur J Clin Pharmacol 19:315-318. – reference: Khosla R, Feely LC, Davis SS. 1989. Gastrointestinal transit of non-disintegrating tablets in fed subjects. Int J Pharm 53:107-117. – year: 1997 – volume: 8 start-page: 360 year: 1991 end-page: 364 article-title: Variation in gastrointestinal transit of pharmaceutical dosage forms in healthy subjects publication-title: Pharm Res – volume: 16 start-page: 1041 year: 1998 end-page: 1049 article-title: A sensitive assay of metoprolol and its metabolite, α‐hydroxy metoprolol in human plasma and determination of dextromethorphan and its metabolite dextrophan in human urine using high‐performance liquid chromatographic methods publication-title: J Pharmaceut Biomed Anal – volume: 6 start-page: 64 year: 1996 end-page: 74 article-title: Mathematical comparison of curves with an emphasis on dissolution profiles publication-title: Pharm Technol – volume: 40 start-page: 205 year: 19898 end-page: 207 article-title: Gastric emptying of large single‐unit dosage forms publication-title: J Pharm Pharmacol – volume: 29 start-page: 11 year: 1997 end-page: 24 article-title: Evaluation of release rate and absorption characteristics of four metoprolol tartrate immediate release tablet formulations publication-title: Pharm Dev Technol – volume: 15 start-page: 464 year: 1998 end-page: 471 article-title: Development and internal validation of an correlation for a hydrophilic metoprolol tartrate extended‐release tablet formulation publication-title: Pharm Res – volume: 19 start-page: 315 year: 1989 end-page: 318 article-title: Determination of dextromethorphan metabolizer phenotype in healthy volunteers publication-title: Eur J Clin Pharmacol – volume: 50 start-page: 247 year: 1998 end-page: 256 article-title: Development of metoprolol tartrate extended‐release matrix tablet formulations for regulatory considerations publication-title: J Controlled Rel – volume: 53 start-page: 107 year: 1989 end-page: 117 article-title: Gastrointestinal transit of non‐disintegrating tablets in fed subjects publication-title: Int J Pharm – volume: 29 start-page: 11 year: 1997 ident: 10.1002/1520-6017(200010)89:10<1354::AID-JPS13>3.0.CO;2-P_bb0025 article-title: Evaluation of in vitro release rate and in vivo absorption characteristics of four metoprolol tartrate immediate release tablet formulations publication-title: Pharm Dev Technol doi: 10.3109/10837459709022605 – volume: 19 start-page: 315 year: 1989 ident: 10.1002/1520-6017(200010)89:10<1354::AID-JPS13>3.0.CO;2-P_bb0040 article-title: Determination of dextromethorphan metabolizer phenotype in healthy volunteers publication-title: Eur J Clin Pharmacol doi: 10.1007/BF00558166 – volume: 16 start-page: 1041 year: 1998 ident: 10.1002/1520-6017(200010)89:10<1354::AID-JPS13>3.0.CO;2-P_bb0045 article-title: A sensitive assay of metoprolol and its metabolite, α‐hydroxy metoprolol in human plasma and determination of dextromethorphan and its metabolite dextrophan in human urine using high‐performance liquid chromatographic methods publication-title: J Pharmaceut Biomed Anal doi: 10.1016/S0731-7085(97)00115-5 – ident: 10.1002/1520-6017(200010)89:10<1354::AID-JPS13>3.0.CO;2-P_bb0060 doi: 10.1111/j.2042-7158.1988.tb05220.x – volume: 53 start-page: 107 year: 1989 ident: 10.1002/1520-6017(200010)89:10<1354::AID-JPS13>3.0.CO;2-P_bb0065 article-title: Gastrointestinal transit of non‐disintegrating tablets in fed subjects publication-title: Int J Pharm doi: 10.1016/0378-5173(89)90234-2 – ident: 10.1002/1520-6017(200010)89:10<1354::AID-JPS13>3.0.CO;2-P_bb0010 – volume: 15 start-page: 464 year: 1998 ident: 10.1002/1520-6017(200010)89:10<1354::AID-JPS13>3.0.CO;2-P_bb0020 article-title: Development and internal validation of an in vitro in vivo correlation for a hydrophilic metoprolol tartrate extended‐release tablet formulation publication-title: Pharm Res doi: 10.1023/A:1011988601696 – volume: 6 start-page: 64 year: 1996 ident: 10.1002/1520-6017(200010)89:10<1354::AID-JPS13>3.0.CO;2-P_bb0050 article-title: Mathematical comparison of curves with an emphasis on dissolution profiles publication-title: Pharm Technol – year: 1997 ident: 10.1002/1520-6017(200010)89:10<1354::AID-JPS13>3.0.CO;2-P_bb0035 – volume: 8 start-page: 360 year: 1991 ident: 10.1002/1520-6017(200010)89:10<1354::AID-JPS13>3.0.CO;2-P_bb0055 article-title: Variation in gastrointestinal transit of pharmaceutical dosage forms in healthy subjects publication-title: Pharm Res doi: 10.1023/A:1015849700421 – ident: 10.1002/1520-6017(200010)89:10<1354::AID-JPS13>3.0.CO;2-P_bb0015 – volume: 50 start-page: 247 year: 1998 ident: 10.1002/1520-6017(200010)89:10<1354::AID-JPS13>3.0.CO;2-P_bb0030 article-title: Development of metoprolol tartrate extended‐release matrix tablet formulations for regulatory considerations publication-title: J Controlled Rel doi: 10.1016/S0168-3659(97)00141-7 |
| SSID | ssj0006055 |
| Score | 1.7907625 |
| Snippet | The purpose of this study was to examine the external predictability of an in vitro–in vivo correlation (IVIVC) for a metoprolol hydrophilic matrix... The purpose of this study was to examine the external predictability of an in vitro-in vivo correlation (IVIVC) for a metoprolol hydrophilic matrix... |
| SourceID | proquest pubmed pascalfrancis crossref wiley istex elsevier |
| SourceType | Aggregation Database Index Database Publisher |
| StartPage | 1354 |
| SubjectTerms | Adrenergic beta-Antagonists - blood Adrenergic beta-Antagonists - pharmacokinetics Adult Antiarythmic agents Biological and medical sciences Cardiovascular system Chemistry, Pharmaceutical correlation Cross-Over Studies drug release extended-release Female Humans in vitro in vivo Linear Models Male mechanism Medical sciences metoprolol Metoprolol - blood Metoprolol - pharmacokinetics Middle Aged Pharmacology. Drug treatments Polymers - pharmacokinetics |
| Title | Evaluation of “External” Predictability of an In Vitro–In Vivo Correlation for an Extended‐Release Formulation Containing Metoprolol Tartrate |
| URI | https://dx.doi.org/10.1002/1520-6017(200010)89:10<1354::AID-JPS13>3.0.CO;2-P https://api.istex.fr/ark:/67375/WNG-BH5HFWZF-1/fulltext.pdf https://onlinelibrary.wiley.com/doi/abs/10.1002%2F1520-6017%28200010%2989%3A10%3C1354%3A%3AAID-JPS13%3E3.0.CO%3B2-P https://www.ncbi.nlm.nih.gov/pubmed/10980510 https://www.proquest.com/docview/72256867 |
| Volume | 89 |
| hasFullText | 1 |
| inHoldings | 1 |
| isFullTextHit | |
| isPrint | |
| link | http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwvV1bb9MwFLamISFeuF8CA_xAK5CWLomd2CkIaetaygRbxTZt4sVybtK0rZnadKI89ScgAW_w5_pLOLablKEigYSQ-hA1iU_ic_sc299B6EmQeTGJJbWdLGI2DWNqR4HLbRI5EYeBTxBI9b3j7XbQ3adbh_7hEhqWe2EMP0T1wU15ho7XysFlNFybk4ZC4oGBj2YJ4mq_ievUFJu4piCokZZLfArH8Ft_vWlv9XZdUiNt0nAarZ0a2fDsHsRtlwSKb3_z3ZxyCuC9XzGMw-DpMgpnMtcqiU-NvGc8bLrOCyWp2aykvDQynoOE3-W6S0qDH9QyTDkETWSmhMYijHsRMuuc17mGvpS9ZZa6HDdGRdSIP_5CJPmfu_M6ujrD0HjdGP0NtJT2b6J6z5Bwj1fx3nxP2XAV13FvTs89voW-tiuCc5xneDr5VjJhTyff8dlAzVwVhr18rC6QfXzUx-dHxSCfTj7rw_Mcx6qqiVlHiAH3q6vK-YTp5JOqRAPwQJ05ndVHw2pTgCnHgU_TIodOPclPcAGuq9g6bqP9Tnuv1bVnxSns2GcesSWERpLRhFO1ec1jScKky9xYT_wmoSMz5gRZnEQs9r3EzQglLPLSwJUZpyl3yB203M_76T2EJY8poVkQcwWYCI-SDFA2CSkDdOHL1EJbpRmJM8NBIgzbtCeU2oRSmzBKEzzU50BdQoCqhFaVIMIRrR3hiZ6FdktDFDOQZcCTAJv4o2YXt1rXNl09nxwcqyWDzBcH26_ERtfvdg7ed4RroZULRl_dwEkAMMlCj0sfEBDn1OSV7Kf5aCgYJJ6AB8xCd41r_NQVIVepxUJvtIH_VR8tehnzx_1_29wDdEWzOOh1oCtouRiM0oeAZ4vokQ5APwCWPIKy |
| linkProvider | Wiley-Blackwell |
| linkToHtml | http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwvV1bb9MwFLbGJgEv3C-BwfxAK5CWLomdxCkIaetautJ1Feu0iRcrV2na1kxtOlGe-hOQ0N7gz_WX4GM3KUNFAgkh9SFqUp_0XHw-376D0AsnsUIS-lQ3ksDVqRdSPXBMppPACJgY-DiOD_Mdux2neUBbR_bREsryszCKH6KYcIPIkP01BDhMSG_MWUNF5hEjH0kTxODAiWmUgE5cchCUSM0kNhXX4rO5s623uvsmKZE6qRiV2l6JbFl69xpaoQKgwJBt-8OcdEoAfLvgGBfDp-vImwndKES-VAJfMa9qGm9AVLVaiHmrhLwWIn6X7VbAhp9gI6Y_FLZIVBGNRSj3KmiWWa9xG13m-lKbXU4qoyyohJ9_oZL83wq9g27NYDTeVH5_Fy3F_Xuo3FU83ON13JsfKxuu4zLuzhm6x_fRZb3gOMdpgqeTbzkZ9nTyHZ8PYPEqUwTmY3jA7-PjPr44zgbpdPJVXl6kOITCJmorIRbQH57KlxSmky9QjEYgBLhzNiuRhuFcgKrIgc_iLBVaPU1PcSaiFwg7HqCDRr1Xa-qz-hR6aLsW0X3RO5KERozC-TXLjSLXN10zlGu_kWf4iWs4SRgFbmhbkZkQStzAih3TTxiNmUEeouV-2o8fI-yzkBKaOCEDzERYECUCaBOPugJg2H6soVbuR_xc0ZBwRThtcTAbB7NxZTTOPHlPmItzYSouTcUJN3htj1u8q6H93BP5DGcp_MSFU_xRs4tbLUunLt7PH5zArkHX5oedd3yraTcbhx8b3NTQ6hWvL37AiCOQkobW8iDgoquD9Su_H6ejIXdF7nGY42rokYqNn1ThMcguGmpLD_8rHS36M-qLJ_-2uTV0o9nbbfP2Tuf9U3RTkjrIbaGraDkbjOJnAt5mwXPZG_0AyA6G0Q |
| linkToPdf | http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwvV1bb9MwFLbGJk28cL8EBvMDrUBauiR2bKcgpK1r6crYol20iRcrV2na1lRtOlGe-hOQgDf4c_0l-NKkDBUJJITUh6hJfBKfc3w-xz7fAeAZSZ0IRQE2rTSkJvYibIbEZiYKrZCJiQ8hgfze8W6XtI9w58Q9WQCDIhdG80OUH9ykZ6jxWjp4L07XZ6ShIvCIiY9iCWIy38S2KpJNXFEQVFDDRi4Wx-K3sb1ldvwDG1VQE9WsWmOvgjYd078GljARCEQiqf0Z55TA925JMS5mT8vAmwpdL0U-1wJfMK9uW6-kqHq9FPNaC3kpRPwu2C1JFX6Q-zCDgVBFqmtozAO5VzGzCnqtm-BL0V16r8tZbZiHtejjL0yS_7k_b4EbUxANN7TV3wYLSfcOqPqahXu0Bg9nSWWDNViF_oyfe3QXfG2WDOcwS-Fk_K2gwp6Mv8NeXy5d5Zq-fCQvCLrwtAsvT_N-Nhl_VoeXGYxkWRO9kRAK4C-vKhYUJuNPshSNwAfyzMW0QBqUWQG6Hge8SPJMdOp5dg5z4buSruMeOGo1Dxttc1qdwoxc6iAzEGMjSnHMsMxec2gc08CmdqRWfmPPClJqkTSKQxq5TmynCCMaOgmxg5ThhFnoPljsZt3kIYABizDCKYmYREyIhXEqYDbyMBXwwg0SA3QKM-I9TULCNd20w6XauFQb10rjzFPnhLo4F6riSlUccYs39rjDfQMcFIbIpyhLoycubOKPmp3falXZdPl8Qf9M7hmkLj_efcM32267dfy-xW0DrFwx-vIGhojASQZYLXyAi4FOrl4F3SQbDjgVkYcwQg3wQLvGT13hMRlbDLCjDPyv-mjey-g_Hv3b5lbBsr_V4jvbu28fg-uK0UHtCV0Bi3l_mDwR2DYPn6qx6Aecm4WA |
| openUrl | ctx_ver=Z39.88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF-8&rfr_id=info%3Asid%2Fsummon.serialssolutions.com&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Evaluation+of+%22external%22+predictability+of+an+in+vitro-in+vivo+correlation+for+an+extended-release+formulation+containing+metoprolol+tartrate&rft.jtitle=Journal+of+pharmaceutical+sciences&rft.au=Mahayni%2C+H&rft.au=Rekhi%2C+G+S&rft.au=Uppoor%2C+R+S&rft.au=Marroum%2C+P&rft.date=2000-10-01&rft.issn=0022-3549&rft.volume=89&rft.issue=10&rft.spage=1354&rft_id=info:doi/10.1002%2F1520-6017%28200010%2989%3A10%3C1354%3A%3Aaid-jps13%3E3.0.co%3B2-p&rft.externalDBID=NO_FULL_TEXT |
| thumbnail_l | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/lc.gif&issn=0022-3549&client=summon |
| thumbnail_m | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/mc.gif&issn=0022-3549&client=summon |
| thumbnail_s | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/sc.gif&issn=0022-3549&client=summon |