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

References

• Sharma OP, Patel V, Mehta T. Design of experiment approach in development of febuxostat nanocrystal: application of soluplus® as stabilizer. Powder Technology. 2016;302:396–405.
   Web of Science ®Google Scholar
• Hu J, Johnston KP, Williams IIIRO. Nanoparticle engineering processes for enhancing the dissolution rates of poorly water soluble drugs. Drug Dev Ind Pharm. 2004;30:233–245.
   PubMed Web of Science ®Google Scholar
• Jain S, Patel N, Lin S. Solubility and dissolution enhancement strategies: current understanding and recent trends. Drug Dev Ind Pharm. 2015;41:875–887.
   PubMed Web of Science ®Google Scholar
• Junyaprasert VB, Morakul B. Nanocrystals for enhancement of oral bioavailability of poorly water-soluble drugs. Asian J Pharm Sci. 2015;10:13–23.
   Web of Science ®Google Scholar
• Sinha B, Müller RH, Möschwitzer JP. Bottom-up approaches for preparing drug nanocrystals: formulations and factors affecting particle size. Int J Pharm. 2013;453:126–141.
   PubMed Web of Science ®Google Scholar
• Gao L, Zhang D, Chen M, et al. Preparation and characterization of an oridonin nanosuspension for solubility and dissolution velocity enhancement. Drug Dev Ind Pharm. 2007;33:1332–1339.
   PubMed Web of Science ®Google Scholar
• Möschwitzer J, Müller R. Drug nanocrystals – The universal formulation approach for poorly soluble drugs. Nanoparticulate drug delivery systems by Taylor & Francis Group, LLC 2007;166:71–88.
   Google Scholar
• Tuomela A, Laaksonen T, Laru J, et al. Solid formulations by a nanocrystal approach: critical process parameters regarding scale-ability of nanocrystals for tableting applications. Int J Pharm. 2015;485:77–86.
   PubMed Web of Science ®Google Scholar
• Dizaj SM, Vazifehasl Z, Salatin S, et al. Nanosizing of drugs: effect on dissolution rate. Res Pharm Sci. 2015;10:95.
   PubMed Web of Science ®Google Scholar
• Sutradhar KB, Khatun S, Luna IP. Increasing possibilities of nanosuspension. J Nanotechnol. 2013;2013:1.
   Google Scholar
• Gajera BY. To evaluate hot melt extruder as a novel technique to dry nanosuspension and develop a mechanistic understanding of polymeric factors influencing the stabilization of nanosuspension. Doctoral dissertation, Long Island University, The Brooklyn Center; 2018.
   Google Scholar
• Müller R, Jacobs C, Kayser O. Nanosuspensions as particulate drug formulations in therapy. Rationale for development and what we can expect for the future. Adv Drug Deliv Rev. 2001;47:3–19.
   PubMed Web of Science ®Google Scholar
• Xia D, Quan P, Piao H, et al. Preparation of stable nitrendipine nanosuspensions using the precipitation-ultrasonication method for enhancement of dissolution and oral bioavailability. Eur J Pharm Sci. 2010;40:325–334.
   PubMed Web of Science ®Google Scholar
• Jacobs C, Müller RH. Production and characterization of a budesonide nanosuspension for pulmonary administration. ‎Pharm. Res. 2002;19:189–194.
   PubMed Web of Science ®Google Scholar
• Kocbek P, Baumgartner S, Kristl J. Preparation and evaluation of nanosuspensions for enhancing the dissolution of poorly soluble drugs. Int J Pharm. 2006;312:179–186.
   PubMed Web of Science ®Google Scholar
• Merisko-Liversidge E, Liversidge GG. Nanosizing for oral and parenteral drug delivery: a perspective on formulating poorly-water soluble compounds using wet media milling technology. Adv Drug Deliv Rev. 2011;63:427–440.
   PubMed Web of Science ®Google Scholar
• Juhnke M, Märtin D, John E. Generation of wear during the production of drug nanosuspensions by wet media milling. Eur J Pharm Biopharm. 2012;81:214–222.
   PubMed Web of Science ®Google Scholar
• Patel VR, Agrawal Y. Nanosuspension: an approach to enhance solubility of drugs. J Adv Pharm Tech Res. 2011;2:81.
   PubMedGoogle Scholar
• Tesfai A, El-Zahab B, Bwambok DK, et al. Controllable formation of ionic liquid micro- and nanoparticles via a melt-emulsion-quench approach. Nano Lett. 2008;8:897–901.
   PubMed Web of Science ®Google Scholar
• Anton N, Benoit J-P, Saulnier P. Design and production of nanoparticles formulated from nano-emulsion templates-a review. J Control Release. 2008;128:185–199.
   PubMed Web of Science ®Google Scholar
• Croom KF, Wellington K. Modified-release nifedipine: a review of the use of modified-release formulations in the treatment of hypertension and angina pectoris. Drugs 2006;66:497–528.
   PubMed Web of Science ®Google Scholar
• Masters SB. Katzung & Trevor's pharmacology. New York: Lange Medical Books/McGraw Hill.
   Google Scholar
• Patel B, Parikh RH, Swarnkar D. Enhancement of dissolution of nifedipine by surface solid dispersion technique. J Pharm Bioall Sci. 2012;4:64–46.
   PubMedGoogle Scholar
• Verma S, Huey BD, Burgess DJ. Scanning probe microscopy method for nanosuspension stabilizer selection. Langmuir 2009;25:12481–12487.
   PubMed Web of Science ®Google Scholar
• Gajera BY, Dugar RP, Dave RH. Formulation development and optimization of ibuprofen poloxamer melt granules using hydrophilic excipients. Br J Pharm Res. 2016;13:1.
   Web of Science ®Google Scholar
• Murdande SB, Shah DA, Dave RH. Impact of nanosizing on solubility and dissolution rate of poorly soluble pharmaceuticals. J Pharm Sci. 2015;104:2094–2102.
   PubMed Web of Science ®Google Scholar
• Zhang X, Guan J, Ni R, et al. Preparation and solidification of redispersible nanosuspensions. J Pharm Sci. 2014;103:2166–2176.
   PubMed Web of Science ®Google Scholar
• Deng Z, Xu S, Li S. Understanding a relaxation behaviour in a nanoparticle suspension for drug delivery applications. ‎Int J Pharm. 2008;351:236–243.
   PubMed Web of Science ®Google Scholar
• Zuo B, Sun Y, Li H, et al. Preparation and in-vitro/in-vivo evaluation of fenofibrate nanocrystals. ‎Int. J. Pharm. 2013;455:267–275.
   PubMed Web of Science ®Google Scholar
• Liang LH, Li JC, Jiang Q. Size-dependent melting depression and lattice contraction of Bi nanocrystals. Physica B: Condensed Matter. 2003;334:49–53.
   Web of Science ®Google Scholar
• Yamasaki K, Kwok PC, Fukushige K, et al. Enhanced dissolution of inhalable cyclosporine nano-matrix particles with mannitol as matrix former. Int J Pharm. 2011;420:34–42.
   PubMed Web of Science ®Google Scholar