Systematic implementation of quality-by-design (QbD) to develop NSAID-loaded nanostructured lipid carriers for ocular application: preformulation screening studies and statistical hybrid-design for optimization of variables

References

• Tsubota K. Tear dynamics and dry eye. Prog Retinal Eye Res. 1998;17(4):565–596.
   PubMed Web of Science ®Google Scholar
• Maharjan P, Cho KH, Maharjan A, et al. Pharmaceutical challenges and perspectives in developing ophthalmic drug formulations. J Pharm Investig. 2018;49:215–228.
   Google Scholar
• Kovačević AB, Müller RH, Savić SD, et al. Solid lipid nanoparticles (SLN) stabilized with polyhydroxy surfactants: preparation, characterization and physical stability investigation. Colloids Surf A Physicochem Eng Aspects. 2014;444:15–25.
   Web of Science ®Google Scholar
• Vandamme TF. Microemulsions as ocular drug delivery systems: recent developments and future challenges. Prog Retinal Eye Res. 2002;21(1):15–34.
   PubMed Web of Science ®Google Scholar
• Hegde RR, Verma A, Ghosh A. Microemulsion: new insights into the ocular drug delivery. ISRN Pharm. 2013;2013:1–11.
   Google Scholar
• Jaiswal M, Dudhe R, Sharma P. Nanoemulsion: an advanced mode of drug delivery system. 3 Biotech. 2015;5(2):123–127.
   PubMedGoogle Scholar
• Sánchez-López E, Espina M, Doktorovova S, et al. Lipid nanoparticles (SLN, NLC): overcoming the anatomical and physiological barriers of the eye–Part II-Ocular drug-loaded lipid nanoparticles. Eur J Pharm Biopharm. 2017;110:58–69.
   PubMed Web of Science ®Google Scholar
• Shah DA, Murdande SB, Dave R. A review: pharmaceutical and pharmacokinetic aspect of nanocrystalline suspensions. J Pharm Sci. 2016;105(1):10–24.
   PubMed Web of Science ®Google Scholar
• Almeida H, Amaral MH, Lobão P, et al. Applications of polymeric and lipid nanoparticles in ophthalmic pharmaceutical formulations: present and future considerations. J Pharm Pharm Sci. 2014;17(3):278–293.
   PubMed Web of Science ®Google Scholar
• Ahuja M, Dhake AS, Sharma SK, et al. Topical ocular delivery of NSAIDs. AAPS J. 2008;10(2):229–241.
   PubMed Web of Science ®Google Scholar
• Almeida H, Lobão P, Frigerio C, et al. Preparation, characterization and biocompatibility studies of thermoresponsive eyedrops based on the combination of nanostructured lipid carriers (NLC) and the polymer Pluronic F-127 for controlled delivery of ibuprofen. Pharm Dev Technol. 2017;22(3):336–349.
   PubMed Web of Science ®Google Scholar
• Joshi M, Patravale V. Formulation and evaluation of nanostructured lipid carrier (NLC)-based gel of Valdecoxib. Drug Dev Ind Pharm. 2006;32(8):911–918.
   PubMed Web of Science ®Google Scholar
• Negi LM, Jaggi M, Talegaonkar S. Development of protocol for screening the formulation components and the assessment of common quality problems of nano-structured lipid carriers. Int J Pharm. 2014;461(1–2):403–410.]
   PubMedGoogle Scholar
• Kasongo W, Pardeike J, Müller RH, et al. Selection and characterization of suitable lipid excipients for use in the manufacture of didanosine-loaded solid lipid nanoparticles and nanostructured lipid carriers. J Pharm Sci. 2011;100(12):5185–5196.
   PubMed Web of Science ®Google Scholar
• Kovacevic A, Savic S, Vuleta G, et al. Polyhydroxy surfactants for the formulation of lipid nanoparticles (SLN and NLC): effects on size, physical stability and particle matrix structure. Int J Pharm. 2011;406(1–2):163–172.
   PubMedGoogle Scholar
• Shete H, Patravale V. Long chain lipid based tamoxifen NLC. Part I: preformulation studies, formulation development and physicochemical characterization. Int J Pharm. 2013;454(1):573–583.
   PubMed Web of Science ®Google Scholar
• Gonzalez-Mira E, Egea M, Garcia M, et al. Design and ocular tolerance of flurbiprofen loaded ultrasound-engineered NLC. Colloids Surf B: Biointerfaces. 2010;81(2):412–421.
   PubMed Web of Science ®Google Scholar
• Yerlikaya F, Ozgen A, Vural I, et al. Development and evaluation of paclitaxel nanoparticles using a quality-by-design approach. J Pharm Sci. 2013;102(10):3748–3761.
   PubMed Web of Science ®Google Scholar
• Garg NK, Sharma G, Singh B, et al. Quality by Design (QbD)-enabled development of aceclofenac loaded-nano structured lipid carriers (NLCs): an improved dermatokinetic profile for inflammatory disorder (s). Int J Pharm. 2017;517(1–2):413–431.
   PubMed Web of Science ®Google Scholar
• Ravi PR, Aditya N, Kathuria H, et al. Lipid nanoparticles for oral delivery of raloxifene: optimization, stability, in vivo evaluation and uptake mechanism. Eur J Pharm Biopharm. 2014;87(1):114–124.
   PubMed Web of Science ®Google Scholar
• Severino P, Andreani T, Macedo AS, et al. Current state-of-art and new trends on lipid nanoparticles (SLN and NLC) for oral drug delivery. J Drug Deliv. 2012;2012:1–10.
   Google Scholar
• Patel PJ, Gajera BY, Dave RH. A quality-by-design study to develop nifedipine nanosuspension: examining the relative impact of formulation variables, wet media milling process parameters, and excipient variability on drug product quality attributes. Drug Dev Ind Pharm. 2018;44(12):1–33.
   PubMed Web of Science ®Google Scholar
• Gajera BY, Shah DA, Dave R. Investigating a novel hot melt extrusion-based drying technique to solidify an amorphous nanosuspension using design of experiment methodology. AAPS PharmSciTech. 2018;19(8):3778–3790.
   PubMed Web of Science ®Google Scholar
• Murdande SB, Shah DA, Dave R. Impact of nanosizing on solubility and dissolution rate of poorly soluble pharmaceuticals. J Pharm Sci. 2015;104(6):2094–2102.
   PubMed Web of Science ®Google Scholar
• Jia L-J, Zhang D-R, Li Z-Y, et al. Preparation and characterization of silybin-loaded nanostructured lipid carriers. Drug Deliv. 2010;17(1):11–18.
   PubMed Web of Science ®Google Scholar
• Luo Q, Zhao J, Zhang X, et al. Nanostructured lipid carrier (NLC) coated with chitosan oligosaccharides and its potential use in ocular drug delivery system. Int J Pharm. 2011;403(1–2):185–191.
   PubMed Web of Science ®Google Scholar
• Barbosa JP, Neves AR, Silva AM, et al. Nanostructured lipid carriers loaded with resveratrol modulate human dendritic cells. Int J Nanomedicine. 2016;11:3501.
   PubMed Web of Science ®Google Scholar
• Shah DA, Patel M, Murdande SB, et al. Influence of spray drying and dispersing agent on surface and dissolution properties of griseofulvin micro and nanocrystals. Drug Dev Ind Pharm. 2016;42(11):1842–1850.
   PubMed Web of Science ®Google Scholar
• Gajera BY, Shah DA, Dave R. Development of an amorphous nanosuspension by sonoprecipitation-formulation and process optimization using design of experiment methodology. Int J Pharm. 2019;559:348–359.
   PubMed Web of Science ®Google Scholar
• Shelley H, Rodriguez-Galarza RM, Duran SH, et al. In situ gel formulation for enhanced ocular delivery of Nepafenac. J Pharm Sci. 2018;107(12):3089–3097.
   PubMed Web of Science ®Google Scholar
• Attama AA, Reichl S, Müller-Goymann CC. Diclofenac sodium delivery to the eye: in vitro evaluation of novel solid lipid nanoparticle formulation using human cornea construct. Int J Pharm. 2008;355(1–2):307–313.
   PubMed Web of Science ®Google Scholar
• Richard A, Barras A, Younes AB, et al. Minimal chemical modification of reductive end of dextran to produce an amphiphilic polysaccharide able to incorporate onto lipid nanocapsules. Bioconjug Chem. 2008;19(7):1491–1495.
   PubMed Web of Science ®Google Scholar
• Naguib YW, Rodriguez BL, Li X, et al. Solid lipid nanoparticle formulations of docetaxel prepared with high melting point triglycerides: in vitro and in vivo evaluation. Mol Pharm. 2014;11(4):1239–1249.
   PubMed Web of Science ®Google Scholar
• Zhai Y, Yang X, Zhao L, et al. Lipid nanocapsules for transdermal delivery of ropivacaine: in vitro and in vivo evaluation. Int J Pharm. 2014;471(1–2):103–111.
   PubMedGoogle Scholar
• Leonardi A, Bucolo C, Romano GL, et al. Influence of different surfactants on the technological properties and in vivo ocular tolerability of lipid nanoparticles. Int J Pharm. 2014;470(1–2):133–140.
   PubMedGoogle Scholar
• Ivanova R, Lindman B, Alexandridis P. Evolution in structural polymorphism of Pluronic F127 poly(ethylene oxide)–poly(propylene oxide) block copolymer in ternary systems with water and pharmaceutically acceptable organic solvents: from “glycols” to “oils”. Langmuir. 2000;16(23):9058–9069.
   Web of Science ®Google Scholar
• Han F, Li S, Yin R, et al. Effect of surfactants on the formation and characterization of a new type of colloidal drug delivery system: nanostructured lipid carriers. Colloids Surf A Physicochem Eng Aspects. 2008;315(1–3):210–216.
   Web of Science ®Google Scholar
• de Souza ALR, Andreani T, Nunes FM, et al. Loading of praziquantel in the crystal lattice of solid lipid nanoparticles: studies by DSC and SAXS. J Therm Anal Calorim. 2012;108(1):353–360.
   Web of Science ®Google Scholar
• Pardeike J, Weber S, Haber T, et al. Development of an itraconazole-loaded nanostructured lipid carrier (NLC) formulation for pulmonary application. Int J Pharm. 2011;419(1–2):329–338.
   PubMed Web of Science ®Google Scholar
• Dudhipala N, Veerabrahma K. Candesartan cilexetil loaded solid lipid nanoparticles for oral delivery: characterization, pharmacokinetic and pharmacodynamic evaluation. Drug Deliv. 2016;23(2):395–404.
   PubMed Web of Science ®Google Scholar