[en] When developing a new formulation, the development, calibration and validation steps of analytical methods based on vibrational spectroscopy are time-consuming. For each new formulation, real samples must be produced and a “reference method” must be used in order to determine the Active Pharmaceutical Ingredient (API) content of each sample. To circumvent this issue, the paper presents a simple approach based on the film-casting technique used as a calibration tool in the framework of hot-melt extrusion process.
Confocal Raman microscopic method was successfully validated for the determination of itraconazole content in film-casting samples. Then, hot-melt extrusion was carried out to produce real samples in order to confront the results obtained with confocal Raman microscopy and Ultra High Performance Liquid Chromatography (UHPLC). The agreement between both methods was demonstrated using a comparison study based on the Bland and Altman’s plot.
Research Center/Unit :
Centre Interfacultaire de Recherche du Médicament - CIRM
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
S. Shah, S. Maddineni, J. Lu, and M.A. Repka Melt extrusion with poorly soluble drugs Int. J. Pharm. 453 2013 233 252
M. Maniruzzaman, A. Nair, M. Renault, U. Nandi, N. Scoutaris, R. Farnish, M.S.A. Bradley, M.J. Snowden, and D. Douroumis Continuous twin-screw granulation for enhancing the dissolution of poorly water soluble drug Int. J. Pharm. 496 2015 52 62
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Guidance for Industry: Waiver of in vivo Bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on biopharmaceutics classification systems, 2000.
M.A. Repka, S. Shah, J. Lu, S. Maddineni, J. Morott, K. Patwardhan, and N.N. Mohammed Melt extrusion: process to product Expert Opin. Drug Deliv. 9 2012 105 125
J. Thiry, F. Krier, and B. Evrard A review of pharmaceutical extrusion: critical process parameters and scaling-up Int. J. Pharm. 479 2015 227 240
Particle Sciences Drug Development Services, Dissolving films, Particle Sciences, 3, 2010, pp. 1-2
K. Kolter, M. Karl, A. Gryczke, Hot-Melt Extrusion with BASF Pharma Polymers, 2nd ed., Extrusion Compendium, 2012
T. Parikh, S.S. Gupta, A.K. Meena, I. Vitez, N. Mahajan, and A.T.M. Serajuddin Application of film-casting technique to investigate drug-polymer miscibility in solid dispersion and hot-melt extrudate J. Pharm. Sci. 104 2015 2142 2152
S. Janssens, A. Zeure, A. Paudel, R. Humbeeck, and G.V. Der Mooter Influence of preparation methods on solid state supersaturation of amorphous solid dispersions: a case study with itraconazole and Eugragit E 100 Pharm. Res. 27 2010 775 785
I. Weuts, F. Van Dycke, J. Voorspoels, S. De Cort, S. Stokbroekx, R. Leemans, M.E. Brewster, D. Xu, B. Segmuller, Y.T.A. Turner, C.J. Roberts, M.C. Davies, S. Qi, D.Q.M. Craig, and M. Reading Physicochemical properties of the amorphous drug, cast films, and spray dried powders to predict formulation probability of success for solid dispersions: etravirine J. Pharm. Sci. 100 2011 260 274
P.J. Marsac, S.L. Shamblin, and L.S. Taylor Theoretical and practical approaches for prediction of drug-polymer miscibility and solubility Pharm. Res. 23 2006 2417 2426
F. Meng, V. Dave, and H. Chauhan Qualitative and quantitative methods to determine miscibility in amorphous drug - polymer systems Eur. J. Pharm. Sci. 77 2015 106 111
J.C.C. Ferreira, T.S. Monteiro, A.C. Lopes, C.M. Costa, M.M. Silva, A.V. Machado, and S. Lanceros - Mendez Variation of the physicochemical and morphological characteristics of solvent casted poly(vinylidene fluoride) along its binary phase diagram with dimethylformamide J. Non Cryst. Solids 412 2015 16 23
S. Sasic, and Y. Ozaki Raman, Infrared and Near-infrared Chemical Imaging 2010 John Wiley & Sons New Jersey
N. Scoutaris, K. Vithani, I. Slipper, B. Chowdhry, and D. Douroumis SEM/EDX and confocal Raman microscopy as complementary tools for the characterization of pharmaceutical tablets Int. J. Pharm. 2014 88 98
L. Netchacovitch, J. Thiry, C. De Bleye, P.-F. Chavez, F. Krier, P.-Y. Sacré, B. Evrard, Ph Hubert, and E. Ziemons Vibrational spectroscopy and microspectroscopy analyzingqualitatively and quantitatively pharmaceutical hot melt extrudates J. Pharm. Biomed. Anal. 113 2015 21 33
International Conference on Harmonization (ICH) of Technical Requirements for registration of Pharmaceuticals for Human Use, Topic Q2 (R1), Validation of Analytical Procedures: Text and Methodology, Geneva, 2005.
Ph Hubert, J.-J. Nguyen-Huu, B. Boulanger, E. Chapuzet, P. Chiap, N. Cohen, P.-A. Compagnon, W. Dewé, M. Feinberg, M. Lallier, M. Laurentie, N. Mercier, G. Muzard, C. Nivet, and L. Valat Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal - (Part I) J. Pharm. Biomed. Anal. 36 2004 579 586
Ph. Hubert, J.-J. Nguyen-Huu, B. Boulanger, E. Chapuzet, P. Chiap, N. Cohen, P.-A. Compagnon, W. Dewé, M. Feinberg, M. Lallier, M. Laurentie, N. Mercier, G. Muzard, C. Nivet, L. Valat, and E. Rozet Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal - (Part II) J. Pharm. Biomed. Anal. 45 2007 70 81
Ph Hubert, J.-J. Nguyen-Huu, B. Boulanger, E. Chapuzet, N. Cohen, P.-A. Compagnon, W. Dewé, M. Feinberg, M. Laurentie, N. Mercier, G. Muzard, L. Valat, and E. Rozet Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal - (Part III) J. Pharm. Biomed. Anal. 45 2007 82 96
E. Rozet, V. Wascotte, N. Lecouturier, V. Préat, W. Dewé, B. Boulanger, and Ph Hubert Improvement of the decision efficiency of the accuracy profile by means of a desirability function for analytical methods validation. Application to a diacetyl-monoxime colorimetric assay used for the determination of urea in transdermal iontophoretic extracts Anal. Chim. Acta 591 2007 239 247
E. Rozet, C. Hubert, A. Ceccato, W. Dewé, E. Ziemons, F. Moonen, K. Michail, R. Wintersteiger, B. Streel, B. Boulanger, and Ph Hubert Using tolerance intervals in pre-study validation of analytical methods to predict in-study results. The fit-for-future-purpose concept J. Chromatogr. A 1158 2007 126 137
D. Guillarme, D.T.-T. Nguyen, S. Rudaz, and J.-L. Veuthey Method transfer for fast liquid chromatography in pharmaceutical analysis: application to short column packed with small particle. Part II: gradient experiments Eur. J. Pharm. Biopharm. 68 2008 430 440
D.L. Massart, B.G.M. Vandeginste, L.M.C. Buydens, S. De Jong, P.J. Lewi, and J. Smeyers-Verbeke Handbook of Chemometrics and Qualimetrics: Part A 1997 Elsevier Amsterdam, The Netherlands
B.G.M. Vandeginste, D.L. Massart, L.M.C. Buydens, S. De Jong, P.J. Lewi, and J. Smeyers-Verbeke Handbook of Chemometrics and Qualimetrics: Part B 1998 Elsevier Amsterdam, The Netherlands
P. Matousek, and M.D. Morris Emerging Raman Applications and Techniques in Biomedical and Pharmaceutical Fields 2009 Springer Berlin, Heidelberg
E. Rozet, V. Wascotte, N. Lecouturier, V. Préat, W. Dewé, B. Boulanger, and Ph Hubert Improvement of the decision efficiency of the accuracy profile by means of a desirability function for analytical methods validation. Application to a diacetyl-monoxime colorimetric assay used for the determination of urea in transdermal iontophoretic extracts Anal. Chim. Acta 591 2007 239 247
J.M. Bland, and D.G. Altman Statistical methods for assessing agreement between two methods of clinical measurement Lancet 327 1986 307 310
J.M. Bland, and D.G. Altman Measuring agreement in method comparison studies Stat. Methods Med. Res. 8 1999 135 160
Similar publications
Sorry the service is unavailable at the moment. Please try again later.
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.