Process analytical quality control of tailored drug release formulation prepared via hot-melt extrusion technology
Tài liệu tham khảo
Pritchard, 2010, Silk fibroin encapsulated powder reservoirs for sustained release of adenosine, J. Control. release, 144, 159, 10.1016/j.jconrel.2010.01.035
Ochoa, 2010, In vivo evaluation of two new sustained release formulations elaborated by one-step melt granulation: level A in vitro–in vivo correlation, Eur. J. Pharm. Biopharm., 75, 232, 10.1016/j.ejpb.2010.02.008
Wadher, 2011, Formulation and evaluation of sustained release matrix tablets of metformin hydrochloride using pH dependent and pH independent methacrylate polymers, Br. J. Pharm. Res., 1, 29, 10.9734/BJPR/2011/255
Park, 2013, Drug release-modulating mechanism of hydrophilic hydroxypropylmethylcellulose matrix tablets: distribution of atoms and carrier and texture analysis, Curr. drug Deliv., 10, 732, 10.2174/156720181006131125155652
Park, 2013, New investigation of distribution imaging and content uniformity of very low dose drugs using hot-melt extrusion method, Int. J. Pharm., 458, 245, 10.1016/j.ijpharm.2013.10.027
Tiwari, 2016, Contribution of hot-melt extrusion technology to advance drug delivery in the 21st century, Expert Opin. Drug Deliv., 13, 451, 10.1517/17425247.2016.1126246
Repka, 2009, Hot melt extrusion-Hot-Melt Extrusion, Am. Pharm. Rev., 12, 18
Repka, 2007, Pharmaceutical applications of hot-melt extrusion: Part II, Drug Dev. industrial Pharm., 33, 1043, 10.1080/03639040701525627
Repka, 2008, Applications of hot-melt extrusion for drug delivery, Expert Opin. Drug Deliv., 5, 1357, 10.1517/17425240802583421
Crowley, 2004, Physicochemical properties and mechanism of drug release from ethyl cellulose matrix tablets prepared by direct compression and hot-melt extrusion, Int. J. Pharm., 269, 509, 10.1016/j.ijpharm.2003.09.037
Yu, 2004, Applications of process analytical technology to crystallization processes, Adv. Drug Deliv. Rev., 56, 349, 10.1016/j.addr.2003.10.012
Puchert, 2011, A new PAT/QbD approach for the determination of blend homogeneity: combination of on-line NIRS analysis with PC Scores Distance Analysis (< i> PC-SDA</i>), Eur. J. Pharm. Biopharm., 78, 173, 10.1016/j.ejpb.2010.12.015
Aitken-Nichol, 1996, Hot melt extrusion of acrylic films, Pharm. Res., 13, 804, 10.1023/A:1016076306279
Repka, 1999, Influence of plasticizers and drugs on the physical-mechanical properties of hydroxypropylcellulose films prepared by hot melt extrusion, Drug Dev. industrial Pharm., 25, 625, 10.1081/DDC-100102218
USP36-NF31, 2013, 431
Bergum, 2007
Cholayudth, 2008, Using Bergum's new method and MS excel to determine the probability of passing the new ICH USP 29 content uniformity test, J. validation Technol., 14, 62
Dalby, 2004, A review of the development of Respimat® soft Mist™ inhaler, Int. J. Pharm., 283, 1, 10.1016/j.ijpharm.2004.06.018
Travo, 2010, IR spectral imaging of secreted mucus: a promising new tool for the histopathological recognition of human colonic adenocarcinomas, Histopathology, 56, 921, 10.1111/j.1365-2559.2010.03563.x
Bakri, 2015, Assessment of powder blend uniformity: comparison of real-time NIR blend monitoring with stratified sampling in combination with HPLC and at-line NIR Chemical Imaging, Eur. J. Pharm. Biopharm., 97, 78, 10.1016/j.ejpb.2015.10.002
Ewing, 2015, Evaluating drug delivery with salt formation: drug disproportionation studied in situ by ATR-FTIR imaging and Raman mapping, J. Pharm. Biomed. analysis, 111, 248, 10.1016/j.jpba.2015.03.040
An, 2014, Spectral measurement of electron antineutrino oscillation amplitude and frequency at Daya Bay, Phys. Rev. Lett., 112, 061801, 10.1103/PhysRevLett.112.061801
Marian, 2009, Structure Investigations of Some Complexes of Theophylline with Transitional Metals, Revista de Chimie (Bucharest, Romania), 60, 599