Application of quality by design (QbD) to formulation and processing of naproxen pellets by extrusion–spheronization

References

• Lawrence XY. Pharmaceutical quality by design: product and process development, understanding, and control. Pharm Res 2008;25:781–791
   PubMed Web of Science ®Google Scholar
• Xu X, Khan MA, Burgess DJ. A quality by design (QbD) case study on liposomes containing hydrophilic API: II. Screening of critical variables, and establishment of design space at laboratory scale. Int J Pharm 2012;423:543–553
   PubMed Web of Science ®Google Scholar
• Xu X, Khan MA, Burgess DJ. A quality by design (QbD) case study on liposomes containing hydrophilic API: I. Formulation, processing design and risk assessment. Int J Pharm 2011;419:52–59
   PubMed Web of Science ®Google Scholar
• Basalious EB, El-Sebaie W, El-Gazayerly O. Application of pharmaceutical QbD for enhancement of the solubility and dissolution of a class II BCS drug using polymeric surfactants and crystallization inhibitors: development of controlled-release tablets. AAPS PharmSciTech 2011;12:799–810
   PubMed Web of Science ®Google Scholar
• Zhang L, Yan B, Gong X, et al. Application of quality by design to the process development of botanical drug products: a case study. AAPS PharmSciTech 2013;14:277–286
   PubMed Web of Science ®Google Scholar
• Jain SP, Pal Singh P, Amin PD. Alternative extrusion-spheronization aids. Drug Dev Ind Pharm 2010;36:1364–1376
   PubMed Web of Science ®Google Scholar
• Jain SP, Mehta DC, Shah SP, et al. Melt-in-mouth pellets of fexofenadine hydrochloride using crospovidone as an extrusion–spheronisation aid. AAPS PharmSciTech 2010;11:917–923
   PubMed Web of Science ®Google Scholar
• Trivedi NR, Rajan MG, Johnson JR, Shukla AJ. Pharmaceutical approaches to preparing pelletized dosage forms using the extrusion-spheronization process. Crit Rev Ther Drug Carrier Syst 2007;24:1–40
   PubMed Web of Science ®Google Scholar
• Sinha VR, Agrawal M, Agarwal A, et al. Extrusion-spheronization: process variables and characterization. Crit Rev Ther Drug Carrier Syst 2009;26:275–331
   PubMed Web of Science ®Google Scholar
• Garekani HA, Nokhodchi A, Rayeni MA, Sadeghi F. Preparation and characterization and release properties of Eudragit RS based ibuprofen pellets prepared by extrusion spheronization: effect of binder type and concentration. Drug Dev Ind Pharm 2013;39:1238–1246
   PubMed Web of Science ®Google Scholar
• Liu Y, Liu S, Dai Q. Design and evaluation of pH-independent pulsatile release pellets containing isosorbide-5-mononitrate. Chem Pharm Bull 2009;57:55–60
   PubMed Web of Science ®Google Scholar
• Oddsson E, Gudjonsson H, Thjodleifsson B. Endoscopic findings in the stomach and duodenum after treatment with enteric-coated and plain naproxen tablets in healthy subjects. Scand J Gastroenterol 1990;25:231–234
   PubMed Web of Science ®Google Scholar
• Song J-S, Sohn Y-T. Crystal forms of naproxen. Arch Pharm Res 2011;34:87–90
   PubMed Web of Science ®Google Scholar
• Barakat NS. Evaluation of glycofurol-based gel as a new vehicle for topical application of naproxen. AAPS PharmSciTech 2010;11:1138–1146
   PubMed Web of Science ®Google Scholar
• Üstündağ Okur N, Apaydın Ş, Karabay Yavaşoğlu NÜ, et al. Evaluation of skin permeation and anti-inflammatory and analgesic effects of new naproxen microemulsion formulations. Int J Pharm 2011;416:136–144
   PubMed Web of Science ®Google Scholar
• Junco S, Casimiro T, Ribeiro N, et al. Optimisation of supercritical carbon dioxide systems for complexation of naproxen: beta-cyclodextrin. J Incl Phenom Macrocycl Chem 2002;44:69–73
   Web of Science ®Google Scholar
• Hsu HY, Toth S, Simpson GJ, et al. Effect of substrates on naproxen-polyvinylpyrrolidone solid dispersions formed via the drop printing technique. J Pharm Sci 2013;102:638–648
   PubMed Web of Science ®Google Scholar
• Kayaert P, Van den Mooter G. Is the amorphous fraction of a dried nanosuspension caused by milling or by drying?. A case study with Naproxen and Cinnarizine. Eur J Pharm Biopharm 2012;81:650–656
   PubMed Web of Science ®Google Scholar
• Piao Z-Z, Lee M-K, Lee B-J. Colonic release and reduced intestinal tissue damage of coated tablets containing naproxen inclusion complex. Int J Pharm 2008;350:205–211
   PubMed Web of Science ®Google Scholar
• Shah RB, Park JT, Read EK, et al. Quality by design (QbD), biopharmaceutical manufacture. In: Flickinger MC, ed. Encyclopedia of industrial biotechnology: bioprocess, bioseparation, and cell technology. Oxford, UK: Wiley-Blackwell; 2010
   Google Scholar
• Aksu B, Paradkar A, de Matas M, et al. A quality by design approach using artificial intelligence techniques to control the critical quality attributes of ramipril tablets manufactured by wet granulation. Pharm Dev Technol 2013;18:236–245
   PubMed Web of Science ®Google Scholar
• Rahman Z, Zidan AS, Habib MJ, Khan MA. Understanding the quality of protein loaded PLGA nanoparticles variability by Plackett–Burman design. Int J Pharm 2010;389:186–194
   PubMed Web of Science ®Google Scholar
• Awotwe-Otoo D, Zidan AS, Rahman Z, Habib MJ. Evaluation of anticancer drug-loaded nanoparticle characteristics by nondestructive methodologies. AAPS PharmSciTech 2012;13:611–622
   PubMed Web of Science ®Google Scholar
• Wong PM, Chan LW, Heng PWS. Investigation on side-spray fluidized bed granulation with swirling airflow. AAPS PharmSciTech 2013;14:211–221
   PubMed Web of Science ®Google Scholar
• Murphy C, Pillay V, Choonara YE, et al. Optimization of a dual mechanism gastrofloatable and gastroadhesive delivery system for narrow absorption window drugs. AAPS PharmSciTech 2012;13:1–15
   PubMed Web of Science ®Google Scholar
• Pai R, Kohli K, Shrivastava B. Compression and evaluation of extended release matrix pellets prepared by the extrusion/spheronization process into disintegrating tablets. Brazil J Pharm Sci 2012;48:117–129
   Web of Science ®Google Scholar
• Chapman S, Rowe R, Newton J. Characterization of the sphericity of particles by the one plane critical stability. J Pharm Pharmacol 1988;40:503–505
   PubMed Web of Science ®Google Scholar
• Gouldson M, Deasy P. Use of cellulose ether containing excipients with microcrystalline cellulose for the production of pellets containing metformin hydrochloride by the process of extrusion-spheronization. J Microencapsul 1997;14:137–153
   PubMed Web of Science ®Google Scholar
• Matsaridou I, Barmpalexis P, Salis A, Nikolakakis I. The influence of surfactant HLB and oil/surfactant ratio on the formation and properties of self-emulsifying pellets and microemulsion reconstitution. AAPS PharmSciTech 2012;13:1319–1330
   PubMed Web of Science ®Google Scholar
• Boutell S, Newton J, Bloor J, Hayes G. The influence of liquid binder on the liquid mobility and preparation of spherical granules by the process of extrusion/spheronization. Int J Pharm 2002;238:61–76
   PubMed Web of Science ®Google Scholar
• Bhaskaran S, Lakshmi P. Extrusion spheronization – a review. Int J Pharm Tech Res 2012;2:2429–2433
   Google Scholar
• Dyer A, Khan K, Aulton M. Effect of the drying method on the mechanical and drug release properties of pellets prepared by extrusion-spheronization. Drug Dev Ind Pharm 1994;20:3045–3068
   Web of Science ®Google Scholar