Development of posaconazole nanocrystalline solid dispersion: preparation, characterization and in vivo evaluation

References

• Abutaleb A, Lolla D, Aljuhani A, Shin HU, Rajala JW, Chase GG. 2017. Effects of surfactants on the morphology and properties of electrospun polyetherimide fibers. Fibers. 5(3):33. doi: 10.3390/fib5030033.
   Google Scholar
• Al-Kassas R, Bansal M, Shaw J. 2017. Nano sizing techniques for improving bioavailability of drugs. J Control Release. 260:202–212. doi: 10.1016/j.jconrel.2017.06.003.
   PubMed Web of Science ®Google Scholar
• Aykaç K, Yenilmez E, Demirel M, Başaran E. 2020. Posaconazole loaded ocular inserts for antifungal activity. JPT. 1(1):1–6. doi: 10.37662/jpt.2020.0.
   Google Scholar
• Breitenbach J. 2002. Melt extrusion: from process to drug delivery technology. Eur J Pharm Biopharm. 54(2):107–117. doi: 10.1016/s0939-6411(02)00061-9.
   PubMed Web of Science ®Google Scholar
• Brouwers J, Brewster ME, Augustijns P. 2009. Supersaturating drug delivery systems: the answer to solubility-limited oral bioavailability? J Pharm Sci. 98(8):2549–2572. Aug 1 doi: 10.1002/jps.21650.
   PubMed Web of Science ®Google Scholar
• Chakraborty S, Shukla D, Mishra B, Singh S. 2009. Lipid–an emerging platform for oral delivery of drugs with poor bioavailability. Eur J Pharm Biopharm. 73(1):1–15. doi: 10.1016/j.ejpb.2009.06.001.
   PubMed Web of Science ®Google Scholar
• Chen L, Krekels EH, Verweij PE, Buil JB, Knibbe CA, Brüggemann RJ. 2020. Pharmacokinetics and pharmacodynamics of posaconazole. Drugs. 80(7):671–695. May doi: 10.1007/s40265-020-01306-y.
   PubMed Web of Science ®Google Scholar
• Chen Y, Tuo J, Huang H, Liu D, You X, Mai J, Song J, Xie Y, Wu C, Hu H. 2015. Optimized mixed oils remarkably reduce the amount of surfactants in microemulsions without affecting oral bioavailability of ibuprofen by simultaneously enlarging microemulsion areas and enhancing drug solubility. Int J Pharm. 487(1-2):17–24. doi: 10.1016/j.ijpharm.2015.03.075.
   PubMedGoogle Scholar
• Choi YK, Poudel BK, Marasini N, Yang KY, Kim JW, Kim JO, Choi HG, Yong CS. 2012. Enhanced solubility and oral bioavailability of itraconazole by combining membrane emulsification and spray drying technique. Int J Pharm. 434(1-2):264–271. doi: 10.1016/j.ijpharm.2012.05.039.
   PubMedGoogle Scholar
• Davis ME, Brewster ME. 2004. Cyclodextrin-based pharmaceutics: past, present and future. Nat Rev Drug Discov. 3(12):1023–1035. doi: 10.1038/nrd1576.
   PubMed Web of Science ®Google Scholar
• Di L, Kerns EH, Carter GT. 2009. Drug-like property concepts in pharmaceutical design. Curr Pharm Des. 15(19):2184–2194. doi: 10.2174/138161209788682479.
   PubMed Web of Science ®Google Scholar
• Durgun ME, Kahraman E, Güngör S, Özsoy Y. 2020. Optimization and characterization of aqueous micellar formulations for ocular delivery of an antifungal drug, posaconazole. Curr Pharm Des. 26(14):1543–1555. doi: 10.2174/1381612826666200313172207.
   PubMed Web of Science ®Google Scholar
• Durgun ME, Kahraman E, Hacıoğlu M, Güngör S, Özsoy Y. 2022. Posaconazole micelles for ocular delivery: in vitro permeation, ocular irritation, and antifungal activity studies. Drug Deliv Transl Res. 12(3):662–675. doi: 10.1007/s13346-021-00974-x.
   PubMed Web of Science ®Google Scholar
• Fenske DB, Chonn A, Cullis PR. 2008. Liposomal nanomedicines: an emerging field. Toxicol Pathol. 36(1):21–29. doi: 10.1177/0192623307310960.
   PubMed Web of Science ®Google Scholar
• Fule R, Amin P. 2014. Hot melt extruded amorphous solid dispersion of posaconazole with improved bioavailability: investigating drug-polymer miscibility with advanced characterization. Biomed Res Int. 2014:146716–146781. doi: 10.1155/2014/146781.
   Web of Science ®Google Scholar
• Gao L, Zhang D, Chen M. 2008. Drug nanocrystals for the formulation of poorly soluble drugs and its application as a potential drug delivery system. J Nanopart Res. 10(5):845–862. doi: 10.1007/s11051-008-9357-4.
   Web of Science ®Google Scholar
• Garcia CV, Costa GR, Mendez AS. 2012. Stability-indicating HPLC method for Posaconazole bulk assay. Sci Pharm. 80(2):317–327. Jun doi: 10.3797/scipharm.1111-11.
   PubMedGoogle Scholar
• Jarvis M, Krishnan V, Mitragotri S. 2019. Nanocrystals: a perspective on translational research and clinical studies. Bioeng Transl Med. 4(1):5–16. doi: 10.1002/btm2.10122.
   PubMed Web of Science ®Google Scholar
• Junghanns JU, Müller RH. 2008. Nanocrystal technology, drug delivery and clinical applications. Int J Nanomedicine. 3(3):295–309. doi: 10.2147/ijn.s595.
   PubMed Web of Science ®Google Scholar
• Kawakami K, Yoshikawa T, Moroto Y, Kanaoka E, Takahashi K, Nishihara Y, Masuda K. 2002. Microemulsion formulation for enhanced absorption of poorly soluble drugs: i. Prescription design. J Control Release. 81(1-2):65–74. doi: 10.1016/s0168-3659(02)00049-4.
   PubMed Web of Science ®Google Scholar
• Keck CM, Müller RH. 2006. Drug nanocrystals of poorly soluble drugs produced by high pressure homogenisation. Eur J Pharm Biopharm. 62(1):3–16. doi: 10.1016/j.ejpb.2005.05.009.
   PubMed Web of Science ®Google Scholar
• Kipp JE, Wong JC, Doty MJ, Rebbeck CL. inventors; Baxter International Inc, assignee. 2003 Aug 19. Microprecipitation method for preparing submicron suspensions. United States patent US 6,607,784.
   Google Scholar
• Kolipaka T, Sen S, Mane SS, Bajad GD, Dengale SJ, Ranjan OP. 2023. Development of posaconazole nanosuspension for bioavailability enhancement: formulation optimization, in vitro characterization, and pharmacokinetic study. J Drug Delivery Sci Technol. 83:104434. doi: 10.1016/j.jddst.2023.104434.
   Web of Science ®Google Scholar
• Kuminek G, Cavanagh KL, da Piedade MF, Rodríguez-Hornedo N. 2019. Posaconazole cocrystal with superior solubility and dissolution behavior. Crystal Growth Design. 19(11):6592–6602. doi: 10.1021/acs.cgd.9b01026.
   Web of Science ®Google Scholar
• Kumrulu, Vildan, inventors; Polifarma Ilac sanayi ve ticaret anonim srketi assignee. 2018. December 28. Stable Injectable posaconazole formulations comparing Cyclodextrin and Sugar. WO2020/139209A1.
   Google Scholar
• Lipp HP. 2010. Clinical pharmacodynamics and pharmacokinetics of the antifungal extended‐spectrum triazole posaconazole: an overview. Br J Clin Pharmacol. 70(4):471–480. doi: 10.1111/j.1365-2125.2010.03680.x.
   PubMed Web of Science ®Google Scholar
• Liu C, Chen Z, Chen Y, Lu J, Li Y, Wang S, Wu G, Qian F. 2016. Improving oral bioavailability of sorafenib by optimizing the “spring” and “parachute” based on molecular interaction mechanisms. Mol Pharm. 13(2):599–608. doi: 10.1021/acs.molpharmaceut.5b00837.
   PubMed Web of Science ®Google Scholar
• Lu X, Li M, Huang C, Lowinger MB, Xu W, Yu L, Byrn SR, Templeton AC, Su Y. 2020. Atomic-level drug substance and polymer interaction in posaconazole amorphous solid dispersion from solid-state NMR. Mol Pharm. 17(7):2585–2598. doi: 10.1021/acs.molpharmaceut.0c00268.
   PubMedGoogle Scholar
• Malam Y, Loizidou M, Seifalian AM. 2009. Liposomes and nanoparticles: nanosized vehicles for drug delivery in cancer. Trends Pharmacol Sci. 30(11):592–599. doi: 10.1016/j.tips.2009.08.004.
   PubMed Web of Science ®Google Scholar
• Matloob AH, Mourtas S, Klepetsanis P, Antimisiaris SG. 2014. Increasing the stability of curcumin in serum with liposomes or hybrid drug-in-cyclodextrin-in-liposome systems: a comparative study. Int J Pharm. 476(1-2):108–115. doi: 10.1016/j.ijpharm.2014.09.041.
   PubMedGoogle Scholar
• Matteucci ME, Brettmann BK, Rogers TL, Elder EJ, Williams RO, Johnston KP. 2007. Design of potent amorphous drug nanoparticles for rapid generation of highly supersaturated media. Mol Pharm. 4(5):782–793. doi: 10.1021/mp0700211.
   PubMedGoogle Scholar
• Merisko-Liversidge E, Liversidge GG, Cooper ER. 2003. Nanosizing: a formulation approach for poorly-water-soluble compounds. Eur J Pharm Sci. 18(2):113–120. doi: 10.1016/s0928-0987(02)00251-8.
   PubMed Web of Science ®Google Scholar
• Merisko-Liversidge E, Liversidge GG. 2011. Nanosizing for oral and parenteral drug delivery: a perspective on formulating poorly-water soluble compounds using wet media milling technology. Adv Drug Deliv Rev. 63(6):427–440. doi: 10.1016/j.addr.2010.12.007.
   PubMed Web of Science ®Google Scholar
• Merlos R, Amighi K, Wauthoz N. 2014. Recent developments in inhaled triazoles against invasive pulmonary Aspergillosis. Curr Fungal Infect Rep. 8(4):331–342. doi: 10.1007/s12281-014-0199-5.
   Google Scholar
• Mudie DM, Stewart AM, Biswas N, Brodeur TJ, Shepard KB, Smith A, Morgen MM, Baumann JM, Vodak DT. 2020. Novel high-drug-loaded amorphous dispersion tablets of posaconazole; in vivo and in vitro assessment. Mol Pharm. 17(12):4463–4472. doi: 10.1021/acs.molpharmaceut.0c00471.
   PubMedGoogle Scholar
• Müller RH, Jacobs C, Kayser O. 2001. Nanosuspensions as particulate drug formulations in therapy: rationale for development and what we can expect for the future. Adv Drug Deliv Rev. 47(1):3–19. doi: 10.1016/s0169-409x(00)00118-6.
   PubMed Web of Science ®Google Scholar
• Parmar PK, Bansal AK. 2021. Novel nanocrystal-based formulations of apremilast for improved topical delivery. Drug Deliv Transl Res. 11(3):966–983. doi: 10.1007/s13346-020-00809-1.
   PubMed Web of Science ®Google Scholar
• Pouton CW. 1997. Formulation of self-emulsifying drug delivery systems. Adv Drug Delivery Rev. 25(1):47–58. doi: 10.1016/S0169-409X(96)00490-5.
   Web of Science ®Google Scholar
• Pouton CW. 2000. Lipid formulations for oral administration of drugs: non-emulsifying, self-emulsifying and ‘self-microemulsifying’drug delivery systems. Eur J Pharm Sci. 11 Suppl 2: S93–8. doi: 10.1016/s0928-0987(00)00167-6.
   PubMed Web of Science ®Google Scholar
• Pu X, Sun J, Li M, He Z. 2009. Formulation of nanosuspensions as a new approach for the delivery of poorly soluble drugs. CNANO. 5(4):417–427. doi: 10.2174/157341309789378177.
   Google Scholar
• Rabinow BE. 2004. Nanosuspensions in drug delivery. Nat Rev Drug Discov. 3(9):785–796. doi: 10.1038/nrd1494.
   PubMed Web of Science ®Google Scholar
• Ravichandran R. 2009. Nanotechnology-based drug delivery systems. Nanobiotechnol. 5(1-4):17–33. doi: 10.1007/s12030-009-9028-2.
   Google Scholar
• Salazar J, Müller RH, Möschwitzer JP. 2014. Combinative particle size reduction technologies for the production of drug nanocrystals. J Pharm (Cairo). 2014:265754–265714. doi: 10.1155/2014/265754.
   PubMedGoogle Scholar
• Shah S, Maddineni S, Lu J, Repka MA. 2013. Melt extrusion with poorly soluble drugs. Int J Pharm. 453(1):233–252. doi: 10.1016/j.ijpharm.2012.11.001.
   PubMedGoogle Scholar
• Shegokar R, Müller RH. 2010. Nanocrystals: industrially feasible multifunctional formulation technology for poorly soluble actives. Int J Pharm. 399(1-2):129–139. doi: 10.1016/j.ijpharm.2010.07.044.
   PubMed Web of Science ®Google Scholar
• Sinha B, Müller RH, Möschwitzer JP. 2013. Bottom-up approaches for preparing drug nanocrystals: formulations and factors affecting particle size. Int J Pharm. 453(1):126–141. doi: 10.1016/j.ijpharm.2013.01.019.
   PubMed Web of Science ®Google Scholar
• Sravya NJ, Vijetha KA. 2022. Formulation and Evaluation of Posaconazole Bilayer Delayed Release Tablets Using Solid Dispersion Technique. Sch Int J Linguist Lit. 5(9):276–288. doi: 10.36348/sijll.2022.v05i09.006.
   Google Scholar
• Srivalli KM, Mishra B. 2016. Drug nanocrystals: a way toward scale-up. Saudi Pharm J. 24(4):386–404. doi: 10.1016/j.jsps.2014.04.007.
   PubMed Web of Science ®Google Scholar
• Stella VJ, He Q. 2008. Cyclodextrins. Toxicol Pathol. 36(1):30–42. doi: 10.1177/0192623307310945.
   PubMed Web of Science ®Google Scholar
• Sun J, Wang F, Sui Y, She Z, Zhai W, Wang C, Deng Y. 2012. Nov 12: effect of particle size on solubility, dissolution rate, and oral bioavailability: evaluation using coenzyme Q10 as naked nanocrystals. Int J Nanomedicine. 7:5733–5744. doi: 10.2147/IJN.S34365.
   PubMed Web of Science ®Google Scholar
• Tang PH. 2017. Determination of posaconazole in plasma/serum by high-performance liquid chromatography with fluorescence detection. Separations. 4(2):16. doi: 10.3390/separations4020016.
   Web of Science ®Google Scholar
• TImpe C. 2010. Drug solubilization strategies applying nanoparticulate formulation and solid dispersion approaches in drug development. Pharm Rev. 13:12–21.
   Google Scholar
• Tønnesen HH, Másson M, Loftsson T. 2002. Studies of curcumin and curcuminoids. XXVII. Cyclodextrin complexation: solubility, chemical and photochemical stability. Int J Pharm. 244(1-2):127–135. doi: 10.1016/s0378-5173(02)00323-x.
   PubMed Web of Science ®Google Scholar