Nanoparticle-containing lyophilized dry powder inhaler formulations optimized using central composite design with improved aerodynamic parameters and redispersibility

References

• Abadelah M, Chrystyn H, Bagherisadeghi G, Abdalla G, Larhrib H. 2018. Study of the emitted dose after two separate inhalations at different inhalation flow rates and volumes and an assessment of aerodynamic characteristics of indacaterol Onbrez Breezhaler® 150 and 300 μg. AAPS PharmSciTech. 19(1):251–261.
   PubMed Web of Science ®Google Scholar
• Adi H, Young PM, Chan H-K, Agus H, Traini D. 2010. Co-spray-dried mannitol–ciprofloxacin dry powder inhaler formulation for cystic fibrosis and chronic obstructive pulmonary disease. Eur J Pharm Sci. 40(3):239–247.
   PubMed Web of Science ®Google Scholar
• Akdag Cayli Y, Sahin S, Buttini F, Balducci AG, Montanari S, Vural I, Oner L. 2017. Dry powders for the inhalation of ciprofloxacin or levofloxacin combined with a mucolytic agent for cystic fibrosis patients. Drug Dev Ind Pharm. 43(8):1378–1389.
   PubMed Web of Science ®Google Scholar
• Akdag Y. 2019. Development of dry powder inhaler formulations for drug delivery systems. J Res Pharm. 23(6):973–987.
   Google Scholar
• Akdag Y, Gulsun T, Izat N, Cetin M, Oner L, Sahin S. 2020. Characterization and comparison of deferasirox fast disintegrating tablets prepared by direct compression and lyophilization methods. J Drug Deliv Sci Technol. 57:101760.
   Web of Science ®Google Scholar
• Akdag Y, Gulsun T, Izat N, Oner L, Sahin S. 2022. Formulation and characterization of mometasone furoate and formoterol fumarate containing dry powder inhaler by spray drying and homogenization methods. JRP. 26 (2)(26 (2):383–396.
   Google Scholar
• Alhajj N, O'Reilly NJ, Cathcart H. 2021. Leucine as an excipient in spray dried powder for inhalation. Drug Discov Today. 26(10):2384–2396.
   PubMed Web of Science ®Google Scholar
• Altay Benetti A, Bianchera A, Buttini F, Bertocchi L, Bettini R. 2021. Mannitol polymorphs as carrier in DPIs formulations: isolation characterization and performance. Pharmaceutics. 13(8):1113.
   PubMed Web of Science ®Google Scholar
• Anhorn MG, Mahler H-C, Langer K. 2008. Freeze drying of human serum albumin (HSA) nanoparticles with different excipients. Int J Pharm. 363(1-2):162–169.
   PubMed Web of Science ®Google Scholar
• Aquino R, Prota L, Auriemma G, Santoro A, Mencherini T, Colombo G, Russo P. 2012. Dry powder inhalers of gentamicin and leucine: formulation parameters, aerosol performance and in vitro toxicity on CuFi1 cells. Int J Pharm. 426(1-2):100–107.
   PubMed Web of Science ®Google Scholar
• Aziz A, Sefidbakht Y, Rezaei S, Kouchakzadeh H, Uskoković V. 2022. Doxorubicin-loaded, pH-sensitive albumin nanoparticles for lung cancer cell targeting. J Pharm Sci. 111(4):1187–1196.
   PubMed Web of Science ®Google Scholar
• Bi R, Shao W, Wang Q, Zhang N. 2008. Spray-freeze-dried dry powder inhalation of insulin-loaded liposomes for enhanced pulmonary delivery. J Drug Target. 16(9):639–648.
   PubMed Web of Science ®Google Scholar
• Bilensoy E, Gürkaynak O, Ertan M, Sen M, Hincal AA. 2008. Development of nonsurfactant cyclodextrin nanoparticles loaded with anticancer drug paclitaxel. J Pharm Sci. 97(4):1519–1529.
   PubMed Web of Science ®Google Scholar
• Chang RYK, Chen L, Chen D, Chan H-K. 2020. Overcoming challenges for development of amorphous powders for inhalation. Expert Opin Drug Deliv. 17(11):1583–1595.
   PubMed Web of Science ®Google Scholar
• Chow AH, Tong HH, Chattopadhyay P, Shekunov BY. 2007. Particle engineering for pulmonary drug delivery. Pharm Res. 24(3):411–437.
   PubMed Web of Science ®Google Scholar
• Claus S, Schoenbrodt T, Weiler C, Friess W. 2011. Novel dry powder inhalation system based on dispersion of lyophilisates. Eur J Pharm Sci. 43(1-2):32–40.
   PubMed Web of Science ®Google Scholar
• Claus S, Weiler C, Schiewe J, Friess W. 2013. Optimization of the fine particle fraction of a lyophilized lysozyme formulation for dry powder inhalation. Pharm Res. 30(6):1698–1713.
   PubMed Web of Science ®Google Scholar
• Cui Y, Zhang X, Wang W, Huang Z, Zhao Z, Wang G, Cai S, Jing H, Huang Y, Pan X, et al. 2018. Moisture-resistant co-spray-dried netilmicin with l-leucine as dry powder inhalation for the treatment of respiratory infections. Pharmaceutics. 10(4):252.
   PubMed Web of Science ®Google Scholar
• Deng J, Huang L, Liu F. 2010. Understanding the structure and stability of paclitaxel nanocrystals. Int J Pharm. 390(2):242–249.
   PubMedGoogle Scholar
• Desai NP, Soon-Shiong P, Trieu V, inventors; Abraxis Bioscience LLC, assignee. 2010 Sep 09. Compositions and methods of delivery of pharmacological agents. United States patent US 20,100,226,996.
   Google Scholar
• Devi S, Williams D. 2013. Morphological and compressional mechanical properties of freeze-dried mannitol, sucrose, and trehalose cakes. J Pharm Sci. 102(12):4246–4255.
   PubMed Web of Science ®Google Scholar
• de Waard H, De Beer T, Hinrichs WL, Vervaet C, Remon J-P, Frijlink HW. 2010. Controlled crystallization of the lipophilic drug fenofibrate during freeze-drying: elucidation of the mechanism by in-line Raman spectroscopy. AAPS J. 12(4):569–575.
   PubMed Web of Science ®Google Scholar
• Ertugen E, Tunçel A, Yurt F. 2020. Docetaxel loaded human serum albumin nanoparticles; synthesis, characterization, and potential of nuclear imaging of prostate cancer. J Drug Deliv Sci Technol. 55:101410.
   Web of Science ®Google Scholar
• Franks F. 1998. Freeze-drying of bioproducts: putting principles into practice. Eur J Pharm Biopharm. 45(3):221–229.
   PubMed Web of Science ®Google Scholar
• Gong G, Zhi F, Wang K, Tang X, Yuan A, Zhao L, Ding D, Hu Y. 2011. Fabrication of a nanocarrier system through self-assembly of plasma protein and its tumor targeting. Nanotechnology. 22(29):295603.
   PubMed Web of Science ®Google Scholar
• Grohganz H, Gildemyn D, Skibsted E, Flink JM, Rantanen J. 2010. Towards a robust water content determination of freeze-dried samples by near-infrared spectroscopy. Anal Chim Acta. 676(1-2):34–40.
   PubMed Web of Science ®Google Scholar
• Gryparis E, Mattheolabakis G, Bikiaris D, Avgoustakis K. 2007. Effect of conditions of preparation on the size and encapsulation properties of PLGA-mPEG nanoparticles of cisplatin. Drug Deliv. 14(6):371–380.
   PubMed Web of Science ®Google Scholar
• Gulsun T, Akdag Y, Izat N, Cetin M, Oner L, Sahin S. 2020. Development and characterization of metformin hydrochloride-and glyburide-containing orally disintegrating tablets. Pharm Dev Technol. 25(8):999–1009.
   PubMed Web of Science ®Google Scholar
• Guzmán EAT, Sun Q, Meenach SA. 2019. Development and evaluation of paclitaxel-loaded aerosol nanocomposite microparticles and their efficacy against air-grown lung cancer tumor spheroids. ACS Biomater Sci Eng. 5(12):6570–6580.
   PubMed Web of Science ®Google Scholar
• Han Y, Jin B-S, Lee S-B, Sohn Y, Joung J-W, Lee J-H. 2007. Effects of sugar additives on protein stability of recombinant human serum albumin during lyophilization and storage. Arch Pharm Res. 30(9):1124–1131.
   PubMed Web of Science ®Google Scholar
• Hawe A, Friess W. 2006. Physicohemical characterization of the freezing behavior of mannitol-human serum albumin formulations. AAPS PharmSciTech. 7(4):94–E94.
   PubMed Web of Science ®Google Scholar
• Hertel N, Birk G, Scherließ R. 2020. Performance tuning of particle engineered mannitol in dry powder inhalation formulations. Int J Pharm. 586:119592.
   PubMedGoogle Scholar
• Kaialy W, Hussain T, Alhalaweh A, Nokhodchi A. 2014. Towards a more desirable dry powder inhaler formulation: large spray-dried mannitol microspheres outperform small microspheres. Pharm Res. 31(1):60–76.
   PubMed Web of Science ®Google Scholar
• Kaialy W, Nokhodchi A. 2013. Freeze-dried mannitol for superior pulmonary drug delivery via dry powder inhaler. Pharm Res. 30(2):458–477.
   PubMed Web of Science ®Google Scholar
• Kaialy W, Nokhodchi A. 2015. Dry powder inhalers: physicochemical and aerosolization properties of several size-fractions of a promising alterative carrier, freeze-dried mannitol. Eur J Pharm Sci. 68:56–67.
   PubMed Web of Science ®Google Scholar
• Kasper JC, Friess W. 2011. The freezing step in lyophilization: physico-chemical fundamentals, freezing methods and consequences on process performance and quality attributes of biopharmaceuticals. Eur J Pharm Biopharm. 78(2):248–263.
   PubMed Web of Science ®Google Scholar
• Lee HW, Lee CH, Park YS. 2018. Location of stage I–III non‐small cell lung cancer and survival rate: systematic review and meta‐analysis. Thorac Cancer. 9(12):1614–1622.
   PubMed Web of Science ®Google Scholar
• Li S, Wang X, Li W, Yuan G, Pan Y, Chen H. 2016. Preparation and characterization of a novel conformed bipolymer paclitaxel-nanoparticle using tea polysaccharides and zein. Carbohydr Polym. 146:52–57.
   PubMed Web of Science ®Google Scholar
• Li X, Vogt FG, Hayes D Jr, Mansour HM. 2014. Design, characterization, and aerosol dispersion performance modeling of advanced spray-dried microparticulate/nanoparticulate mannitol powders for targeted pulmonary delivery as dry powder inhalers. J Aerosol Med Pulm Drug Deliv. 27(2):81–93.
   PubMed Web of Science ®Google Scholar
• Liggins RT, Hunter W, Burt HM. 1997. Solid-state characterization of paclitaxel. J Pharm Sci. 86(12):1458–1463.
   PubMed Web of Science ®Google Scholar
• Lin J, Huang J, Chen J, Lin Z, Ou Y, Yao L, Zhang X, Kang Q, Pan Y. 2016. Low cytotoxic d-mannitol isolated from the industrial wastewater of Agaricus bisporus. J Food Nutr Res. 4(9):610–614.
   Google Scholar
• Malakar J, Nayak AK, Das A. 2013. Modified starch (cationized)–alginate beads containing aceclofenac: formulation optimization using central composite design. Starch/Stärke. 65(7-8):603–612.
   Web of Science ®Google Scholar
• Momin MA, Sinha S, Tucker IG, Das SC. 2019. Carrier-free combination dry powder inhaler formulation of ethionamide and moxifloxacin for treating drug-resistant tuberculosis. Drug Dev Ind Pharm. 45(8):1321–1331.
   PubMed Web of Science ®Google Scholar
• Morsy M, Abdel-Salam AI, Mostafa M, Elzwawy A. 2022. Promoting the humidity sensing capabilities of titania nanorods/rGO nanocomposite via de-bundling and maximizing porosity and surface area through lyophilization. Micro Nano Eng. 17:100163.
   Google Scholar
• Newman S, Busse W. 2002. Evolution of dry powder inhaler design, formulation, and performance. Respir Med. 96(5):293–304.
   PubMed Web of Science ®Google Scholar
• Ohori R, Kiuchi S, Sugiyama S, Miyamoto K, Akita T, Yamashita C. 2020. Efficient optimization of high-dose formulation of novel lyophilizates for dry powder inhalation by the combination of response surface methodology and time-of-flight measurement. Int J Pharm. 581:119255.
   PubMedGoogle Scholar
• Pabari RM, Ramtoola Z. 2012. Application of face centred central composite design to optimise compression force and tablet diameter for the formulation of mechanically strong and fast disintegrating orodispersible tablets. Int J Pharm. 430(1-2):18–25.
   PubMed Web of Science ®Google Scholar
• Puri V, Dantuluri AK, Kumar M, Karar N, Bansal AK. 2010. Wettability and surface chemistry of crystalline and amorphous forms of a poorly water soluble drug. Eur J Pharm Sci. 40(2):84–93.
   PubMed Web of Science ®Google Scholar
• Qu N, Sun Y, Li Y, Hao F, Qiu P, Teng L, Xie J, Gao Y. 2019. Docetaxel-loaded human serum albumin (HSA) nanoparticles: synthesis, characterization, and evaluation. Biomed Eng Online. 18(1):11–14.
   PubMedGoogle Scholar
• Ramalingam S, Belani CP. 2004. Paclitaxel for non-small cell lung cancer. Expert Opin Pharmacother. 5(8):1771–1780.
   PubMed Web of Science ®Google Scholar
• Rezazadeh M, Davatsaz Z, Emami J, Hasanzadeh F, Jahanian-Najafabadi A. 2018. Preparation and characterization of spray-dried inhalable powders containing polymeric micelles for pulmonary delivery of paclitaxel in lung cancer. J Pharm Pharm Sci. 21(1s):200s–214s.
   PubMedGoogle Scholar
• Roscoe JM, Abbatt JP. 2005. Diffuse reflectance FTIR study of the interaction of alumina surfaces with ozone and water vapor. J Phys Chem A. 109(40):9028–9034.
   PubMed Web of Science ®Google Scholar
• Sankarganesh P, Parthasarathy V, Kumar AG, Saraniya M, Udayakumari N, Ragu S. 2022. Development of novel mannitol blended PVA hydrogel membrane and its anticancer and antimicrobial drug delivery potential for wound dressing applications. J Sol-Gel Sci Technol. 103(2):447–456.
   Web of Science ®Google Scholar
• Shah SP, Misra A. 2004. Liposomal amikacin dry powder inhaler: effect of fines on in vitro performance. AAPS PharmSciTech. 5(4):107–113.
   Web of Science ®Google Scholar
• Shen Y, Li W. 2018. HA/HSA co-modified erlotinib–albumin nanoparticles for lung cancer treatment. Drug Des Devel Ther. 12:2285–2292.
   PubMed Web of Science ®Google Scholar
• Shur J, Nevell TG, Ewen RJ, Price R, Smith A, Barbu E, Conway JH, Carroll MP, Shute JK, Smith JR. 2008. Cospray-dried unfractionated heparin with L-leucine as a dry powder inhaler mucolytic for cystic fibrosis therapy. J Pharm Sci. 97(11):4857–4868.
   PubMed Web of Science ®Google Scholar
• Sibum I, Hagedoorn P, Kluitman MP, Kloezen M, Frijlink HW, Grasmeijer F. 2019. Dispersibility and storage stability optimization of high dose isoniazid dry powder inhalation formulations with L-leucine or trileucine. Pharmaceutics. 12(1):24.
   PubMed Web of Science ®Google Scholar
• Siegel RL, Miller KD, Fuchs HE, Jemal A. 2022. Cancer statistics, 2022. CA A Cancer J Clin. 72(1):7–33.
   PubMed Web of Science ®Google Scholar
• Telko MJ, Hickey AJ. 2005. Dry powder inhaler formulation. Respir Care. 50(9):1209–1227.
   PubMedGoogle Scholar
• Ulubayram K, Eroglu I, Hasirci N. 2002. Gelatin microspheres and sponges for delivery of macromolecules. J Biomater Appl. 16(3):227–241.
   PubMed Web of Science ®Google Scholar
• Wang J-L, Hanafy MS, Xu H, Leal J, Zhai Y, Ghosh D, Williams RO III, Smyth HDC, Cui Z. 2021. Aerosolizable siRNA-encapsulated solid lipid nanoparticles prepared by thin-film freeze-drying for potential pulmonary delivery. Int J Pharm. 596:120215.
   PubMedGoogle Scholar
• Xu Y, Harinck L, Lokras AG, Gerde P, Selg E, Sjöberg C-O, Franzyk H, Thakur A, Foged C. 2022. Leucine improves the aerosol performance of dry powder inhaler formulations of siRNA-loaded nanoparticles. Int J Pharm. 621:121758.
   PubMedGoogle Scholar
• Yamashita C, Akagi A, Fukunaga Y, inventors; Otsuka Pharmaceutical Co Ltd, assignee. 2010 Jun 15. Dry powder inhalation system for transpulmonary administration. United States patent US773,548,5B2.
   Google Scholar
• Yip WL, Gausemel I, Sande SA, Dyrstad K. 2012. Strategies for multivariate modeling of moisture content in freeze-dried mannitol-containing products by near-infrared spectroscopy. J Pharm Biomed Anal. 70:202–211.
   PubMed Web of Science ®Google Scholar
• Zhong Q. 2018. Co-spray dried mannitol/poly (amidoamine)-doxorubicin dry-powder inhaler formulations for lung adenocarcinoma: morphology, in vitro evaluation, and aerodynamic performance. AAPS PharmSciTech. 19(2):531–540.
   PubMed Web of Science ®Google Scholar
• Zillies JC, Zwiorek K, Hoffmann F, Vollmar A, Anchordoquy TJ, Winter G, Coester C. 2008. Formulation development of freeze-dried oligonucleotide-loaded gelatin nanoparticles. Eur J Pharm Biopharm. 70(2):514–521.
   PubMed Web of Science ®Google Scholar