Implant; NIR Spectroscopy; Raman Spectroscopy; Hot Melt Extrusion; Process Analytical Technology; Raman Imaging
Abstract :
[en] Hot melt extrusion is a novel pharmaceutical manufacturing process technique. In this study, we identified four Critical Quality Attributes (CQAs) of the implant manufacturing process by hot melt extrusion: the implant diameter, the quantity of the Active Pharmaceutical Ingredient (API), the homogeneity distribution of API and the thickness of the membrane. We controlled the implant diameter and the quantity of API in-line with a laser measurement, NIR and Raman spectroscopy, respectively. These two different spectroscopic techniques provided comparable results. In fact, the RMSEC and RMSECV were very close in each PAT technique but NIR spectroscopy was easier to use and less sensitive to external changes. For the control of the homogeneity of API distribution and the thickness of the membrane, we used successfully Raman spectroscopy imaging. These PAT tools help reducing analysis time.
Research Center/Unit :
Centre Interfacultaire de Recherche du Médicament - CIRM
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Krier, Fabrice ; Université de Liège - ULiège > Département de pharmacie > Pharmacie galénique
Mantanus, Jérome
Sacre, Pierre-Yves ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Chavez, Pierre-François ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Thiry, Justine ; Université de Liège - ULiège > Département de pharmacie > Pharmacie galénique
Pestieau, Aude ; Université de Liège - ULiège > Département de pharmacie > Pharmacie galénique
Rozet, Eric ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Ziemons, Eric ; Université de Liège - ULiège > Département de pharmacie > Département de pharmacie
Hubert, Philippe ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Evrard, Brigitte ; Université de Liège - ULiège > Département de pharmacie > Pharmacie galénique
Language :
English
Title :
PAT tools for the control of co-extrusion implants manufacturing process
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
(FDA), U.S.F.a.D.A. Guidance for Industry PAT-A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance 2004 FDA
I. Alig, D. Fischer, D. Lellinger, and B. Steinhoff Combination of NIR, Raman, ultrasonic and dielectric spectroscopy for in-line monitoring of the extrusion process Macromol. Symposia 230 2005 51 58 (Pubitemid 43120137)
J. Amigo Practical issues of hyperspectral imaging analysis of solid dosage forms Anal. Bioanal. Chem. 398 2010 93 109
S. Armenta, S. Garrigues, and M. de la Guardia Green analytical chemistry Trends Anal. Chem. 27 2008 497 511
R.M. Balabin, R.Z. Safieva, and E.I. Lomakina Gasoline classification using near infrared (NIR) spectroscopy data: Comparison of multivariate techniques Anal. Chim. Acta 671 2010 27 35
R.J. Barnes, M.S. Dhanoa, and S.J. Lister Standard normal variate transformation and de-trending of near-infrared diffuse reflectance spectra Appl. Spectrosc. 43 1989 772 777
S.E. Barnes, E.C. Brown, M.G. Sibley, H.G.M. Edwards, and P.D. Coates Vibrational spectroscopic and ultrasound analysis for the in-process monitoring of poly(ethylene vinyl acetate) copolymer composition during melt extrusion Analyst 130 2005 286 292 (Pubitemid 40388929)
S.E. Barnes, E.C. Brown, M.G. Sibley, H.G.M. Edwards, I.J. Scowen, and P.D. Coates Vibrational spectroscopic and ultrasound analysis for in-process characterization of high-density polyethylene/polypropylene blends during melt extrusion Appl. Spectrosc. 59 2013 611 619
S.E. Barnes, M.G. Sibley, H.G.M. Edwards, and P.D. Coates Process monitoring of polymer melts using in-line spectroscopy Trans. Inst. Measure. Control 29 2007 453 465
J.M. Bland, and D.G. Altman Statistical methods for assessing agreement between two methods of clinical measurement Int. J. Nurs. Stud. 47 2010 931 936
B. Boulanger, E. Rozet, F. Moonen, S. Rudaz, and P. Hubert A risk-based analysis of the AAPS conference report on quantitative bioanalytical methods validation and implementation J. Chromatogr. B 877 2009 2235 2243
J. Breitenbach Melt extrusion: from process to drug delivery technology Eur. J. Pharm. Biopharm. 54 2002 107 117 (Pubitemid 34919382)
R. Cheung, S. Krishnaswami, and K. Kowalski Analgesic efficacy of celecoxib in postoperative oral surgery pain: a single-dose, two-center, randomized, double-blind, active- and placebo-controlled study Clin. Ther. 29 2007 2498 2510 (Pubitemid 350299462)
R. Chokshi, and H. Zia Hot-Melt extrusion technique Iran. J. Pharm. Res. 3 2004 3 16
P.D. Coates, S.E. Barnes, M.G. Sibley, E.C. Brown, H.G.M. Edwards, and I.J. Scowen In-process vibrational spectroscopy and ultrasound measurements in polymer melt extrusion Polymer 44 2003 5937 5949 (Pubitemid 37046101)
L.C. Costantini, S.R. Kleppner, J. McDonough, M.R. Azar, and R. Patel Implantable technology for long-term delivery of nalmefene for treatment of alcoholism Int. J. Pharm. 283 2004 35 44 (Pubitemid 39200924)
M.M. Crowley, F. Zhang, M.A. Repka, S. Thumma, S.B. Upadhye, S. Kumar Battu, J.W. McGinity, and C. Martin Pharmaceutical applications of hot-melt extrusion: Part I Drug Dev. Ind. Pharm. 33 2007 909 926 (Pubitemid 47463803)
S. Daniels, J. Robbins, C.R. West, and M.A. Nemeth Celecoxib in the treatment of primary dysmenorrhea: results from two randomized, double-blind, active- and placebo-controlled, crossover studies Clin. Ther. 31 2009 1192 1208
A. Dash, and G. Cudworth Ii Therapeutic applications of implantable drug delivery systems J. Pharmacol. Toxicol. Methods 40 1998 1 12 (Pubitemid 29062900)
A. de Juan, and R. Tauler Chemometrics applied to unravel multicomponent processes and mixtures: Revisiting latest trends in multivariate resolution Anal. Chim. Acta 500 2003 195 210 (Pubitemid 37487780)
E.F. Ekman, M. Wahba, and F. Ancona Analgesic efficacy of perioperative celecoxib in ambulatory arthroscopic knee surgery: a double-blind, placebo-controlled study Arthroscopy: J. Arthrosc. Related Surg. 22 2006 635 642 (Pubitemid 43817427)
D. Fischer, T. Bayer, K.J. Eichhorn, and M. Otto In-line process monitoring on polymer melts by NIR-spectroscopy Fresenius J. Anal. Chem 359 1997 74 77 (Pubitemid 127713862)
D. Fischer, K. Sahre, M. Abdelrhim, B. Voit, V.B. Sadhu, J. Pionteck, H. Komber, and J. Hutschenreuter Process monitoring of polymers by in-line ATR-IR, NIR and Raman spectroscopy and ultrasonic measurements Comptes Rendus Chimie 9 2006 1419 1424 (Pubitemid 44849184)
J.S. Gimbel, A. Brugger, W. Zhao, K.M. Verburg, and G.S. Geis Efficacy and tolerability of celecoxib versus hydrocodone/acetaminophen in the treatment of pain after ambulatory orthopedic surgery in adults Clin. Ther. 23 2001 228 241 (Pubitemid 32231113)
P. 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 (Pubitemid 39441329)
J. Jaumot, R. Gargallo, A. de Juan, and R. Tauler A graphical user-friendly interface for MCR-ALS: a new tool for multivariate curve resolution in MATLAB Chemometrics Intellig. Lab. Syst 76 2005 101 110 (Pubitemid 40342915)
L. Li, O. AbuBaker, and Z.J. Shao Characterization of poly(ethylene oxide) as a drug carrier in hot-melt extrusion Drug Dev. Ind. Pharm. 32 2006 991 1002 (Pubitemid 44359761)
K.H. Liland, T. Almøy, and B.-H. Mevik Optimal choice of baseline correction for multivariate calibration of spectra Appl. Spectrosc. 64 2010 1007 1016
J. Luypaert, D.L. Massart, and Y. Vander Heyden Near-infrared spectroscopy applications in pharmaceutical analysis Talanta 72 2007 865 883 (Pubitemid 46635544)
J. Mantanus, E. Rozet, K. Van Butsele, C. De Bleye, A. Ceccato, B. Evrard, P. Hubert, and E. Ziémons Near infrared and Raman spectroscopy as Process Analytical Technology tools for the manufacturing of silicone-based drug reservoirs Anal. Chim. Acta 699 2011 96 106
Moros, J. Garrigues, S. Guardia, and M. d. l. Vibrational spectroscopy provides a green tool for multi-component analysis Trends Anal. Chem. 29 2010 578 591
R. Petrella, E.F. Ekman, R. Schuller, and J.G. Fort Efficacy of celecoxib, a COX-2-specific inhibitor, and naproxen in the management of acute ankle sprain: results of a double-blind, randomized controlled trial Clin. J. Sport Med. 14 2004 225 231 (Pubitemid 38989679)
B.D. Prakash, and Y.C. Wei A fully automated iterative moving averaging (AIMA) technique for baseline correction Analyst 136 2011 3130 3135
M.A. Repka, S.K. Battu, S.B. Upadhye, S. Thumma, M.M. Crowley, F. Zhang, C. Martin, and J.W. McGinity Pharmaceutical applications of hot-melt extrusion: Part II Drug Dev. Ind. Pharm. 33 2007 1043 1057 (Pubitemid 350034836)
M.A. Repka, S. Majumdar, S. Kumar Battu, R. Srirangam, and S.B. Upadhye Applications of hot-melt extrusion for drug delivery Expert Opin. Drug Deliv. 5 2008 1357 1376
T. Rohe, W. Becker, S. Kölle, N. Eisenreich, and P. Eyerer Near infrared (NIR) spectroscopy for in-line monitoring of polymer extrusion processes Talanta 50 1999 283 290
F.J.M.E. Roumen, and T.O.M. Dieben Clinical acceptability of an ethylene-vinyl-acetate nonmedicated vaginal ring Contraception 59 1999 59 62 (Pubitemid 29174417)
E. Rozet, R.D. Marini, E. Ziemons, B. Boulanger, and P. Hubert Advances in validation, risk and uncertainty assessment of bioanalytical methods J. Pharm. Biomed. Anal. 55 2011 848 858
Sabin, G.P., Souza, A.M.d., Breitkreitz, M.C., Poppi, R.J., 2012. Desenvolvimento de um algoritmo para identificação e correção de spikes em espectroscopia Raman de imagem. Química Nova 35, 612-615.
L. Saerens, L. Dierickx, B. Lenain, C. Vervaet, J.P. Remon, and T.D. Beer Raman spectroscopy for the in-line polymer-drug quantification and solid state characterization during a pharmaceutical hot-melt extrusion process Eur. J. Pharm. Biopharm. 77 2011 158 163
L. Saerens, L. Dierickx, T. Quinten, P. Adriaensens, R. Carleer, C. Vervaet, J.P. Remon, and T. De Beer In-line NIR spectroscopy for the understanding of polymer-drug interaction during pharmaceutical hot-melt extrusion Eur. J. Pharm. Biopharm 81 2012 230 237
A. Savitzky, and M.J.E. Golay Smoothing and differentiation of data by simplified least squares procedures Anal. Chem. 36 1964 1627 1639
R. Tauler Multivariate curve resolution applied to second order data Chemometrics Intellig. Lab. Syst. 30 1995 133 146
L. Taylor, and G. Zografi Spectroscopic characterization of interactions between PVP and indomethacin in amorphous molecular dispersions Pharm. Res. 14 1997 1691 1698 (Pubitemid 28062912)
V.S. Tumuluri, M.S. Kemper, I.R. Lewis, S. Prodduturi, S. Majumdar, B.A. Avery, and M.A. Repka Off-line and on-line measurements of drug-loaded hot-melt extruded films using Raman spectroscopy Int. J. Pharm. 357 2008 77 84
M. Vidal, and J.M. Amigo Pre-processing of hyperspectral images. Essential steps before image analysis Chemometrics Intellig. Lab. Syst. 117 2012 138 148
W. Windig, and J. Guilment Interactive self-modeling mixture analysis Anal. Chem. 63 1991 1425 1432
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.
