A step forward towards the development of stable freeze-dried liposomes: a quality by design approach (QbD)

References

• Patel SM, Pikal MJ. Lyophilization process design space. J Pharm Sci. 2013;102:3883–3887.
   PubMed Web of Science ®Google Scholar
• Chen C, Han D, Cai C, et al. An overview of liposome lyophilization and its future potential. J Control Release. 2010;142:299–311.
   PubMed Web of Science ®Google Scholar
• Mulyadi NA, Rosita N, Yusuf H. Physical characterization of liposomes formulation lyophilized in the presence of disaccharide and HPMC as dispersed matrix. J Biomimet Biomater Biomed Eng. 2017;33:88–94.
   Web of Science ®Google Scholar
• Catalan-Latorre A, Ravaghi M, Manca ML, et al. Freeze-dried eudragit-hyaluronan multicompartment liposomes to improve the intestinal bioavailability of curcumin. Eur J Pharm Biopharm. 2016;107:49–55.
   PubMed Web of Science ®Google Scholar
• Chen Y, Chen J, Cheng Y, et al. A lyophilized sterically stabilized liposome-containing docetaxel: in vitro and in vivo evaluation. J Liposome Res. 2017;27:64–73.
   PubMed Web of Science ®Google Scholar
• Sebaaly C, Greige-Gerges H, Stainmesse S, et al. Effect of composition, hydrogenation of phospholipids and lyophilization on the characteristics of eugenol-loaded liposomes prepared by ethanol injection method. Food Biosci. 2016;15:1–10.
   Web of Science ®Google Scholar
• Li J, Hu M, Xu H, et al. Influence of type and proportion of lyoprotectants on lyophilized ginsenoside Rg3 liposomes. J Pharm Pharmacol. 2016;68:1–13.
   PubMed Web of Science ®Google Scholar
• De Beer TR, Wiggenhorn M, Hawe A, et al. Optimization of a pharmaceutical freeze-dried product and its process using an experimental design approach and innovative process analyzers. Talanta. 2011;83:1623–1633.
   PubMed Web of Science ®Google Scholar
• Vogt NB. Quality by design managing research and development. Chemometr Intell Lab Syst. 1992;14:93–101.
   Web of Science ®Google Scholar
• Amasya G, Badilli U, Aksu B, et al. Quality by design case study 1: Design of 5-fluorouracil loaded lipid nanoparticles by the W/O/W double emulsion – solvent evaporation method. Eur J Pharm Sci. 2016;84:92–102.
   PubMed Web of Science ®Google Scholar
• Yu LX. Pharmaceutical quality by design: product and process development, understanding, and control. Pharm Res. 2008;25:781–791.
   PubMed Web of Science ®Google Scholar
• Sylvester B, Porfire A, Muntean DM, et al. Optimization of prednisolone-loaded long-circulating liposomes via application of Quality by Design (QbD) approach. J Liposome Res. Forthcoming. [cited 16 Nov 2016]. doi: 10.1080/08982104.2016.1254242.
   Google Scholar
• ICH Q8 (R2). Pharmaceutical development [Internet]. 2009 [cited 2016 September 29]. Available from: http://www.fda.gov/downloads/Drugs/Guidances/ucm073507.pdf.
   Google Scholar
• Eon-Duval A, Valax P, Solacroup T, et al. Application of the Quality by Design approach to the drug substance manufacturing process of an Fc fusion protein: towards a global multi-step design space. J Pharm Sci. 2012;101:3604–3618.
   PubMed Web of Science ®Google Scholar
• Sangshetti JN, Deshpande M, Zaheer Z, et al. Quality by design approach: regulatory need. Arab J Chem. 2014;101:1–14.
   Google Scholar
• Sylvester B, Tomuta I, Muntean DM, et al. Formulation optimization of pravastatin-loaded long-circulating liposomes using a design of experiments. Farmacia. 2016;64:449–458.
   Web of Science ®Google Scholar
• Schiffelers RM, Metselaar JM, Fens M, et al. Liposome encapsulated prednisolone phosphate inhibits growth of established tumors in mice. Neoplasia. 2005;7:118–127.
   PubMed Web of Science ®Google Scholar
• Porfire A, Tomuta I, Muntean D, et al. Optimizing long-circulating liposomes for delivery of simvastatin to C26 colon carcinoma cells. J Liposome Res. 2015;25:261–269.
   PubMed Web of Science ®Google Scholar
• Rambhatla S, Pikal MJ. Heat and mass transfer scale-up issues during freeze-drying, I: atypical radiation and the edge vial effect. AAPS PharmSciTech. 2003;4:111–120.
   Google Scholar
• Patel SM, Doen T, Pikal MJ. Determination of end point of primary drying in freeze-drying process control. AAPS PharmSciTech. 2010;11:73–84.
   PubMed Web of Science ®Google Scholar
• Tang X, Pikal MJ. Design of freeze-drying processes for pharmaceuticals: practical advice. Pharm Res. 2004;21:191–200.
   PubMed Web of Science ®Google Scholar
• Abdelwahed W, Degobert G, Stainmesse S, et al. Freeze-drying of nanoparticles: formulation, process and storage considerations. Adv Drug Deliv Rev. 2006;58:1688–1713.
   PubMed Web of Science ®Google Scholar
• Eriksson L, Johansson E, Kettaneh-Wold N, Wikström C, Wold S. Design of experiments – principles and applications. Umeå, Sweden: Umetrics AB; 2008.
   Google Scholar
• Mathworks. D-optimal designs [Internet]. [cited 1 Oct 2016]. Available from: http://www.mathworks.com/help/stats/d-optimal-designs.html.
   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
• Guan T, Miao Y, Xu L, et al. Injectable nimodipine-loaded nanoliposomes: preparation, lyophilization and characteristics. Int J Pharm. 2011;410:180–187.
   PubMed Web of Science ®Google Scholar
• Chaudhury A, Das S, Lee RFS, et al. Lyophilization of cholesterol-free PEGylated liposomes and its impact on drug loading by passive equilibration. Int J Pharm. 2012;430:167–175.
   PubMed Web of Science ®Google Scholar
• Abdelwahed W, Degobert G, Fessi H. Investigation of nanocapsules stabilization by amorphous excipients during freeze-drying and storage. Eur J Pharm Biopharm. 2006;63:87–94.
   PubMed Web of Science ®Google Scholar
• Sun WQ, Leopold AC, Crowe LM, et al. Stability of dry liposomes in sugar glasses. Biophys J. 1996;70:1769–1776.
   PubMed Web of Science ®Google Scholar
• Wang DQ, Hey JM, Nail SL. Effect of collapse on the stability of freeze-dried recombinant factor VIII and alpha-amylase. J Pharm Sci. 2004;93:1253–1263.
   PubMed Web of Science ®Google Scholar
• Passot S, Fonseca F, Barbouche N, et al. Effect of product temperature during primary drying on the long-term stability of lyophilized proteins. Pharm Dev Technol. 2007;12:543–553.
   PubMed Web of Science ®Google Scholar
• Schersch K, Betz O, Garidel P, et al. Systematic investigation of the effect of lyophilizate collapse on pharmaceutically relevant proteins I: stability after freeze-drying. J Pharm Sci. 2010;99:2256–2278.
   PubMed Web of Science ®Google Scholar
• ICH Q9. Quality risk management [Internet]. 2005 [cited 2016 Apr 20]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf.
   Google Scholar
• Depaz RA, Pansare S, Patel SM. Freeze-drying above the glass transition temperature in amorphous protein formulations while maintaining product quality and improving process efficiency. J Pharm Sci. 2016;105:40–49.
   PubMed Web of Science ®Google Scholar
• Searles JA, Carpenter JF, Randolph TW. Annealing to optimize the primary drying rate, reduce freezing-induced drying rate heterogeneity, and determine T’g pharmaceutical lyophilization. J Pharm Sci. 2001;90:872–887.
   PubMed Web of Science ®Google Scholar
• Iurian S, Tomuta I, Bogdan C, et al. Defining the design space for freeze-dried orodispersible tablets with meloxicam. Drug Dev Ind Pharm. 2016;1:1–13.
   Google Scholar
• Awotwe-Otoo D, Agarabi C, Wu GK, et al. Quality by design: impact of formulation variables and their interactions on quality attributes of a lyophilized monoclonal antibody. Int J Pharm. 2012;438:167–175.
   PubMed Web of Science ®Google Scholar
• Singh KP, Singh AK, Gupta S, et al. Optimization of Cr (VI) reduction by zero-valent bimetallic nanoparticles using the surface modeling approach. Desalination. 2011;270:275–284.
   Web of Science ®Google Scholar
• Patil H, Feng X, Ye X, et al. Continuous production of fenofibrate solid lipid nanoparticles by hot-melt extrusion technology: a systematic study based on a quality by design approach. AAPS PharmSciTech. 2015;17:194–205.
   Google Scholar
• Glavas-Dodov M, Fredro-Kumbaradzi E, Goracinova K, et al. The effects of lyophilization on the stability of liposomes containing 5-FU. Int J Pharm. 2005;291:79–86.
   PubMed Web of Science ®Google Scholar
• Kuu W-Y, McShane J, Wong J. Determination of mass transfer coefficients during freeze drying using modeling and parameter estimation techniques. Int J Pharm. 1995;124:241–252.
   Google Scholar
• Crowe JH, Crowe LM, Oliver AE, et al. The trehalose myth revisited: Introduction to a symposium on stabilization of cells in the dry state. Cryobiology. 2001;43:89–105.
   PubMed Web of Science ®Google Scholar
• Van Winden ECA, Crommelin DJA. Short term stability of freeze-dried, lyoprotected liposomes. J Control Release. 1999;58:69–86.
   PubMed Web of Science ®Google Scholar
• Sahagian ME, Goff HD. Effect of freezing rate on the thermal, mechanical and physical aging properties of the glassy state in frozen sucrose solutions. Thermochim Acta. 1994;246:271–283.
   Web of Science ®Google Scholar
• Searles JA, Carpenter JF, Randolph TW. The ice nucleation temperature determines the primary drying rate of lyophilization for samples frozen on a temperature-controlled shelf. J Pharm Sci. 2001;90:860–871.
   PubMed Web of Science ®Google Scholar
• Sandipan R. Quality by design: a holistic concept of building quality in pharmaceuticals. Int J Pharm Biomed Res. 2012;3:100–108.
   Google Scholar