Exploring microfluidics and membrane extrusion for the formulation of temozolomide-loaded liposomes: investigating the effect of formulation and process variables

References

• Akbarzadeh, A., et al., 2013. Liposome : classification, preparation, and applications. Nanoscale research letters, 8 (1), 102.
   PubMed Web of Science ®Google Scholar
• Allen, T.M. and Cullis, P.R., 2013. Liposomal drug delivery systems : from concept to clinical applications. Advanced drug delivery reviews, 65 (1), 36–48.
   PubMed Web of Science ®Google Scholar
• Balasaheb Jadhav, J., Namdeogirawale, N., and Chaudhari, R.A., 2014. Quality by design (QBD) approach used in development of pharmaceuticals. International journal of pure and applied bioscience, 2 (5), 214–223.
   Google Scholar
• Bansal, S., et al., 2016. QbD-enabled systematic development of gastroretentive multiple-unit microballoons of itopride hydrochloride. Drug delivery, 23 (2), 437–451.
   PubMed Web of Science ®Google Scholar
• Barenholz, Y.C., 2012. Doxil ®—the first FDA-approved nano-drug : lessons learned. Journal of controlled release, 160 (2), 117–134.
   PubMed Web of Science ®Google Scholar
• de Barros, C., et al., 2021. Quality by design approach for the development of liposome carrying ghrelin for intranasal administration. Pharmaceutics, 13 (5), 686.
   PubMed Web of Science ®Google Scholar
• Bhattacharjee, S., 2016. DLS and zeta potential – what they are and what they are not? Journal of controlled release : official journal of the controlled release society, 235, 337–351.
   PubMed Web of Science ®Google Scholar
• Bhupendra Pradhan , et al., 2015. Liposome: method of preparation, advantages, evaluation and its application. Journal of applied pharmaceutical research, 3 (2348), 01–08.
   Google Scholar
• Briuglia, M.-L., et al., 2015. Influence of cholesterol on liposome stability and on in vitro drug release. Drug delivery and translational research, 5 (3), 231–242.
   PubMed Web of Science ®Google Scholar
• Bulbake, U., et al., 2017. Liposomal formulations in clinical use : an updated review development. Pharmaceutics, 9 (4), 12–33.
   PubMed Web of Science ®Google Scholar
• Carugo, D., et al., 2016. Liposome production by microfluidics : potential and limiting factors. Scientific reports, 6 (1), 1–15.
   PubMedGoogle Scholar
• Chandra, D., et al., 2014. An overview : the novel carrier for vesicular drug delivery. World journal of pharmaceutical research, 3 (6), 1299–1322.
   Google Scholar
• Clerc, S.G. and Thompson, T.E., 1994. A possible mechanism for vesicle formation by extrusion. Biophysical journal, 67 (1), 475–476.
   PubMed Web of Science ®Google Scholar
• Danson, S.J. and Middleton, M.R., 2001. Temozolomide : a novel oral alkylating agent. Expert review of anticancer therapy, 1 (1), 13–19.
   PubMedGoogle Scholar
• Darkunde, S.L., 2020. A review on quality by design. International journal of pharmaceutical chemistry and analysis, 5 (1), 1–6.
   Google Scholar
• Dormont, F., et al., 2019. Translation of nanomedicines from lab to industrial scale synthesis : the case of squalene-adenosine nanoparticles. Journal of controlled release, 307, 302–314.
   PubMed Web of Science ®Google Scholar
• Fahmy, R., et al., 2012. Quality by design I: application of failure mode effect analysis (FMEA) and Plackett–Burman design of experiments in the identification of “Main Factors” in the formulation and process design space for roller-compacted ciprofloxacin hydrochloride immediate. AAPS PharmSciTech, 13 (4), 1243–1254.
   PubMed Web of Science ®Google Scholar
• Gao, J., et al., 2015. Liposome encapsulated of temozolomide for the treatment of glioma tumor : preparation, characterization and evaluation. Drug discoveries & therapeutics, 9 (3), 205–212.
   PubMed Web of Science ®Google Scholar
• Gim, S., et al., 2016. Evaluation of extrusion technique for nanosizing liposomes. Pharmaceutics, 8 (36), 1–12.
   Google Scholar
• Jigar, V., et al., 2018. Formulation and statistical optimization of intravenous Temozolomide loaded PEGylated liposomes to treat Glioblastoma multiforme by three level factorial design. Drug development and industrial pharmacy, 44 (6), 923–933.
   PubMed Web of Science ®Google Scholar
• Li, J., et al., 2015. A review on phospholipids and their main applications in drug delivery systems. Asian journal of pharmaceutical sciences, 10 (2), 81–98.
   Web of Science ®Google Scholar
• Lim, S.W.Z., et al., 2020. Microfluidic-directed self-assembly of liposomes: role of interdigitation. Journal of colloid and interface science, 578, 47–57.
   PubMed Web of Science ®Google Scholar
• Liu, P., Chen, G., and Zhang, J., 2022. A review of liposomes as a drug delivery system: current status of approved products, regulatory environments, and future perspectives. Molecules, 27 (4), 1372.
   PubMed Web of Science ®Google Scholar
• Lopes, I.C., De Oliveira, S.C.B., and Oliveira-Brett, A.M., 2013. Temozolomide chemical degradation to 5-aminoimidazole-4-carboxamide – electrochemical study. Journal of electroanalytical chemistry, 704, 183–189.
   Web of Science ®Google Scholar
• Maritim, S., Boulas, P., and Lin, Y., 2021. Comprehensive analysis of liposome formulation parameters and their influence on encapsulation, stability and drug release in glibenclamide liposomes. International journal of pharmaceutics, 592, 120051.
   PubMed Web of Science ®Google Scholar
• Martinez-Seara, H., et al., 2008. Interplay of unsaturated phospholipids and cholesterol in membranes: effect of the double-bond position. Biophysical journal, 95 (7), 3295–3305.
   PubMed Web of Science ®Google Scholar
• Mishra, D.K., Shandilya, R., and Mishra, P.K., 2018. Lipid based nanocarriers : a translational perspective. Nanomedicine : nanotechnology, biology, and medicine, 14 (7), 2023–2050.
   PubMed Web of Science ®Google Scholar
• Németh, Z., et al., 2021. An updated risk assessment as part of the QbD-based liposome design and development. Pharmaceutics, 13 (7), 1071.
   PubMed Web of Science ®Google Scholar
• Newlands, E.S., et al., 1992. Phase I trial of temozolomide (CCRG 81045 : M & B 39831 : NSC 362856). Bristish journal of caner, 65, 287–291.
   PubMed Web of Science ®Google Scholar
• Pallagi, E. and Gabriella, D., 2020. A proposed methodology for a risk assessment-based liposome development process. Pharmaceutics, 12, 1164.
   PubMed Web of Science ®Google Scholar
• Patel, B.K. and Parikh, R.H., 2016. Formulation development and evaluation of temozolomide loaded hydrogenated soya phosphatidylcholine liposomes for the treatment of brain cancer. Asian journal of pharmaceutical and clinical research, 9 (3), 340–340.
   Google Scholar
• Płaczek, M. and Kosela, M., 2016. Microscopic methods in analysis of submicron phospholipid dispersions. Acta pharmaceutica (Zagreb, Croatia), 66 (1), 1–22.
   PubMed Web of Science ®Google Scholar
• Sangshetti, J.N., et al., 2017. Quality by design approach: regulatory need. Arabian journal of chemistry, 10, S3412–S3425.
   Web of Science ®Google Scholar
• Shukla, S.K., et al., 2019. Metformin-encapsulated liposome delivery system: an effective treatment approach against breast cancer. Pharmaceutics, 11 (11), 559–25.
   PubMed Web of Science ®Google Scholar
• Surianarayanan, R., et al., 2016. Effect of sample concentration on the characterization of liposomes using dynamic light scattering technique. Pharmaceutical methods, 7 (1), 70–74.
   Google Scholar
• Waghule, T., et al., 2021. Design of temozolomide-loaded proliposomes and lipid crystal nanoparticles with industrial feasible approaches: comparative assessment of drug loading, entrapment efficiency, and stability at plasma pH. Journal of liposome research, 31 (2), 158–168.
   PubMed Web of Science ®Google Scholar
• Waghule, T., et al., 2021. Improved skin-permeated diclofenac-loaded lyotropic liquid crystal nanoparticles: QbD-driven industrial feasible process and assessment of skin deposition. Liquid crystals, 48 (7), 991–1009.
   Web of Science ®Google Scholar
• Waghule, T., et al., 2022. Quality by design assisted optimization of temozolomide loaded PEGylated lyotropic liquid crystals: investigating various formulation and process variables along with in-vitro characterization. Journal of molecular liquids, 352, 118724.
   Web of Science ®Google Scholar
• Waghule, T., Narayan, R., and Singhvi, G., 2021. UV spectroscopic method for estimation of temozolomide : Application in stability studies in simulated plasma pH, degradation rate kinetics, formulation design, and selection of disso. Spectrochimica acta. Part A, molecular and biomolecular spectroscopy, 258, 119848.
   PubMed Web of Science ®Google Scholar
• Webb, C., et al., 2019. The impact of solvent selection: strategies to guide the manufacturing of liposomes using microfluidics. Pharmaceutics, 11 (12), 653.
   PubMed Web of Science ®Google Scholar
• Xu, X., Khan, M.A., and Burgess, D.J., 2011. A quality by design (QbD) case study on liposomes containing hydrophilic API: I. Formulation, processing design and risk assessment. International journal of pharmaceutics, 419 (1–2), 52–59.
   PubMed Web of Science ®Google Scholar
• Zhang, L. and Mao, S., 2017. Application of quality by design in the current drug development. Asian journal of pharmaceutical sciences, 12 (1), 1–8.
   PubMed Web of Science ®Google Scholar
• Zook, J.M. and Vreeland, W.N., 2010. Effects of temperature, acyl chain length, and flow-rate ratio on liposome formation and size in a microfluidic hydrodynamic focusing device. Soft matter, 6 (6), 1352–1360.
   Web of Science ®Google Scholar