Evaluation of different in vitro dissolution tests based on level A in vitro–in vivo correlations for fenofibrate self-emulsifying lipid-based formulations
CIRM - Centre Interdisciplinaire de Recherche sur le Médicament - ULiège
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Pestieau, Aude ; Université de Liège > Département de pharmacie > Pharmacie galénique
Lebrun, Sonia; Galephar M/F Research Center
Cahay, Bernard; Galephar M/F Research Center,
Brouwers, Adeline; Galephar M/F Research Center,
Streel, Bruno; Galephar M/F Research Center,
Cardot, Jean-Michel; Université d'Auvergne > Faculté de Pharmacie > Laboratoire de Biopharmacie et de Technologie Pharmaceutique
Evrard, Brigitte ; Université de Liège > Département de pharmacie > Pharmacie galénique
Language :
English
Title :
Evaluation of different in vitro dissolution tests based on level A in vitro–in vivo correlations for fenofibrate self-emulsifying lipid-based formulations
Publication date :
March 2017
Journal title :
European Journal of Pharmaceutics and Biopharmaceutics
scite shows how a scientific paper has been cited by providing the context of the citation, a classification describing whether it supports, mentions, or contrasts the cited claim, and a label indicating in which section the citation was made.
Bibliography
[1] Kawabata, Y., Wada, K., Nakatani, M., Yamada, S., Onoue, S., Formulation design for poorly water-soluble drugs based on biopharmaceutics classification system: basic approaches and practical applications. Int. J. Pharm. 420 (2011), 1–10.
[2] Pestieau, A., Krier, F., Lebrun, P., Brouwers, A., Streel, B., Evrard, B., Optimization of a PGSS (particles from gas saturated solutions) process for a fenofibrate lipid-based solid dispersion formulation. Int. J. Pharm. 485 (2015), 295–305.
[3] Phillips, D.J., Pygall, S.R., Cooper, V.B., Mann, J.C., Overcoming sink limitations in dissolution testing: a review of traditional methods and the potential utility of biphasic systems. J. Pharm. Pharmacol. 64 (2012), 1549–1559.
[4] Long, M., Chen, Y., Chapter 14 - Dissolution Testing of Solid Products. Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, 2009, Academic Press, San Diego, 319–340.
[5] FDA, Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In vivo Correlations, Guidance for Industry - Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In vivo Correlations, 1997.
[6] FDA, Q8 (R2) Pharmaceutical Development, Guidance for Industry - Q8 (R2) Pharmaceutical Development, 2009.
[7] Qiu, Y., Chapter 17 - In Vitro–In Vivo Correlations: Fundamentals, Development Considerations, and Applications. Porter, Y.Q.C.G.Z.Z.L.R., (eds.) Developing Solid Oral Dosage Forms, 2009, Academic Press, San Diego, 379–406.
[8] Thomas, N., Richter, K., Pedersen, T., Holm, R., Müllertz, A., Rades, T., In vitro lipolysis data does not adequately predict the in vivo performance of lipid-based drug delivery systems containing fenofibrate. The AAPS J. 16 (2014), 539–549.
[9] Griffin, B.T., Kuentz, M., Vertzoni, M., Kostewicz, E.S., Fei, Y., Faisal, W., Stillhart, C., O'Driscoll, C.M., Reppas, C., Dressman, J.B., Comparison of in vitro tests at various levels of complexity for the prediction of in vivo performance of lipid-based formulations: case studies with fenofibrate. Eur. J. Pharm. Biopharm. 86 (2014), 427–437.
[10] Kollipara, S., Gandhi, R.K., Pharmacokinetic aspects and in vitro–in vivo correlation potential for lipid-based formulations. Acta Pharmaceutica Sinica B 4 (2014), 333–349.
[11] Lue, B.-M., Nielsen, F.S., Magnussen, T., Schou, H.M., Kristensen, K., Jacobsen, L.O., Müllertz, A., Using biorelevant dissolution to obtain IVIVC of solid dosage forms containing a poorly-soluble model compound. Eur. J. Pharm. Biopharm. 69 (2008), 648–657.
[12] Borkar, N., Xia, D., Holm, R., Gan, Y., Müllertz, A., Yang, M., Mu, H., Investigating the correlation between in vivo absorption and in vitro release of fenofibrate from lipid matrix particles in biorelevant medium. Eur. J. Pharm. Sci. 51 (2014), 204–210.
[13] Do, T.T., Van Speybroeck, M., Mols, R., Annaert, P., Martens, J., Van Humbeeck, J., Vermant, J., Augustijns, P., Van den Mooter, G., The conflict between in vitro release studies in human biorelevant media and the in vivo exposure in rats of the lipophilic compound fenofibrate. Int. J. Pharm. 414 (2011), 118–124.
[14] Grundy, J.S., Anderson, K.E., Rogers, J.A., Foster, R.T., Studies on dissolution testing of the nifedipine gastrointestinal therapeutic system. I. Description of a two-phase in vitro dissolution test. J. Control. Release 48 (1997), 1–8.
[15] Grundy, J.S., Anderson, K.E., Rogers, J.A., Foster, R.T., Studies on dissolution testing of the nifedipine gastrointestinal therapeutic system. II. Improved in vitro-in vivo correlation using a two-phase dissolution test. J. Control. Release 48 (1997), 9–17.
[16] Shi, Y., Gao, P., Gong, Y., Ping, H., Application of a biphasic test for characterization of in vitro drug release of immediate release formulations of celecoxib and its relevance to in vivo absorption. Mol. Pharm. 7 (2010), 1458–1465.
[17] Pestieau, A., Krier, F., Brouwers, A., Streel, B., Evrard, B., Selection of a discriminant and biorelevant in vitro dissolution test for the development of fenofibrate self-emulsifying lipid-based formulations. Eur. J. Pharm. Sci. 92 (2016), 212–219.
[18] Al Durdunji, A., AlKhatib, H.S., Al-Ghazawi, M., Development of a biphasic dissolution test for Deferasirox dispersible tablets and its application in establishing an in vitro–in vivo correlation. Eur. J. Pharm. Biopharm. 102 (2016), 9–18.
[19] F.D.A. US Department of Health and Human Services, Center for Drug Evaluation and Research, Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms, 1997.
[20] Diehl, K.-H., Hull, R., Morton, D., Pfister, R., Rabemampianina, Y., Smith, D., Vidal, J.-M., Vorstenbosch, C.V.D., A good practice guide to the administration of substances and removal of blood, including routes and volumes. J. Appl. Toxicol. 21 (2001), 15–23.
[21] Horkovics-Kovats, S., Efficiency of enterohepatic circulation, its determination and influence on drug bioavailability. Arzneimittelforschung 49 (1999), 805–815.
[22] Cardot, J.M., Davit, B.M., In vitro–in vivo correlations: tricks and traps. AAPS J. 14 (2012), 491–499.
This website uses cookies to improve user experience. Read more
Save & Close
Accept all
Decline all
Show detailsHide details
Cookie declaration
About cookies
Strictly necessary
Performance
Strictly necessary cookies allow core website functionality such as user login and account management. The website cannot be used properly without strictly necessary cookies.
This cookie is used by Cookie-Script.com service to remember visitor cookie consent preferences. It is necessary for Cookie-Script.com cookie banner to work properly.
Performance cookies are used to see how visitors use the website, eg. analytics cookies. Those cookies cannot be used to directly identify a certain visitor.
Used to store the attribution information, the referrer initially used to visit the website
Cookies are small text files that are placed on your computer by websites that you visit. Websites use cookies to help users navigate efficiently and perform certain functions. Cookies that are required for the website to operate properly are allowed to be set without your permission. All other cookies need to be approved before they can be set in the browser.
You can change your consent to cookie usage at any time on our Privacy Policy page.