Cilnidipine loaded poly (ε-caprolactone) nanoparticles for enhanced oral delivery: optimization using DoE, physical characterization, pharmacokinetic, and pharmacodynamic evaluation

References

• Aberturas M, Molpeceres J, Guzman M, Garcia F. 2002. Development of a new cyclosporine formulation based on poly(caprolactone) microspheres. J Microencapsul. 19(1):61–72.
   PubMed Web of Science ®Google Scholar
• Aditya N, Ravi PR, Avula USR, Vats R. 2014. Poly (ε-caprolactone) nanocapsules for oral delivery of raloxifene: process optimization by hybrid design approach, in vitro and in vivo evaluation. J Microencapsulation. 31(5):508–518.
   PubMed Web of Science ®Google Scholar
• Badri W, Miladi K, Robin S, Viennet C, Nazari QA, Agusti G, Fessi H, Elaissari A. 2017. Polycaprolactone based nanoparticles loaded with indomethacin for anti-inflammatory therapy: from preparation to ex vivo study. Pharm Res. 34(9):1773–1783.
   PubMed Web of Science ®Google Scholar
• Beg S, Rahman M, Kohli K. 2019. Quality-by-design approach as a systematic tool for the development of nanopharmaceutical products. Drug Discov Today. 24(3):717–725.
   PubMed Web of Science ®Google Scholar
• Ciapetti G, Ambrosio L, Savarino L, Granchi D, Cenni E, Baldini N, Pagani S, Guizzardi S, Causa F, Giunti A. 2003. Osteoblast growth and function in porous poly epsilon -caprolactone matrices for bone repair: a preliminary study. Biomaterials. 24(21):3815–3824.
   PubMed Web of Science ®Google Scholar
• Dai S, McNeill JH. 1995. Fructose-induced hypertension in rats is concentration- and duration-dependent. J Pharmacol Toxicol Methods. 33(2):101–107.
   PubMed Web of Science ®Google Scholar
• Dash TK, Konkimalla VB. 2012. Poly-є-caprolactone based formulations for drug delivery and tissue engineering: a review. J Control Release. 158(1):15–33.
   PubMed Web of Science ®Google Scholar
• Diwan R, Khan S, Ravi PR. 2020. Comparative study of cilnidipine loaded PLGA nanoparticles: process optimization by DoE, physico-chemical characterization and in vivo evaluation. Drug Deliv Transl Res. 10(5):1442–1458.
   PubMed Web of Science ®Google Scholar
• Diwan R, Ravi PR, Pathare NS, Aggarwal V. 2020. Pharmacodynamic, pharmacokinetic and physical characterization of cilnidipine loaded solid lipid nanoparticles for oral delivery optimized using the principles of Design of Experiments. Colloids Surf, B. 193:111073.
   PubMed Web of Science ®Google Scholar
• Dudhipala N, Veerabrahma K. 2015. Pharmacokinetic and pharmacodynamic studies of nisoldipine-loaded solid lipid nanoparticles developed by central composite design. Drug Dev Ind Pharm. 41(12):1968–1977.
   PubMed Web of Science ®Google Scholar
• Dudhipala N, Veerabrahma K. 2016. Candesartan cilexetil loaded solid lipid nanoparticles for oral delivery: characterization, pharmacokinetic and pharmacodynamic evaluation. Drug Deliv. 23(2):395–404.
   PubMed Web of Science ®Google Scholar
• Espinoza SM, Patil HI, San Martin Martinez E, Casañas Pimentel R, Ige PP. 2018. Poly-ε-caprolactone (PCL), a promising polymer for pharmaceutical and biomedical applications: focus on nanomedicine in cancer. Int J Polymeric Mater Polymeric Biomater. 69(2):85–126.
   Web of Science ®Google Scholar
• Hu L, Song W, Niu F, Jiao K, Jia Z. 2013. Preparation, characterization and tableting of cilnidipine solid dispersions. Pak J Pharm Sci. 26(3):629–636.
   PubMed Web of Science ®Google Scholar
• Hu L, Zhang H, Song W, Gu D, Hu Q. 2012. Investigation of inclusion complex of cilnidipine with hydroxypropyl-β-cyclodextrin. Carbohydr Polym. 90(4):1719–1724.
   PubMed Web of Science ®Google Scholar
• Hwang I-S, Ho H, Hoffman BB, Reaven GM. 1987. Fructose-induced insulin resistance and hypertension in rats. Hypertension. 10(5):512–516.
   PubMed Web of Science ®Google Scholar
• Kamaly N, Yameen B, Wu J, Farokhzad OC. 2016. Degradable controlled-release polymers and polymeric nanoparticles: mechanisms of controlling drug release. Chem Rev. 116(4):2602–2663.
   PubMed Web of Science ®Google Scholar
• Khor HL, Ng KW, Schantz J-T, Phan T-T, Lim TC, Teoh S-H, Hutmacher D. 2002. Poly (ε-caprolactone) films as a potential substrate for tissue engineering an epidermal equivalent. Materials Science and Engineering: C. 20(1–2):71–75.
   Web of Science ®Google Scholar
• Liu X-Q, Zhao Y, Li D, Qian Z-Y, Wang G-J. 2003. Metabolism and metabolic inhibition of cilnidipine in human liver microsomes. Acta Pharmacol Sin. 24(3):263–268.
   PubMed Web of Science ®Google Scholar
• Mishra R, Mir SR, Amin S. 2017. Polymeric nanoparticles for improved bioavailability of cilnidipine. Int J Pharm Pharm Sci. 9(4):129–139.
   Google Scholar
• Mondal D, Griffith M, Venkatraman SS. 2016. Polycaprolactone-based biomaterials for tissue engineering and drug delivery: current scenario and challenges. Int J Polymeric Mater Polymeric Biomater. 65(5):255–265.
   Web of Science ®Google Scholar
• Mujeli M, Hussain S, Ismail M, Biak D, Jami M. 2019. Screening of electrocoagulation process parameters for treated palm oil mill effluent using minimum-runs resolution IV design. Int J Environ Sci Technol. 16(2):811–820.
   Web of Science ®Google Scholar
• Mundada VP, Patel MH, Mundada PK, Sawant KK. 2020. Enhanced bioavailability and antihypertensive activity of nisoldipine loaded nanoemulsion: optimization, cytotoxicity and uptake across Caco-2 cell line, pharmacokinetic and pharmacodynamic studies. Drug Dev Ind Pharm. 46(3):376–387.
   PubMed Web of Science ®Google Scholar
• Murthy A, Ravi PR, Kathuria H, Vats R. 2020. Self-assembled lecithin-chitosan nanoparticles improve the oral bioavailability and alter the pharmacokinetics of raloxifene. Int J Pharm. 588:119731.
   PubMed Web of Science ®Google Scholar
• Pandey AK, Shafiq N, Bhandari RK, Rather II, Kaur N, Bhatia A, Sharma S, Malhotra S. 2020. Pharmacokinetic and pharmacodynamic evaluation of nano-fixed dose combination for hypertension. J Hypertens. 38(8):1593–1602.
   PubMed Web of Science ®Google Scholar
• Rahman M, Laurent S, Tawil N, Yahia LH, Mahmoudi M. 2013. Nanoparticle and protein corona. Protein-nanoparticle interactions. Berlin (Germany): Springer; p. 21–44.
   Google Scholar
• Rahman Z, Zidan AS, Habib MJ, Khan MA. 2010. Understanding the quality of protein loaded PLGA nanoparticles variability by Plackett-Burman design. Int J Pharm. 389(1–2):186–194.
   PubMed Web of Science ®Google Scholar
• Ravi PR, Vats R, Dalal V, Gadekar N, N A. 2015. Design, optimization and evaluation of poly-ε-caprolactone (PCL) based polymeric nanoparticles for oral delivery of lopinavir. Drug Dev Ind Pharm. 41(1):131–140.
   PubMed Web of Science ®Google Scholar
• Shailender J, Ravi PR, Reddy Sirukuri M, Dalvi A, Keerthi Priya O. 2018. Chitosan nanoparticles for the oral delivery of tenofovir disoproxil fumarate: formulation optimization, characterization and ex vivo and in vivo evaluation for uptake mechanism in rats. Drug Dev Ind Pharm. 44(7):1109–1119.
   PubMed Web of Science ®Google Scholar
• Shargel L, Andrew B, Wu-Pong S. 1999. Applied biopharmaceutics and pharmacokinetics. Stamford (CT): Appleton & Lange Stamford.
   Google Scholar
• Sharma N, Madan P, Lin S. 2016. Effect of process and formulation variables on the preparation of parenteral paclitaxel-loaded biodegradable polymeric nanoparticles: a co-surfactant study. Asian J Pharm Sci. 11(3):404–416.
   Web of Science ®Google Scholar
• Shete MM. 2016. Cilnidipine: next generation calcium channel blocker. J Assoc Physicians India. 64(4):95–99.
   PubMedGoogle Scholar
• Snehalatha M, Venugopal K, Saha RN. 2008. Etoposide-loaded PLGA and PCL nanoparticles I: preparation and effect of formulation variables. Drug Delivery. 15(5):267–275.
   Web of Science ®Google Scholar
• Song N-N, Zhang S-Y, Liu C-X. 2004. Overview of factors affecting oral drug absorption. Asian J Drug Metab Pharmacokinet. 4(3):167–176.
   Google Scholar
• Tandel H, Raval K, Nayani A, Upadhay M. 2012. Preparation and evaluation of cilnidipine microemulsion. J Pharm Bioallied Sci. 4(1):S114–S115.
   PubMedGoogle Scholar
• Uesawa Y, Mohri K. 2008. Relationship between lipophilicities of 1,4-dihydropyridine derivatives and pharmacokinetic interaction strengths with grapefruit juice. Yakugaku Zasshi. 128(1):117–122.
   PubMed Web of Science ®Google Scholar
• Uneyama H, Uchida H, Konda T, Yoshimoto R. 2006. Cilnidipine: preclinical profile and clinical evaluation. Cardiovasc Drug Rev. 17(4):341–357.
   Google Scholar
• Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, et al. 2018. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 39(33):3021–3104.
   PubMed Web of Science ®Google Scholar
• Zweers ML, Grijpma DW, Engbers GH, Feijen J. 2003. The preparation of monodisperse biodegradable polyester nanoparticles with a controlled size. J Biomed Mater Res B Appl Biomater. 66(2):559–566.
   PubMed Web of Science ®Google Scholar